DATE: November 21, 2005 MEMORANDUM SUBJECT: TRIETHYLENE GLYCOL  Revised Report of the Antimicrobials Division Toxicology Endpoint Selection Committee.

FROM: Timothy F. McMahon, Ph. D., Chair, ADTC Michelle Centra, Pharmacologist, Executive Secretary, ADTC Antimicrobials Division ( 7510C)

TO: Heather Garvie, Chemical Review Manager Ben Chambliss, Team Leader Mark Hartman, Branch Chief Regulatory Management Branch II Antimicrobials Division ( 7510C)

PC Codes: 083501 On February 25, 2003, the Antimicrobials Division Toxicology Endpoint Selection Committee ( ADTC) reviewed the available toxicology data for triethylene glycol and discussed endpoint selection for use as appropriate in occupational/ residential exposure risk assessments. The potential for increased susceptibility of infants and children from exposure to triethylene glycol was also evaluated by the committee in order to meet the statutory requirements of the Food Quality Protection Act ( FQPA) of 1996. In November of 2005, the ADTC met to discuss the impact of the human studies rule on the hazard characterization of triethylene glycol. This toxicity endpoint document supercedes the ADTC report for triethylene glycol dated May 6, 2003. 2 Committee Members in Attendance Members present: Timothy F. McMahon, Ph. D. Stephen Dapson, Ph. D.; Jonathan Chen, Ph. D.; Timothy Leighton; John Redden; Karen Hamernik, Ph. D., Michelle Centra.

Member( s) in absentia: Roger Gardner, Ph. D.; Sanyvette Williams, D. V. M.; Melba Morrow, D. V. M., Najm Shamim, Ph. D.

DATA PRESENTATION: ___________________________________ Timothy F. McMahon, Ph. D., Chair DRAFT DOCUMENT PREPARATION: ___________________________________ Timothy F. McMahon, Ph. D., Chair FINAL DOCUMENT PREPARATION: ___________________________________ Michelle Centra, Executive Secretary 3 COMMITTEE MEMBERS IN ATTENDANCE ( Signature indicates concurrence unless otherwise stated)

Stephen Dapson Jonathan Chen Roger Gardner Karen Hamernik Tim McMahon ( Chair)

Melba Morrow John Redden Sanyvette Williams Foy Michelle Centra ( Executive Secretary)

Najm Shamim Timothy Leighton OTHER ATTENDEES: 4 I. INTRODUCTION Triethylene glycol is produced commercially as a by product of ethylene glycol production and it is used as a bacteriostat ( against odor causing bacteria) for air sanitization and deodorization. There are numerous active use sites listed for triethylene glycol that include: air treatment ( eating establishments, hospital, commercial, institutional, household, bathroom, transportational facilities); medical premises and equipment, commercial, institutional and industrial premises and equipment; laundry equipment; hard non porous surface treatments ( bathroom facilities); automobiles; air conditioning filters, and refuse and solid waste containers. In combination with other active ingredients, it is used as a fungicide, virucide and miticide for disinfection of hard, non porous surfaces and as an insecticide ( against lice) by direct application to caged birds. As an inert ingredient, triethylene glycol facilitates delivery of formulated pesticide chemical products that are used as herbicides, fungicides, insecticides, growth regulators and attractants on a wide variety of agricultural commodities. Products contain triethylene glycol in a range of 0.1 9.15% a. i.

II. PHYSICAL/ CHEMICAL PROPERTIES 2 FORMULA: C 6 H 14 O 4 / HOCH 2 ( CH 2 CH 2 O) 2 CH 2 OH Active ingredient: triethylene glycol Color: hygroscopic colorless liquid Physical state: liquid Flash point: 165 oC Vapor Pressure: 0.15mmHg at 20 oC; Boiling point: 285 oC Solubility: Soluble in water, alcohol, benzene Molecular mass: 150.2 Density: 1.1274 g/ cc III. HAZARD IDENTIFICATION A. ACUTE AND CHRONIC DIETARY ( Acute and Chronic Reference Doses)

At this time, the product labels for triethylene glycol do not include food contact uses. Therefore, dietary endpoints were not selected and acute and chronic dietary risk assessments are not required.

B. INCIDENTAL ORAL EXPOSURE The Committee determined that there were no incidental oral exposure scenarios for the uses of triethylene glycol as an air sanitizer, and therefore incidental oral toxicity endpoints were not selected at this time. 5 C. OCCUPATIONAL / RESIDENTIAL EXPOSURE 1. DERMAL ABSORPTION No studies have been reported dealing with the skin absorption of triethylene glycol. Although it is possible that under conditions of very severe prolonged exposures to this chemical, absorption through the skin can occur, it is doubtful any appreciable systemic/ dermal injury would occur because triethylene glycol has ( 1) a low order of dermal irritancy, ( 2) is not a dermal sensitizer, and ( 3) showed no evidence of dermal or systemic toxicity following repeated dermal applications of 2ml ( approximately 600 mg/ kg) triethylene glycol applied to the skin of rabbits in a 21 day dermal toxicity study.

2. DERMAL EXPOSURE SCENARIOS ( All Durations)

The dermal route of exposure is not considered a major route of exposure for triethylene glycol as an air sanitizer. The chemical is shown to be a non  sensitizer and of low dermal irritancy. In a 21 day dermal toxicity study, there was no evidence of dermal or systemic toxicity from repeated dermal applications of 2ml ( approximately 600 mg/ kg) triethylene glycol applied to the skin of rabbits. Therefore, toxicological endpoints for dermal exposure scenarios were not selected by the Committee.

3. INHALATION EXPOSURE SCENARIOS ( All Durations)

Repeat dose inhalation toxicities studies conducted with triethylene glycol were submitted to the Agency's Office of Pesticide Programs and Toxic Substances. This is an important route of exposure to characterize hazard, as this chemical is used as an air sanitizer. Although the following studies were not conducted according to the OPPTS 870 Harmonized Test Guidelines, they do provide information that is adequate to characterize the toxicity from repeat dose inhalation exposure to triethylene glycol.

