[Federal Register Volume 85, Number 41 (Monday, March 2, 2020)]
[Notices]
[Page 12362]
[FR Doc No: 2020-04296]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, March 4, 2020.

PLACE: The meeting will be held at the Commission's headquarters, 100 F
Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matters of the closed meeting will consist of the
following topics:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: February 26, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-04296 Filed 2-27-20; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Page 16462]
[FR Doc No: 2011-6943]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Heli Electronics Corp., Order of Suspension of
Trading

March 21, 2011.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Heli Electronics Corp. (``HELI''), a Nevada corporation with
headquarters and operations in the People's Republic of China, which
trades in the over-the-counter market under the symbol ``HELI.''
    Questions have arisen regarding the accuracy and completeness of
information contained in HELI's public filings with the Commission
concerning, among other things, the company's cash balances and
accounts receivable. The company has failed to disclose that the
company's independent auditor has resigned due to accounting
irregularities involving (a) discrepancies between HELI's accounting
records for cash balances and official bank statements obtained by the
auditors from the company's bank, (b) discrepancies concerning the
existence and location of company customers, and (c) the possibility
that accounting records could have been falsified. Due to these
irregularities, the company's auditor has resigned from its engagement
to audit the company's consolidated financial statements for the year
ended December 31, 2010, and has withdrawn its audit opinion issued
June 15, 2010 relating to the audit of the company's consolidated
financial statements as of December 31, 2009 and 2008.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the above-listed
company is suspended for the period from 9:30 a.m. EDT, March 21, 2011,
through 11:59 p.m. EDT, on April 1, 2011.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-6943 Filed 3-21-11; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Page 67442]
[FR Doc No: 2013-26978]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2013-53]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before December 2, 2013.

ADDRESSES: You may send comments identified by Docket Number FAA-2013-
0778 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Katherine L. Haley, ARM-203, Federal
Aviation Administration, Office of Rulemaking, 800 Independence Ave
SW., Washington, DC 20591; email<EMAIL_ADDRESS>(202) 493-
5708.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on November 6, 2013.
Brenda D. Courtney,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2013-0778.
    Petitioner: Embry-Riddle Aeronautical University.
    Section of 14 CFR Affected:
    14 CFR Part: 141 Appendix: C (4)(b)(5).
    Description of Relief Sought:
    Embry-Riddle Aeronautical University (Embry-Riddle) is requesting
relief for an approved training course for the instrument rating. The
relief requested would allow time obtained in an Advanced Aviation
Training Device (AATD) to be creditable for up to 40% of the total hour
requirement of the course.
[FR Doc. 2013-26978 Filed 11-8-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 3, 2008 (Volume 73, Number 107)]
[Notices]
[Page 31735-31736]
[DOCID:fr03jn08-91]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Clarification of Solicitation of Applications and
Notice of Funding Availability for the Capital Assistance to States--
Intercity Passenger Rail Service Program

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Clarification regarding solicitation of applications and notice
of funding availability.

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SUMMARY: On February 19, 2008, FRA issued a Notice of Funding
Availability and Solicitation of Applications for the Capital
Assistance to States--Intercity Passenger Rail Service Program. On
April 18, 2008, in response to questions posed by prospective
applicants, FRA issued Notice of Clarification addressing three issues
related to applicant and project eligibility. FRA is now issuing
further clarification, as described below.

FOR FURTHER INFORMATION CONTACT: Peter Schwartz, Office of Railroad
Development (RDV-11), Federal Railroad Administration, 1200 New Jersey
Avenue, SE., Washington, DC 20590. Phone:<PHONE_NUMBER>; Fax: (202)
493-6330.

SUPPLEMENTARY INFORMATION: The sections of the February 19, 2008 notice
labeled DATES and ``Schedule for Capital Grant Program'' are amended to
read as follows.

DATES: FRA will begin accepting grant applications on March 18, 2008.
Applications may be submitted until the earlier of September 30, 2009,
or the date on which all available funds will have been committed under
this program. The last-mentioned date will be announced in the Federal
Register.
    Applications submitted by June 30, 2008 will be considered in the
first round of awards on the basis of application materials that FRA
has received as of that date. Any subsequent rounds of awards will
depend on the availability of funds after the first round of awards.
    Schedule for Capital Grant Program: FRA will begin accepting grant
applications on March 18, 2008. Applications for the first round of
awards must be submitted by June 30, 2008. For subsequent rounds of
awards, if any, deadlines will be announced in the Federal Register.
Due to the limited funding available under this program: (1) Applicants
are encouraged to submit their applications at the earliest date
practicable in order to maximize the consideration of their
applications in

the competition; (2) applications will be considered in their entirety;
applicants proposing two or more projects, each with independent
utility, are encouraged to submit a separate application for each
project; and (3) FRA may suggest that an applicant submit a revised
application reflecting a refined scope of work and budget.
    Applicants that have submitted an application by June 30, 2008 will
be considered in the first round of awards on the basis of application
materials that FRA has received as of that date. FRA anticipates
announcing the first award(s) pursuant to this notice during FY 2008.
Applications (including any subsequent revisions thereto) not selected
for award in a given round in the competition, along with applications
received subsequent to the cut-off date for the prior round of awards,
may be considered, if merited, in a subsequent round of awards.

    Issued in Washington, DC on May 29, 2008.
Mark E. Yachmetz,
Associate Administrator for Railroad Development.
[FR Doc. 08-1313 Filed 5-29-08; 2:35 pm]

BILLING CODE 4910-06-P


PBT Profiler Methodology [Persistence][ Bioaccumulation][ Toxicity][ Results] Introduction The PBT profiler uses a well defined set of procedures to predict the persistence, bioaccumulation, and toxicity of chemical compounds when experimental data are not available. The only user required inputs for the PBT profiler are a unique identifier (e. g., a CAS Registry Number, product ID, or acronym) and a chemical structure. Chemical structures are entered into the PBT profiler using a SMILES notation [Weininger, D. SMILES, A Chemical and Information System. 1. Introduction to Methodology and Encoding Rules. Journal of Chemical Information and Computer Sciences 28: 31 6 (1988)]. An automatic look up function based on the CAS Registry number simplifies this process by automatically retrieving a chemical's SMILES notation using a pre existing database containing over 100,000 records. The chemical structure is then passed to nine separate estimation modules, and the results are converted electronically to a persistence, bioaccumulation, and toxicity value. The methodology used by the PBT profiler and its estimation modules is discussed in this section.

The persistence, bioaccumulation, and toxicity values estimated by the PBT profiler are automatically compared to criteria published by the EPA and other international agencies. Those values that that meet or exceed the criteria are flagged for the user on the PBT Profiler results page. A discussion of the persistence, bioaccumulation, and toxicity criteria used by the PBT Profiler is provided.

Persistence Air The PBT profiler calculates an atmospheric half life by determining the importance of a chemical's reaction with two of the most prevalent atmospheric oxidants, hydroxyl radicals and ozone. The half life is calculated directly from gas phase hydroxyl radical and ozone reaction rate constants. These rate constants are obtained from a database of measured values or, if no experimental values are available, they are estimated using the method of Atkinson [Meylan, W. M. and Howard. P. H. Computer Estimation of the Atmospheric Gas Phase Reaction Rate of Organic Compounds with Hydroxyl Radicals and Ozone. Chemosphere 26: 2293 9 (1993)]. The half life is calculated from the rate constant and an average atmospheric concentration of these oxidants based on a 24hourday[ Prinn, R., Cunnold, P., Simmonds, R., Alyea, R., Boldi, A., Crawford, P., Fraser, D., Gutzler, D., Hartley, R., Rosen, R., and Rasmussen R. Global Average Concentration and Trend for Hydroxyl Radicals Deduced From ALE/ GAGE Trichloroethane (Methyl Chloroform) Data for 1978 1990. Journal of Geophysical Research 97: 2445 61 (1992); Atkinson, R and Carter, W. P. L. Kinetics and Mechanisms of the Gas Phase Reactions of Ozone with Organic Compounds under Atmospheric Conditions. Chemical Reviews 84: 437 70 (1984)].

