[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Pages 12626-12629]
[FR Doc No: 2012-4911]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66462; File No. SR-NYSE-2012-06]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change Amending the Definition of
Approved Person To Exclude Foreign Affiliates, Eliminating the
Application Process for Approved Persons, and Making Related Technical
and Conforming Changes

February 24, 2012.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on February 14, 2012, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the definition of approved person to
exclude foreign affiliates, eliminate the application process for
approved persons, and make related technical and conforming changes.
The text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text

of those statements may be examined at the places specified in Item IV
below. The Exchange has prepared summaries, set forth in sections A, B,
and C below, of the most significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend the definition of approved person to
exclude foreign affiliates, eliminate the application process for
approved persons, and make related technical and conforming changes.
Following approval of the proposed rule change, the Exchange will
advise member organizations of the implementation date of the rule
change via Information Memo.
Background
    The current rules governing the definition of and application
process for an approved person are NYSE Rules 2 and 304. If the
definition requirements under NYSE Rule 2 are met, then the person or
entity has to apply to the Exchange for approval to register as an
approved person. This requirement is intended to bring certain
affiliates of Exchange member organizations within the Exchange's
jurisdiction and to subject such affiliates' activities to Exchange
rules to the extent their activities are related to the activities of
the member organization.
    NYSE Rule 2(c) defines the term ``approved person'' as ``a person,
other than a member, principal executive or employee of a member
organization, who controls a member organization or is engaged in a
securities or kindred business that is controlled by or under common
control with a member or member organization who has been approved by
the Exchange as an approved person.'' NYSE Rule 2(d) further defines
``person'' to include not only natural persons, but also corporations,
limited liability companies, partnerships, associations and other
organized groups of persons. NYSE Rule 2(e) defines the term
``control'' to mean the power to direct or cause the direction of
management or policies, whether through ownership of securities, by
contract or otherwise, and creates a rebuttable presumption of control
if the person has a right to vote 25 percent or more of the voting
securities, is entitled to receive 25 percent or more of the net
profits, or is a director, general partner, or principal executive of
the member organization. NYSE Rule 2(f) defines ``engage in a
securities or kindred business'' to mean transacting business as a
broker or dealer in securities. Thus, the current definition of
approved person includes a foreign affiliate of a member organization
that is engaged in a broker-dealer business, but does not include, for
example, a registered investment company. NYSE Rules 2A(e) and (f)
further provide that the Exchange has jurisdiction after notice and a
hearing to discipline approved persons in connection with the member
organization's business and has jurisdiction over any and all other
functions of approved persons in connection with the member
organization's business in order for the Exchange to comply with its
statutory obligation as a self-regulatory organization (``SRO'').
    NYSE Rules 304 and 311(a) require, with limited exceptions, that
persons who meet the NYSE Rule 2(c) definition of an approved person
must apply for approval by the Exchange as an approved person. NYSE
Rule 304 further provides that no person may become or remain an
approved person unless such person meets the standards prescribed in
the Exchange's rules, and it prescribes the process that an applicant
must follow to become an approved person. Among other things, this
process involves submission to the Exchange of a completed Form AP-1
(in the case of a corporation or other legal entity) or Forms AD-G 2
and AD-G 3 (in the case of a natural person, collectively referred to
as ``AD-G''), and other pertinent information regarding the candidate
for approval. By executing the Form AP-1 or AD-G, as applicable, the
approved person affirmatively consents to the Exchange's jurisdiction.
Proposed Rule Change
    The Exchange proposes to amend the definition of approved person in
NYSE Rule 2 to revise the definition of which entities are deemed to be
under ``common control'' with a member organization. The Exchange
believes that the current definition, which includes certain foreign
affiliates, is overbroad and it is unnecessary to assert jurisdiction
over a foreign affiliate of a member organization that does not control
a member organization. The Exchange notes that excluding such foreign
affiliates from its jurisdiction would be consistent with Rule 19g2-1
under the Securities Exchange Act of 1934, as amended (the ``Act''),
which provides that an exchange is not required to enforce compliance
with its rules against certain persons \4\; the Exchange has not
identified a rule of any other SRO that asserts jurisdiction over a
foreign affiliate under common control with a member of that SRO. As
such, the Exchange proposes to amend the definition of approved person
so that it would include any person, other than a member, principal
executive or employee of a member organization, who controls a member
organization, is engaged in a securities or kindred business that is
controlled by a member or member organization, or is a U.S. registered
broker-dealer under common control with a member organization.
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    \4\ See 17 CFR 240.19g2-1. Under Rule 19g2-1, a national
securities exchange is not required to enforce compliance, within
the meaning of Section 19(g) of the Act, with the Act and the rules
and regulations thereunder, to [sic] with respect to persons
associated with a member, other than securities persons or persons
who control a member. Under Rule 19g2-1(b)(1), a ``securities
person'' is defined as a ``person who is a general partner or
officer (or person occupying a similar status or performing similar
functions) or employee of a member; provided, however, that a
registered broker or dealer which controls, is controlled by, or is
under common control with, the member and the general partners and
officers (and persons occupying similar status or performing similar
functions) and employees of such a registered broker or dealer shall
be securities persons if they effect, directly or indirectly,
transactions in securities through the member by use of facilities
maintained or supervised by such exchange or association.'' A
foreign broker-dealer not registered in the United States that is
under common control with an NYSE member organization falls outside
of the definition of ``securities person.''
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    By changing the definition of approved person to exclude certain
foreign affiliates, the Exchange does not intend to eliminate certain
controls in Exchange rules related to potential conflicts of interest
associated with having a foreign affiliate under common control with a
member organization. Accordingly, the Exchange proposes several
amendments to its Rules. First, the Exchange proposes to amend
paragraphs (3) and (4) of NYSE Rule 21 to provide that a member of the
Exchange's Board of Directors or an authorized committee who is
associated with a member organization cannot participate in the
deliberations concerning the listing of a security if the Director
knows that an affiliate of the member organization directly or
indirectly owns one percent or more of any class of stock of the issuer
or has a contract, option, or privilege to purchase the security to be
listed. Second, the Exchange proposes to amend NYSE Rule 22 to provide
that a member of certain NYSE boards and committees may not participate
in the consideration of any matter if there are certain types of
indebtedness between the board or committee member and a member
organization's affiliate or other