Sprague Dawley rats exposed ( whole body) to triethylene glycol in an aerosol inhalation study at concentrations of 494, 2011, or 4842 mg/ m3 ( 0.5, 2.0, or 5.0 mg/ L/ day), for six hours a day, nine times over a two week period showed the following toxicities at the highest concentration level tested: ataxia, prostration, unkept fur, labored respiration ( males only), ocular discharge, swollen periocular tissue, perinasal and perioral encrustation, blepharospasm and reduced body weight Necropies revealed hyperinflation of the lungs, ocular opacity, congestion and hemorrhage in many organs and tissues ( pituitary gland, brain, nasal mucosa, kidney, thymus and lungs). All of the rats in the high dose group died or were sacrificed moribund by day 5 of the study. Clinical signs of toxicity observed at the lowand mid dose of 0.5 and 2.0 mg/ L/ day, respectively, were limited to swollen periocular tissues and perinasal encrustations. Treatment related changes in organ weights in mid dose males included an increase in liver and kidney weights relative to body weight; mid dose females showed increases in absolute and relative ( to body and brain weights) liver and kidney weights. Statistically significant clinical chemistry findings for males treated with 2.0 mg/ L/ day triethylene glycol included an increase in ALT activity and a decrease in serum creatinine levels. Mid dose females showed increases in urea nitrogen, inorganic phosphorus, ALT and ALK activity, and decreases in glucose, creatinine, and chloride. However, the changes in organ weights and clinical chemistry findings were not correlated with any histopathological observations. 6 Rats exposed to the test material via a whole body inhalation protocol are also receiving the chemical via the oral and dermal routes. These additional routes of exposure may have increased the total dose received and contributed to the toxicities observed in the whole body exposure inhalation study. Therefore, a second study was conducted using a nose only exposure for 6 hours a day, 9 consecutive days. In this second inhalation toxicity study, mean exposure concentrations of 102, 517, or 1036 mg/ m3 ( approximately 0.1, 0.5, 1.0 mg/ L/ day) triethylene glycol produced no treatment related toxicities at any dose tested.

Monkeys exposed by inhalation to approximately 1 ppm vapor from two weeks to 13 months ( approximately 0.5 to 1 ppm) showed no adverse reactions or histopathological changes suggestive of toxicity from prolonged exposure to triethylene glycol.

Review of these data show that triethylene glycol is of low toxicity by the inhalation route of exposure. Toxicities are only observed at doses that far exceed the testing limits established for repeat exposure studies. Therefore, toxicological endpoints for inhalation exposure scenarios were not selected by the Committee.

4. RECOMMENDATION OF MARGINS OF EXPOSURE Margins of exposure were not established for triethylene glycol because there were no toxicological endpoints of concern identified.

5. AGGREGATE EXPOSURE RISK ASSESSMENTS The ADTC did not identify toxicological endpoints of concern for the active ( air sanitization) and the inert ( agricultural commodities) uses of triethylene glycol. Therefore, aggregate risk assessments are not required.

IV. CLASSIFICATION OF CARCINOGENIC POTENTIAL Published literature sources examining the chronic toxicity and carcinogenic potential of triethylene glycol have shown the chemical to be negative in rodent species.

In a 12 month study, monkeys receiving triethylene glycol ( 0.25 mL to 0.5 mL) orally in egg nog ( approximately 50 to 100 times the quantity an animal could absorb by breathing air saturated with glycol) were without any adverse effects in physiological functions or organ histopathology.

Triethylene glycol administered in feed at levels of 0, 1, 2 or 4% to Osborn Mendel rats for 2 years showed that the body weight gains, hematological parameters and clinical chemistries were not affected by treatment. The dosages tested in rats are equivalent to as much as 3 to 4 g/ kg/ day which are well above the limit dose of 1 g/ kg/ day ( 1000 mg/ kg/ day) for testing pesticides via the oral route in subchronic and chronic toxicity studies. Under the conditions of this study, triethylene glycol was not carcinogenic in rats. 7 V. MUTAGENICITY Triethylene glycol was tested for mutagenic or genotoxic potential and found to be negative in a battery of studies: a bacterial gene mutation assay using Salmonela typhimurium, an in vitro Chinese hamster ovary ( CHO) mutation assay, an in vitro Chinese hamster ovary ( CHO) chromosomal aberration assay and an in vitro sister chromatid exchange assay.

VI. FQPA CONSIDERATIONS A. ADEQUACY OF THE TOXICITY DATA BASE The available toxicity studies conducted with triethylene glycol are from published sources or from studies submitted to the Office of Toxic Substances and do not report all the data that are normally reported under the OPPTS 870 Harmonized Test Guidelines. However, it is apparent that the toxicities observed in these studies are consistently manifested only at doses of triethylene glycol that exceed the established limit doses for animal studies and are of a non specific nature. Therefore, there is no concern for the developmental or reproductive toxicity of triethylene glycol.

B. EVIDENCE OF NEUROTOXICITY From the available repeat dose toxicity studies, there was no evidence of neurotoxicity of triethylene glycol. However, the existing toxicology data do not fully characterize repeated dose neurotoxicity. Neurotoxicity testing could be required if additional data are needed to support new uses of triethylene glycol.

C. DEVELOPMENTAL & REPRODUCTIVE TOXICITY ( 1) Developmental Toxicity In a published study, triethylene glycol did not appear to cause any developmental effects in rats at a dose of 2.25 g/ kg/ day. However, the subcutaneous route of administration is not an acceptable route of exposure for determining the potential prenatal developmental toxicity of triethylene glycol.

In a second study, pregnant Sprague Dawley rats were administered triethylene glycol by gavage on gestation days 6 through 15 at dose levels of 0, 1.0, 5.6, and 11.27 g/ kg/ day. There were no effects on maternal mortality and there were no abortions. Clinical toxicity was observed in maternal rats at the high dose and consisted of audible respiration, periocular encrustation, and perioral wetness. Decreased body weight and food consumption was observed in maternal rats at the 5.6 g/ kg/ day dose. No effects were observed at the 1.0 g/ kg/ day dose. In offspring, mean fetal body weight was decreased at the 11.27 g/ kg/ day dose level, however, there were no treatment related increases in external, visceral, or skeletal malformations. 8 In this same study, triethylene glycol was administered orally at doses of 0, 0.5, 5.6, and 11.27 g/ kg/ day in timed pregnant CD 1 mice from gestation Days 6 through 15. There were no treatment related maternal deaths and no abortions. Hyperactivity and rapid respiration were observed at the highest dose level. No effects were observed on maternal weight gain or food consumption at any dose level. Pregnancy outcome was unaffected at any dose level tested. There were no treatment related effects on external or visceral malformations in offspring. Some evidence of delayed ossification was observed only at the high dose level of 11.27 g/ kg/ day.