The atmoshperic half life for each process is calculated as follows:

Hydroxyl radicals t1/ 2 = 0. 693/( rate constant cm 3 /molecule sec x 5x10 5 molecules/ cm 3 * 86400 sec/ day)

Ozone t1/ 2 = 0. 693/( rate constant cm 3 /molecule sec x 7x10 11 molecules/ cm 3 * 86400 sec/ day)

and the overall half life is obtained as:

1/ t1/ 2overall = 1/ t1/ 2 Hydroxyl radicals + 1/ t1/ 2 Ozone Water, Soil, and Sediment Half lives for water, soil, and sediment are determined using the ultimate biodegradation expert survey module of the BIOWIN estimation program [Boethling, R. S., Howard, P. H., Meylan, W. M., Stiteler, W., Beauman, J., and Tirado, N., Group Contribution Method for Predicting Probability and Rate of Aerobic Biodegradation. Environmental Science and Technology 28: 459 65 (1994)]. This estimation program provides an indication of a chemical's environmental biodegradation rate in relative terms such as hours, hours to days, days, days to weeks, and so on; the terms represent the approximate amount of time needed for degradation to be "complete". This output cannot be directly compared to established half life criteria for purposes of identifying chemicals with PBT characteristics, nor can it be used directly by the Level III fugacity model. These conversion factors consider that 6 half lives constitute "complete" degradation of a chemical substance to occur (assuming first order kinetics) and are based on the mean value within the estimated time range. The resulting conversion factors for water are provided below.

BIOWIN Output Converted Half Life (days)

Hours 0. 17 Hours to Days 1. 25 Days 2.33 Days to Weeks 8. 67 Weeks 15 Weeks to Months 37.5 Months 60 Recalcitrant 180 Note that the maximum value returned by this model is 180 days even though the half life of recalcitrant molecules in the environment is likely to be substant ially longer.

It is known that ultimate biodegradation is generally slower under anaerobic condit ions than under aerobic condit ions. The BIOWIN ult imate survey model that is used in this Profiler assumes aerobic conditions, but deeper layers of aquatic sediments are usually anaerobic. To account for the slower rate of ultimate biodegradation in sediment, the PBT Profiler uses a conversion factor developed in EPA's P2 framework. The PBT Profiler assumes that sediments are anaerobic and that the rate of ultimate biodegradation in sediment is on average one ninth (1/ 9) of that in the water column (which is assumed to be aerobic).

Similarly, the PBT Profiler makes an adjustment for the biodegradation rate for soil. It is generally believed that the biodegradation rate for a chemical in soil is, on average, one half (1/ 2) that in water. The PBT Profiler, therefore, assigns the half life in soil to be twice that estimated for water.

Percentage in Each Medium The PBT profiler uses the Level III fugacity model of Mackay [Mackay D., Paterson S., and Shiu W. Y. Generic Models for Evaluating the Regional Fate of Chemical. Chemosphere 24: 695 718 (1992)] to determine the percentage of a chemical in each medium. The Level III fugacity model is a multimedia model that uses a chemical's physical/ chemical properties and degradation half lives for air, water, soil and sediment. The Level III fugacity model was chosen for the PBT profiler because it is available in an electronic format, could be readily modified for use in a web based application, and has been validated in several studies [for example, see Kuhne R. et al. Environmental Toxicology and Chemistry 16: 2067 9 (1997); Matoba Y et al. Journal of the Air and Waste Management Association 48: 969 78; Suzuki N et al. Chemosphere 37: 2239 59 (1998)].

The Level III fugacity model is a non equilibrium, steady state multimedia fate model that is designed to provide information on environmental partitioning and intermedia transport at the screening level. This additional information is consistent with the basic purpose of the Profiler, which is to provide the user with valuable information to help establish whether a more rigorous investigation of PBT characteristics is required.

The fugacity model requires a series of physical/ chemical properties and environmental half lives as input. Environmental half lives are determined for air, water, soil, and sediment as discussed above. Physical/ chemical properties are provided by SRC's suite of structure based estimation programs. Physical properties are used directly by the fugacity model to determine the transport between environmental compartments. These properties, and citations to the methodology used for each, are:

  Henry's Law constant [Meylan, W. M. and Howard, P. H. Bond contribution method for estimating Henry's Law Constants. Environmental Toxicology and Chemistry 10: 1283 93 (1991)];   Vapor pressure [Lyman, W. J., Reehl, W. F. and Rosenblatt, D. H. Handbook of Chemical Property Estimation Methods. Washington, DC: American Chemical Society (1990)];   Melting point [Stein, S. E. and Brown, R. L. Estimation of Normal Boiling Points from Group Contributions. Journal of Chemical Information and Computer Sciences 34: 581 7 (1994); Reid, R. C., Prausnitz, J. M., and Poling, B. E. The Properties of Gases and Liquids. Fourth edition. NY: McGraw Hill, Inc., Chapter 2 (1987)];   Water solubility [Meylan, W. M. and Howard, P. H. Improved Method for Estimating Water Solubility from Octanol/ Water Partition Coefficient. Environmental Toxicology and Chemistry 15: 100 6 (1996)];   Octanol/ water partition coefficient [Meylan, W. M. and Howard, P. H. Atom/ Fragment Contribution Method for Estimating Octanol Water Partition Coefficients. Journal of Pharmaceutical Science 84: 83 92 (1996)]; and   Molecular weight (determined from the SMILES notation).

The PBT profiler will automatically use experimental values for Henry's Law constant and octanol/ water partition coefficient through an automatic database look up function in preference to estimated values. Future versions will indicate when an experimental value was used in the persistence estimation.

If the Henry's Law constant can not be estimated from chemical structure, the PBT Profiler then determines if a water solubility and vapor pressure are available. If they are, the Henry's Law constant is determined by dividing the vapor pressure by the water solubility (after converting each value to the proper units).

The PBT profiler uses the default settings of the Level III fugacity model [Mackay D., Paterson S., and Shiu W. Y. Generic Models for Evaluating the Regional Fate of Chemical. Chemosphere 24: 695 718 (1992)] for its calculations, and displays the results of these calculations as the percentage of the chemical expected at steady state in the different environmental media. Default emission rates are equal amounts (1, 000 kg/ hr) to air, soil, and water (direct discharges to sediment are unlikely). The model treats a generic environment of 100,000 square km with 10% water; 90% soil surface; water depth 20 m; soil depth 20 cm; sediment depth 5 cm; atmospheric height 1000 m.

The PBT Profiler also provides the user with different release scenarios for a chemical to aid in identifying P2 opportunities that may be more consistent with it's expected life cycle. On the P2 considerations page, the emission rate is set at either 1 or 1, 000 kg/ hr for soil, water, and air, and the resulting distribution and half life in each environmental compartment is provided.

The Level III fugacity model, by design, does not consider a chemical's potential to migrate to groundwater. Therefore, the PBT Profiler does not explicitly consider the fate of a chemical substance in groundwater. Because a complete P2 assessment should consider a chemical's potential to migrate to groundwater, the PBT Profiler contains a simple set of algorithms to highlight chemicals that may travel through soil into an underground aquifer based on its octanol water partition coefficient (Kow). The PBT Profiler only highlights chemicals that are expected to have the potential to persist in groundwater. If the log Kow of an individual chemical is < 4 and it is found to be persistent in sediment (half life > 60 days), then the PBT Profiler flags this chemical as one that has the potential to migrate to and be persistent in groundwater. This information is provided to the user on the P2 considerations page.