related parties. Third, the Exchange proposes to amend NYSE Rule 98A,
which provides that no issuer, or partner or subsidiary thereof, may
become an approved person of a Designated Market Maker (``DMM'') unit
that is registered in the stock of that issuer, to provide instead that
a DMM unit may not be registered in a stock of an issuer, or a partner
or subsidiary thereof, if such entity is either an approved person or
an affiliate of the DMM unit's member organization. Finally, the
Exchange proposes to amend Supplementary Material .30(c) of Rule 402 to
provide that when securities are callable in part under the Rule, a
member organization may not allocate any called securities to the
account of an affiliate until all customer positions have been
satisfied.\5\
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    \5\ The Exchange does not believe any amendment to NYSE Rules
22, 91, 96, 112, 422, 410A, 460, or 1301 is necessary as a result of
the proposed rule change; the Exchange believes such Rules would
continue to be consistent with the requirements of the Exchange Act
and the manner in which such they address potential conflicts of
interest is appropriate under the circumstances.
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    The Exchange also proposes to amend its rules to remove the
requirement that the Exchange affirmatively approve each application to
become an approved person. If a person meets the definition of an
approved person, as proposed, the Exchange will obtain jurisdiction by
consent as described below. The Exchange believes that the current
application process requires the submission of a substantial amount of
information and documents related to member organization affiliates
that is unnecessary to carry out the Exchange's regulatory
responsibilities. In particular, because the Exchange is no longer the
Designated Examining Authority (``DEA'') for Exchange member
organizations,\6\ the Exchange does not believe that it needs to engage
in a detailed financial review of approved persons of its member
organization applicants. The Exchange further notes that other SROs do
not require that such persons undergo such an application and approval
process.\7\ The Exchange, therefore, proposes to remove all references
to an approval process and the submission of an application for such
approval from NYSE Rules 304, 308, and 311. The Exchange also would
eliminate use of the Forms AP-1 and AD-G.
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    \6\ Prospective member organization applicants must be either a
member of FINRA or, if the applicant does not transact business with
public customers or conduct business on the Floor of the Exchange, a
member of another registered securities exchange, before being
approved as an Exchange member organization. See NYSE Rule 2(b)(i).
Generally, FINRA or the other exchange already is, or will be,
designated as the DEA under SEC Rule 17d-1 and the Exchange will not
be designated as such. Currently, the Exchange is not the DEA for
any of its member organizations, but if it were designated as the
DEA, the Exchange has retained FINRA to perform services related to
meeting the Exchange's DEA responsibilities for a member
organization.
    \7\ For example, the rules of FINRA and The NASDAQ Stock Market,
Inc. do not impose application and approval requirements on member
affiliates. See also note 9, infra.
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    Nevertheless, the Exchange's jurisdiction over approved persons in
accordance with the revised definition would remain. Thus, the Exchange
proposes to amend NYSE Rule 304 to provide specifically that a member
organization would be required to identify all of its approved persons
to the Exchange and each such approved person would continue to be
required to consent to the Exchange's jurisdiction. Specifically, an
approved person would continue to have to agree to (i) inform the
Exchange of any statutory disqualification of the approved person under
Section 3(a)(39) of the Act, (ii) abide by the Rules of the Exchange
relating to approved persons, and (iii) permit examination by the
Exchange, or any person designated by it, of its books and records to
verify the accuracy of the information required to be supplied under
Exchange Rules.\8\
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    \8\ The Exchange proposes to eliminate the text in current Rule
304(e)(1), which requires an approved person to supply information
concerning its relationship with the member organization. This
provision relates to information required to be submitted on Form
AP-1 or AD-G, and as such it is not necessary to retain it in
proposed Rule 304.
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    The focus on identification of approved persons by each member
organization and consent to jurisdiction by each approved person,
instead of review and approval of applications by the Exchange, would
make the entire process more efficient while maintaining appropriate
regulatory standards. The proposed rule change would remove unnecessary
paperwork in the process while holding each member organization
accountable for identifying to the Exchange its affiliates and approved
persons. The remaining jurisdictional requirements for approved persons
would enable the Exchange to continue to pursue matters involving or
affecting its member organizations.\9\
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    \9\ The Exchange notes that FINRA is in the process of
harmonizing legacy NASD and NYSE Rules, and has published a proposal
to harmonize membership rules. See FINRA Regulatory Notice 10-01.
While FINRA has proposed that a member firm be required to provide
certain information about affiliates, FINRA has not proposed to
adopt the approved person definition or application process, or
assert jurisdiction over such persons. When FINRA completes that
harmonization process for the membership rules, the Exchange will
consider whether further amendments to its approved person rules are
advisable. Until such time, the Exchange believes that the narrowing
of the approved person definition and the elimination of the
approved person application process will remove unnecessary
complexities and excessive informational requirements and thereby
reduce burdens on membership applicants and member organizations
while still maintaining high regulatory standards consistent with
the Act.
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    The Exchange also proposes to make technical and conforming changes
to other rules. Specifically, the Exchange proposes to amend Rule 476A,
which addresses minor rule violations, to correct a citation to Rule
304. The Exchange further proposes to make technical amendments to
replace the term ``allied member'' with ``principal executive'' in
Rules 21, 22, 91, 96, 112, 308, 410A, 422, 460, and 1301 and NYSE Rule
Interpretation for Rule 304, delete ``allied member'' from Rule 304A,
and delete NYSE Rule Interpretation for Rule 304A entirely; the
Exchange replaced the term ``allied member'' with the term ``principal
executive'' in an earlier rule filing and the proposed amendments are
consistent with the previous rule filing.\10\
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    \10\ See Securities Exchange Act Release No. 58549 (September
15, 2008), 73 FR 54444 (September 19, 2008) (SR-NYSE-2008-80).
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2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \11\ of
the Act, in general, and furthers the objectives of Section 6(b)(5)
\12\ in particular in that it is designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. More specifically, the NYSE believes that the proposed
approved person definition and consent to jurisdiction process would
remove unnecessary complexities and excessive informational
requirements and create a more efficient and less burdensome process
for membership applicants and member organizations while maintaining
appropriate regulatory standards. As such, the proposed rule change
would contribute to removing impediments to and perfecting the
mechanism of a free and open market and a national market system.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not

necessary or appropriate in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2012-06 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2012-06. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549-1090, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the filing will also be available for
inspection and copying at the NYSE's principal office and on its
Internet Web site at www.nyse.com. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSE-2012-06 and should be submitted on or before March
22, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-4911 Filed 2-29-12; 8:45 am]
BILLING CODE 8011-01-P


1 CREOSOTE HUMAN RISK CHARACTERIZATION Background Creosote is a fungicide, insecticide, and sporicide used as a wood preservative for above and below ground wood protection treatments as well as for treating wood in marine environments. All 16 Creosote products currently registered are Restricted Use Pesticides; 15 are End Use Products and 1 is a Manufacturing Use Product for formulating industrial end use wood preservative products. Creosote wood preservatives are used primarily to pressure treat railroad ties/ crossties ( represents close to 70% of all Creosote use) and utility poles/ crossarms ( represents 15  20% of all Creosote use). Assorted Creosote treated lumber products ( e. g., timbers, poles, posts and groundline support structures) represent the remaining uses for this wood preservative. The industry refers to different blends of creosote, based on the wood treatment standards set by the American Wood Preservers' Association ( AWPA), as P1/ P13 and P2. Typically, railroad ties/ crossties are treated with a P2 blend, which is more viscous than the P1/ P13 blend used for treating utility poles.