( 2) Reproductive Toxicity Published literature examined the effect of triethylene glycol on reproduction in Swiss CD 1 mice. Doses of 0, 0.3, 1.5, and 3% triethylene glycol were administered in drinking water using a continuous breeding protocol. No effects on reproductive function were observed at any dose level tested. Although reduced pup weight was observed in the mid and high dose ( 1.5% and 3% triethylene glycol, approximate equivalent doses of 3390 mg/ kg/ day and 6780 mg/ kg/ day, respectively) treated mice, this effect occurred at doses in excess of the established testing limit doses ( 1000 mg/ kg/ day) for this type of study.

In a second study submitted to the Agency, rats were exposed via inhalation to an atmosphere saturated with triethylene glycol ( approx. 1 ppm) for 12 18 months with no adverse reproductive effects noted.

The ADTC concluded that the toxicity observed from these data were not significant and were apparent only at doses of triethylene glycol in excess of limit doses for animal studies. Therefore, there is no concern for reproductive toxicity of this chemical.

D. DETERMINATION OF SUSCEPTIBILITY The ADTC concluded from the available animal data that there is no evidence of increased susceptibility to fetuses or offspring following exposure to triethylene glycol. As there are no active food uses registered by the Agency for triethylene glycol, the ADTC recommended that the special hazard based safety factor under the FQPA be reduced to 1x. This issue can be revisited if direct or indirect food uses for triethylene glycol become active in the future.

E. DETERMINATION OF THE NEED FOR A DEVELOPMENTAL NEUROTOXICITY STUDY The ADTC has not identified a basis for requesting a developmental neurotoxicity study at this time.

F. DATABASE UNCERTAINTY FACTOR No additional database uncertainty factor is needed at this time for triethylene glycol.

VII. HAZARD CHARACTERIZATION 9 The hazard of triethylene glycol is characterized by reports in the open scientific literature, submitted by the CSMA Glycol Joint Venture in response to Phase IV under FIFRA. The acute oral and dermal toxicity of the chemical appears to be low, with reported oral LD 50 values ranging from 15 22 g/ kg compiled from monographs and review articles. The data available on acute dermal toxicity were insufficient to establish a dermal LD 50 , but the data requirement was waived based on the low order of toxicity observed in other studies with triethylene glycol. Data on inhalation toxicity showed a maximum tolerated level of 800 mg/ m3 in rats, but intratracheal instillation of 0.25 cc undiluted chemical caused marked pulmonary irritation, edema, and later, fibrosis and abcess formation in these animals ( intratracheal instillation is not an accepted route of administration for the Agency's toxicity testing guidelines). Published literature data on the skin and eye irritation as well as skin sensitization showed triethylene glycol to be non irritating to the skin and eye ( when tested at the limit doses established by the Agency for acute toxicity testing) and not a dermal sensitizer. 1 6 Repeated oral dosing studies of triethylene glycol toxicity showed in general that the chemical was without any adverse effects. Only one study, a 90 day oral toxicity study in rats used more than one dose level and reported the doses in mg/ kg. In this study, oral doses of 748, 1522, or 3849 mg/ kg/ day ( males), and 848, 1699, or 4360 mg/ kg ( females) were administered in the diet. Significant effects were noted at the high dose in male and female rats, including decreases in body weight, slight decreases in hemoglobin and hematocrit, slight increase in mean corpuscular volume, and increased kidney and brain weight. As noted, however, these effects were seen at doses in excess of the Agency's limit dose ( 1000 mg/ kg/ day) for repeated oral toxicity testing. 7, 8 Repeated dose inhalation toxicity studies conducted with triethylene glycol show the chemical to be without adverse effects in experimental animals at doses up to an exceeding the limit dose ( 1 mg/ L). Therefore there are no inhalation toxicity concerns for the chemical. 9,10,11 Published literature sources examining the chronic toxicity and carcinogenic potential of triethylene glycol have shown the chemical to be negative in rodent species. 11,12,13, 14 Triethylene glycol was tested for mutagenic or genotoxic potential and found to be negative in a battery of studies: a bacterial gene mutation assay using Salmonela typhimurium, an in vitro Chinese hamster ovary ( CHO) mutation assay, an in vitro Chinese hamster ovary ( CHO) chromosomal aberration assay and an in vitro sister chromatid exchange assay. 15  18 Following oral dosing, the rat and rabbit excreted most of the triethylene glycol in both unchanged and/ or oxidized forms ( mono and dicarboxylic acid derivatives of triethylene glycol). In rabbits dosed with 200 or 2000 mg/ kg triethylene glycol respectively excreted 34.3% or 28%, of the administered dose in the urine as unchanged triethylene glycol and 35.2% as a hydroxyacid form of this chemical. In the studies with rats, little if any C14 oxalate or C14 triethylene glycol in conjugated form was found in the urine. Trace amounts of orally administered 14C triethylene glycol were excreted in expired air as carbon dioxide (< 1%) and in detectable amounts in feces ( 2 to 5 %). The total elimination of radioactivity ( urine, feces and CO 2 ) during the five day period following an oral dose of labeled compound ( 22.5 mg) ranged from 91 to 98%. The majority of the radioactivity appeared in the urine. 19 Developmental toxicity testing of triethylene glycol showed unremarkable effects. Studies in rats and 10 mice tested the chemical at very high dose levels ( 11.27 g/ kg/ day, 4.4 g/ kg/ day, and 2.25 g/ kg/ day) without developmental effects. Sprague Dawley rats were administered triethylene glycol by gavage on gestation days 6 through 15 at dose levels of 0, 1.0, 5.6, and 11.27 g/ kg/ day. There were no effects on maternal mortality and there were no abortions. Clinical toxicity was observed in maternal rats at the high dose and consisted of audible respiration, periocular encrustation, and perioral wetness. Decreased body weight and food consumption was observed in maternal rats at the 5.6 g/ kg/ day dose. No effects were observed at the 1.0 g/ kg/ day dose. In offspring, mean fetal body weight was decreased at the 11.27 g/ kg/ day dose level, however, there were no treatment related increases in external, visceral, or skeletal malformations. In this same study, triethylene glycol was administered orally at doses of 0, 0.5, 5.6, and 11.27 g/ kg/ day in timed pregnant CD 1 mice from gestation Days 6 through 15. There were no treatment related maternal deaths and no abortions. Hyperactivity and rapid respiration were observed at the highest dose level. No effects were observed on maternal weight gain or food consumption at any dose level. Pregnancy outcome was unaffected at any dose level tested. There were no treatment related effects on external or visceral malformations in offspring. Some evidence of delayed ossification was observed only at the high dose level of 11.27 g/ kg/ day. 20, 21 Published literature examined the effect of triethylene glycol on reproduction in Swiss CD 1 mice. Doses of 0, 0.3, 1.5, and 3% were administered in drinking water using a continuous breeding protocol. No effects on reproductive function were observed at any dose level tested ( up to the high dose of 6.78 g/ kg). Reduced pup weight was observed at the 1.5 and 3% doses of triethylene glycol. In a study submitted to the Agency, rats were exposed to an atmosphere saturated with triethylene glycol ( approx. 1 ppm) for 12 18 months with no adverse reproductive effects noted. 22, 23 VIII. DATA GAPS / REQUIREMENTS The toxicological database for triethylene glycol is currently comprised of published and unpublished studies either submitted to the Agency or obtained directly from the published literature. These acceptable non guideline studies include: acute, subchronic, developmental, and reproductive toxicity; carcinogenicity, mutagenicity, metabolism/ pharmacokinetics and dermal absorption studies. Although the available studies do not meet the requirements of the Agency's OPPTS harmonized test guidelines published in 1998, the ADTC concluded that the existing toxicological data base is adequate for hazard characterization of triethylene glycol. Therefore, the Agency has determined that there are no data gaps for the labelled non food uses of this chemical as an air sanitizer and deodorizer. If a direct or indirect food use is sought in the future for triethylene glycol, the existing data base would be considered inadequate and additional data may be required to support these new uses. 11 IX. ACUTE TOXICITY Acute Toxicity Profile for Triethylene Glycol Guideline No. Study Type MRID #( S). Results Toxicity Category 81 1 Acute Oral 42814404 LD 50 = 15 22 g/ kg IV 81 2 Acute Dermal 42814404 LD 50 not established Study Requirement Waived 81 3 Acute Inhalation 42814404 LC 50 not assigned II ( irritant)