Persistence Ranking The PBT Profiler provides a persistence summary (also called the persistence ranking) as the initial level of its integrated output. The persistence ranking is based on the results of the physical/ chemical properties estimates (excluding those for toxicity and bioconcentration) as summarized in the second level of the PBT Profiler output  the quantitative estimate of a chemical's persistence in and partitioning to the four environmental media. The persistence ranking is derived used the following methodology.

PBT strategies typically consider the persistence of a chemical in water, soil, and sediment because these are the media associated with bioaccumulation. The PBT Profiler first determines the amount of the chemical expected to be found in water, soil, and sediment (expressed as a percentage of the total amount in the environment) using the fugacity model. It then determines which of these three compartments the chemical is most likely to partition to (the one with the highest percentage). Using this predominant compartment, the half life in that compartment is then compared to the PBT Profiler criteria to determine the persistence ranking. If the half life in the predominant compartment exceeds the PBT Profiler criteria, the chemical is designated as persistent or very persistent in the summary output.

The advantage of this methodology is that it considers the two most important components of a chemical's fate in the environment; its removal and its partitioning. If only one aspect of a chemical's likely fate were considered, the potential for misclassification increases. For example, a chemical that partitions only to water and soil may have an estimated half life in water of 15 days, an estimated half life in soil of 30 days, and an estimated half life in sediment of 135 days. This chemical would exceed the PBT Profiler persistence criteria for sediment based upon its half life; however, the results of the fugacity model indicate that it is not expected to be present in sediment. Its ranking in either soil and water, therefore, are more representative of its persistence in the environment.

The PBT Profiler methodology was developed with the aid of a database of experimental biodegradation rates for 136 chemicals. Comparison of the PBT Profiler results to an evaluated data set is provided in the results section.

Overall Persistence It is important to distinguish between persistence in a single medium and overall environmental persistence. Persistence in an individual medium is controlled by transport of the substance to other media, as well as transformation to other molecular species. Persistence in the environment as a whole is a distinct concept. It is based on the observations that the environment behaves as a set of interconnected media, and that a chemical substance released to the environment will become distributed in these media in accordance with its intrinsic (physical/ chemical) properties and reactivity. Multimedia mass balance models offer the most convenient means to estimate overall environmental persistence from information on sources and loadings, chemical properties and transformation processes, and intermedia partitioning.

The PBT Profiler uses a model similar to the TaPL3 model, available from the Trent University website, to obtain an estimate of overall persistence in which all net loss from the defined model environment is due to reaction (e. g., biodegradation) only; i. e., there are no advective losses from the model environment. This is appropriate in screening level review for PBT potential since advective losses merely relocate a chemical rather than alter it chemically. Overall persistence can be thought of as the integration of medium specific halfliveswith intermedia transportand partitioning to give a weighted averageofthe persistences in the individual media. The results are expressed as the environmental residence time tauR, which is equivalent to the total amount of the chemical in the defined environment divided by the total loss rate due to reaction (or the input rate, since these are equal in a steady state, level III model). The overall persistence provides a meaningful way of expressing relative persistence when, for example, a chemical is discharged to one medium but rapidly partitions to another, where the half life is very different. Users should consult the recent work by Webster et al. for further details [Webster E., Mackay, D., and Wania, F. Evaluating Environmental Persistence. Environmental Science and Technology 17: 2148 2158 (1998)]. Characteristic Travel Distance (CTD)

Characteristic Travel Distance is an expression of a chemical's long range transport (LRT) potential. LRT refers to the ability of a substance to be transported long distances (generally, on a continental or global scale) via advection, potentially resulting in widespread distribution and deposition in regions far from where the chemical was produced or used. Most attention to LRT potential focuses on atmospheric transport. LRT potential is linked to overall environmental persistence, but no simple relationship between the two exists because the medium or media of transport may not be the media in which persistence is longest. The PBT Profiler uses a model similar to the TaPL3 model to calculate a chemical's CTD in air over soil and water, LA, expressedin kilometers. The model assumes release is ent irely to air, but otherwise uses the same defaults as in the Level III fugacity model with advection off. For further details users should consult the recent work by Beyer et al. [Beyer A., Mackay, D., Matthies, M., Wania, F. and Webster, W. Assessing Long range Transport Potential of Persistent Organic Pollutants. Environmental Science and Technology. 34: 699 703 (2000)].

Bioaccumulation The PBT profiler determines a chemical's potential to bioaccumulate directly from an estimated bioconcentration factor (BCF). The bioconcentration factor is estimated using SRC's BCFWIN estimation program [Meylan, W. M., Howard, P. H., Boethling, R. S., Aronson, D., Printup, H., and Gouchie, S. Improved Method for Estimating Bioconcentration Factor (BCF) from Octanol Water Partition Coefficient. Environmental Toxicology and Chemistry 18: 664 72 (1997)]. The estimated bioconcentration factors are compared to those contained in the PBT Profiler Criteria. The BCFWIN program yields a screening level prediction of BCF based on a chemical's octanol/ water partition coefficient and one or more chemical structure based correction factors, if applicable. The model does not explicitly address a variety of factors that may influence bioaccumulation under field conditions, such as possible metabolism of the chemical in exposed organisms, which could lead to actual bioaccumulation being lower than predicted. The user needs to exercise due caution when interpreting BCFWIN results.

Toxicity The PBT Profiler considers only aquatic toxicity and estimates it using the ECOSAR (Ecological Structure Activity Relationships) program. ECOSAR predicts the toxicity of industrial chemicals to aquatic organisms such as fish, invertebrates, and algae by using Structure Activity Relationships (SARs). ECOSAR uses SARs to predict the aquatic toxicity of chemicals based on their structural similarity to chemicals for which aquatic toxicity data are available. SARs express the correlations between a compound's physical/ chemical properties and its aquatic toxicity. SARs measured for one compound can be used to predict the toxicity of similar compounds belonging to the same chemical class. The SARs contained within the ECOSAR are based on test data and many of the SAR predictions have been validated. More information on ECOSAR, as well as the program itself, is available from the EPA.

ECOSAR estimates a chemical's acute (short term) aquatic toxicity and, when available, chronic (long term or delayed) toxicity. For the PBT Profiler, the fish chronic (ChV) values are used to predict toxicity. If the ChV cannot be estimated using the QSAR equations available in ECOSAR, the PBT Profiler will return "not estimated." The PBT Profiler identifies chemicals that exceed the log octanol/ water partition coefficient cutoffs for the QSARs used by ECOSAR. If the cutoffs are exceeded for a specific chemical, the PBT Profiler will return a ChV value of "Not Estimated" and it will not run the ECOSAR estimation. Because of the algorithms used by ECOSAR, this program estimates a water solubility separately using the octanol/ water partition coefficient.

The PBT Profiler compares the ChV (in mg/ l) of each chemical to its water solubility. If the water solubility is less than the ChV, then there are no effects at saturation. For chemicals that the PBT Profiler identifies as potentially persistent and bioaccumulative, the no effects at saturation flag is not used in the overall ranking as these chemicals may accumulate to higher levels over time. For all other chemicals that may display no effects at saturation, the PBT Profiler returns a green Toxicity ranking.

The PBT Profiler uses QSARs for neutral organic compounds for estimating the fish ChV. For a comprehensive description of how these QSARs were developed, please see the ECOSAR technical manual.

Results PBTs and POPs The results of the PBT profiler were compared to organic chemicals generally recognized as being PBTs; the 64 chemicals in EPA's final rule on Persistent Bioaccumulative Toxic (PBT) Chemicals and the 12 United Nations Environment Programme (UNEP) Persistent Organic Pollutants (POPs) .

