[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Rules and Regulations]
[Pages 48064-48066]
[FR Doc No: 2019-19694]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0609]
RIN 1625-AA00

Safety Zone; Fireworks Display, Indian River Bay, DE

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of the Indian River Bay near Long Neck, DE, on September 14,
2019, with September 15, 2019 as an alternate date for inclement
weather, to provide for safety of life during the Long Neck Style
fireworks display. The safety zone is necessary to ensure the safety of
participant vessels, spectators, and the boating public during the
event. This regulation prohibits persons and non-participant vessels
from entering, transiting through, anchoring in, or remaining within
the safety zone unless authorized by the Captain of the Port (COTP)
Delaware Bay or a designated representative.

DATES: This rule is effective from 8:00 p.m. to 10:30 p.m. on September
14, 2019 (with September 15, 2019 as an alternate date for inclement
weather).

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0609 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Thomas Welker, U.S. Coast Guard Sector
Delaware Bay, Waterways Management Division: Telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    This fireworks display safety zone is listed in the table to 33 CFR
165.506, section (a), row (2), except that instead of taking place on
Labor Day as published, it is being moved two weeks later. Due to this
date change, the Coast Guard is issuing a new temporary rule instead of
a notice of enforcement of the published rule. Additionally, the Coast
Guard is reducing the size of the safety zone from a circle with a 700
yard radius as published to a circle with a 150 yard radius around the
launch site.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable and contrary to
the public interest to do so. There is insufficient time to allow for a
reasonable comment period prior to the date of the event. The rule must
be in force by September 14, 2019. We are taking immediate action to
ensure the safety of spectators and the general public from hazards
associated with the fireworks display. Hazards include accidental
discharge of fireworks, dangerous projectiles, and falling hot embers
or other debris.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to mitigate the potential safety
hazards associated

with a fireworks displays in this location.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Delaware Bay
(COTP) has determined that potential hazards associated with the
fireworks to be used in this September 14, 2019 (with September 15,
2019 as an alternate date for inclement weather), display will be a
safety concern for anyone within a 150-yard radius of the launch site.
The purpose of this rule is to ensure safety of vessels and the
navigable waters in the safety zone before, during, and after the
scheduled event.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone on the waters of the
Indian River Bay near Long Neck, DE, during a fireworks display
scheduled to take place between 8:00 p.m. and 10:30 p.m. on September
14, 2019 (with September 15, 2019 as an alternate date for inclement
weather). The fireworks will be set off from a pier over the bay at
approximate position latitude 38[deg]36'42'' N, longitude
075[deg]08'18'' W. The safety zone will extend 150 yards around the
launch site. No person or vessel will be permitted to enter, transit
through, anchor in, or remain within the safety zone without obtaining
permission from the COTP Delaware Bay or a designated representative.
If the COTP Delaware Bay or a designated representative grants
authorization to enter, transit through, anchor in, or remain within
the safety zone, all persons and vessels receiving such authorization
must comply with the instructions of the COTP Delaware Bay or a
designated representative. The Coast Guard will provide public notice
of the safety zone by Local Notice to Mariners and Broadcast Notice to
Mariners.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    The impact of this rule is not significant for the following
reasons: (1) The enforcement period will last one and a half hour when
vessel traffic is usually low; (2) although persons and vessels may not
enter, transit through, anchor in, or remain within the safety zone
without authorization from the COTP Delaware Bay or a designated
representative, they may operate in the surrounding area during the
enforcement period; (3) persons and vessels will still be able to enter
or transit through the regulated area if authorized by the COTP
Delaware Bay; (4) the Coast Guard will provide advance notification of
the safety zone to the local maritime community by Local Notice to
Mariners and Broadcast Notice to Mariners; and (5) as noted in Section
II above the Coast Guard is reducing the radius of the zone from 700
(as published in the table to 33 CFR 165.501, section (a), row (2)) to
150 yards.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this rule will not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule

will not result in such an expenditure, we do discuss the effects of
this rule elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a determination that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This rule involves a temporary safety zone that
prohibits persons and vessels from entering, transiting through,
anchoring in, or remaining within a limited area on the navigable water
in the Delaware River, during a fireworks display lasting approximately
one and a half hours. It is categorically excluded from further review
under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental
Planning Implementing Procedures 5090.1. A Record of Environmental
Consideration (REC) supporting this determination is available in the
docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0609 to read as follows:

Sec.  165.T05-0609  Safety Zone; Fireworks Display, Indian River Bay,
DE.

    (a) Location. The following area is a safety zone: All waters of
Indian River Bay off Long Neck, DE within 150 yards of the launch site
at approximate position latitude 38[deg]36'42'' N, longitude
075[deg]08'18'' W.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard petty
officer, warrant or commissioned officer on board a Coast Guard vessel
or on board a federal, state, or local law enforcement vessel assisting
the Captain of the Port (COTP), Delaware Bay in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter or remain in the zone, contact the
COTP or the COTP's representative via VHF-FM channel 16 or 215-271-
4807. Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (3) This section applies to all vessels except those engaged in law
enforcement, aids to navigation servicing, and emergency response
operations.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the safety zone by Federal, State, and local
agencies.
    (e) Enforcement period. This zone will be enforced from
approximately 8:00 p.m. through 10:30 p.m. on September 14, 2019 (with
September 15, 2019 as an alternate date for inclement weather).

    Dated: September 6, 2019.
Jonathan D. Theel,
Captain, U.S. Coast Guard, Acting Captain of the Port Delaware Bay.
[FR Doc. 2019-19694 Filed 9-11-19; 8:45 am]
 BILLING CODE 9110-04-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES October 28, 2003 MEMORANDUM SUBJECT: Review of Atrazine Cancer Epidemiology DP Barcode D295200, Chemical # 080803 FROM: Jerome Blondell, Ph. D., Health Statistician Chemistry and Exposure Branch Health Effects Division ( 7509C)

Vicki Dellarco, Ph. D., Senior Science Advisor Health Effects Division ( 7509C)

THRU: Francis B. Suhre, Chief Chemistry and Exposure Branch Health Effects Division ( 7509C)

Margaret Stasikowski, Director Health Effects Division ( 7509C)

TO: Eric Olson, Ph. D., PM Team Reviewer Michael Goodis, Product Manager Special Review and Reregistration Division ( 7508C)

This review summarizes scientific studies related to atrazine and cancer epidemiology including a consideration of animal mode of action related to selected cancers. The review starts with an examination of animal mode of action issues related to prostate and ovarian cancers and non Hodgkin's lymphoma. This section is followed by a review of EPA findings concerning prostate cancer in a manufacturing plant, the Agricultural Health Study, and two California studies. The following section addresses the evidence concerning non Hodgkin's lymphoma and then, other cancers. The review concludes with a summary of three published reviews of atrazine and cancer epidemiology published 1996 1999, followed by a listing of those studies published since 1999 and considering their impact on the weight of evidence. In order to be comprehensive all known epidemiologic studies of atrazine and triazines have been included. The U. S. Environmental Protection Agency ( EPA) requested a review of atrazine and 2 prostate cancer by the Scientific Advisory Panel ( SAP) made up of outside experts. A report of the SAP findings ( meeting minutes) from the July 17, 2003 meeting can be found at http:// www. epa. gov/ scipoly/ sap/. This review considers the SAP findings and, where appropriate, revises the Agency's findings related to atrazine and prostate cancer. This review also explains why studies of other cancers where not presented to the Panel at the July 2003 meeting. To assist the reader, an outline of this review is provided below:

I. Examination of prostate and ovarian cancers and NHL in the context of the animal mode of action II. Atrazine and prostate cancer epidemiology A. Prostate Cancer  Manufacturing plant study B. Prostate Cancer  Agricultural Health Study in Iowa and North Carolina C. Prostate Cancer  Pesticide use data and cancer incidence in California counties D. Prostate Cancer  Overall conclusion III. Atrazine and epidemiology of Non Hodgkin's Lymphoma IV. Atrazine and epidemiology related to other cancers V. Results of other reviews of cancer and atrazine through 1999 VI. Studies published since 1999 or not included in the three published reviews VII. EPA Conclusion: Atrazine exposure and NHL and other cancers I. Examination of prostate and ovarian cancers and NHL in the context of the animal mode of action As discussed in the January 31, 2003 Interim Reregistration Eligibility Decision, atrazine's mode of action ( i. e., a decrease LH surge, failed ovulation and estrous cycle disruption) for induction of mammary gland tumors ( the only tumor observed in animal bioassays) in SD female rats is not considered relevant to humans. Because the epidemiology literature on atrazine ( triazines) report that atrazine exposure may be associated with an increased incidence of prostate and ovarian cancers and NHL, the available chronic toxicity animal bioassays were closely examined for any indication of either prostate, ovarian cancer or NHL, as well as the etiology of these tumor types.