81 4 Primary Eye Irritation 42814404 mild irritant III 81 5 Primary Skin Irritation 42814404 slight irritant IV 81 6 Dermal Sensitization 00104805 non sensitizer N/ A X. SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINT SELECTION There were no toxicological endpoints of concern for triethylene glycol. 12 XI. REFERENCES 1. Davis, K.( 1993) Compilation of Toxicology Data References for Triethylene Glycol: Lab Project Number: TEGTOX. Unpublished study prepared by RegWest Co. 131 p. MRID No. 42814404.

2. Budavari, S., M. J. O'Neill, A. Smith, and P. E. Heckelman ( eds.) 1989. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. Rahway ( eleventh edition), NJ: Merck & Co., Inc.

3. Clayton, G. D. and F. E. Clayton ( eds.). Patty's Industrial Hygiene and Toxicology: Volume 2A, 2B, 2C: Toxicology. 3rd ed. New York: John Wiley Sons, 1981 1982. 3839.

4. Smyth, H. F. et al ( 1941) The single dose toxicity of some glycol derivatives. J. Ind. Hyg. Toxicol. 23( 6): 259 268.

5. Nachreiner, D. J. ( 1991) Triethylene Glycol ( TEG) Acute Aerosol Inhalation Toxicity Test in Rats. Bushy Run Research Center; Project Report 53 139 ( BRCC No. 90 22 40272), March 4, 1991; NTIS Report No. OTS0527779 1. Unpublished.

6. Lauter, W. M. and V. L. Vria ( 1940) Toxicity of Triethylene Glycol and the Effect of Para aminobenzene Sulfonamide Upon the Toxicity of this Glycol. J. Am. Pharmaceutical Assoc. 29: 5 8.

7. Union Carbide ( 1989) Triethylene Glycol: Fourteen day Dietary Toxicity Study in Fischer 344 Rats. NTIS Report No. OTS0527779 1. Unpublished.

8. Union Carbide ( 1990) Triethylene Glycol: Ninety day Dietary Toxicity Study in Fischer 344 Rats. NTIS Report No. OTS0527779 1. Unpublished..

9. Norris, J. and W. Kintigh ( 1994) Triethylene Glycol: Nine day Aerosol Inhalation ( Nose only Exposure) toxicity study in Rats. Bushy Run Research Center, Union Carbide Corporation, Inc., Export, PA. Laboratory Project ID: 93U1293, October 26, 1994. NTIS Report No. OTS0537563 1. Unpublished.

10. Sun, J. and W. Kintigh ( 1992) Triethylene Glycol: Nine day Aerosol Inhalation study in Rats. Bushy Run Research Center, Union Carbide Chemicals and Plastics Company, Inc., Export, PA. Laboratory Project ID: 91U0027, December 14, 1992. NTIS Report No. OTS0537563 1 with cover letter dated 010693 ( 1992). Unpublished.

11. Robertson, O. H., et al. ( 1947) Tests for the Chronic Toxicity of Propylene Glycol and Triethylene Glycol on Monkeys and Rats by vapor inhalation and Oral Administration. J. Pharm. Exp. Ther., 91: 52.

12. Goldstein, I., et al. ( 1970) Toxicity of Glycol Derivatives. Igenia, 19: 209.

13. Stenger, E. G., er al. ( 1968) Zur Toxikologie des Triathylenglkol. Arzneimittel Forsch, 18: 1536.

14. Fitzhugh, O. G. and Nelson, A. A. ( 1946) Comparison of the Chronic Toxicity of Triethylene Glycol with that of Diethylene Glycol. J. Ind. Hyg. Toxicol. 28( 2): 40 43.

15. Guzzie, P., Slesinski, F. Frank, et al. ( 1986) Triethylene Glycol Salmonella/ Microsome ( Ames) 13 Bacterial Mutagenicity Assay. Bushy Run Research Center, Export, PA. Project Report 49 58. April 29, 1986. NTIS Report No. OTS0527779 1. Unpublished.

16. Slensinski, R., F. Frank, and P. Guzzie ( 1986) Triethylene Glycol: In vitro Genotoxicity Studies: CHO/ HGPRT Mutation Test; Sister Chromatid Exchange Assay. Bushy Run Research Center, Export, PA. Project Report 49 83. June 26, 1986. NTIS Report No. OTS0527779 1. Unpublished.

17. Guzzie, P., Slesinski, F. Frank, et al. ( 1986) Triethylene Glycol: In vitro Chromosome Aberration Study. Bushy Run Research Center, Export, PA. Project Report 49 82. July 1, 1986. NTIS Report No. OTS0527779 1. Unpublished.

18. Slensinski, R., F. Frank, and P. Guzzie ( 1986) Triethylene Glycol: In vitro Mammalian Cell Gene Mutation Assay in CHO Cells. Bushy Run Research Center, Export, PA. Project Report 49 82. June 26, 1986. NTIS Report No. OTS0527779 1. Unpublished.