For the 64 chemicals in EPA's TRI Rule, the PBT Profiler flagged 49 as PBTs and 13 as persistent and bioaccumulative with the toxicity "not estimated." As indicated on the "Interpreting the PBT Profiler Results" Page, persistent and bioaccumulate chemicals may accumulate in the environment to relatively high levels. Therefore, persistent and bioaccumulative chemicals without an estimated toxicity should be reviewed carefully (and using the same techniques as one estimated to be a PBT) when identifying P2 opportunities. Similar results were obtained for the 12 POPs (using a representative structure for the PCBs, polychlorinated dioxins, and polychlorinated furans). All but 3 of the POPs are listed in the final TRI rule.

The results described above are summarized in the following tables.

Persistent, bioaccumulative, and toxic organic chemicals in EPA's final PBT Rule for TRI.

CAS Name PBT Profiler Results 1 115 32 2 Dicofol P B T 2 118 74 1 Hexachlorobenzene P B T 3 1582 09 8 Trifluralin P B T 4 1746 01 6 2, 3, 7, 8 Tetrachlorodibenzo p dioxin P B T 5 189 55 9 Benzo( r, s, t) pentaphene P B T 6 189 64 0 Dibenzo( a, h) pyrene P B T 7 191 24 2 Benzo( g, h, i) perylene P B T 8 191 30 0 Dibenzo( a, i) pyrene P B T 9 192 65 4 Dibenzo( a, e) pyrene P B T 10 193 39 5 Indeno( 1,2, 3 cd) pyrene P B T 11 19408 74 3 1,2,3, 7,8, 9 Hexachlorodibenzo p dioxin P B T 12 194 59 2 7H Dibenzo( c, g) carbazole P B T 13 205 82 3 Benzo( j) fluoranthene P B T 14 205 99 2 Benzo( b) fluoranthene P B T 15 206 44 0 Benzo( j, k) fluorene (fluoranthene) P BT 16 207 08 9 Benzo( k) fluoranthene P B T 17 218 01 9 Benzo( a) phenanthrene P B T 18 224 42 0 Dibenz( a, j) acridine P B T 19 226 36 8 Dibenz( a, h) acridine P B T 20 29082 74 4 Octachlorostyrene P BT 21 309 00 2 Aldrin P BT 22 31508 00 6 2,3', 4, 4', 5 Pentachlorobiphenyl P B T 23 32598 13 3 3,3', 4, 4' Tetrachlorobiphenyl P B T 24 32598 14 4 2,3,3', 4, 4' Pentachlorobiphenyl P B T 25 3268 87 9 1,2,3, 4,6, 7,8, 9 Octachlorodibenzo pdioxin P B T 26 32774 16 6 3,3', 4, 4', 5,5' Hexachlorobiphenyl P B T 27 35822 46 9 1,2,3, 4,6, 7,8 Heptachlorodibenzo pdioxin P B T 28 3697 24 3 5 Methylchrysene P B T 29 38380 08 4 2,3,3', 4, 4', 5 Hexachlorobiphenyl P B T 30 39001 02 0 1,2,3, 4,6, 7,8, 9 Octachlorodibenzofuran P B T 31 39227 28 6 1,2,3, 4,7, 8 Hexachlorodibenzo p dioxin P BT 32 39635 31 9 2,3,3', 4, 4', 5,5' Heptachlorobiphenyl P B T 33 40321 76 4 1,2,3, 7,8 Pentachlorodibenzo p dioxin P B T 34 40487 42 1 Pendimethalin P BT 35 465 73 6 Isodrin P BT 36 50 32 8 Benzo( a) pyrene P B T 37 51207 31 9 2,3,7, 8 Tetrachlorodibenzofuran P B T 38 52663 72 6 2,3', 4, 4', 5,5' Hexachlorobiphenyl P B T 39 53 70 3 Dibenzo( a, h) anthracene P B T 40 5385 75 1 Dibenzo( a, e) fluoranthene P B T 41 5522 43 0 1 Nitropyrene P B T 42 55673 89 7 1,2,3, 4,7, 8,9 Heptachlorodibenzofuran P B T 43 56 49 5 3 Methylcholanthrene P B T 44 56 55 3 Benzo( a) anthracene P B T 45 57117 31 4 2,3,4, 7,8 Pentachlorodibenzofuran P B T 46 57117 41 6 1,2,3, 7,8 Pentachlorodibenzofuran P B T 47 57117 44 9 1,2,3, 6,7, 8 Hexachlorodibenzofuran P B T 48 57465 28 8 3,3', 4, 4', 5 Pentachlorobiphenyl P B T 49 57653 85 7 1,2,3, 6,7, 8 Hexachlorodibenzo p dioxin P B T 50 57 74 9 Chlordane P BT 51 57 97 6 7, 12 Dimethylbenz( a) anthracene P B T 52 60851 34 5 2,3,4, 6,7, 8 Hexachlorodibenzofuran P B T 53 608 93 5 Pentachlorobenzene P B T 54 65510 44 3 2', 3, 4, 4', 5 Pentachlorobiphenyl P B T 55 67562 39 4 1,2,3, 4,6, 7,8 Heptachlorodibenzofuran P B T 56 69782 90 7 2,3,3', 4, 4', 5' Hexachlorobiphenyl P B T 57 70648 26 9 1,2,3, 4,7, 8 Hexachlorodibenzofuran P B T 58 72 43 5 Methoxychlor P B T 59 72918 21 9 1,2,3, 7,8, 9 Hexachlorodibenzofuran P B T 60 74472 37 0 2,3,4, 4', 5 Pentachlorobiphenyl P B T 61 76 44 8 Heptachlor P BT 62 79 94 7 Tetrabromobisphenol A P B T 63 8001 35 2 Toxaphene P B T 64 1336 36 3 Polychlorinated Biphenyls (PCBs) P B T Persistent Organic Pollutants (POPs)

# CAS Name PBT Profiler Results 1 309 00 2 Aldrin P BT 2 57 74 9 Chlordane P BT 3 50 29 3 DDT P BT 4 60 57 1 Dieldrin P B T 5 72 20 8 Endrin P B T 6 76 44 8 Heptachlor P BT 7 118 74 1 Hexachlorobenzene P B T 8 8001 35 2 Toxaphene P B T 9 2385 85 5 Mirex P B T 10 1336 36 3 Polychlorinated biphenyls (PCBs) P B T 11 57653 85 7 Polychlorinated dibenzo p dioxins P B T 12 60851 34 5 Polychlorinated dibenzofurans P B T PBT Profiler Results for Chemicals in an Evaluated Data Set Introduction The persistence estimates from the PBT Profiler were compared to a published data set containing environmental persistence summaries [Mackay, D; Shiu, W. Y.; Ma, K. Physical Chemical Properties & Environmental Fate on CD ROM. CRC Press . ISBN/ ISSN: 0849321921 (2000)]. In this compilation, published data were used to place a chemical's half life into one of nine evaluated persistence classes as shown in the following table (for water, soil, and sediment).

Evaluated Class Mean Half Life (d) Half Life Range (d)

1 0. 21 <0.42 2 0. 71 0. 42 1.2 3 2. 3 1.2 4.2 4 7. 0 4.2 12.5 5 23 12.5 42 6 70.8 42 125 7 229 125 417 8 708 417 1250 9 2292 >1250 Classes 1 5 correspond to the PBT Profiler "not persistent" criteria (Green, half life < 60 days ) and classes 8 and 9 correspond to the "very persistent" (Red, > 180 days )criteria. The half life ranges for classes 6 & 7 overlap more than one Profiler criteria and, therefore, chemicals in these classes can not be compared directly to the "persistent" category (Yellow, >60 days and < 180 days).