Creosote is applied by occupational handlers only. Since it is a restricted use pesticide that can only be applied by certified applicators or someone under their direct supervision, it is not available for sale to or use by homeowners. On September 29, 2003, in accordance with section 6( f)( 1) of FIFRA, as amended, EPA issued a Notice of Receipt of Requests by Registrants of Pesticide Products containing Creosote to voluntarily cancel non pressurized and/ or to amend to terminate non pressurized use of affected products.

The Antimicrobials Division ( AD), Office of Pesticide Programs ( OPP), U. S. EPA, has evaluated the toxicological database for P1/ P13 and P2 creosote and determined that the data are adequate to support a reregistration eligibility decision.

Hazard Profile The Toxicology database for Creosote is adequate to assess the hazard profile of creosote for use in a Preliminary Risk Assessment ( PRA). Review of the database shows concern for the mutagenicity and carcinogenicity of creosote as well as cardiomyopathy after inhalation exposure and dermal inflammation after repeated dermal exposure. Results of developmental toxicity testing of creosote in experimental animal species shows qualitative evidence of susceptibility from creosote , thus raising concern for creosote as a potential developmental toxicant.

Cardiotoxicity was observed in a subchronic inhalation toxicity study in rats with the P1/ P13 blend of creosote ( MRID # 43601001). Diffuse myocardial degeneration affecting the right side of the heart as well as arterial medial hypertrophy of the small arterioles of the lung were observed after 13 weeks of exposure to 0.049 mg/ L creosote. Exposure to the P2 blend of creosote by inhalation resulted in changes to the olfactory epithelium ( inflammation, hyperplasia, metaplasia). 2 Follicular cell hypertrophy of the thyroid was also observed as well as increased thyroid weight. Both blends produced granular pigment deposition within the lungs, a s shown by the presence of granular pigment within the alveolar macrophages. In 90 day dermal toxicity studies with both blends of creosote, these effects were not observed, although a significant dermal response ( inflammation) was observed for both blends.

The developmental and reproductive toxicity of creosote was evaluated. Developmental toxicity studies in the rat with both blends showed qualitative evidence of susceptibility to offspring. For the P1/ P13 blend, significantly increased resorptions and post implantation loss as well as decreased live fetuses per litter were observed at a dose of 175 mg/ kg/ day, while the only maternal effect at this dose was increased incidence of hair loss. In addition, increased incidence of cardiovascular, vertebral, and digital malformations was observed which exceeded both concurrent and historical control incidence. For the P2 blend, single incidences of malformations of the skull and eye were considered treatment related, in the absence of maternal toxicity. A developmental toxicity study in rabbits with P1/ P13 creosote showed increased abortions, decreased number of live litters, and decreased mean implantation sites at a dose of 75 mg/ kg/ day in maternal rabbits. There were no significant effects on fetuses from treated dams at any dose level. A 2 generation reproduction study using P1/ P13 Creosote showed decreased pre mating body weights in F1 female rats and F1 males rats at a dose of 25 mg/ kg/ day, the lowest dose tested in this study. At 25 mg/ kg/ day and above there was reduced fertility and pregnancy indices in the F1 generation in comparison to controls, but the control fertility index was also lower than expected. Thus although there was no evidence of susceptibility in this study, the low fertility and pregnancy indices for F1 female parental animals introduced uncertainty in the interpretation of the results in treated animals.

Although there are no current Agency guideline neurotoxicity studies available for creosote, the existing studies on creosote indicate no evidence of neurotoxicity for either the P1/ P13 or P2 blends of creosote ( ATSDR, 2002). Based on the above, and realizing that creosote is currently registered only for non  food use and is a restricted use pesticide, no additional neurotoxicity testing will be required at this time.

In consideration of the available evidence that creosote is a positive mutagen, the Agency waived the requirement for the standard mutagenicity battery, and instead required dominant lethal testing of both the P1/ P13 and P2 blends. The results of testing of both the P1/ P13 blend and P2 blend of creosote showed that, at doses toxic to the dosed animals ( 330.5 mg/ kg for the P1/ P13 blend, and 194 mg/ kg for the P2 blend), there was no evidence of a dominant lethal effect of either creosote blend.

As there are no existing tolerances or other clearances for residues of creosote in food, an FQPA assessment is not necessary. Potential post application exposures to residents, including children ( e. g., from use of railroad ties by homeowners), could not be assessed due to lack of exposure data. The available evidence on developmental and reproductive effects of creosote was assessed by the Health Effects Division ( HED) Hazard Identification Assessment Review Committee on 3 April 1, 1999 The committee expressed concern for potential infants and children's susceptibility of creosote, based on the severity of offspring vs. maternal effects observed with testing of creosote in the P1/ P13 blend developmental toxicity study in rats at the 175 mg/ kg/ day dose level as well as deficiencies observed in the 2 generation reproduction toxicity study in rats.

A large body of experimental evidence exists which shows a positive relationship between dermal exposure to creosote and development of tumors in experimental animals. In addition to its tumor promoting potential, the ability of creosote to induce lung tumors after dermal application was examined. Dermally applied creosote ( 0.25ml undiluted, twice weekly for 8 months) induced 5.8 lung adenomas per mouse in mice housed in stainless steel cages, while untreated controls showed 0.5 lung adenomas/ mouse ( Roe et al, Cancer Res. 18: 1176 1178, 1958). Carcinogenicity of two high temperature derived creosote oils was studied by Poel and Kammer ( JNCI 18: 41 55, 1957). The light creosote fraction is composed mainly of benzene, toluene, xylene, and solvent naphtha, while the blended oil is composed of creosote oil, anthracene oil, and oil drained from recovery of naphthalene. Oils were applied by drops to the skin of mice at concentrations of 20%, 50%, or 80% three times a week for life. By weeks 21 26, both oils had induced skin tumors. Several mice exhibited metastases to the lungs or regional lymph nodes. Coal tar carcinogenicity was studied by Culp et al. ( 1996) in which female B6C3F1 mice ( 48/ group) were administered coal tar in the diet at concentrations of 0, 0.01, 0.03, 0.1, 0.3, 0.6, and 1% for 2 years. The coal tar was a mixture of samples from seven waste sites. Tumors of the forestomach were observed in all groups fed the coal tar containing diet, as were small intestine tumors fed the 0.6% or 1.0% concentrations of coal tar. In a second study by Culp et al. ( 1998) female B6C3F1 mice were given coal tar samples in the diet, derived from manufactured gas plant waste sites at 0, 12, 33, 117, 333, 739, and 1300 mg/ kg/ day ( coal tar sample 1) or 40, 120, and 346 mg/ kg/ day ( coal tar sample 2) for 2 years. Coal tar sample 1 was a mixture of samples from seven waste sites and coal tar sample 2 was a mixture from two of the waste sites plus a third waste site with a high benzo( a) pyrene content. Significant concentration related increases in incidence of tumors of the liver, lung, forestomach, and increased incidence of hemangiosarcoma, histiocytic sarcoma, and sarcoma were observed for both coal tar sample 1 and 2. Tumors of the small intestine were also observed in addition in those mice receiving coal tar sample1, similar to the earlier study.