The prostate glands in male laboratory animals do not appear to be a target of atrazine toxicity. Subchronic and chronic rodent and dog studies and the multigeneration rat studies conducted for atrazine and its major metabolites have not demonstrated treatment related tumors or prostatitis and only shown inconsistent changes in prostates weights. The SD and Fisher rats and CD 1 mice are poor models for evaluating prostate cancer. Atrazine has been shown to result in prostatic inflammation of the adult rat offspring ( Stoker et al., 1999) but this is not due to direct treatment of the offspring, but rather treatment of the dams. In this case, atrazine leads to a decrease in early lactational exposure to prolactin ( via treatment of the mothers). Alterations in neonatal prolactin regulation lead to hyperprolactemia, which in turns lead to the prostatic inflammation found in the adult offspring. This work supports the neuroendocrine mode of action 3 for atrazine rather than a mode of action that would explain prostate cancer in adult male workers. Although the etiology of prostate cancer is not clearly understood, the hormonal changes caused by atrazine would be in the opposite direction ( i. e., decreased prolactin) of what would be expected for the development of prostate cancer. Furthermore, it has not been clearly established that prostatitis increases the risk to prostate cancer. Therefore, the animal data do not support a mechanism for atrazine contributing to the onset or promotion of prostate cancer in humans.

Ovarian tumors in most laboratory animals are a rare occurrence ( Damjanov, 1989). A dose related increase in ovarian tumor incidence is not seen in any study using atrazine, simazine or propazine, and in all studies, the incidences of ovarian tumors are ( as would be expected) very low. Although the causes of ovarian cancer are not definitively known, the key events in the mode of action established for atrazine, i. e., decreased serum LH levels and a decreased number of ovulations over a lifetime, are the opposite of the events hypothesized to be associated with ovarian carcinogenesis. Some hypotheses have been advanced for ovarian carcinogenesis with the predominant hypotheses being the " incessant ovulation" hypothesis and the " gonadotropin" hypothesis ( e. g., Fathalla, 1971). This hypothesis suggests that damage to the ovarian epithelium, resulting from frequent ovulations, leads to increased risk of cancer as this leads to increased epithelial cell proliferation. It should be noted that epidemiology studies show that factors which decrease the number of lifetime ovulations  such as pregnancy, breast feeding and oral contraceptive use  reduce ovarian cancer risk ( Berchuck and Carney, 1997). Therefore, animal data do not support a biologically plausible mechanism for atrazine contributing to ovarian cancer in humans.

There was not an increase in any dose group for a lymphoma of any type, including non Hodgkin's lymphomas ( NHL) in atrazine treated SD or F344 rats. The simazine chronic bioassay using both sexes of SD rat also failed to see any lymphomas in any animal in any dose group ( McCormick, 1988). Likewise, no animal in either of the two groups examined ( control and high dose tested  1000 ppm) in the propazine chronic bioassay, had a lymphoma of any type ( Jessup, 1980). The alterations in reproductive hormones that atrazine exposure is associated with have not been linked to an increased risk of NHL. NHLs are a broad group of neoplasias which originate from lymphoid tissues such as B cells, T cells and histiocytes, though the vast majority are B cell in origin. The etiology of NHLs are unclear. Generally speaking, increased risk of developing NHL appears to be associated with conditions or xenobiotic exposures that result in immune dysfunction ( Scherr and Mueller, 1996). An association between NHL and reproductive hormones such as LH, FSH, estrogens and prolactin, does not appear to be present. A mechanistic role for atrazine contributing to NHL has not been identified in laboratory studies.

In summary, multiple animal bioassays do not reveal an increased incidence of tumors at any endocrine site other than mammary gland in female SD rats. Other endocrine tumors that have been raised in epidemiological studies can not be biologically tied to atrazine's mode of action ( i. e., decrease prolactin, decrease LH and suppression of ovulation). Thus, at this time, based on the available animal cancer and mode of action data and epidemiological studies, there is no tumor endpoint on which to base a cancer risk assessment for atrazine. EPA has considered 4 other possible modes of action ( e. g., stimulation of aromatase activity) and finds that there are inadequate data to support these hypotheses. EPA's Office of Research and Development National Health and Environmental Effects Laboratory is currently conducting a detailed investigation of the effects of atrazine and related chlorotriazines on aromatase activity and steroidogenesis in an effort to determine whether or not these compounds can change estrone, estradiol and testostosterone synthesis in response to atrazine treatment in rats. As additional data become available, EPA will review them.

Berchuck A, Carney M. Human ovarian cancer of the surface epithelium. Biochem Pharmacol. 1997 Sep 1; 54( 5): 541_ 4.

Bosland MC. Male reproductive system. In Carcinogenesis. Eds., MP Waalkes, JM Ward. New Your: Raven Press, Ltd., 1994, pp. 339 402.

Damjanov I., Ovarian tumours in laboratory and domestic animals. Curr Top Pathol. 1989; 78: 1_ 10.

Fathalla MF. Incessant ovulation__ a factor in ovarian neoplasia? Lancet. 1971 Jul 17; 2( 7716): 163.

Jessup, D. 1980. Two year oral chronic toxicity study in rats. IRDC study no. 382 007. MRID 00041408; Acc. No. 219502401.

McCormick, C. C. and Arthur, A. T. Simazine Technical: 104 Week Oral Chronic Toxicity and Carcinogenicity Study in Rats. 1988. Study Number: 2 0011 09. MRID number: 406144 05. Pharmaceuticals Division, Ciba Geigy Corp., Summit, NJ.

Scherr PA and Mueller NE, Non Hodgkin's lymphomas, in Eds D. Schottenfeld and JF Fraumeni Jr.. Cancer Epidemiology and Prevention New York, Oxford University Press, 1996, pgs. 920 945.

Stoker, T. E., Robbinette, C. L., Cooper, R. L. 2000. Maternal exposure to atrazine during lactation suppresses suckling_ induced prolactin release and results in prostatitis in the adult offspring. Toxicol Sci. 1999 Nov; 52( 1): 68_ 79.

II. Atrazine and prostate cancer epidemiology The following review addresses epidemiology related to prostate cancer, non Hodgkin's 5 lymphoma, other cancers and includes a brief summary of earlier reviews and the most recently submitted studies related to atrazine and triazines.

A. Prostate Cancer  Manufacturing plant study An epidemiology study was conducted of workers at the Syngenta St. Gabriel plant where atrazine is manufactured. That study reported a statistically significant increase in the incidence of prostate cancer among plant workers. The Agency, upon review of this study, requested additional information on the exposure profile of the employees diagnosed with prostate cancer and this information was provided and reviewed. To further analyze the question of exposure a nested case control study was proposed by Syngenta and conducted for them by Health Practice Exponent Inc. ( Hessel et al. 2003). Preliminary results of this study, a review by the Agency, comments from four external peer reviewers, a Syngenta sponsored expert panel review, and comments by the Natural Resources Defense Council were provided to the EPA's Scientific Advisory Panel in July of 2003. EPA's view of the study was that the increase in prostate cancer observed in the St. Gabriel workers was probably due to the increase in PSA screening for these workers.

The Panel was requested to comment on the Agency's conclusion regarding prostate cancer and particularly the results from this study. The specific Agency conclusion that EPA asked the SAP to comment on was: " Due to the lack of a detailed exposure analysis based on job history and the limited statistical power due to the small sample size, atrazine could not be ruled out as a potential cause but a role for atrazine seems unlikely."