Comparison of the evaluated data set to the PBT Profiler results Initial results were obtained by running the 293 chemicals in this data set through the PBT Profiler. The predominant compartment returned by the PBT Profiler was identified and the evaluated half life class for that compartment was determined. The resulting halflife was then compared to the persistence ranking estimated by the PBT Profiler. For example, the PBT Profiler predicts that acetone will be found predominately in water and that it is not persistent (half life < 60 days). The evaluated pertsitence class for acetone in water is 4, which corresponds to a mean half life of 7 days (range ~4 12 days). Therefore, the results for the evaluated data and the PBT Profiler are in agreement for acetone and this chemical is represented in the area shaded green in the following pie chart. The results for all 293 chemicals in the data set are summarized in the following pie charts (using the PBT Profiler paradigm) by evaluated class (or combined classes, as appropriate).

Of the 164 chemicals in the not persistent category, 133 (81%) were shown to have a half life of < 60 days for both the evaluated data set and the PBT Profiler estimate. However, if one reviews the likely fate of the chemicals that are categorized differently, the literatue indicates that biodegradation is not their primary removal process in the environment. For the 2 chemicals (1%) predicted by the PBT Profiler to be very persistent and the 30 chemicals (18%) predicted to be persistent, all but 3 can be put into one of six chemical groups based on common functionality: chlorephenols and chlorophenyl ethers; beta chloroethers; aromatic amines; carbothiomate pesticides; thiophosphates; and aromatic carbamates. These chemical classes, as well as the remaing three chemicals, are expected to undergo rapid (half life <60 days) chemical degradation in the environment via hydrolysis and/ or photolysis (either direct or indirect phtooxidation) based on the available literature. Even though chemcials that undergo hdyrolysis or other chemical degradation processes should not be run through the PBT Profiler, it is cuurrently the responsibility of the user to identify those chemicals that meet this criteria. For a screening level method developed for a wide range of potential users, it is, therfore, not appropriate to remove these 20 chemicals from this exercise. Nevertheless, it emphaisizes the high degree of agreement between the PBT Profiler estimates and the evaluated data set for this category of chemicals. Future versions of the PBT Profiler may incorporate structure recognition capabilities that will be able to identify functional groups that are known to undergo rapid chemical degradation. Analysis of the PBT Profiler estimates for very persistent chemicals from classes 8 and 9 was also performed. For these 42 chemicals, the Profiler estimated that 36 chemicals would be very persistent and 6 would be persistent.

The 6 chemicals that the PBT Profiler estimated to be persistent include 3 chlorinated biphenyls (a mono, di, and trichloro congenor), pyrene, flouranthene, and trichlorofluoromethane. All of these chemicals should be reviewed carefully when considering P2 opportunies and, from this standpoint, the PBT Profiler estimates are in excellent agreement with the evaluated data.

The pie charts for the chemicals in evaluated classes 6 and 7 are also provided. The halflife range in class 6 overlap the not persistent and persistent categories and those in class 7 overlap the persistent and very persistent categories. Because these two classes do not directly correspond to PBT Profiler criteria, the results should be viewed with caution and a thorough analysis is not warranted. The general trend from class 6 to 7 is consistent with what one would expect in that there was a decrease in the percentage of chemicals that the PBT Profiler predicted to be not persistent with a concomitant (but smaller) increase in the number predicted to be very persistent.

Comparison of the PBT Profiler Results with the Evaluated Data Set The PBT Profiler estimates were compared with 293 chemicals from the evaluated data set containing environmental persistence summaries [Mackay, D; Shiu, W. Y.; Ma, K. Physical Chemical Properties & Environmental Fate on CD ROM. CRC Press. ISBN/ ISSN: 0849321921 (2000)] discussed above. The purpose of this exercise was to evaluate the water, soil, and sediment half life multipliers (1, 4 and 9) used by the PBT Profiler as well as using the predominant compartment instead of the media specific halflife for the persistence ranking (see the PBT Profiler Methodology section on persistence).

The PBT Profiler results were used to separate the 293 chemicals into three groups (not persistent, persistent, and very persistent) and the evaluated half life class for water, soil, and sediment were plotted for each chemical. The predominate compartment, as determined by the PBT Profiler for each chemical, is also provided for each chemical. These graphs were then reorganized for presentation (using a primary sort on water halflife secondary sort on soil half life, tertiary sort on sediment half life). The numbers on the x axis are simply place holders and each graph tick represents a different chemical.

As discussed above, the results must be interpreted with caution because some of the evaluated classes do not directly correspond with the PBT Profiler criteria. In the following graphs, the area shaded red corresponds with the very persistent PBT Profiler category and the area shaded green corresponds with the not persistent category. The PBT Profiler persistent category does not directly correspond to the evaluated classes 6 and 7. Analysis of these data reveals that, in general, the PBT Profiler estimates are in very good agreement with the evaluated data. The results also indicate that the chemicals in the persistent category overwhelmingly (94%) had soil as the predominant compartment while those in the very persistent and not persistent category had essentially an even split of soil or sediment and soil or water as the predominant compartment, respectively. These graphs suggest that using the predominant compartment to determine the persistence ranking is not an overwhelming factor for assigning the overall persistence ranking. For the majority of the chemicals in this data set, selecting the half life in soil instead of sediment would not have changed the persistence ranking. Similarly, selecting the half life in soil instead of water would not have changed the ranking for the not persistent chemicals.

Using the predominant compartment to determine the persistence ranking, however, appears to increase the overall predictive accuracy of the methodology. This is most evident when the half life in one (or more) of the three environmental compartments fall into different persistence categories. For example, chemicals 10 15 in the very persistent group could be placed in either the very persistent or not persistent category based on their medium specific half lives in sediment and water, respectively. Given that these chemicals partition predominantly to sediment, their half life in this media (> 180 days) is likely more representative of thier persistence in the environment. An opposite trend is observed for chemicals in the not persistent group that have estimated sediment half lives greater than 60 days and water (and possibly soil) halflives less than 60 days. If the persistence ranking was based solely on the highest estimated half life in water, soil, or sediment, the environmental persistence would likely be overestimated for these chemicals. This arises directly from the water: soil: sediment half life multipliers of 1: 2: 9 used by the PBT Profiler. If the persistence ranking were based on the highest medium specific half life, the value for sediment (a factor of 9 that of water) would always be used. The expected outcome, therefore, would be a general trend that overestimates a chemical's persistence in the environment. Analysis of the available data indicates that using the predominant compartment half life attenuates this bias and reduces the potential for overestimating a chemical's persistence in the environment.

Developed by the Environmental Science Center under contract to the Office of Pollution Prevention and Toxics , U. S. Environmental Protection Agency Computer Resources Donated by Syracuse Research Corporation Ver 0. 911 BetaR Restricted Access Last Updated April 18, 2001


[Federal Register: December 29, 2006 (Volume 71, Number 250)]
[Rules and Regulations]
[Page 78369-78374]
[DOCID:fr29de06-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2004-0357; FRL-8264-2]
RIN 2060-AO03

National Emission Standards for Hazardous Air Pollutants:
Shipbuilding and Ship Repair (Surface Coating) Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is taking direct final action on amendments to the
national emission standards for hazardous air pollutants (NESHAP) for
shipbuilding and ship repair (surface coating) operations (subpart II)
promulgated on December 15, 1995 (60 FR 64330), under the authority of
section 112(d) of the Clean Air Act (CAA). These direct final rule
amendments close an unintended gap in the scope of activities subject
to the NESHAP by amending the definition of ``ship'' to include all
marine or fresh-water vessels that are either (1) 20 meters or more in
length regardless of the purpose for which the vessel is constructed or
used, or (2) less than 20 meters in length and designed and built
specifically for military or commercial purposes. All shipbuilding and
ship repair coating operations performed on ``ships,'' as so defined,
are subject to Subpart II if they take place at an ``affected source,''
as defined in 40 CFR 63.782. The only exception is that this NESHAP
shall not be construed to apply to coating activities that are subject
to emission limitations or work practices under the NESHAP for the boat
manufacturing at 40 CFR part 63 subpart VVVV. We have also added a
definition of ``commercial'' to further clarify the types of
nonmilitary vessels less than 20 meters that we consider to be ships.
The amended definition of ``ship'' renders the term ``pleasure craft''
unnecessary and the amendments, therefore, eliminate the use of that
term in subpart II.