19. McKennis, Jr., et al. ( 1962) The Excretion and Metabolism of Triethylene Glycol. Toxic. Appl. Pharmacol., 91: 52.

20. Union Carbide ( 1990) Developmental Toxicity Study of Triethylene Glycol Administered by Gavage to CD 1 Mice. NTIS Report No. OTS0527779 1. Unpublished.

21. Union Carbide ( 1991) Developmental Toxicity Study of Triethylene Glycol Administered by Gavage to CD ( Sprague Dawley) Rats. NTIS Report No. OTS0527779 4. Unpublished.

22. Bossert, N. L., et al. ( 1992) Reproductive Toxicity of Triethylene Glycol and its Diacetate and Dimethyl ether Derivatives in a Continuous Breeding Protocol in Swiss CD 1 mice. Fund. Appl. Pharmacol. 18: 602 608.

23. Lamb, I. V. et al. ( 1997) Triethylene Glycol. Environ. Health Perspectives, 105( Suppl 1): 235 236. Also available as an NTP Report No. PB85 137073.


[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15116-15117]
[FR Doc No: 2014-05886]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0355; FRL-9907-83-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Clay Ceramics Manufacturing,
Glass Manufacturing and Secondary Nonferrous Metals Processing Area
Sources (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NESHAP for Clay Ceramics
Manufacturing, Glass Manufacturing and Secondary Nonferrous Metals
Processing Area Sources (40 CFR Part 63, Subparts RRRRRR, SSSSSS, and
TTTTTT)'' (EPA ICR No. 2274.04, OMB Control No. 2060-0606), to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq).
This is a proposed extension of the ICR, which is currently approved
through April 30, 2014. Public comments were previously requested via
the Federal Register (78 FR 35023) on June 11, 2013 during a 60-day
comment period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. 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: Additional comments may be submitted on or before April 17,
2014.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0355, to: (1) EPA online, using www.regulations.gov (our
preferred method), or 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; and (2) OMB via email to<EMAIL_ADDRESS>Address comments to OMB Desk Officer for EPA.
    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: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. 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<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The affected entities are subject to the General
Provisions of the NESHAP (40 CFR Part 63, subpart A), and any changes,
or additions to the Provisions, specified at 40 CFR Part 63, subparts
RRRRRR, SSSSSS, and TTTTTT. Owners or operators of the affected
facilities must submit a one-time-only report of any physical or
operational changes, initial performance tests, and periodic reports
and results. Owners or operators are also required to maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative.
    Form Numbers: None.
    Respondents/affected entities: Owners or operators of clay ceramics
manufacturing, glass manufacturing, and secondary nonferrous metals
processing area sources.
    Respondent's obligation to respond: Mandatory (40 CFR Part 63,
subparts RRRRRR, SSSSSS, and TTTTTT).
    Estimated number of respondents: 82.
    Frequency of response: Initially and occasionally.
    Total estimated burden: 1,763 hours (per year). ``Burden'' is
defined at 5 CFR 1320.3(b).
    Total estimated cost: $182,301 (per year), which includes $9,854 in
annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is no change in the labor hours in
this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is non-existent, so
there is no significant change in the overall burden. However, there is
an adjustment increase in the respondent burden cost due to an update
in labor rates. There is also an adjustment decrease in the total O&M
costs due to a correction. The previous ICR included annualized capital
costs of initial performance tests and equipment as O&M costs. This ICR
corrects the O&M costs to only include ongoing costs to maintain the
monitors.

Richard T. Westlund,
Acting Director, Collection Strategies Division.
[FR Doc. 2014-05886 Filed 3-17-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Notices]
[Pages 1930-1931]
[FR Doc No: 2012-456]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0053; FRL-9617-6]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Clean Air Interstate Rule To Reduce Interstate
Transport of Fine Particle Matter and Ozone (Renewal); EPA ICR No.
2152.05, OMB Control No. 2060-0570

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) for the Clean Air Interstate Rule (CAIR) to the Office of
Management and Budget (OMB). This ICR is scheduled to expire on
February 29, 2012. Before submitting the ICR to OMB for review and
approval, EPA is soliciting comments on specific aspects of the
proposed information collection as described below.

DATES: Comments may be submitted on or before March 12, 2012.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2003-0053.
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air Docket, Environmental Protection Agency,
Mailcode: 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
    Hand Delivery: Docket Center, (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC 20460. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2003-0053. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through http://www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Karen VanSickle, Clean Air Markets
Division, (6204J), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How can I access the docket and/or submit comments?

    EPA has established a public docket for this ICR under EPA Docket
ID No. EPA-HQ-OAR-2003-0053, which is available for online viewing at
www.regulations.gov, or in person viewing at the Air and Radiation
Docket, in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC 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 (202) 566-
1744, and the telephone number for the Air and Radiation Docket is
(202) 566-1742.
    Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above.

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits 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. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.

    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What information collection activity or ICR does this apply to?

Docket ID No. EPA-HQ-OAR-2003-0053

    Affected entities: Entities potentially affected by this action are
units producing electric power which are affected by the Clean Air
Interstate Rule (CAIR).
    Title: Clean Air Interstate Rule to Reduce Interstate Transport of
Fine Particle Matter and Ozone (Renewal).
    ICR number: EPA ICR No. 2152.05, OMB Control No. 2060-0570.
    ICR Status: This ICR is currently scheduled to expire on February
29, 2012. Under OMB regulations, the Agency may continue to conduct or
sponsor the collection of information while this submission is pending
at OMB. 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 in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The United States (U.S.) Environmental Protection Agency
(EPA) promulgated the Clean Air Interstate Rule to Reduce Interstate
Transport of Fine Particulate Matter and Ozone, which includes
reporting requirements and combines these requirements with existing
requirements from the Consolidated Emissions Reporting Rule (CERR), the
Emission Reporting Requirements for Ozone State Implementation Plan
(SIP) Revisions Relating to Statewide Budgets for NOX
Emissions to Reduce Regional Transport of Ozone (NOX SIP
Call) and the Acid Rain Program under Title IV of the CAA Amendments of
1990. Each of these three existing requirements has an approved ICR in
place. The current ICRs are: For the CERR, ICR 0916.13, for
the NOX SIP Call, ICR 1857.05, and for the Acid
Rain Program, ICR 1633.15. The supporting statement references
the burden analysis included in ICR s 0916.13, 1857.05, and
1633.15. This ICR renewal is open for public review and comment.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 77
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, 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 which have subsequently changed; 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 the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 1,221.
    Frequency of response: Quarterly.
    Estimated total annual burden hours: 407,039 hours.
    Estimated total annual costs: $51,492,383, which included
$26,329,380 in capital and O&M costs.
    This ICR incorporates the burden associated with all CAIR-affected
sources, including those located in NOX SIP Call States.