In humans, evidence for carcinogenicity of creosote varies. Several studies have associated occupational exposure to creosote with development of skin cancer, with a latency period of 20 25 years. These studies are very old ( 1920' s to 1940' s), when occupational safety practices were much more lax than today. More recent reports ( 1980) show no increase in risk of skin, bladder, or lung cancer in wood treatment plant workers, or after treatment for 4 years with coal tar medicinal therapy for treatment of dermatitis. These reports, however, were limited in scope. Those reports associated with therapeutic use of coal tar did not mention the fact that the composition of the coal tar used therapeutically is different than that used for wood treatment. In the report on wood treatment workers, the population studied was small, and the follow up 4 period was too short to allow a long enough latency for tumor development.

The carcinogenicity data base submitted to the Agency for creosote consists of a six month initiation/ promotion study of creosote conducted in mice. Creosote in this study was tested both as an initiator ( 5 dermal applications per week for 2 weeks at doses of 500

g/ mouse, 25 mg/ mouse, or 56 mg/ mouse followed by TPA for 26 weeks) and as a promotor ( DMBA as a positive initiator at 50

g/ mouse followed by twice weekly applications of creosote at the same doses as used for the initiation protocol). As an initiator, creosote did not produce any increase in incidence of benign tumors, but at the 25 and 50 mg doses, squamous cell carcinomas were observed in 2/ 30 mice at each dose. As a promotor in DMBA initiated mice, creosote produced dose related increases in skin papillomas, keratoacanthoma, squamous cell carcinoma, and basal cell carcinoma at the 25 and 50 mg doses. Increases in these tumor types were also observed when creosote was used as both initiator and promotor. This study shows that creosote acts most effectively as a promotor but also functions as a " complete" carcinogen.

The Agency in 1988 acknowledged limitations on conducting a quantitative risk assessment from use of a single component of creosote ( Guidance for the Reregistration of Pesticide Products Containing Coal Tar/ Creosote As the Active Ingredient, USEPA, 1988), but it was also observed that creosote mixtures are " complex mixtures with known synergistic effects" on carcinogenicity. A specific quantitative risk assessment on carcinogenicity of creosote has not been performed by the Agency, but a cancer slope factor ( q*) exists for one of the more prominent components of creosote, benzo( a) pyrene, with a q* value of 7.3 as published in the Agency's IRIS database. The Antimicrobials Division proposes to use benzo( a) pyrene as an indicator for conduct of the cancer risk assessment for creosote. Administration of benzo( a) pyrene by inhalation has been shown to result in respiratory tract tumors, and administration by the dermal route results in skin tumor production, similar to the tumors observed from administration of creosote. Benzo( a) pyrene has also been shown to be a " complete" carcinogen similar to creosote, and also tests positive for mutagenicity in a variety of assays. Cancer risk estimates for oral exposure to polycyclic aromatic hydrocarbon mixtures as well as inhalation exposure to coal tar/ pitch condensation aerosol ( Schenider et al., J. Appl. Toxicol 22( 1), 2002; Heinrich et al., Toxicol. Lett. 72( 1 3), 1994) have been performed using benzo( a) pyrene as an indicator. The use of benzo( a) pyrene as an indicator is not felt to be overly conservative and may underestimate carcinogenic risk of creosote, as other components of creosote including naphthalene, 1 methylnaphthalene, carbazole, quinoline, and beno[ b] fluoranthene have also shown carcinogenic potential in animal studies ( Nesnow et al., Exp. Lung Res. 24( 4): 1998; Murata et al., Fundam Appl. Toxicol. 21( 1): 1993 ) and could likely contribute additional potency over that of benzo( a) pyrene alone. While the Agency proposes this approach, the Agency is also aware of the recent study of Culp et al. ( 1998) that examined tumors induced by coal tar as well as the recent publications by Gaylor et al. ( 2000) and Schneider et al. ( 2002) which analyzed these data for purposes of quantitative cancer risk. The Agency is considering these publications and their potential modification of the approach proposed above for quantification of creosote carcinogenicity. The metabolism of Creosote has not been examined, due to the extremely complex nature of the components of creosote. Information from the Agency for Toxic Substances and Disease 5 Registry indicates that some of the components of creosote are persistent within the body.

Dose Response Assessment On April 1, 1999, the Health Effects Division's Hazard Identification Assessment Review Committee ( HIARC) evaluated the toxicological endpoints selected for occupational and residential ( dermal and inhalation) exposure risk assessments for Creosote. On September 3, 2003, the Antimicrobials Division Toxicity Endpoint Selection Committee ( ADTC) met to verify the selected endpoints for long term dermal risk assessments for creosote and inhalation risk assessment, and also discussed whether dermal and inhalation Margins of Exposure should becombined for creosote risk assessment. The toxicological endpoints selected for various exposure scenarios are summarized in the table below. 6 Table 1 Toxicology Endpoint Selection for Creosote EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute and Chronic Dietary Acute and Chronic Dietary risk assessment not required Carcinogenicity ( Dietary) Creosote has been shown to exert positive mutagenic effects in vitro, and has been shown to be positive for carcinogenicity in an initiation/ promotion study. Creosote has been classified as a B1 carcinogen in IRIS. Oral cancer slope factor for benzo( a) pyrene, a component of creosote, used as indicator for carcinogenic potential of creosote: 7.3 ( mg/ kg/ day) 1 + 50% dermal absorption.

Short Term Dermal ( 1 30 days) Oral NOAEL= 50 decreased body weight gain at 175 mg/ kg/ day Developmental Toxicity  Rat MOE = 100 ( 50% dermal absorption)

Intermediate term Dermal ( 1 6 months) Dermal NOAEL = 40 Decreased body weight gain at 400 mg/ kg/ day 90 Day Dermal Toxicity Study in the Rat MOE = 100 Long Term Dermala (> 6 months) Oral LOAEL = 25 mg/ kg/ day decreased pre mating body weight 2 generation reproduction study  Rat MOE = 300 ( 10x, 10x, 3x for use of a LOAEL)

Inhalationb ( any time period) NOAEL = 0.0047mg/ L MOE = 100 decreased body weight, body weight gain, altered hematology 90 day Inhalation Study in the Rat Dermal absorption c 50%, estimated from ratio of oral/ dermal LOAEL aafter re examination of the toxicology data, the ADTC concluded that the 2 generation reproduction toxicity study was appropriate for long term dermal risk assessment for the following reasons: the duration of the 2 generation reproduction study is more representative of the time frame ( i. e. long term) than the 90 day dermal study, and is consistent with OPP policy regarding duration of the study vs. route of exposure; body weight gain decreases in the 2 generation reproduction toxicity study were observed in the F2 generation, supporting the time frame for the long term endpoint ( i. e. > 6 months). The 90 day dermal study effects are not as representative of the time frame for the long term dermal risk assessment. However, the two studies can be considered co critical studies for this endpoint. Correction of the LOAEL from the 2 generation reproduction toxicity study for dermal absorption ( 50%) and use of a LOAEL ( 3x extra UF) yields a MOE and endpoint ( 300 and 50 mg/ kg/ day) similar to the 90 day dermal toxicity study ( 40 mg/ kg/ day and MOE of 300 [ extra 3x to extrapolate to long term endpoint]).

bthe ADTC re examined the use of the inhalation toxicity study selected for inhalation risk assessment for creosote and concluded that a developmental toxicity study, as used for the oral and dermal risk assessments of creosote, is not appropriate for inhalation risk assessment because: ( 1) the inhalation toxicity study showed significant effects on body weight gain early in the study ( one week) and is therefore relevant for short term assessment ( 2) it is also a route specific study; and ( 3) the inhalation NOAEL is more sensitive than the developmental NOAEL. Therefore, the inhalation study will remain as the study for the short term inhalation endpoint.