The Panel's analysis of the St. Gabriel study differed to a degree from the Agency's conclusion. The SAP did conclude that " the increase in Prostate Specific Antigen ( PSA) screening at the St. Gabriel plant likely led to an increase in the detection of cases of prostate cancer." Further, the Panel noted that "[ s] ubstantive and persuasive arguments have been made to support the EPA's conclusion that PSA screening could explain the observed increase in prostate cancer incidence in the workers." Nonetheless, the Panel did not believe there was sufficient evidence to conclude that it was " unlikely" that atrazine had a role in the increased prostate cancer cases " given the severe limitations of the St. Gabriel study, particularly those pertaining to small sample size, questionable exposure assessment and lack of an appropriate comparison group." According to the SAP, PSA screening may be only a " partial explanation" for the increase in prostate cancer and that " atrazine cannot be ruled out as a potential cause."

The Agency agrees with the SAP's analysis and has rewritten its conclusion as follows:

The increase in prostate cancer incidence at the St. Gabriel plant in Louisiana is consistent 6 with the intensive PSA screening. This is because prostate cancer was found primarily in active employees who received intensive prostate specific antigen ( PSA) screening, there was no increase in advanced tumors or mortality, and proximity to atrazine manufacturing did not appear to be correlated with risk. No evidence was identified that permit a determination that some of the increase was likely due to exposure to atrazine although atrazine exposure cannot be ruled out at this time. However, the study was insufficiently large and suffered from other limitations that prevent a determination that all of the increase in prostate cancer was probably due to the intensive screening program.

One of EPA's external reviewers agreed with this finding regarding the role of PSA screening. Dr. Edward Giovannucci of the Harvard School of Public Health stated, " Thus, the increased excess of prostate cancer observed in the Novartis study is compatible with increases expected in a population that is receiving intensive PSA screening." Another reviewer, Dr. Aaron Blair of the National Cancer Institute, though not in full agreement with Dr. Giovannucci, agreed that there was evidence to " suggest that PSA screening may well explain the excess incidence of prostate cancer in this cohort."

The Scientific Advisory Panel suggested that the Agency consider additional analysis of the St. Gabriel cohort. However, the resulting sample size would still limit the opportunity to draw further conclusions. The Agency questions whether additional analysis is warranted for other potential risk factors ( such as smoking, diet and previous work history, and nonoccupational or pre employment exposure to triazine herbicides). Because of the way the study was designed this information is not available to investigators and it may not be feasible to obtain such information. The same applies to the suggested analysis of family history, history of prostate disease, ( e. g., benign prostatic hypertrophy and prostatitis), and additional biologic samples that allow DNA extraction. The St. Gabriel study was a study based on available records and it might be difficult or impossible for investigators to obtain permission from all or most subjects or nextof kin to get the additional information outlined by the SAP. The SAP repeatedly acknowledges " The St. Gabriel cohort study suffered from several limitations that could lead to negative findings in epidemiologic studies of similar design, particularly with regard to the very small sample size" which can greatly hinder the statistical power to detect an effect.

In October, 2003, Syngenta provided a completed report on the nested case control study ( cases and controls selected from within the cohort) by Health Practice Exponent Inc. that examined in more detail the exposure of 12 of 17 prostate cancer cases and examined the effect of screening on prostate cancer incidence ( Hessel et al. 2003). EPA has not yet reviewed this study in depth, but a preliminary reading did not find any evidence that prostate cancers could be attributed to atrazine exposure. Statistical analysis suggest that PSA screening would explain some or all of the elevated rates of prostate cancer. The study authors concluded " There is no evidence for an association between atrazine exposure and prostate cancer among the workers at the Syngenta plant in St. Gabriel. The increased incidence of prostate cancer observed in the previous study could be explained by the PSA screening program." 7 B. Prostate Cancer  Agricultural Health Study in Iowa and North Carolina Tied into the assessment of atrazine and prostate cancer is the recently published study Alavanja et al. ( 2003). This large prospective cohort study of 55,332 male pesticide applicators, known as the Agricultural Health Study, reported on the risk of prostate cancer and computed odds ratios for individual pesticides within the cohort. For atrazine the reported odds ratio ( ratio of odds in favor of disease among exposed to the odds of disease among the unexposed, an odds ratio of 1.0 implies no increased risk from exposure) was 0.94 for ever/ never use reported by questionnaire with a 95% confidence interval of 0.78 to 1.14. The Agricultural Health Study has a number of advantages over other epidemiologic studies of pesticides. It is the largest study of its kind, determines exposure prior to disease ( thus, eliminating recall bias), analyzes a wide variety of potential and known confounders including other pesticide exposures, and has greater statistical power to detect small effects.

The Scientific Advisory Panel expressed concern that the use of ever/ never use atrazine was " likely an inappropriate exposure metric" and that other factors such as measures of continuous or intermittent use should be considered. The Panel appeared to place little weight on the dose response analysis based on cumulative exposure which combined duration, frequency, and intensity into one metric that did not show any association between atrazine and prostate cancer. The Agency agrees that other exposure metrics might be considered but disagrees that ever/ never use and cumulative exposure is an inappropriate measure. Available pesticide usage data suggest that the pattern of use of atrazine as a preharvest herbicide limits variability in duration, frequency, and intensity of use and the dose response analysis is a sufficient measure to account for this source of variation.

The Scientific Advisory Panel expressed concern that this study had a short follow up period " with exposure information collected at the start of follow up" and incorrectly stated this was less than five years. Because study subjects were queried about past as well as present use of atrazine, the follow up period was much longer than five years. The National Cancer Institute is planning to redo the prostate cancer study with a much larger cohort next year when the sample size will be approximately twice as large. However, given the relatively tight confidence interval on the current estimate and the lack of any evidence of dose response, the Agency does not expect the new study to produce results different from those already reported. Nevertheless, the Agency will revisit and revise these conclusions if the updated prostate cancer study produces different results suggesting a risk from exposure to atrazine.

C. Prostate Cancer  Pesticide use data and cancer incidence in California counties Two studies were conducted in California which has maintained a population based cancer registry since 1988 and a state wide pesticide use reporting system. Mills ( 1998) obtained 1993 8 pesticide usage data for six pesticides with a suspicion of carcinogenicity based on other toxicologic and epidemiologic studies. These data were compared using regression analysis with county age and race adjusted cancer incidence rates ( 1988 92). A borderline statistically significant correlation was found between atrazine usage and prostate cancer in black males, but not among Hispanic, White, or Asian males. This study is subject to aggregation bias because the exposure of individuals in the county was not measured. EPA considers such studies useful for guiding future studies, but not for reaching conclusions about causation.

A second study by Mills and Yang ( 2003) examined the effect of simazine rather than atrazine on prostate cancer among members of the United Farm Workers of America. The study found a borderline significant association between high simazine use and prostate cancer. Like the earlier Mills ( 1998) study, this study suffers from aggregation bias and a crude measure of exposure ( total poundage of active ingredient by crop and county for a given time period) which may not reflect exposure among farmworkers, 90% of whom are not actively involved in applying or handling pesticides ( 1999 2002 data from presentation on National Agricultural Workers Survey by S. Gabbard, J. Nakamoto, and D. Carroll, September 24, 2003, funded by the Department of Labor). The use of total poundage of active ingredient by county was not normalized by number of workers and is especially problematic because it correlates with the size of the crop and acreage in the county and many other factors which might have little to do with exposure of farmworkers. For example, a county with double the poundage would be counted as having double exposure, even if it also had double the number of farmworkers and their exposure was the same in both counties.

D. Prostate Cancer  Overall conclusion Studies of manufacturing and farming populations do not support a finding that atrazine is a likely cause of prostate cancer. The Scientific Advisory Panel stated that neither the Syngenta St. Gabriel Plant study or the Agricultural Health Study were " sufficient for EPA to conclude that there is no causal association between atrazine exposure and prostate cancer." However, the Agency does not find any results among these studies that would lead us to conclude that potential cancer risk is likely from exposure to atrazine.

III. Atrazine and epidemiology of non Hodgkin's lymphoma The National Cancer Institute has performed a number of studies of non Hodgkin's lymphoma ( NHL) in farming populations. The key findings related to atrazine are noted below.

A study by Schroeder et al. 2001 examined two subtypes of NHL for association with pesticide exposure based on earlier data from Iowa and Minnesota. The negative NHL subtype was significantly associated with 5 pesticides. For atrazine, the odds ratio was borderline significant ( Odds ratio = 1.7 with 95% confidence interval 1.0 2.8). The Schroeder study 9 cautiously stated " In conclusion, we found weak to relatively strong associations between many agricultural exposures and t( 14; 18) positive, but not t( 14; 18) negative NHL." and " Causal relationships . . . are plausible, but associations should be confirmed in a larger study."