Are there changes in the estimates from the last approval?

    To date, there are no changes in the number of hours in the total
estimated respondent burden compared with that identified in the ICR
currently approved by OMB. However, EPA is still evaluating information
that may lead to a change in the estimates.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: January 5, 2012.
Larry F. Kertcher,
Acting Director, Clean Air Markets Division.
[FR Doc. 2012-456 Filed 1-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 176 (Wednesday, September 11, 2019)]
[Notices]
[Page 47998]
[FR Doc No: 2019-19609]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86875; File No. SR-NASDAQ-2019-057]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Designation of Longer Period for Commission Action on a
Proposed Rule Change To Amend Rule 4121

September 5, 2019.
    On July 16, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Nasdaq Rule 4121 (Trading Halts Due to
Extraordinary Market Volatility) to enhance the re-opening auction
process for Nasdaq-listed securities following trading halts due to
extraordinary market volatility. The proposed rule change was published
for comment in the Federal Register on July 25, 2019.\3\ The Commission
received no comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86412 (July 19,
2019), 84 FR 35900.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of the 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 45th day after publication of the notice for this
proposed rule change is September 8, 2019.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. 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. Accordingly, pursuant to Section 19(b)(2) of the
Act,\5\ the Commission designates October 23, 2019 as the date by which
the Commission shall either approve, disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-NASDAQ-2019-057).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-19609 Filed 9-10-19; 8:45 am]
 BILLING CODE 8011-01-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2006-0059; FRL- ]

	Approval and Promulgation of Air Quality Implementation Plans;
Virginia; State Implementation Plan Revision for Burlington Industries,

                                               Clarksville, Virginia

AGENCY:	Environmental Protection Agency (EPA).

ACTION:	Final rule.

SUMMARY:  EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Virginia.  This revision consists of
the removal of a Consent Agreement (Agreement) currently in the SIP for
the control of sulfur dioxide emissions from Burlington Industries
located in Clarksville, Virginia.  This Agreement has been superseded by
a federally enforceable state operating permit that imposes operating
restrictions on the facility’s boilers and the shutdown of the
remainder of the facility.  This action is being taken under the Clean
Air Act (CAA).

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket
ID Number EPA-R03-OAR-2006-0059.  All documents in the docket are listed
in the www.regulations.gov website.   Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute.  Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form.  Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Virginia Department of Environmental
Quality, 629 East Main Street, Richmond, Virginia, 23219.

FOR FURTHER INFORMATION CONTACT:  Sharon McCauley,<PHONE_NUMBER>, or by
e-

mail at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Background

On July 11, 2006 (71 FR 39330), EPA published a notice of proposed
rulemaking (NPR) for the

Commonwealth of Virginia.  The NPR proposed approval of the removal of
an Agreement from

the Virginia SIP.  The Agreement was written for the control of
emissions of sulfur dioxide from

the Burlington Industries facility located in Clarksville, Mecklenburg
County, Virginia.

This Agreement has been superseded by a federally enforceable state
operating permit dated

May 17, 2004, which imposes operating restrictions on the facility’s
boilers and the subsequent

shutdown of the remainder of the facility.  The formal SIP revision was
submitted by Virginia on

July 12, 2004.

Other specific requirements of the SIP revision for Burlington
Industries, Clarksville, Virginia and the rationale for EPA's proposed
action are explained in the NPR and will not be restated here.  No
public comments were received on the NPR.

II. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

In 1995, Virginia adopted legislation that provides, subject to certain
conditions, for an environmental assessment (audit) (privilege(' for
voluntary compliance evaluations performed by a regulated entity.  The
legislation further addresses the relative burden of proof for parties
either asserting the privilege or seeking disclosure of documents for
which the privilege is claimed.  Virginia's legislation also provides,
subject to certain conditions, for a penalty waiver for violations of
environmental laws when a regulated entity discovers such violations
pursuant to a voluntary compliance evaluation and voluntarily discloses
such violations to the Commonwealth and takes prompt and appropriate
measures to remedy the violations.  Virginia's Voluntary Environmental
Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege
that protects from disclosure documents and information about the
content of those documents that are the product of a voluntary
environmental assessment. The Privilege Law does not extend to documents
or information (1) that are generated or developed before the
commencement of a voluntary environmental assessment; (2) that are
prepared independently of the assessment process; (3) that demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the Privilege
law, Va. Code Sec. 10.1-1198,  precludes granting a privilege to
documents and information (required by law,( including documents and
information (required by Federal law to maintain program delegation,
authorization or approval,( since Virginia must (enforce Federally
authorized environmental programs in a manner that is no less stringent
than their Federal counterparts. . . .(   The opinion concludes that
([r]egarding ( 10.1-1198, therefore, documents or other information
needed for civil or criminal enforcement under one of these programs
could not be privileged because such documents and information are
essential to pursuing enforcement in a manner required by Federal law to
maintain program delegation, authorization or approval.(

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that ([t]o
the extent consistent with requirements imposed by Federal law,(  any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or civil
penalty.  The Attorney General's January 12, 1998 opinion states that
the quoted language renders this statute inapplicable to enforcement of
any Federally authorized programs, since (no immunity could be afforded
from administrative, civil, or criminal penalties because granting such
immunity would not be consistent with Federal law, which is one of the
criteria for immunity.(

Therefore, EPA has determined that Virginia's Privilege and Immunity
statutes will not preclude the Commonwealth from enforcing its program
consistent with the Federal requirements.  In any event, because EPA has
also determined that a state audit privilege and immunity law can affect
only state enforcement and cannot have any impact on Federal enforcement
authorities, EPA may at any time invoke its authority under the Clean
Air Act, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort.  In addition, citizen
enforcement under section 304 of the Clean Air Act is likewise
unaffected by this, or any, state audit privilege or immunity law.

III.	Final Action

EPA is approving the removal of the Consent Agreement for Burlington
Industries, Clarksville, Virginia as a revision to the Virginia SIP.