CNo dermal absorption studies for creosote are available. The HIARC estimated a dermal absorption of 50% based on the results of an oral developmental toxicity in rats and a 90 day dermal toxicity studies in the same species ( rats) with similar endpoints ( e. g., decrease in body weight gains). Benzo( a) pyrene has also shown a similar extent of dermal absorption ( Ng et al., Toxicol. Appl. Pharamcol. 115: 216 223, 1992) and supports the HIARC's decision for creosote. 7 An acute and chronic Reference Dose value were not selected for creosote, as there are no food uses for creosote and a dietary risk assessment is not needed.

As there are no existing tolerances or other clearances for residues of creosote in food, an FQPA assessment is not necessary. Potential post application exposures to residents, including children ( e. g., from use of railroad ties by homeowners), could not be assessed due to lack of exposure data. The available evidence on developmental and reproductive effects of creosote was assessed by the Health Effects Division ( HED) Hazard Identification Assessment Review Committee on April 1, 1999 The committee expressed concern for potential infants and children's susceptibility of creosote, based on the severity of offspring vs. maternal effects observed with testing of creosote in the P1/ P13 blend developmental toxicity study in rats at the 175 mg/ kg/ day dose level as well as deficiencies observed in the 2 generation reproduction toxicity study in rats.

Human Exposure Dietary Exposure Based upon its classification as a restricted use pesticide and restrictions on use sites since 1984, dietary exposure to creosote is not expected through food. In drinking water, the Agency has determined that the use pattern of Creosote is not expected to impact water resources through labeled uses. In light of this finding, EPA believes that Creosote's use will not impact ground or surface water and therefore is not expected to lead to exposure to humans through drinking water.

Non Dietary Exposure Occupational uses of creosote are restricted to pressure treatments. To estimate handler and postapplication exposure at pressure treatment facilities, the Agency used dermal and inhalation exposure data from a worker exposure study ( MRID 453234 01) submitted by the Creosote Council II:

1. This study was designed to estimate the exposure to creosote of individuals performing job functions involved in commercial pressure treatment of lumber, utility poles, and railroad ties at four typical commercial treatment facilities in the United States and Canada ( referred to as Sites A through D). Three end use products for coal tar creosote were used. Twenty five workers and 11 job functions ( tasks) were monitored for up to 4 or 5 consecutive work days each ( 8 hour shifts). Many of the job functions may have been performed by one or more worker( s). Where a single worker performed the duties of more than one job function, the title of the job function which represented the majority of their work efforts was used to identify the worker. Employee positions monitored were: treatment operator, treatment assistant, cylinder area loader operator, cylinder area loader helper, checker, drip pad laborer, load out area loader operator, load out area loader helper, load out area forklift operator, oil unloader, test borer, and water treatment system operator.

2. Dermal and inhalation exposure levels were estimated. Dermal exposure levels were 8 estimated by passive dosimetry using whole body dosimeters ( WBDs) and cloth dosimeter gloves. The WBDs and cloth dosimeter gloves were worn under the workers' protective clothing and chemical resistant gloves. Inhalation exposure levels were estimated by active dosimetry using a sampling train ( placed in the worker's breathing zone) that consisted of a PTFE air filter upstream from two in line XAD 2 resin filled air sampling tubes. The air was pulled through the sampling train by a portable air sampling pump.

3. Creosote cannot be measured directly because it is a mixture of many component compounds. In this study dermal exposure to " total creosote" was estimated by measuring the levels of ten individual polynuclear aromatic hydrocarbon ( PNA) compounds. Each analyte was determined in each WBD and glove sample as if it represented total creosote. Inhalation exposure was estimated for 11 individual PNA compounds as well as for benzene soluble PNAs and related compounds collectively known as coal tar pitch volatiles ( CTPVs). The PTFE filter retained the CTPVs, while the PNAs were retained in the XAD 2 resin tubes. ( However, there was no attempt by the study sponsors to relate inhalation levels found for PNAs and CTPVs to " total creosote"  a significant weakness with the study.)

4. The creosote worker exposure study ( MRID No. 453234 01) used personal air samplers to determine air concentrations of 11 PNAs in the breathing zone of the workers. The samplers worn by the workers consisted of PTFE filters ( 2

m pore size) backed by XAD 2 sorbent tubes. Analyzes were performed for 11 PNAs. Of the 11 PNAs, naphthalene was detected in 100 percent of the samples. Because naphthalene was present in all samples for each of the 12 job classifications, it has been selected to indicate potential risks to workers exposed to creosote.

Potential post application exposures to residents, including children ( e. g., from use of railroad ties by homeowners), could not be assessed due to lack of data.

Risk Characterization Summary Dietary Risk food Based upon its classification as a restricted use pesticide and restrictions on use sites since 1984, dietary risk assessment is is not applicable to currently registered uses of creosote.

Dietary Risk  drinking water The Agency has determined that the use pattern of Creosote is not expected to impact water resources through labeled uses. In light of this finding, EPA believes that Creosote's use will not impact ground or surface water and therefore is not expected to lead to exposure to humans through drinking water. If new uses are added in the future, the Agency will reassess the 9 potential impacts of creosote on drinking water as a part of the aggregate risk assessment for this chemical.

Occupational Risk AD has determined that Short and Intermediate term Occupational Handler dermal risk estimates do not exceed AD's level of concern ( i. e. MOEs are greater than 100)

AD has determined that Chronic Occupational Handler dermal risk estimates exceed AD's level of concern ( i. e. MOE < 300) for the treatment operator. The MOE for the treatment assistant does not exceed the target MOE For inhalation exposure to creosote, AD has determined that Occupational Handler Inhalation risk estimates exceed AD's level of concern ( i. e. MOEs < 100) for both the treatment operator and treatment assistant.

Cancer risks from dermal and inhalation exposure exceed the level of 1 x 10 4 for all handler scenarios described.

The results of the post application occupational exposure and risk assessment indicate that the short term non cancer margins of exposure for dermal exposures do not exceed the level of concern for most post application scenarios with the exception of the oil unloader ( MOE= 93). Intermediate term dermal margins of exposure are for most scenarios not of concern with the exception of the cylinder area loader helper, checker, and oil unloader. Long term dermal margins of exposure are of concern with the exception of the load out area loader operator and helper. Inhalation margins of exposure were all of concern for all exposure druation ( i. e. MOEs less than 100). In addition, cancer risks for all post application occupational scenarios exceed the level of concern ( 1E 04); all are greater than 1E 02.