The study by Schroeder et al. ( 2001) contrasted with an earlier study by Zahm et al. ( 1993) conducted in these same two states plus Kansas and Nebraska which concluded, " In our judgment, these data provide little evidence that atrazine is associated with NHL among white men."

Added to these two conflicting studies is a study by DeRoos et al. ( 2003) published electronically in September 2003. EPA has not had time to review this study in depth, but did not find evidence sufficient to implicate atrazine as a likely cause of NHL. This study stated that " Reported use of several individual pesticides was associated with increased NHL incidence" but that " limitations of our data hinder the inferences we can make regarding specific pesticides". The hierarchical regression odds ratio ( odds ratio adjusted for the effect of exposure to other pesticides) for atrazine was 1.5 ( 95% CI = 1.0 to 2.2) which, like the study by Schroeder et al ( 2001), has borderline significance. Studies with borderline significance increase the likelihood that chance or some confounder may be an explanation for the observed findings. The authors caution that " some of the positive results could be due to chance" though adjustment for the influence of other pesticides in the analysis makes this somewhat less likely.

Given the conflicting results and the extreme caution exhibited by the National Cancer Institute ( NCI) in making its conclusion regarding specific pesticides, the EPA has concluded that evidence is not sufficient to implicate atrazine as a likely cause of non Hodgkin's lymphoma. Nevertheless, EPA will consider these studies in conjunction with other evidence and may request additional external review. An exhaustive and thorough analysis of non Hodgkin's lymphoma and pesticide use is planned by NCI for 2004 5. This analysis will include consideration of NHL subtypes and many other factors as well. Absent compelling information in the interim, EPA has determined that a thorough review of atrazine and NHL should be conducted when the NCI data are available.

IV. Atrazine and epidemiology related to other cancers Other cancers besides prostate and non Hodgkin's lymphoma were found to have an elevated, though not statistically significant, increase in risk at the St. Gabriel plant ( Delzell et al. 2001). Other studies have suggested an increased risk for ovarian, breast, and other cancers. However, these studies are at best preliminary and should not serve as a basis for implicating atrazine as a human carcinogen due to their methodological limitations and the absence of replication in other populations. The National Cancer Institute is planning a review of atrazine and all types of cancers in 2004. Given the much larger sample size and strengths of this Agricultural Health Study, the Agency has decided further review of other cancers and atrazine should take place when results from this planned analysis are available. However, if other studies 10 or additional compelling evidence becomes available in the interim, the Agency will expeditiously review the new evidence and the potential risk resulting from exposure to atrazine. A summary of evidence from previous reviews of atrazine and cancer epidemiology, and studies published subsequently, are reviewed in the following section V. Results of other reviews of cancer and atrazine through 1999 Three reviews of triazines including atrazine and cancer epidemiology have been reported in the 1996 1999 time period:

IARC. 1999. IARC Monographs on the evaluation of carcinogenic risks to humans. Volume 73: Some chemicals that cause tumours of the kidney or urinary bladder in rodents and some other substances. World Health Organization, Lyon, France.

Neuberger JS. 1996. Atrazine and/ or triazine herbicides exposure and cancer: an epidemiologic review. Journal of Agromedicine 3( 2): 9 30.

Sathiakumar N, Delzell E. 1997. A review of epidemiologic studies of triazine herbicides and cancer. Critical Reviews in Toxicology 27: 599 613.

These three reviews identified the 10 case control studies ( see numbered references at the end of this review, 1 10) and two published cohort studies of workers exposed to triazines at manufacturing plants ( 11 12).

Neuberger ( 1996) concluded " based on the data to date . . . there is no convincing evidence of a causal association between atrazine and/ or triazine( s) and colon cancer, soft tissue sarcoma, Hodgkin's disease, multiple myeloma, or leukemia. . . . There is a suggestion of a possible association between atrazine and/ or triazine( s) with ovarian cancer and non Hodgkin's lymphoma. However, the ovarian cancer study needs to be replicated and the NHL studies fall short of providing conclusive evidence of risk because the results could be due to chance, bias, or confounding."

Sathiakumar and Delzell ( 1997) concluded " The available epidemiologic studies, singly and collectively, do not provide any consistent, convincing evidence of a causal relationship between exposure to triazine herbicides and cancer in humans."

The International Agency for Research on Cancer ( 1999) summarized the human carcinogenicity data as follows:

A combined analysis of results of two cohort studies of agricultural chemical 11 production workers in the United States showed decreased mortality from cancers at all sites combined among the subset of workers who had had definite or probable exposures to triazine. Site specific analyses in this subset of workers yielded no significant findings; a non significant increase in the number of deaths from non Hodgkin's lymphoma was seen, but was based on very few observed cases.

A pooled analysis of the results of three population based case control studies of men in Kansas, eastern Nebraska and Iowa Minnesota, United States, in which the risk for non Hodgkin's lymphoma in relation to exposure to atrazine and other herbicides on farms was evaluated, showed a significant association; however, the association was weaker when adjustment was made for reported use of phenoxyacetic acid herbicides or organophosphate insecticides. A sub analysis of results for farmers in Nebraska, the State in which the most detailed information on atrazine use was available, showed no excess risk for non Hodgkin's lymphoma among farmers who had used atrazine for at least 15 years, after adjustment for use of other pesticides. In a case control study of non Hodgkin's lymphoma among women in eastern Nebraska, a slight, nonsignificant increase in risk was seen. In all these studies, the farmers tended to have an increased risk for non Hodgkin's lymphoma, but the excess could not be attributed to atrazine.

Less information was available to evaluate the assoication between exposure to atrazine and other cancers of the lymphatic and haematopoietic tissues. One study of Hodgkin disease in Kansas, one study of leukaemia in Iowa Minnesota and one study of multiple myeloma from Iowa gave no indication of excess risk among persons handling triazine herbicides.

In a population based study in Italy, definite exposure to triazines was associated with a two to threefold increase of borderline significance in the risk for ovarian cancer. The study was small, and potential confounding by exposure to other herbicides was not controlled in the analysis.

Based on these findings the IARC concluded " There is inadequate evidence in humans for the carcinogenicity of atrazine." In a critique of IARC monographs, Huff ( 2002) questioned the decision on atrazine and animal carcinogenicity and based this partly on the Delzell et al. ( 2001) report showing increased risk for prostate cancer and above expected levels for certain cancers including buccal cavity ( 3 observed, 2.1 expected), esophagus ( 2 observed, 0.7 expected), stomach ( 2 observed, 0.9 expected), bladder ( 3 observed, 1.6 expected), thyroid ( 2 observed, 0.6 expected) and leukemia/ lymphomas ( 7 observed, 4.5 expected). These data are based on Table 7 of the Syngenta report by Delzell et al. ( 2001). This table shows 9 different estimates of risk, not counting prostate ( already discussed) and certain grouped categories. Therefore, 6 of 9 categories exhibited an excess, though statistically insignificant risk. Chance alone is a possible explanation for such findings. In addition, bias and confounding could produce such results. Therefore, these elevated, nonsignficant incidence ratios must be considered preliminary findings. Until these findings are replicated in other studies that address the serious methodological 12 limitations ( especially the low statistical power) of the present study, they should be regarded as spurious or suggestive at best. Therefore, the EPA disagrees with Huff ( 2002) that the epidemiology studies provide support for a revision of the IARC classification for atrazine.

Independent of these three reviews, EPA has performed internal reviews of all of the above studies which had statistically significant findings relevant to atrazine or triazines including additional updates to the manufacturing plant studies submitted to EPA but not published. With the exception of the possible association with ovarian cancer, which EPA reviewers stated needed to be confirmed in other populations, the Agency did not find convincing evidence of an association between triazines or atrazine and cancer.

Huff J. 2002. IARC monographs, industry influence, and upgrading, downgrading, and under_ grading chemicals: a personal point of view. International Agency for Research on Cancer. Int J Occup Environ Health. 8( 3): 249 70.

VI. Studies published since 1999 or not included in the three published reviews The following six studies were reviewed by EPA and submitted to the Scientific Advisory Panel for review in July 2003.

Alavanja MCR, Samanic C, Dosemeci M, et al. 2003. Use of agricultural pesticides and prostate cancer risk in the Agricultural Health Study cohort. Am J Epidemiol 157: 800 814.