IV.   Statutory and Executive Order Reviews

A.   General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action
is not a "significant regulatory action" and therefore is not subject to
review by the Office of Management and Budget.  For this reason, this
action is also not subject to Executive Order 13211, "Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use" (66 FR 28355, May 22, 2001).  This action merely approves state law
as meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law.  Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).  Because this rule approves pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it 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).   This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).  This action also
does not have Federalism implications because it does not 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, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999).  This
action merely approves a state rule implementing a Federal requirement,
and does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act.  This rule also is
not subject to Executive Order 13045 (Protection of Children from
Environmental Health Risks and Safety Risks( (62 FR 19885, April 23,
1997), because it is not economically significant.

In reviewing SIP submissions, EPA(s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  In this
context, in the absence of a prior existing requirement for the State to
use voluntary consensus standards (VCS), EPA has no authority to
disapprove a SIP submission for failure to use VCS.  It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.  This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B.   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.  Section 804 exempts from section 801 the following types of
rules: (1) rules of particular applicability; (2) rules relating to
agency management or personnel; and (3) rules of agency organization,
procedure, or practice that do not substantially affect the rights or
obligations of non-agency parties.  5 U.S.C. 804(3).   EPA is not
required to submit a rule report regarding today(s action under section
801 because this is a rule of particular applicability establishing
source-specific requirements for one named source.

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be

filed in the United States Court of Appeals for the appropriate circuit
by [insert date 60 days

from date of publication of this document in the Federal Register].
Filing a petition for

reconsideration by the Administrator of this final rule does not affect
the finality of this rule 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.  This action,

to approve the removal of the Consent Agreement for Burlington
Industries, Clarksville,

Virginia, 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, Reporting and
recordkeeping requirements, Sulfur oxides.

                        __________/s/_________________

Dated:        11/03/06                    				Donald S. Welsh,
                      								Regional Administrator,

                                  						Region III.

40 CFR part 52 is amended as follows:

PART 52 - [AMENDED]

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

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

Subpart VV( Virginia

2. In ( 52.2420, the table in paragraph (d) is amended by removing the
entry for Burlington Industries.

 PAGE

 PAGE   2


[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6875-6877]
[FR Doc No: 2022-02472]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0053]

Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice of availability that
appeared in the Federal Register of January 11, 2022. In the notice of
availability, FDA requested comments on draft guidance for industry and
FDA staff entitled ``Notifying the Food and Drug Administration of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act.'' The
Agency is taking this action in response to a request for an extension
to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the document published
January 11, 2022 (87 FR 1417). Submit either electronic or written
comments on the draft guidance by April 11, 2022, 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-2022-D-0053 for ``Notifying the Food and Drug Administration of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act.''
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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act'' to the
Office of Policy, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002 or the Center for Biologics Evaluation and
Research, Office of Communication, Outreach, and Development, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993. Send one
self-addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Brittany Caldwell, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5556, Silver Spring, MD 20993-0002, 301-
796-5900 or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 11, 2022, FDA published a notice
of availability with a 60-day comment period to request comments on
draft guidance for industry and FDA staff entitled ``Notifying FDA of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act.''
    The Agency has received a request for an extension of the comment
period. The request conveyed concern that the current 60-day comment
period does not allow sufficient time to develop a meaningful or
thoughtful response.
    FDA has considered the request and is extending the comment period
for the notice of availability for 30 days, until April 11, 2022. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments without significantly delaying
guidance on these important issues.
    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 ``Notifying
FDA of a Permanent Discontinuance or Interruption in Manufacturing of a
Device Under Section 506J of the Federal Food, Drug, and Cosmetic
Act.'' 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.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document
is also available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Persons unable to download an electronic copy of ``Notifying FDA of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the Federal Food, Drug, and Cosmetic Act'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please

use the document number 21003 and complete title to identify the
guidance you are requesting.

    Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02472 Filed 2-4-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Rules and Regulations]
[Pages 7525-7526]
[FR Doc No: 2012-3149]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0610; Airspace Docket No. 11-AWP-10]

Revision of Class D and Class E Airspace; Hawthorne, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action revises Class D and Class E airspace at Jack
Northrop Field/Hawthorne Municipal Airport, Hawthorne, CA. Additional
controlled airspace is needed to accommodate aircraft departing and
arriving under Instrument Flight Rules (IFR) at the airport. Also, the
airspace designations are revised to show a new city location. This
action is a result of the FAA's biennial review, along with a study of
the Jack Northrop Field/Hawthorne Municipal Airport airspace area that
further enhances the safety and management of aircraft operations at
the airport.

DATES: Effective date, 0901 UTC, May 31, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On October 31, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to amend controlled airspace at
Hawthorne, CA (76 FR 67103). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    Class D airspace and Class E airspace designations are published in
paragraph 5000 and 6004, respectively, of FAA Order 7400.9V dated
August 9, 2011, and effective September 15, 2011, which is incorporated
by reference in 14 CFR Part 71.1. The Class D airspace and Class E
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by revising Class D airspace and Class E surface airspace
designated as an extension to Class D surface area at Jack Northrop
Field/Hawthorne Municipal Airport, Hawthorne, CA, creating additional
airspace necessary for IFR departures and arrivals at the airport. This
action, initiated by FAA's biennial review of the Jack Northrop Field/
Hawthorne Municipal Airport airspace area, and based on results of a
study conducted by the Los Angeles Visual Flight Rules (VFR) Task
Force, and the Los Angeles Class B Workgroup, enhances the safety and
management of aircraft operations at the airport. This action also
revises the airspace designation for Class D and Class E airspace,
changing the city location from Los Angeles, CA, to Hawthorne, CA.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (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
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses 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 revises
controlled airspace at Jack Northrop Field/Hawthorne Municipal Airport,
Hawthorne, CA.

List 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 14 CFR Part 71 continues to read as
follows:

    Authority:  49 U.S.C. 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 Part 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

AWP CA D Hawthorne, CA [Revised]

Jack Northrop Field/Hawthorne Municipal Airport, CA
    (Lat. 33[deg]55'22'' N., long. 118[deg]20'07'' W.)

    That airspace extending upward from the surface to and including
2,500 feet MSL within 2.6-mile radius of the Jack Northrop Field/
Hawthorne Municipal Airport, and that airspace 1.5 miles north and 2
miles south of the 229[deg] bearing from the airport extending from
the 2.6-mile radius to 3.8 miles southwest, and that airspace 2
miles north

and 1.5 miles south of the 096[deg] bearing from the airport
extending from the 2.6-mile radius to 3.9 miles east of the airport,
excluding the Los Angeles Airport Class D airspace. This Class D
airspace is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

Paragraph 6004 Class E airspace areas designated as an extension to
Class D or Class E surface area.