Combined Occupational Margins of Exposure Separate Margins of Exposure were calculated for dermal and inhalation routes of exposure for occupational scenarios. The Antimicrobials Division's ADTC committee determined that the MOEs for dermal and inhalation exposure should not be combined. First, effects are observed in the 90 day inhalation study that are not observed in the 90 day dermal study and include hematological changes, serum biochemistry, thyroid follicular cell hypertrophy, lesions of the nasal epithelium, and increased absolute and relative liver weights. Only decreased body weight and dermal irritation were observed in the 90 day dermal toxicity study. Thus, MOEs will not be combined for the dermal and inhalation routes of exposure. 10 Data Needs There are no additional toxicology data requirements for creosote at this time. However, additional toxicological data requirements may be identified as the PRA is refined. In addition, risk mitigation measures ( e. g., engineering controls) need to be discussed with the Creosote Council prior to requiring any potential exposure data for occupational workers. Additional data are needed to assess exposure and risks to railroad workers, utility pole installers, and residential exposure to utility poles and/ or railroad ties.

Cumulative Exposure Section 408( b)( 2)( D)( v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity. As there are no tolerances for creosote, the Agency is not considering whether creosote has a common mechanism of toxicity with any other chemicals. However, based on the complex nature of the creosote mixture, components of this mixture may act in similar ways to produce the adverse effects noted for creosote.

Endocrine Disruption EPA is required under FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all active pesticides or other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), the EPA has determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC recommendation, that program include evaluations of potential effects in wildlife may. For pesticide chemicals, EPA will use FIFRA and, to some extent that effects in wildlife may help determine whether a substance may have an effect on humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening additional hormone systems may be added to the Endocrine Disruptor Screening Program.

When the appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, creosote may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption. 11 Risk Characterization Overview Dermal Margin of Exposures ( MOEs)  Summary: Toxicological endpoints for short, intermediate, and long term dermal exposures to creosote have been selected A Margin Of Exposure ( MOE) of greater than 100 for creosote is considered to indicate no risk concern for short term ( 1 day to 1 month) and intermediate term ( 1 to 6 months) exposures, and a MOE of greater than 300 for creosote is considered to indicate no risk concern for long term ( 6 months or longer) exposures.

Inhalation MOEs  Summary: Toxicological endpoints for short, intermediate, and long term inhalation exposure have been selected for creosote as well as naphthalene. Naphthalene has been selected as an indicator or worker risks because it was detectable in all worker inhalation exposure samples. For creosote, a MOE of greater than 100 is considered to indicate no risk concern. For naphthalene, the Antimicrobials Division used the inhalation reference concentration ( RfC) for naphthalene published in the EPA's IRIS database. The RfC was derived from a 2 year chronic inhalation study in the mouse in which exposure was for 6 hours/ day, 5 days/ week. The ACGIH documentation for recommending the TLV cited the same 2 year mouse study as EPA. However, the RfC value of 0.0031 mg/ m3 differs dramatically from the TLV's 8 hr TWA value of 52 mg/ m3. The RfC was derived by adjusting the inhalation mouse study's 6 hour/ day 5 day/ week LOAEL of 52 mg/ m3 to a 24 hour/ day 7 day/ week value of 9.3 mg/ m3 and then dividing by an uncertainty factor of 3000 ( 10x intra species variability, 10x inter species extrapolation, 10x for a lack of a NOAEL, and 3x for data base deficiencies). On the other hand, the TLV recommendation of 52 mg/ m3 was based on reviewing human poisoning incidents and other animal studies, including the inhalation mouse study. For the purposes of using naphthalene as an indicator of inhalation risk concerns for workers exposed to creosote, EPA is using the inhalation route specific LOAEL of 52 mg/ m3 with a target MOE of 300 ( 10x intra species variability, 10x inter species extrapolation, and 3x for a lack of a NOAEL). While EPA recognizes that the 24 hour/ day 7 day/ week adjustment to the RfC is not representative of a typical work day, uncertainty factors are warranted to account for inter species extrapolation and variability among workers. Therefore, a inhalation MOE of greater than 300 is considered to indicate no risk concern.

Carcinogenicity  Summary: The carcinogenicity data base for creosote as required by the Agency in the 1988 DCI consist of a six month dermal oncogenicity study of creosote conducted in mice. Creosote in this study was tested both as an initiator ( 5 dermal applications per week for 2 weeks at doses of 500

g/ mouse, 25 mg/ mouse, or 56 mg/ mouse followed by TPA for 26 weeks) and as a promotor ( DMBA as a positive initiator at 50

g/ mouse followed by twice weekly applications of creosote at the same doses as used for the initiation protocol). As an initiator, creosote did not produce any increase in incidence of benign tumors, but at the 25 and 50 mg doses, squamous cell carcinomas were observed in 2/ 30 mice at each dose. As a promotor in DMBA initiated mice, creosote produced dose related increases in skin papillomas, keratoacanthoma, squamous cell carcinoma, and basal cell carcinoma at the 25 and 50 mg doses. 12 Increases in these tumor types were also observed when creosote was used as both initiator and promotor. This study shows that creosote acts most effectively as a promotor but also functions as a " complete" carcinogen.

The Agency proposes to use benzo( a) pyrene as an indicator for carcinogenic potential of creosote, but is also examining new published data on carcinogenicity of creosote itself to determine whether these data will modify the current proposal. This approach has been discussed in the Hazard Profile section of this document.

Creosote Worker Exposure Study: Although there are issues with the analytical portion of this study, the Agency has relied heavily on this study to assess dermal and inhalation exposures and cancer and non cancer risks to workers in creosote pressure treatment plants. A brief summary of this study was presented earlier.

An in depth discussion of exposures ( excluding naphthalene) can be found in the human exposure chapter, but a summary of our findings for application ( handler) and post application scenarios is presented here:

Handler Exposures and Risks Handler Scenarios with Non Cancer Dermal Risk Concerns ( Short and Intermediate term Risk)

Short and intermediate term non cancer dermal risks for handlers ( mixing/ loading applying liquids at a pressure treatment facility treatment operators and treatment assistant) are not of concern ( i. e. MOEs are > 100) with additional engineering controls utilized.

Handler Scenarios with Non Cancer Dermal Risk Concerns ( Long term Risk)

A risk of concern ( i. e. MOE < 300) was identified for the non cancer long term dermal exposure of treatment operators mixing/ loading/ applying liquids at a pressure treatment facility ( long term MOE of 140) with engineering controls.