Delzell E, et al. 2001. Cancer Incidence Among Workers in Triazine related Operations at the Novartis St. Gabriel Plant" Oct. 12, 2001. MRID# 451521 01 and 455184 01, Chemical # 080803. [ Technical Report 170 pp.]

MacLennan PA, Delzell E, Sathiakumar N, et al. 2002. Cancer incidence among triazine herbicide manufacturing workers. J Occup Environ Med. 44: 1048 1058.

MacLennan PA, Delzell E, Sathiakumar N, et al. 2003. Mortality among triazine herbicide manufacturing workers. J Toxicol Environ Health A 66( 6): 501 517.

Mills PK. 1998. Correlation analysis of pesticide use data and cancer incidence rates in California counties. Arch Environ Health. 53: 410 3.

Mills PK, Yang R. Prostate cancer risk in California farm workers. 2003. J Occup Environ Med. 45: 249 258.

Results from the Alavanja ( 2003), Delzell ( 2001), Mills ( 1998), and Mills and Yang ( 2003) have already been discussed above. The two reports by MacLennan et al. are updates to the two earlier reports by Sathiakumar ( 1992, 1995). Most of the results in these two studies are covered in much more detail by Delzell et al. ( 2001) which has already been discussed above in 13 the sections on prostate cancer and other cancers. The mortality study ( MacLennan et al. 2003) did find a borderline significant result for non Hodgkin's lymphoma based on 4 observed deaths versus 1.1 deaths expected. The authors noted, however, that " one of the decedents whose death certificate included a diagnosis of NHL had medical records, including a biopsy report that indicated a diagnosis of poorly differentiated nasopharyngeal cancer. This case was not removed from our analysis. To have done so would have introduced a bias because there is no satisfactory procedure for removing similarly misclassified cases from the numerator of general population mortality rates used to calculate the expected number of deaths. Our data were not of adequate statistical precision to demonstrate trends in NHL rates or SMRs by years worked and years since hire." This acknowledgment of bias based on a misclassified case means that borderline statistically significant finding would no longer be significant if the case were excluded. As stated above, this evidence is not sufficient to support a finding that atrazine is a likely cause of non Hodgkin's lymphoma.

The following six studies, including two published since July 2003 meeting were not submitted to the Scientific Advisory Panel.

De Roos AJ, Zahm SH, Cantor KP, Weisenburger DD, Holmes FF, Burmeister LF, Blair A. 2003. Integrative assessment of multiple pesticides as risk factors for non Hodgkin's lymphoma among men. Occup Environ Med 60: e11.( http:// www. occenvmed. com/ cgi/ content/ full/ 60/ 9/ e11)

Hessel PA, Kalmes R, Smith TJ, Lau E, Mink P, Mandel J. 2003. A Nested Case Control Study of Prostate Cancer and Atrazine Exposure. Final Report, October 3, 2003 performed by Health Practice Exponent, Inc. and submitted by Syngenta Crop Protection, Inc.

Hopenhayn Rich C, Stump ML, Browning SR. 2002. Regional assessment of atrazine exposure and incidence of breast and ovarian cancers in Kentucky. Arch Environ Contam Toxicol 42: 127 136.

Kettles MA, Browning SR, Prince TS, Horstman SW. 1997. Triazine herbicide exposure and breast cancer incidence: an ecologic study of Kentucky counties. Environmental Health Perspectives 105: 1222 1227.

Schroeder JC, Olshan AF, Baric R, et al. 2001. Agricultural risk factors for t( 14; 18) subtypes of non Hodgkin's lymphoma. Epidemiology 12: 701 709.

Van Leeuwen JA, Waltner Toews D, Abernathy T, et al. 1999. Associations between stomach cancer incidence and drinking water contamination with atrazine and nitrate in Ontario ( Canada) agroecosystems, 1987 1991. Int J Epidemiol. 28: 836 40.

DeRoos et al. ( 2003), Hessel et al. ( 2003), Schroeder et al. ( 2001) have already been discussed above. Hessel et al. ( 2003) is discussed at the end of the section on " Prostate Cancer  Manufacturing Plant Study". DeRoos et al. ( 2003) and Schroeder et al. ( 2001) are discussed in 14 the section on non Hodgkin's lymphoma.

The other three studies by Hopenhayn Rich et al. ( 2002), Kettles et al. ( 1997), and Van Leeuwen et al. ( 1999) are ecological studies where the unit of analysis are populations or groups of people rather than individuals. An earlier study by Kettles et al ( 1997) suggested an association between triazine exposure and breast cancer in Kentucky. However, a later follow up study by Hopenhayn Rich et al. ( 2002) did not support this finding for Kentucky and instead found results suggesting a protective effect for atrazine for ovarian cancer and no effect on breast cancer. The Hopenhayn Rich et al. study was based on 5 year, age adjusted cancer rates which are likely to be more stable than the two year rates used by Kettles et al. A study by Van Leeuwen et al. ( 1999) found a positive association between atrazine water contamination levels and stomach cancer among 40 ecodistricts in Ontario, Canada, and a negative association with colon cancer suggesting a protective effect for atrazine. The authors " noted that so called ` ecologic studies', the type of analysis conducted in this research, have a number of weaknesses, including ecologic fallacy and multiple collinearity." Stomach cancer has been declining for many years and is likely associated with a number of dietary and lifestyle factors, not controlled for in the Van Leewen et al. ( 1999) study ( Cancer Rates and Risks, 4th edition, National Cancer Institute 1996). All of these studies are subject to aggregation bias because the actual exposures of individuals in the county/ district or how long they resided there is not known. As noted in standard epidemiology texts, ecologic studies " can suggest avenues of research that may be promising . . . In and of themselves, however, they do not demonstrate that a causal association exists" ( Gordis L. Epidemiology. W. B. Saunders Company, Philadelphia, 1996). The authors themselves warn " conclusions concerning causality cannot be drawn" ( Kettles et al. 1997). An ecologic study in Kentucky of similar design to those above, found a whole host of factors that vary across an urban rural gradient ( Blondell JM. Urban rural factors affecting cancer mortality in Kentucky, 1950 1969. Cancer Detection and Prevention 11: 209 223, 1988). Persons living in rural areas differ not only in terms of pesticide exposures, but also diet, parity, physical activity, exposure to viruses, and other lifestyle factors. Appropriate controls are critical when studying the relationship between pesticide exposure and cancer.

VII. EPA Conclusion: Atrazine exposure and NHL and other cancers The Agency does not find any results among the available studies that would lead us to conclude that potential cancer risk is likely from exposure to atrazine. EPA plans to revisit this conclusion upon receipt of new studies, especially those from NCI's Agricultural Health Study on atrazine and all cancers, prostate cancer, and non Hodgkin's lymphoma, all of which are planned for completion in the next 1 2 years.

Numbered references 1. Brown LM, Blair A, Gibson R, et al. 1990. Pesticide exposures and other agricultural risk 15 factors for leukemia among men in Iowa and Minnesota. Cancer Research 50: 6585 6591.

2. Brown LM, Burmeister LF Everett GD, et al. 1993. Pesticide exposures and multiple myeloma in Iowa men. Cancer Causes Control 4: 153 156.

3. Burmeister LF. 1990. Cancer in Iowa farmers: recent results. Am J Ind Med 18: 295 301.

4. Cantor KP, Blair A, Everett G, et al. 1992. Pesticides and other agricultural risk factors for non Hodgkin's lymphoma among men in Iowa and Minnesota. Cancer Research 52: 2447 2455.

5. Donna A, Crosignani P, Robutti F, et al. 1989. Triazine herbicides and ovarian epithelial neoplasms. Scan J Work Environ Health 15: 47 53.

6. Hoar SK, Blair A, Holmes FF, et al. 1986. Agricultural herbicide use and risk of lymphoma and soft tissue sarcoma. JAMA. 256: 1141 7.

7. Hoar SK, Blair A, Holmes FF, et al. 1985. Herbicides and colon cancer. Lancet. 1( 8440): 1277 8.

8. Hoar Zahm S, Weisenburger DD, Babbitt PA, et al. 1988. Case control study of non Hodgkin's lymphoma and agricultural factors in eastern Nebraska ( abstract). Am J Epidemiol 128: 901.