* * * * *

AWP CA E4 Hawthorne, CA [Revised]

Jack Northrop Field/Hawthorne Municipal Airport, CA
    (Lat. 33[deg]55'22'' N., long. 118[deg]20'07'' W.)

    That airspace extending upward from the surface within 2 miles
north and 1.5 miles south of the 096[deg] bearing from Jack Northrop
Field/Hawthorne Municipal Airport, beginning 3.9 miles east of the
airport extending to 6.3 miles east of the airport. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

    Issued in Seattle, Washington, on February 1, 2012.
Johanna Forkner,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2012-3149 Filed 2-10-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 33 (Friday, February 19, 2016)]
[Notices]
[Page 8519]
[FR Doc No: 2016-03449]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4248-DR; Docket ID FEMA-2016-0001]

Mississippi; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Mississippi (FEMA-4248-DR), dated January 4, 2016, and
related determinations.

DATES: Effective Date: February 11, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Mississippi is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of January 4, 2016.

    Chickasaw County for Public Assistance.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-03449 Filed 2-18-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25260-25261]
[FR Doc No: 2022-09017]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-R06-OW-2022-0371; FRL-9257-01-R6]

Proposed Issuance of the NPDES General Permit for Discharges From
Hydrostatic Testing of New and Existing Vessels in New Mexico
(NMG270000), Oklahoma (OKG27F000), and Indian Country Within the States
of Texas, Oklahoma, New Mexico, and Louisiana (TXG27I000, OKG27I000,
NMG27I000, & LAG27I000)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed NPDES General Permit Issuance.

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

SUMMARY: The Environmental Protection Agency (EPA) Region 6 Water
Division, is proposing for public comment the issuance of a National
Pollutant Discharge Elimination System (NPDES) general permit
authorizing discharges resulting from the hydrostatic testing of new
and existing vessels (e.g., pipelines, storage tanks, etc.) in New
Mexico (NMG270000) and Oklahoma (OKG27F000). This authorization also
covers Indian Country within the States of Texas, Oklahoma, New Mexico,
and Louisiana (TXG27I000, OKG27I000, NMG27I000, & LAG27I000).
    To determine whether your facility, company, business,
organization, etc., may be affected by this action, you should
carefully examine the applicability criteria in Part I, Section A.3 of
the draft permit. If you have questions regarding the applicability of
this action to a particular entity, consult the person listed for
technical information in the preceding FOR FURTHER INFORMATION CONTACT
section.

DATES: Comments must be submitted in writing to EPA on or before June
27, 2022.
    Proposed Documents: A copy of the proposed permit and the fact
sheet which sets forth principal facts and the significant factual,
legal, and policy questions considered in the development of the
proposed general permit may be obtained via the internet at: https://www.epa.gov/publicnotices. To obtain hard copies of these documents or
any other information in the administrative record, please contact Ms.
Evelyn Rosborough using the contact information provided below.

Other Legal Requirements

A. State/Tribal Certification

    Under section 401(a)(1) of the CWA, EPA may not issue an NPDES
permit until the State or Tribe in which the discharge will occur
grants or waives certification to ensure compliance with appropriate
requirements of the CWA and State/Tribal law. EPA will seek
certification from the New Mexico Environment Department, Oklahoma
Department of Environmental Quality, and the respective Tribe within
the States of Texas, Oklahoma, New Mexico and Louisiana prior to
issuing a final permit. EPA is the certifying authority and certifies
the permit for areas where neither a state nor tribe has CWA 401(a)(1)
certification authority.

B. Other Regulatory Requirements

    This is a first-time permit issuance. EPA had conducted evaluations
required by Coastal Zone Management Act, Endangered Species Act,
Magnuson-Stevens Fishery Conservation and Management Act, Historic
Preservation Act, Paperwork Reduction Act, and Regulatory Flexibility
Act. These requirements are discussed in the fact sheet.
How do I comment on this proposal?
    Comment Submittals: You may send comments, identified by Docket ID.
No. EPA-R06-OW-2022-0371 by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method).
     By Email: Send comments by email to
[email protected]. Include Docket ID. No EPA-R06-OW-2022-0371
in the subject line of the email.
     By Mail/Hand Delivery/Courier: Deliver comments to U.S.
EPA, Attn: Evelyn Rosborough, 1201 Elm Street, Dallas, Texas 75270.
     We encourage the public to submit comments via
www.Regulations.gov or via email as there may be a delay in processing
mail and hand deliveries will be accepted by appointment only due to
public health concerns related to COVID-19.
     Please submit your comments within the specified time
period cited in the DATES section of this document. Comments received
after the close of the comment period will be marked ``late''. The EPA
is not required to consider these late comments. All comments received
by the EPA in accordance with this section by the ending date of the
comment period will be considered by the EPA before a final decision is
made regarding permit issuance.
     Once submitted, comments cannot be edited or removed from
the docket. The EPA may publish any comment received to its public
docket.
    Do not submit to EPA's docket or email 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. The 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, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    For Technical Information Contact: Maria Okpala, NPDES Permitting
Section (6WD-PE), U.S. Environmental Protection Agency, 1201 Elm
Street, Suite 500, Dallas, TX 75270; Telephone:<PHONE_NUMBER>; email
address: [email protected].
    Administrative record: All documents and references used in the
development of this permit are part of the Administrative Record for
this permit. Although listed in the index, some information is not
publicly available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available materials are available either electronically or in hard copy
from Ms. Evelyn Rosborough at the address above. The Administrative
Record may also be viewed at the EPA Region 6 Offices from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. For more
information on scheduling a time to view the Record or to obtain copies
of available documents, please contact Ms. Evelyn Rosborough at 214-
665-7515 or [email protected].
Public Hearings
    All persons have the right to provide written comments during the
public comment period. However, interested persons may request a public
hearing pursuant to 40 CFR 124.12 concerning the proposed permit.
Requests for a public hearing must be sent or delivered in writing to
the same address as provided above for public comments prior to the
close of the comment period. Requests for a public hearing must state
the nature of the issues proposed to be raised in the hearing. Pursuant
to 40 CFR 124.12, EPA shall hold a public hearing if it finds, on the
basis of requests, a significant degree of public interest in a public
hearing on

the proposed permit. If EPA decides to hold a public hearing, a public
notice of the date, time and place of the hearing will be made at least
30 days prior to the hearing. Any person may provide written or oral
statements and data pertaining to the proposed permit at the public
hearing.
    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

Charles W. Maguire,
Director, Water Division, EPA Region 6.
[FR Doc. 2022-09017 Filed 4-27-22; 8:45 am]
BILLING CODE 6560-50-P