In addition to reporting creosote inhalation non cancer risks, naphthalene has been selected to indicate worker risk concerns. Naphthalene has been selected because it was detected in all samples for each of the 12 job classifications in the creosote worker exposure study. The geometric mean air concentrations of naphthalene for the 12 job classifications are reported in Table 2. Table 2 presents these air concentrations as a percent of the TLV value ( i. e., worker air concentration / TLV air concentration). Although the measured naphthalene air concentrations in 13 the worker's breathing zone represents only from 0.1 to 2.5 percent of the TLV, EPA considers additional uncertainty factors in the risk assessment. Table 2 also presents MOEs as which indicate a risk concern for the creosote workers. The target MOE is 300. The MOEs range from the highest potential risk of 12 for the cylinder area loader helper ( CH) to the lowest potential risk of 390 for the load out area loader helper ( LH) activity. The MOEs are estimated using the following equation:

MOE = ( LOAEL 52 mg/ m3 x 6 hr/ day mouse study) / ( worker air conc mg/ m3 x 8 hr/ day workday x ( 1 m3/ hour working breathing rate / 0.4 m3/ hour resting breathing rate)

where: 1 m3/ hour working breathing rate represents for light activity; and 0.4 m3/ hour resting breathing rate to account for the fact that the mouse was " at rest" during the toxicity testing.

Table 2. Naphthalene Air Concentrations as an Indicator of Creosote Risks.

Job Classification a Naphthalene Air Conc.( mg/ m3) Geo Mean ( range) b % of TLV c MOE ( Target 300) d Cylinder area loader helper ( CH) 1.291 ( 0.0794 to 5.918) n= 10 2.5 12 Oil unloader ( OU) 0.896 ( 0.701 to 1.399) n= 5 1.7 17 Test borer ( TB) 0.778 ( 0.514 to 1.648) n= 5 1.5 20 Water treatment system operator ( WO) 0.763 ( 0.500 to 1.987) n= 5 1.5 20 Cylinder area loader operator ( CLO) 0.596 ( 0.105 to 2.696) n= 14 1.1 26 Treating operator ( TO) 0.595 ( 0.133 to 2.624) n= 14 1.1 26 Load out area forklift operator ( LLO ( F)) 0.433 ( 0.0750 to 1.259) n= 5 0.8 36 Drip pad labor ( DP) 0.255 ( 0.142 to 0.874) n= 4 0.5 61 Load out area loader operator ( LLO) 0.138 ( 0.0282 to 1.540) n= 14 0.3 110 Checker ( CK) 0.083 ( 0.0308 to 0.268) n= 5 0.2 190 Load out area loader helper ( LH) 0.04 ( 0.0269 to 0.0612) n= 4 0.1 390 Treating assistant ( TA) 0.346 ( 0.117 to 0.575) n= 4 0.7 45 a Job classifications are based on the descriptions provided in MRID No. 453234 01). b Geometric mean air concentration are used to estimate MOEs from MRID No. 453234 01. c % TLV = ( air conc mg/ m3 / TLV 52 mg/ m3) * 100. d MOE = ( LOAEL 52 mg/ m3 x 6 hr/ day mouse study) / ( air conc mg/ m3 x 8 hrs/ day working x ( 1 m3 work activity / 0.4 m3 resting)) 14 Short term, intermediate term, and long term 15 16 17 Note: Exposure data were not available for assessing short term non cancer risks for the following two scenarios:

a. Railroad worker; and b. Pole installer.

Post Application Cancer Risks from Dermal and Inhalation Exposures to Creosote The Agency has determined that all of the post application scenarios exceed the 1E 04 cancer risk levels. This is based upon calculated dermal and inhalation residues from the Creosote Council's worker exposure study. Therefore, all of the post application scenarios are expected to pose a risk concern.

Note that the Agency has adjusted cancer risk calculations by factors of 0.005 and 0.01. This was done because:

a. The cancer risk assessment is based upon benzo( a) pyrene, a component found in creosote formulations; and b. Available information indicates that benzo( a) pyrene occurs as a component in creosote at levels of 0.5%. However, in order to provide a conservative assessment the Agency has assumed that levels of benzo( a) pyrene may occur from 0.5% to 1% of total creosote formulations.

Even with use of the 0.005 and 0.01 adjustment factors the 1E 04 cancer risk level of concern is exceeded. 18 Post Application Non Occupational ( Residential) Scenarios Potential post application, non occupational exposure scenarios likely include the following:

( 1) Incidental ingestion and dermal contact with soil contaminated with creosote ( e. g., soil contaminated by creosote treated telephone poles) ( child);

( 2) Dermal contact with pressure treated wood products ( e. g., utility poles, railroad ties used in home settings, posts) ( adult); and ( 3) Hand to mouth and dermal contact with industry pressure treated wood products ( e. g., utility poles, railroad ties used in home settings, posts) ( child).

However, adequate data are not available to assess these post application exposures and risks.

Risk Mitigation The majority of the calculated non cancer and cancer risks are based upon the results of the Creosote Council II's 2001 worker exposure study which examined workers under actual creosote use conditions in wood treatment plants. Since each NAFTA partner ( PMRA and CALDPR has questions and issues associated with this study ( e. g., analytical issues), further discussion among NAFTA partners, as well as with the Creosote Council II and study authors, is required to determine if there are any appropriate risk mitigation measures that can be taken to reduce non cancer and cancer risks. Additionally, PMRA has indicated that they have videotapes from several of the sites studied; NAFTA partners have view of these tapes to assist in identifying any further risk mitigation measures that could be taken.

Data Gaps, Uncertainties, and Limitations Data Gaps 1. Occupational Exposures: Although the Creosote Council II submitted a worker exposure study which addresses worker exposures in creosote pressure treatment plants, no data are available to assess railroad workers and utility pole installers.

2. Non occupational ( Residential) Exposures: Data are not adequate to characterize nonoccupational ( residential) post application exposures. 19 Uncertainties/ Limitations With The Occupational Handler and Post Application Data Issues with the Creosote Council II's worker exposure study ( MRID 45323401):

a. The study sponsors made no attempt to relate inhalation levels found for PNAs and CTPVs to " total creosote"  a significant weakness with the study;

b. There were inconsistencies in raw data and examples provided by the study authors: e. g., inhalation raw data did not reflect data found in bar graphs;

c. Air samplers did not show quantifiable levels for several of the PNAs monitored: ( e. g., benzo( a) pyrene was not detected in any of the worker samples);

d. Inhalation field fortification percent recoveries for CTPVs were poor: overall recoveries ranged from 51 %  57%.

Uncertainties/ Limitations With Agency Cancer Risk Estimates A specific quantitative cancer assessment on the carcinogenicity of creosote has not been performed by the Agency, but a cancer potency factor exists for one of the components of creosote, benzo( a) pyrene, with a Q1* value of 7.3( mg/ kg/ dy) 1. The Agency proposes to use the risk assessment for benzo( a) pyrene as an indicator for carcinogenic potential of creosote.

Considering the above, EPA adjusted creosote cancer risk calculations by factors of 0.005 and 0.01. This was done because:

a. The cancer risk assessment is based upon benzo( a) pyrene, a component found in creosote formulations; and b. Available information indicates that benzo( a) pyrene occurs as a component in creosote at levels of 0.5%. However, in order to provide a conservative assessment the Agency assumed that levels of benzo( a) pyrene may occur from 0.5% to 1% of total creosote formulations.