DATES: The direct final rule is effective on February 27, 2007 without
further notice, unless EPA receives adverse comment by January 29, 2007
or if a public hearing is requested by January 8, 2007. If adverse
comments are received or a public hearing is requested, EPA will
publish a timely withdrawal of the direct final rule in the Federal
Register and inform the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2004-0357 (Legacy No. A-92-11), by one of the following methods:
    1. http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER> and<PHONE_NUMBER>.
    4. Mail: EPA Docket Center, Environmental Protection Agency,
Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Please include a duplicate copy, if possible.
    5. Hand Delivery: Air and Radiation Docket, Environmental
Protection Agency, 1301 Constitution Avenue, NW., Room B-108,
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.
    We request that a separate copy also be sent to the contact person
listed below (see FOR FURTHER INFORMATION CONTACT).
    Instructions. Direct your comments to Docket ID No. OAR-2004-0357.
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.epa.gov/edocket
, 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 EDOCKET, http://www.regulations.gov, or

e-mail. The EPA EDOCKET and the Federal Web sites are ``anonymous
access'' systems, 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 e-mail comment directly to EPA without going through
EDOCKET or http://www.regulations.gov, your e-mail 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 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
EDOCKET on-line or see the Federal Register of May 31, 2002 (67 FR
38102).
    Docket. All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket. Although listed in the index, some

information is not publicly available, i.e., 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 in EDOCKET or in hard
copy at the Air and Radiation Docket, EPA/DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC. The 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 Public Reading Room is (202)
566-1744, and the telephone number for the Air Docket is (202) 566-
1742.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006), or the EPA Web site
at http://www.epa.gov/epahome/dockets.htm for current information on

docket operations, locations and telephone numbers. The Docket
Center's mailing address for U.S. mail and the procedure for
submitting comments to http://www.regulations.gov are not affected by the

flooding and will remain the same.

FOR FURTHER INFORMATION CONTACT: Dr. Mohamed Serageldin, Environmental
Protection Agency, Office of Air Quality Planning and Standards, Sector
Policies and Programs Division (E143-03), Research Triangle Park, NC
27711, telephone number<PHONE_NUMBER>, electronic mail address
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Regulated Entities. The regulated category
and entities affected by this action include:

------------------------------------------------------------------------
            Category                  Examples of regulated entities
------------------------------------------------------------------------
Industry........................  Facilities that are engaged in
                                   shipbuilding and ship repair
                                   operations. The term ship means all
                                   marine or fresh-water vessels that
                                   are either (1) 20 meters or more in
                                   length regardless of the purpose for
                                   which the vessel is constructed or
                                   used, or (2) that are less than 20
                                   meters in length and are designed and
                                   built specifically for military or
                                   commercial purposes. This includes,
                                   but is not limited to, all military
                                   and Coast Guard vessels, commercial
                                   cargo and passenger (cruise) ships,
                                   ferries, tankers, container ships,
                                   patrol and pilot boats, yachts, and
                                   dredges.
------------------------------------------------------------------------
Note: An offshore oil and gas drilling platform is not considered a ship
                    for purposes of this regulation.
------------------------------------------------------------------------
Federal Govt....................  Federal Agencies which undertake
                                   shipbuilding or repair operations
                                   (see above) such as the Navy and
                                   Coast Guard.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather to provide
a guide for readers regarding entities likely to be regulated by this
rule.
    To determine whether your facility, company, business,
organization, etc., is regulated by this action, you should carefully
examine all of the applicability criteria in 40 CFR 63.781 of the rule,
as well as in this direct final rule. If you have any questions
regarding the applicability of this rule to a particular activity,
consult the person listed in the preceding FOR FURTHER INFORMATION
CONTACT section.
    World Wide Web (WWW). In addition to being available in the docket,
an electronic copy of the direct final rule will also be available on
the WWW through EPA's Technology Transfer Network (TTN). Following
signature by the EPA Administrator, a copy of the direct final rule
will be posted on the TTN's policy and guidance page for newly proposed
or promulgated rules at http://www.epa.gov/ttn/oarpg/. The TTN provides

information and technology exchange in various areas of air pollution
control. If more information regarding the TTN is needed, call the TTN
HELP line at<PHONE_NUMBER>.
    Comments. We are publishing the direct final rule without prior
proposal because we do not believe that the changes are controversial.
As explained below, the changes are being made to fill a gap in
coverage which was inadvertently created in an effort to address an
issue raised by commenters in response to the proposed rule (59 FR
62681, December 6, 1994). These amendments are wholly consistent with
the intent of the 1995 rule. Moreover, we are issuing these amendments
as a direct final rule to ensure that the activities made subject to
subpart II by the amended definition of ``ship'' are covered under
subpart II, as opposed to the Miscellaneous Metal Parts and Products
(Surface Coating) NESHAP (subpart MMMM). Subpart MMMM is a catch-all
category intended to cover all metal surface coating activities not
specifically covered by another NESHAP. In the absence of these direct
final rule amendments, any shipbuilding and ship repair operations
performed on vessels that do not meet the definition of ship would not
be covered by subpart II and would be subject to subpart MMMM on the
initial compliance date of January 2, 2007.
    In the Proposed Rules Section of this Federal Register, we are
publishing a separate document that will serve as the proposal to amend
the NESHAP for Shipbuilding and Ship Repair (Surface Coating)
Operations (40 CFR part 63, subpart II) in the event that this direct
final rule is withdrawn. If we receive any adverse comment or a request
for a public hearing, we will publish a timely withdrawal of the direct
final rule in the Federal Register and inform the public that the rule
will not take effect. We will address all public comments received on
the proposed rule in a subsequent final rule, we will not institute a
second comment period on the proposed rule. Any parties interested in
commenting on the proposed rule must do so at this time.
    Judicial Review. Under section 307(b)(1) of the CAA, judicial
review of the direct final rule is available only by filing a petition
for review in the U.S. Court of Appeals for the District of Columbia
Circuit by February 27, 2007. Under section 307(d)(7)(B) of the CAA,
only an objection to the direct final rule that was raised with
reasonable specificity during the period for public comment can be
raised during judicial review. Moreover, under section 307(b)(2) of the
CAA, the requirements established by the direct final rule may not be
challenged separately in any civil or criminal proceedings brought by
the EPA to enforce these requirements.
    Outline. The information presented in this preamble is organized as
follows:

I. Why are we amending the rule?
II. What amendments are we making to the rule?
III. What are the compliance dates?
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Congressional Review Act