9. Zahm SH, Wisenburger DD, Cantor KP, et al. 1993a. Role of the herbicide atrazine in the development of non Hodgkin's lymphoma. Scan J Work Environ Health 19: 108 114.

10. Zahm SH, Weisenburger DD, Saal RC, et al. 1993b. The role of agricultural pesticide use in the development of non Hodgkin's lymphoma in women. Arch Environ Health. 48( 5): 353 358.

11. Sathiakumar N, Delzell E, Austin H, Cole P. 1992. A follow up study of agricultural chemical production workers. American Journal of Industrial Medicine 21: 320 330.

12. Sathiakumar N, Delzell E, Cole P. 1995. Mortality among workers at two triazine manufacturing plants. American Journal of Industrial Medicine 29: 143 151.

cc: atrazine file ( 080803) Catherine Eiden ( 7509C)


[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Rules and Regulations]
[Pages 44886-44890]
[FR Doc No: 2013-17842]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0894; FRL-9837-1]

Approval and Promulgation of Implementation Plans; Tennessee: New
Source Review-Prevention of Significant Deterioration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to approve portions of a revision
to the Tennessee State Implementation Plan (SIP), submitted by the
Tennessee Department of Environment and Conservation (TDEC) through the
Division of Air Pollution Control, to EPA on October 4, 2012, for
parallel processing. TDEC submitted the final version of this SIP
revision on May 10, 2013. The SIP revision approved in this action
modifies Tennessee's New Source Review (NSR) Prevention of Significant
Deterioration (PSD) program to adopt, into the Tennessee SIP, federal
regulatory requirements regarding PSD increments for fine particles
with an aerodynamic diameter of less than or equal to 2.5 micrometers.
EPA is approving portions of Tennessee's May 10, 2013, SIP revision
because the Agency has made the determination that these portions of
the SIP revision are in accordance with the Clean Air Act (CAA or Act)
and EPA regulations regarding NSR permitting.

DATES: This rule will be effective August 26, 2013.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2012-0894. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section for
further information. The Regional Office's official hours of business
are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.

FOR FURTHER INFORMATION CONTACT: For information regarding the
Tennessee SIP, contact Ms. Twunjala Bradley, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. Ms. Bradley's telephone number
is<PHONE_NUMBER>; email address<EMAIL_ADDRESS>For
information regarding NSR, contact Ms. Yolanda Adams, Air Permits
Section, at the same address above. Ms. Adams' telephone number is
(404) 562-9241; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. This Action
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    On October 4, 2012, TDEC submitted a draft SIP revision for
parallel processing. The October 4, 2012, draft SIP revision changes
Tennessee's Air Quality Regulations, Chapter 1200-03-09--Construction
and Operating Permits, Rule Number .01--Construction Permits, to adopt
PSD requirements related to the implementation of the PM2.5
NAAQS as promulgated in the rule entitled ``Prevention of Significant
Deterioration (PSD) for Particulate Matter Less Than 2.5 Micrometers
(PM2.5)--Increments, Significant Impact Levels (SILs) and
Significant Monitoring Concentration (SMC),'' Final Rule, 75 FR 64864
(October 20, 2010) (hereafter referred to as the ``PM2.5 PSD
Increments-SILs-SMC Rule''). TDEC submitted its final SIP revision to
EPA on May 10, 2013.
    In addition, on February 26, 2013, Tennessee provided a final
submission to EPA that corrects the State's definition of ``regulated
NSR pollutant'' at Chapter 1200-03-09-.01(4)(b)47(vi) by removing the
term ``particulate matter (PM) emissions.'' Tennessee made this change
to be consistent with EPA's October 25, 2012, rulemaking entitled
``Implementation of the New Source Review (NSR) Program for Particulate
Matter Less Than 2.5 Micrometers (PM2.5): Amendment to the
Definition of `Regulated NSR Pollutant' Concerning Condensable
Particulate Matter, Final Rule,'' 77 FR 65107 (hereafter referred to as
the ``Condensable PM Correction Rule''). EPA never took action to
include this term into Tennessee's SIP. Therefore, this submission is
administrative in nature to correct Tennessee's state laws and does not
require any action by EPA--EPA is simply pointing out this issue for
clarification purposes.
    On April 22, 2013, EPA proposed to approve, through parallel
processing, Tennessee's draft October 4, 2012, SIP revision to address
the PM2.5 increment requirements.\1\ EPA's April 22, 2013,
proposed rulemaking was contingent upon Tennessee providing a final SIP
revision that was substantively the same as their October 4, 2012,
draft SIP revision. See 78 FR 23704. Comments on EPA's April 22, 2013,
proposed rulemaking were due on or before May 22, 2013. EPA received no
comments adverse or otherwise. TDEC submitted the final version of its
SIP revision on May 10, 2013. Tennessee's October 4, 2012, May 10,
2013, and February 26, 2013, submissions are provided in the docket for
today's final action (Docket ID: EPA-R04-OAR-2012-0894). The SIP
submittal changes are briefly summarized below. Please refer to EPA's
April 22, 2013, proposed rulemaking for more detailed information
regarding the state's submission as well as the Agency's rationale for
today's final rulemaking.
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    \1\ EPA's April 22, 2013, proposed rulemaking stated that as a
result of the January 22, 2013, D.C. Circuit decision to vacate and
remand the PM2.5 SILs and vacate the PM2.5
SMCs as well as consultations with EPA Region 4, TDEC would request
in their final SIP submission that EPA not take action to approve
into the Tennessee SIP the PM2.5 SILs and SMC. See 78 FR
23704.
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    Tennessee's May 10, 2013, final SIP revision reflects two changes
from the State's October 4, 2012, draft submittal. These two changes,
made by TDEC at EPA's request, were needed to make Tennessee's rule
consistent with EPA's PM2.5 PSD Increment-SILs-SMC Rule. As
EPA explained in the April 22, 2013, proposed rulemaking, Tennessee
inadvertently omitted from the October 4, 2012, draft submission
certain provisions established in the PM2.5 PSD Increment-
SILs-SMC Rule including: (1) The Class I variances for PM2.5
increments at 1200-03-09-.01(4)(n)3, and the administrative change to
replace the term ``particulate matter'' with ``PM2.5,
PM10''\2\ (consistent with federal rule at 40 CFR 51.166(c)
and (p)(5)); and (2) the administrative changes to the definition of
``baseline date'' at 1200-03-09-.01(4)(b)15(i) and (ii)(I) to replace
the term ``particulate matter'' with ``PM10.'' In the April
22, 2013, proposed rulemaking, EPA explained that TDEC had committed to
addressing these inadvertent omissions in the final SIP submission. See
78 FR at 23708. Tennessee's May 10, 2013, final SIP revision addressed
the provisions for PM2.5 Increments for Class I variances
and changes to the definition of ``baseline date'' in accordance with
the October 20, 2010 rule and to appropriately implement the PSD
increments for the PM2.5 NAAQS.
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    \2\ PM10 means particulate matter with an aerodynamic
diameter of less than or equal to a nominal ten micrometers in
diameter.
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    Additionally, Tennessee's May 10, 2013, final SIP submission cover
letter requested that EPA not take action to approve into Tennessee's
SIP the portions of the state rule that establish PM2.5 SILs
(at 1200-03-09-.01(5)(b)1(xix)) and SMCs (at 1200-03-
09-.01(4)(d)6(i)(III)).\3\ Tennessee made this request to be consistent
with a D.C. Circuit court decision that occurred as the State was going
through its rulemaking process. See Sierra Club v. EPA, 705 F.3d 458
(D.C. Cir. 2013).\4\ As requested by the State of Tennessee, EPA is not
taking final action in this rulemaking on the portions of the May 10,
2013, SIP submittal related to the PM2.5 SILs and SMC
thresholds as promulgated in EPA's PM2.5 PSD Increment-SILs-
SMC Rule. Besides the abovementioned changes, there were no significant
differences between Tennessee's October 4, 2012, draft SIP revision,
and the State's May 10, 2013, final SIP revision to adopt the
PM2.5 PSD increments.
---------------------------------------------------------------------------