However, it should be noted that although corrections to cancer risk estimates were made, data from the worker exposure study were not provided on the actual amount of benzo( a) pyrene found as dermal residues. Further, in this study all inhalation samples of benzo( a) pyrene were found to be at levels below the Level of Detection ( LOD). These factors, therefore, increase the uncertainty of the cancer risk assessment. 20 Aggregate risk assessments Acute Aggregate Risk Under the current policy of the Office of Pesticide Programs, acute aggregate risk assessment determines the acute risk from combined dietary consumption of pesticide residues, separate from residential exposures ( Health Effects Division, Standard Operating Procedure 97.2, April 1998). In the case of creosote, an acute aggregate ( food + water) risk estimate was not performed for creosote. Creosote is not registered for any food use, and it has also been determined that creosote is not likely to impact the diet or drinking water.

Short and Intermediate Term Aggregate Risks Aggregate short and intermediate term risk assessments are designed to provide estimates of risk likely to result from exposures to the pesticide or pesticide residues in food, water, and from residential ( or other non occupational) pesticide uses. Due to the lack of exposure through food or water, short and intermediate term aggregate risks were not performed. Residential exposures to creosote residues may occur, but data are not available to assess these risks.

Chronic ( Non Cancer) Aggregate Risk Based on the lack of potential for chronic exposure to creosote through food and water, a chronic ( non cancer) aggregate risk assessment was not performed. 21 References MRID REFERENCE 453234 01 Creosote Council II, 2001. " Assessment of Potential Creosote Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Creosote." Submitted by John H. Butala, Creosote Council II. Field work by Mark G. Bookbinder, Ph. D, c/ o American Agricultural Services Inc. Analytical work by Bert Clayton, EN CAS Laboratories and Stephanie Guilyard, USX Engineers and Consultants.

None Agency for Toxic Substances and Disease Registry ( 1995): Toxicological Profile for Polycyclic Aromatic Hydrocarbons. U. S. Department of Health and Human Services: Public Health Service.

None Agency for Toxic Substances and Disease Registry ( 2002): Toxicological Profile for Creosote ( update). U. S. Department of Health and Human Services: Public Health Service.

None Butala, J. H. 1999. Creosote Council II memorandum with attachment to Nader Elkassabany, U. S. Environmental Protection Agency, Antimicrobials Division. February, 1999.

None Murata et al. 1993. Chronic Toxicity and Carcinogenicity Studies of 1 methylnapthalene in B6C3F1 mice. Fundam Appl. Toxicol. 21( 1): 1993.

None McMahon, Timothy F. 1999. Creosote: Report of the Hazard Identification Assessment Review Committee. May, 1999. HED document no. 013375. Unpublished.

None National Toxicology Program. TR 410. Toxicology and Carcinogenesis Studies of Naphthalene in B6C3F1 Mice ( Inhalation Studies).

None National Toxicology Program. TR 500. Toxicology and Carcinogenesis Studies of Naphthalene in F344/ N Rats ( Inhalation Studies).

None Nesnow et al. 1998. Mechanistic relationships between DNA adducts, oncogene mutations, and lung tumorigenesis in strain A mice. Exp. Lung Res. 24( 4): 1998.

None USEPA, 1984: Wood Preservative Pesticides: Creosote, Pentachlorophenol, Inorganic Arsenicals. Position Document 4.

None USEPA, 1997. FIFRA Science Advisory Panel. A Set of Scientific Issues Being Considered by the Agency to Discuss and Evaluate the Inhalation Risk 22 Assessments and the Combining of Margins of Exposure. Transmittal of the Final Report of the FIFRA Scientific Advisory Panel Meeting for March 19 and 20, 1997. April 28, 1997.

None Whalen, John E. vand Hugh M. Pettigrew. Inhalation Risk Characterizations and the Aggregate Risk Index ( ARI). USEPA. Health Effects Division. November 25, 1998.

None York, Raymond G. ( 1994): Developmental Toxicity Study in New Zealand White Rabbits. Study conducted by IRDC, Mattawan, MI for Koppers Inductries, Pittsburgh, PA. Report no. 672 002. Unpublished.

None York, Raymond G. ( 1995): Two Generation Reproduction/ Fertility Study in Rats. Study conducted by IRDC, Mattawan, MI for Koppers Inductries, Pittsburgh, PA. Report no. 672 006. Unpublished.

43032101 North American P1/ P13 Creosote: Acute Oral Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032102 North American P1/ P13 Creosote: Acute Dermal Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032103 North American P1/ P13 Creosote: Acute Inhalation Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032104 North American P1/ P13 Creosote: Eye Irritation Study in Rabbits. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032105 North American P1/ P13 Creosote: Primary Dermal Irritation Test in Rabbits. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032106 North American P1/ P13 Creosote: Dermal Sensitization Study ( Buehler) in the Albino Guinea Pig. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032301 North American P2 Creosote: Acute Oral Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033. 23 43032302 North American P2 Creosote: Acute Dermal Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished.

43032303 North American P2 Creosote: Acute Inhalation Toxicity Evaluation in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032304 North American P2 Creosote: Eye Irritation Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032305 North American P2 Creosote: Primary Dermal Irritation Test in Rabbits. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43032306 North American P2 Creosote: Dermal Sensitization Study ( Buehler) in the Albino Guinea Pig. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Unpublished. HED document no. 011033.

43601001 North American P1/ P13 Creosote: Thirteen Week Subchronic Inhalation Toxicity Study on North American P1/ P13 Creosote CTM in Rats: Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Report No. 671 016 ( 1995). Unpublished.

43600901 North American P2 Creosote: Thirteen Week Subchronic Inhalation Toxicity Study on North American P2 Creosote CTM in Rats: Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Report No. 671 018 ( 1995). Unpublished.

43616101 North American P1/ P13 Creosote: 90 Day Subchronic Dermal Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Report No. 671 013 ( 1995). Unpublished.

43616201 North American P2 Creosote: 90 Day Subchronic Dermal Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Report No. 671 014 ( 1993). Unpublished.

43584201 North American P1/ P13 Creosote: Developmental Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Report No. 671 020 ( 1995). Unpublished.

43584202 North American P2 Creosote: Developmental Toxicity Study in Rats. Study conducted by IRDC, Mattawan, MI for the Creosote Council II. Report No. 671 022 ( 1995). Unpublished. 24 44844401 A 6 Month Dermal Oncogenicity Study of Creosote in Mice. Study conducted by WIL Research Laboratories, Ashland, OH for Koppers Industries, Pittsburgh, PA. Report no. WIL 100005. Unpublished.

45323401 Creosote Council II, 2001. " Assessment of Potential Creosote Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Creosote." Submitted by John H. Butala, Creosote Council II. Field work by Mark G. Bookbinder, Ph. D, c/ o American Agricultural Services Inc. Analytical work by Bert Clayton, EN CAS Laboratories and Stephanie Guilyard, USX Engineers and Consultants.