I. Why are we amending the rule?

    On December 15, 1995, EPA issued a NESHAP section 112 of the CAA
for shipbuilding and ship repair (surface coating) operations (60 FR
64330). The shipbuilding and ship repair rule requires existing and new
major sources to control emissions of hazardous air pollutants to the
level achievable using maximum achievable (MACT) control technology.
The rule applies to shipbuilding and ship repair operations at any
facilities that are major sources, that apply marine coatings to
``ships'' and that meet the definition of ``affected source'' in 40 CFR
63.782 (Section 63.782 defines ``affected source'' as ``any
shipbuilding or ship repair facility having surface coating operations
with a minimum 1,000 liters (L) (264 gallons annual marine coatings
usage that is subject to this subpart.'') ``Ship building and ship
repair operations,'' as defined in subpart II (40 CFR 63.782), means
``any building, repair, repainting, converting, or alteration of
ships.''
    In the December 6, 1994, proposed rule (59 FR 62681) the term
``ship'' was defined as ``any marine or fresh-water vessel used for
military or commercial operations.'' The term ``commercial,'' in turn,
was defined broadly as ``any vessel not owned and operated by the U.S.
military or the U.S. Coast Guard.'' During the public comment period on
the proposed rule, EPA received public comments which expressed concern
that the definition of ``ship'' in the proposed rule was too broad and
could be read to cover facilities engaged in building or repairing
vessels that are small in size and are intended for, or used for, only
recreational use. In response to these comments, EPA added a definition
for ``pleasure craft'' in the final rule and excluded ``pleasure
craft'' as so defined from the definition of ``ship.'' Specifically,
EPA defined ``ship'' and ``pleasure craft'' in the final rule as
follows:
     Ship means any marine or fresh-water vessel used for
military or commercial operations, including self-propelled vessels,
those propelled by other craft (barges), and navigational aids (buoys).
This definition includes, but is not limited to, all military and Coast
Guard vessels, commercial cargo and passenger (cruise) ships, ferries,
barges, tankers, container ships, patrol and pilot boats, and dredges.
For purposes of this subpart, pleasure crafts and off-shore oil and gas
drilling platforms are not considered ships.
     Pleasure craft, which is excluded from the definition of
ship, is defined as any marine or fresh-water vessel used by
individuals for noncommercial, nonmilitary, and recreational purposes
that is less than 20 meters in length. A vessel rented exclusively to
or chartered by individuals for such purposes shall be considered
pleasure craft.
    Although EPA had proposed a broad definition for the term
``commercial'' in the proposed rule, it did not adopt that definition
in the final rule issued in 1995. It did, however, use the undefined
term ``commercial'' in defining what constitutes a ``ship.'' In
creating the definition of ``pleasure craft'' in the final NESHAP and
excluding pleasure craft from the definition of ``ship,'' we intended
that only those vessels less than 20 meters in length used by
individuals for nonmilitary and noncommercial purposes (i.e.,
recreational purposes) would be exempt from subpart II. Our use of the
terms ``noncommercial, nonmilitary and recreational'' in the definition
of ``pleasure craft'' and our failure to adopt the proposed broad
definition of ``commercial'' coupled with the ``commercial and
military'' restriction in the definition of ``ship'' have led to
questions as to whether the final NESHAP applies to shipbuilding and
ship repair operations conducted on vessels that measure 20 meters or
more in length, that are neither military nor commercial vessels. In
reviewing this applicability question, we have determined that vessels
measuring 20 meters or more in length that are neither military nor
commercial do not meet the current definition of ``ship'' in 40 CFR
63.782, and are therefore not subject to the requirements of subpart
II. Thus, the gap in coverage in the existing regulations relates to
the following operations conducted at shipbuilding and ship repair
facilities that meet the definition of affected source in 40 CFR
63.782: Shipbuilding and ship repair operations that are conducted on
vessels 20 meters or greater in length that are designed and built for
nonmilitary and noncommercial operations. Because we had intended to
cover such operations in the 1995 final NESHAP, we are issuing these
amendments to fill this unintended gap in the existing regulations.
    Specifically, these amendments fill the gap by, amending the
regulatory definition of ``ship'' to cover, among other things, all
marine or fresh-water vessels measuring 20 meters or more in length;
including a definition of ``commercial'' to clarify which vessels less
than 20 meters are subject to subpart II; and eliminating the term
``pleasure craft'' in subpart II, because that definition has created
unnecessary confusion. In reviewing the definition of pleasure craft,
we realized that the definition was too limiting because it defined
pleasure craft by reference to a vessel's actual use. Although defining
pleasure craft in such a manner may be appropriate for purposes of ship
repair activities, it is not an appropriate criterion for ship building
activities because it is unrealistic to expect a shipbuilder to know
definitively at the time of construction of the vessel whether the
vessel will be used for recreational or commercial purposes.
    In summary, these amendments fill an unintended gap in the coverage
of subpart II by establishing that shipbuilding and ship repair
operations performed on all marine or fresh-water vessels measuring 20
meters or more in length are subject to the requirements of subpart II
regardless of the purpose for which the vessel is designed, built, or
used. These amendments also clarify that subpart II shall not be
construed to apply to coating activities that are subject to emission
limitations or work practices under the NESHAP for boat manufacturing
at 40 CFR part 63 subpart VVVV.

II. What amendments are we making to the rule?

    Specifically, we are: (1) Revising the definition of ship to
include all vessels measuring 20 meters or more in length regardless of
the purpose for which the vessel is constructed or used and any vessels
that are less than 20 meters in length, designed and built specifically
for military or commercial purposes; (2) including a definition of
commercial to further identify those nonmilitary vessels that are less
than 20 meters in length that we consider to meet the definition of
ship in subpart II as those that are specifically designed and built
for the purposes of generating compensation for products or services;
(3) eliminating the term ``pleasure

craft''; and (4) excluding from subpart II those coating activities
that are subject to emission limitations or work practices under the
NESHAP for boat manufacturing at 40 CFR part 63 subpart VVVV. As a
result of this action, shipbuilding and ship repair operations on all
marine or fresh-water vessels measuring 20 meters or more in length,
regardless of the purpose for which the vessel is constructed or used,
will now be subject to subpart II, not subpart MMMM which contains the
default requirements for any metal surface coating not specifically
covered by another NESHAP.
    The compliance period for the shipbuilding and ship repair
operations that are subject to subpart II for the first time as the
result of these amendments is described below in section III.
    The revised definitions are as follows:
     Commercial means any enterprise or activity that receives
compensation for products and/or services rendered.
     Ship means all marine or fresh-water vessels that are
either (1) 20 meters or more in length regardless of the purpose for
which the vessel is constructed or used, or (2) that are less than 20
meters in length and are designed and built specifically for military
or commercial purposes. This definition includes, but is not limited
to, all military and Coast Guard vessels, commercial cargo and
passenger (cruise) ships, ferries, tankers, container ships, patrol and
pilot boats, yachts, and dredges. For purposes of this subpart,
offshore oil and gas drilling platforms are not ships.

III. What are the compliance dates?

    We address the compliance date for those affected sources that
conduct the type of operations that are, as the result of these
amendments, newly subject to subpart II. Specifically, those existing
affected sources that are engaged in the type of shipbuilding and ship
repair operations that became subject to the Shipbuilding and Ship
Repair NESHAP as the result of these amendments must comply with the
requirements applicable to those operations by December 31, 2007. The
1-year compliance deadline allows these affected sources a reasonable
period of time in which to deplete existing inventories of coatings and
to plan and implement appropriate compliance procedures. Additionally,
the 1-year period provides sources an opportunity to obtain compliant
coatings and/or identify alternative methods of limiting emissions. The
EPA does not expect that any new affected source engaged solely in the
operations that are the subject of these amendments will be built;
however, in the event that such a new facility is built, it must comply
according to the schedule in 40 CFR 63.6(b). (For purposes of this
discussion, a new affected source is an ``affected source,'' as defined
by 40 CFR 63.782, at which shipbuilding and ship repair operations are
conducted exclusively on vessels 20 meters or greater in length that
are designed and constructed for nonmilitary and noncommercial
operations, for which construction or reconstruction is commenced after
the date of this companion proposed rule.)

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and, therefore, subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. It has been determined
that this direct final rule is not a ``significant regulatory action''
under the terms of Executive Order 12866 and are, therefore, not
subject to OMB review.