    \3\ EPA's April 22, 2013, proposed rulemaking stated that as a
result of the January 22, 2013, D.C. Circuit decision to vacate and
remand the PM2.5 SILs and vacate the PM2.5
SMCs as well as consultations with EPA Region 4, TDEC would request
in their final SIP submission (to adopt permitting provisions
promulgated in the PM2.5 Increments-SILs-SMC Rule) that
EPA not take action to approve into the Tennessee SIP the
PM2.5 SILs and SMC. See 78 FR 23704.
    \4\ The Sierra Club challenged EPA's authority to implement the
PM2.5 SILs and SMC for PSD purposes as promulgated in the
October 20, 2010, PM2.5 PSD Increment-SILs-SMC Rule. See
Sierra Club v. EPA, 705 F.3d 458 (D.C. Cir. 2013). On January 22,
2013, the court issued an order vacating and remanding to EPA for
further consideration the portions of its PM2.5 PSD
Increment-SILs-SMC Rule addressing the PM2.5 SILs, except
for the parts codifying the PM2.5SILs in the NSR rule at
40 CFR 51.165(b)(2). The court also vacated parts of the
PM2.5 PSD Increment-SILs-SMC Rule establishing the
PM2.5 SMC, finding that the Agency had exceeded its
statutory authority with respect to these provisions. The D.C.
Circuit Court's decision can be found in the docket for today's
rulemaking at www.regulations.gov using docket ID: EPA-R04-OAR-2012-
0894.
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A. PM2.5 PSD Increment SILs-SMC Rule

    The PM2.5 PSD Increment-SILs-SMC Rule provided
additional regulatory provisions under the PSD program regarding the
implementation of the PM2.5 NAAQS for NSR including: (1)
PM2.5 increments pursuant to section 166(a) of the CAA to
prevent significant deterioration of air quality in areas meeting the
NAAQS; (2) SILs used as a screening tool (by a major source subject

to PSD) to evaluate the impact a proposed major source or modification
may have on the NAAQS or PSD increment; and (3) a SMC, (also a
screening tool) used by a major source subject to PSD to determine the
subsequent level of PM2.5 data gathering required for a PSD
permit application. PSD increments prevent air quality in attainment/
unclassifiable areas from deteriorating to the level set by the NAAQS.
Therefore, an increment is the mechanism used to estimate ``significant
deterioration'' \5\ of air quality for a pollutant in an area.
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    \5\ Significant deterioration occurs when the amount of the new
pollution exceeds the applicable PSD increment, which is the
``maximum allowable increase'' of an air pollutant allowed to occur
above the applicable baseline concentration for that pollutant.
Section 169(4) of the CAA provides that the baseline concentration
of a pollutant for a particular baseline area is generally the air
quality at the time of the first application for a PSD permit in the
area.
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    Under section 165(a)(3) of the CAA, a PSD permit applicant must
demonstrate that emissions from the proposed construction and operation
of a facility ``will not cause, or contribute to, air pollution in
excess of any maximum allowable increase or allowable concentration for
any pollutant.'' When a source applies for a permit to emit a regulated
pollutant in an area that meets the NAAQS, the state and EPA must
determine if emissions of the regulated pollutant from the source will
cause significant deterioration in air quality. As described in the
PM2.5 PSD Increment-SILs-SMC Rule, pursuant to the authority
under section 166(a) of the CAA, EPA promulgated numerical PSD
increments for PM2.5 as a new pollutant\6\ for which NAAQS
were established after August 7, 1977,\7\ and derived 24-hour and
annual PM2.5 increments for the three area classifications
(Class I, II and III) using the ``contingent safe harbor'' approach.
See 75 FR 64869 and the ambient air increment tables at 40 CFR
51.166(c)(1) and 52.21(c). In addition to PSD increments for the
PM2.5 NAAQS, the PM2.5 PSD Increment-SILs-SMC
Rule amended the definition at 40 CFR 51.166 and 52.21 for ``major
source baseline date'' and ''minor source baseline date'' (including
trigger date) to establish the PM2.5 NAAQS specific dates
associated with the implementation of PM2.5 PSD increments.
See 75 FR 64864. As mentioned above, due to the January 22, 2013, D.C.
Circuit court decision, TDEC requested in its May 10, 2013, final SIP
submission that EPA not take action to approve the PM2.5
SILs and SMC screening tools \8\ into the Tennessee SIP.
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    \6\ EPA generally characterized the PM2.5 NAAQS as a
NAAQS for a new indicator of PM. EPA did not replace the
PM10 NAAQS with the NAAQS for PM2.5 when the
PM2.5 NAAQS were promulgated in 1997. EPA rather retained
the annual and 24-hour NAAQS for PM2.5 as if
PM2.5 was a new pollutant even though EPA had already
developed air quality criteria for PM generally. See 75 FR 64864
(October 20, 2010).
    \7\ EPA interprets 166(a) to authorize EPA to promulgate
pollutant-specific PSD regulations meeting the requirements of
section 166(c) and 166(d) for any pollutant for which EPA
promulgates a NAAQS after 1977.
    \8\ In the October 20, 2010, final rulemaking EPA explained that
the SILs and SMCs are not required by the Act as part of an
approvable SIP program; therefore states are not under any SIP-
related deadline for revising their PSD programs to add these
screening tools. See 75 FR 64864, 64900.
---------------------------------------------------------------------------

B. Condensable PM Correction

    Tennessee's February 26, 2013, submission removes the term
``particulate matter emissions'' from Tennessee's state law definition
of ``regulated NSR pollutant.'' As explained above, Tennessee made this
rule change to be consistent with EPA's October 25, 2012, final
Condensable PM Correction Rule, which revised the definition of
``regulated NSR pollutant'' \9\ to remove an inadvertent requirement
promulgated in the May 16, 2008 NSR PM2.5 Rule.\10\
Specifically, the NSR PM2.5 Rule inadvertently established
that measurement of condensable ``particulate matter emissions'' \11\
must be included as part of the measurement and regulation of
particulate matter. See 77 FR 15656. However, EPA's final Condensable
PM Correction Rule removed this inadvertent requirement from the
definition of ``regulated NSR pollutant.'' See 77 FR 65107. EPA
interprets Tennessee's February 26, 2013, submittal as superseding the
portion of Tennessee's July 29, 2011,\12\ SIP submittal that included
the term ``particulate matter emissions'' in the definition of
``regulated NSR pollutant.'' As such, there is no longer a SIP
submittal to include the term ``particulate matter emissions'' in the
definition of ``regulated NSR pollutant'' before the Agency, and thus,
no further action is required as the provision was never approved into
the SIP--EPA is simply pointing out this issue for clarification
purposes.
---------------------------------------------------------------------------

    \9\ The final rulemaking revised the definition of regulated NSR
pollutant at 40 CFR 51.166(b)(49)(vi), 52.21(b)(50)(vi) and part 51,
appendix S (``Emissions Offset Interpretative Ruling'').
    \10\ The NSR PM2.5 Rule entitled ``Implementation of
the New Source Review Program for Particulate Matter Less than 2.5
Micrometers,'' Final Rule, 73 FR 28321 (May 16, 2008) revised the
federal NSR program requirements at 40 CFR 51.166, 51.165, 52.21 and
``Emissions Offset Interpretative Ruling'' (40 CFR part 51, appendix
S) to establish the framework for implementing preconstruction
permit review for the PM2.5 NAAQS in both attainment and
nonattainment areas.
    \11\ The term ``particulate matter emissions'' includes
filterable particles that are larger than PM2.5 and
PM10 and is an indicator measured under various New
Source Performance Standards (NSPS) (40 CFR part 60). In addition to
the NSPS for PM, it is noted that states have regulated
``particulate matter emissions'' for many years in their SIPs for
PM, and the same indicator has been used as a surrogate for
determining compliance with certain standards contained in 40 CFR
part 63, regarding National Emission Standards for Hazardous Air
Pollutants.
    \12\ Tennessee's July 29, 2011, SIP revision adopted NSR
permitting requirements promulgated in the May 16, 2008, NSR
PM2.5 Rule including the requirement to consider
condensable PM for PSD applicability. As a result of EPA's then
March 16, 2012 (77 FR 15656), proposed Condensable PM Correction
Rule Tennessee submitted a letter to EPA on May 1, 2012, requesting
that EPA not approve into the Tennessee SIP the term ``particulate
matter emissions'' (at rule 1200-03-09-.01(4)(b)47(vi)) as part of
the definition for ``regulated NSR pollutant.'' Consistent with this
request, EPA took final action to approve Tennessee's July 29, 2011,
NSR PM2.5 Rule SIP revision on July 30, 2012, excluding
the term ``particulate matter emissions,'' and at the time did not
act on the portion of Tennessee's revised ``regulated NSR
pollutant'' definition as requested by the State. See 77 FR 44481.
---------------------------------------------------------------------------