B. Paperwork Reduction Act

    This action may impose additional information collection burden for
sources currently subject to and complying with subpart II. Sources
currently complying with subpart II that choose to build or repair
marine or fresh-water vessels that are 20 meters or more in length and
are not either military or commercial vessels will need to expand their
current subpart II recordkeeping and reporting to include these
additional shipbuilding and ship repair activities. However, we believe
that the additional information collection burden is minimal as the
proportion of these activities at most shipyards is minimal; therefore,
the information collection requests have not been revised. OMB has
previously approved the information collection requirements contained
in the existing regulations under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., and has assigned OMB control
number 2060-0330 (EPA ICR No.1712.05).
    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;
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.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the Agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of the direct final rule on
small entities, a small entity is defined as: (1) A small business
mostly in the North American Industrial Classification System (NAICS)
code 336611 that has less than 1000 or fewer employees; (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field.
    After considering the economic impacts of this rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This rule
will not impose any requirements on small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local,

and tribal governments, in the aggregate, or by the private sector, of
$100 million or more in any 1 year. Before promulgating an EPA rule for
which a written statement is needed, section 205 of the UMRA generally
requires EPA to identify and consider a reasonable number of regulatory
alternatives and adopt the least-costly, most cost-effective, or least
burdensome alternative that achieves the objectives of the rule. The
provisions of section 205 do not apply when they are inconsistent with
applicable law. Moreover, section 205 allows the EPA to adopt an
alternative other than the least-costly, most cost effective, or least-
burdensome alternative if the Administrator publishes with the final
rule an explanation why that alternative was not adopted. Before EPA
establishes any regulatory requirements that may significantly or
uniquely affect small governments, including tribal governments, it
must have developed under section 203 of the UMRA a small government
agency plan. The plan must provide for notifying potentially affected
small governments, enabling officials of affected small governments to
have meaningful and timely input in the development of EPA regulatory
proposals with significant Federal intergovernmental mandates, and
informing, educating, and advising small governments on compliance with
the regulatory requirements.
    EPA has determined that the direct final rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or the
private sector in any 1 year. Therefore, the direct final rule is not
subject to the requirements of sections 202 and 205 of the UMRA. In
addition, EPA has determined that the direct final rule contains no
regulatory requirements that might significantly or uniquely affect
small governments because the burden is small and the regulation does
not apply to small governments. Therefore, the direct final rule is not
subject to the requirements of section 203 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999) requires the
EPA to develop an accountable process to ensure ``meaningful and timely
input by State and local officials in the development of regulatory
policies that have federalism implications.'' ``Policies that have
federalism implications'' is defined in the Executive Order to include
regulations that have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.''
    The direct final rule does not have federalism implications. They
will 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. Thus, Executive
Order 13132 does not apply to the direct final rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175 (65 FR 67249, November 9, 2000) requires EPA
to develop an accountable process to ensure ``meaningful and timely
input by tribal officials in the development of regulatory policies
that have tribal implications.'' The direct final rule does not have
tribal implications, as specified in Executive Order 13175. This rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to the direct final rule.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any
rule that: (1) is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that the EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the EPA must evaluate the environmental health or safety
effects of the planned rule on children, and explain why the planned
regulation is preferable to other potentially effective and reasonably
feasible alternatives considered by the EPA.
    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Executive Order has
the potential to influence the regulation. The direct final rule is not
subject to Executive Order 13045 because the rule (subpart II) is based
on technology performance, not health or safety risks. Furthermore, the
direct final rule has been determined not to be economically
significant as defined under Executive Order 12866.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    The direct final rule is not subject to Executive Order 13211 (66
FR 28355, May 22, 2001), because it is not a significant regulatory
action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note),
directs the EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs the EPA to
provide Congress, through OMB, explanations when the Agency decides not
to use available and applicable voluntary consensus standards.
    No new standard requirements are specified in the direct final
rule. Therefore, the EPA is not proposing or adopting any voluntary
consensus standards in the direct final rule.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing the direct final
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the direct final rule in the Federal Register.
The direct final rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: December 22, 2006.
Stephen L. Johnson,
Administrator.

0
For the reasons set out in the preamble, title 40, chapter I, part 63,
of the Code of Federal Regulations is amended as follows:

PART 63--[AMENDED]

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart II--[Amended]

0
2. Section 63.781 is amended by redesignating paragraphs (b), (c) and
(d) as (c), (d) and (e) respectively and adding a new paragraph (b).

Sec.  63.781  Applicability.

* * * * *
    (b) The provisions of this subpart do not apply to coating
activities subject to emission limitations or work practices under 40
CFR part 63 subpart VVVV.
* * * * *

0
3. Section 63.782 is amended by adding a definition for ``Commercial'',
removing the definition of ``Pleasure craft'', and revising the
definition of ``Ship'':

Sec.  63.782  Definitions.

* * * * *
    Commercial means any enterprise or activity that receives
compensation for products and/or services rendered.
* * * * *
    Ship means all marine or fresh-water vessels that are either 20
meters or more in length regardless of the purpose for which the vessel
is constructed or used, or that are less than 20 meters in length and
are designed and built specifically for military or commercial
purposes. This definition includes, but is not limited to, all military
and Coast Guard vessels, commercial cargo and passenger (cruise) ships,
ferries, tankers, container ships, patrol and pilot boats, yachts, and
dredges. For purposes of this subpart, offshore oil and gas drilling
platforms are not ships.
* * * * *

0
4. Section 63.784(a) is revised to read as follows:

Sec.  63.784  Compliance dates.

    (a) Each owner or operator of an existing affected source shall
comply within two years after the effective date of this subpart,
except that the owner or operator of an existing affected source that
conducts shipbuilding and ship repair operations that first became
subject to this NESHAP on [date of publication of this direct final
rule and FR cite], shall comply with the requirements of this subpart,
as they apply to those operations, by December 31, 2007.
* * * * *
 [FR Doc. E6-22426 Filed 12-28-06; 8:45 am]

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[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Notices]
[Pages 25357-25358]
[FR Doc No: 2011-10813]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Advisory Committee; Medical Imaging Drugs Advisory Committee;
Reestablishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

reestablishment of the Medical Imaging Drugs Advisory Committee in the
Division of Advisory Committee and Consultants Management, Center for
Drug Evaluation and Research.

FOR FURTHER INFORMATION CONTACT: Minh Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, rm. 2424, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8533<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Federal Advisory Committee Act of
October 6, 1972 (Pub. L. 92-463 (5 U.S.C. app. 2)); section 904 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394), as amended by the
Food and Drug Administration Revitalization Act (Pub. L. 101-635); and
21 CFR 14.40(b), FDA is announcing the reestablishment of the Medical
Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs
(the Commissioner). A notice announcing a request for nominations for
members and representatives on the committee as well as a final rule
adding the committee to the current list of committees in 21 CFR 14.100
will be published at a later date.
    The Medical Imaging Drugs Advisory Committee reviews and evaluates
data concerning the safety and effectiveness of marketed and
investigational human drug products for use in diagnostic and
therapeutic procedures using radioactive pharmaceuticals and contrast
media used in diagnostic radiology and makes appropriate
recommendations to the Commissioner.
    The Medical Imaging Drugs Advisory Committee shall consist of a
core of 12 voting members including the chair. Members and the chair
are selected by the Commissioner or designee from among authorities
knowledgeable in the fields of nuclear medicine, radiology,
epidemiology or statistics, and related specialties. Almost all non-
Federal members of this committee serve as special Government
employees. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the committee may include
one nonvoting member who is identified with industry interests.
    This notice is given under the Federal Advisory Committee Act and
21 CFR part 14, relating to advisory committees.

    Dated: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10813 Filed 5-3-11; 8:45 am]
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