II. This Action

    In this rulemaking, EPA is taking final action to approve portions
of Tennessee's May 10, 2013, final SIP revision to adopt the
PM2.5 PSD increments promulgated in the October 20, 2010,
PM2.5 Increment-SILs-SMC Rule (pursuant to section 166(a) of
the CAA and codified at 40 CFR 51.166) into the Tennessee SIP at
Chapter 1200-03-09 \13\ including: (1) The PM2.5 PSD
increments at TDEC's ambient air increments table Rule 1200-.03-
09-.01(4)(f); (2) revisions to the definition of ``baseline date'' at
Rule 1200-03-09-.01(4)(b)15 to establish the PM2.5 ``major
source baseline date'' (consistent with 40 CFR 51.166(b)(14)(i)(a) and
(c)) and to establish the PM2.5 ``trigger date'' used for
determining the ``minor source baseline date'' (consistent with 40 CFR
51.166(b)(14)(ii)(c)); and, (3) a revision to the definition of
``baseline area'' at Rule 1200-03-09-.01(4)(b)14 to specify pollutant
air quality impact annual averages (consistent with 40 CFR
51.166(b)(15)(i) and (ii)). In addition, as discussed in EPA's April
22, 2013 proposal, TDEC's October 4, 2012, parallel processing
submission did not update the state's Class I variances (at Rule 1200-
03-09-.01(4)(n)3) to include the PM2.5 increments or
administrative

amendments to the definition of ``baseline area'' (at Rule 1200-03-
09-.01(4)(b)15(i) and (ii)(I)) established in the October 20, 2010,
rule and codified at 40 CFR 51.166. See 77 FR 68279. Tennessee's May
10, 2013, final submission adopting the PM2.5 PSD increments
addresses the two abovementioned provisions to be consistent with the
PSD increments portion of the PM2.5 Increments-SILs-SMC
Rule. These changes provide for the implementation of the
PM2.5 PSD increments for the PM2.5 NAAQS in the
State's PSD program and became state effective on April 24, 2013.
---------------------------------------------------------------------------

    \13\ Tennessee currently has a SIP-approved NSR program for new
and modified stationary sources. TDEC's PSD preconstruction rules
are found at Air Quality Regulations, Chapter 1200-03-09--
Construction and Operating Permits, Rule Number .01--Construction
Permits and apply to major stationary sources or modifications
constructed in areas designated attainment areas or unclassifiable/
attainment areas as required under part C of title I of the CAA with
respect to the NAAQS.
---------------------------------------------------------------------------

    Pursuant to section 110 of the CAA, EPA is approving portions of
Tennessee's May 10, 2013, SIP revision to address PM2.5 PSD
increments. In EPA's April 22, 2013, proposed rulemaking, EPA proposed
not to approve into the Tennessee SIP the PM2.5 SILs and SMC
as a result of the January 22, 2013, D.C. Circuit Court's decision. As
requested in TDEC's May 10, 2013, SIP submission, EPA is not taking
final action at this time on any portions of Tennessee's PSD SIP
submission regarding the PM2.5 SILs and SMC provisions as
codified at 40 CFR 51.166 and 52.21.

III. Final Action

    EPA is taking final action to approve portions of Tennessee's May
10, 2013, SIP revision to adopt only the PM2.5 increments as
amended in the October 20, 2010, PM2.5 PSD Increments-SILs-
SMC Rule. EPA has made the determination that these portions of
Tennessee's SIP revision are approvable because they are in accordance
with section 110 of the CAA and EPA regulations regarding NSR
permitting.

IV. Statutory and Executive Order Reviews

    Under the CAA, 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 CAA. 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 Order
12866 (58 FR 51735, October 4, 1993);
     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 (Pub. L. 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 CAA; 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, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by September 23, 2013. 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. 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, Greenhouse gases,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: July 12, 2013.
Beverly H. Banister,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart RR--Tennessee

0
2. In Section 52.2220, Table 1 in paragraph (c) is amended by revising
the entry for Section 1200-3-9-.01 ``Definitions'' to read as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (c) * * *

                                   Table 1-EPA Approved Tennessee Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State
         State citation             Title/subject    effective date   EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                               CHAPTER 1200-3-9 CONSTRUCTION AND OPERATING PERMITS
----------------------------------------------------------------------------------------------------------------
Section 1200-3-9-.01...........  Definitions.......       4/24/2013  7/25/2013 [Insert   7/25/2013 [Insert
                                                                      citation of         citation of
                                                                      publication].       publication]--EPA is
                                                                                approving Tennessee's
                                                                                May 10, 2013, SIP
                                                                                revision to Chapter
                                                                                1200-3-9-.01 with the
                                                                                exception of the PM2.5
                                                                                SILs (at 1200-3-9-
                                                                                .01(5)(b)1(xix)) and
                                                                                SMC (at 1200-3-9-
                                                                                .01(4)(d)6(i)(III)) as
                                                                                promulgated in the
                                                                                October 20, 2010,
                                                                                PM2.5 Increments-SILs-
                                                                                SMC Rule.
                                                                                February 7, 2012 (77 FR
                                                                                6016)--EPA is
                                                                                approving Tennessee's
                                                                                May 28, 2009, SIP
                                                                                revisions to Chapter
                                                                                1200-3-9-.01 with the
                                                                                exception of the
                                                                                ``baseline actual
                                                                                emissions''
                                                                                calculation revision
                                                                                found at 1200-3-9-
                                                                                .01(4)(b)45(i)(III),
                                                                                (4)(b)45(ii)(IV),
                                                                                (5)(b)1(xlvii)(I)(III)
                                                                                and
                                                                                (5)(b)1(xlvii)(II)(IV)
                                                                                of the submittal.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-17842 Filed 7-24-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 5, 2009 (Volume 74, Number 191)]
[Notices]
[Page 51148]
[DOCID:fr05oc09-44]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER02-2001-008; Docket No. ER06-63-000]

Electric Quarterly Reports; Take Two, LLC; Notice of Revocation
of Market-Based Rate Tariffs

October 23, 2008.
    On September 18, 2008, the Commission issued an order announcing
its intent to revoke the market-based rate authority of two public
utilities that had failed to file their required Electric Quarterly
Reports.\1\ The Commission gave the utilities fifteen days in which to
file their overdue Electric Quarterly Reports or face revocation of
their market-based rate tariffs.
---------------------------------------------------------------------------

    \1\ Electric Quarterly Reports, 124 FERC ] 61,242 (2008)
(September 18 Order).
---------------------------------------------------------------------------

    In Order No. 2001, the Commission revised its public utility filing
requirements and established a requirement for public utilities,
including power marketers, to file Electric Quarterly Reports
summarizing the contractual terms and conditions in their agreements
for all jurisdictional services (including market-based power sales,
cost-based power sales, and transmission service) and providing
transaction information (including rates) for short-term and long-term
power sales during the most recent calendar quarter.\2\
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    \2\ Revised Public Utility Filing Requirements, Order No. 2001,
67 FR 31,043, FERC Stats. & Regs. ] 31,127 (April 25, 2002), reh'g
denied, Order No. 2001-A, 100 FERC ] 61,074, reconsideration and
clarification denied, Order No. 2001-B, 100 FERC ] 61,342, order
directing filings, Order No. 2001-C, 101 FERC ] 61,314 (2002).
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    In the September 18 Order, the Commission directed Solaro Energy
Marketing Corporation and Take Two, LLC. each to file the required
Electric Quarterly Reports within 15 days of the date of issuance of
the order or face revocation of their authority to sell power at
market-based rates and termination of their electric market-based rate
tariffs. \3\
---------------------------------------------------------------------------

    \3\ September 18 Order at Ordering Paragraph A.
---------------------------------------------------------------------------

    The time period for compliance with the September 18 Order has
elapsed. One company identified in the September 18 Order (Take Two,
LLC) has failed to file its delinquent Electric Quarterly Reports.
    The Commission hereby revokes this company's market-based rate
authority and terminates the electric market-based rate tariff.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-23950 Filed 10-2-09; 8:45 am]

BILLING CODE 6717-01-P