[Federal Register Volume 86, Number 114 (Wednesday, June 16, 2021)]
[Rules and Regulations]
[Pages 31948-31950]
[FR Doc No: 2021-12610]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0073; FRL-10023-91]

Purpureocillium Lilacinum Strain PL11; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Purpureocillium lilacinum strain PL11 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. LAM International
Corporation submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), requesting an exemption from the requirement
of a tolerance. This regulation eliminates the need to establish a
maximum permissible level for residues of Purpureocillium lilacinum
strain PL11 under FFDCA when used in accordance with this exemption.

DATES: This regulation is effective June 16, 2021. Objections and
requests for hearings must be received on or before August 16, 2021,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0073, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Publishing Office's e-CFR site at
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2016-0073 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
August 16, 2021. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2016-0073, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of August 24, 2018 (83 FR 42818) (FRL-9982-
37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F8690) by LAM International Corporation, 117 South
Parkmont St., Butte, MT 59701. The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of Purpureocillium lilacinum strain PL11 in or
on all food commodities. That document referenced a summary of the
petition prepared by the petitioner LAM International Corporation,
which is available in the docket via http://www.regulations.gov. One
comment was received on the notice of filing. EPA's

response to this comment is discussed in Unit III.C.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
making a safety determination to establish an exemption from the
requirement of a tolerance, EPA must take into account the factors set
forth in FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance exemption and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .'' Additionally, FFDCA section 408(b)(2)(D) requires that
EPA consider ``available information concerning the cumulative effects
of [a particular pesticide's] residues and other substances that have a
common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on
Purpureocillium lilacinum strain PL11 and considered its validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on that data can be found
within the May 20, 2021, document entitled ``Federal Food, Drug, and
Cosmetic Act (FFDCA) Safety Determination for Purpureocillium lilacinum
strain PL11.'' This document, as well as other relevant information, is
available in the docket for this action as described under ADDRESSES.
    The available data demonstrated that, with regard to humans,
Purpureocillium lilacinum strain PL11 is not toxic, pathogenic, or
infective via any reasonably foreseeable route of exposure. Although
there may be dietary and non-occupational exposure to residues when
Purpureocillium lilacinum strain PL11 is used on food commodities,
there is not a concern due to the lack of potential for adverse
effects. EPA also determined that retention of the Food Quality
Protection Act safety factor for infants and children under FFDCA
408(b)(2)(C) was not necessary as part of the qualitative assessment
conducted for Purpureocillium lilacinum strain PL11.
    Based upon its evaluation, EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to residues of
Purpureocillium lilacinum strain PL11. Therefore, an exemption from the
requirement of a tolerance is established for residues of
Purpureocillium lilacinum strain PL11 in or on all food commodities
when used in accordance with label directions and good agricultural
practices.

B. Analytical Enforcement Methodology

    An analytical method for enforcement purposes is not required
because EPA has determined that reasonably foreseeable exposure to
residues of Purpureocillium lilacinum strain PL11 from use of the
pesticide will be safe, due to lack of toxicity, pathogenicity, and
infectivity. Under those circumstances, it is unnecessary to have an
analytical method to monitor for residues.

C. Response to Comments

    One comment was received in response to the notice of filing. The
comment discusses concerns regarding the use of ``GRAS'' (generally
recognized as safe) determinations to support decisions regarding
pesticide products and promotes a complete review of data. Consistent
with FFDCA section 408(b)(2)(D), EPA reviews the available scientific
data and other relevant information and considers their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. EPA also considers available information
concerning the variability of the sensitivities of major identifiable
subgroups of consumers, including infants and children. EPA relied on a
variety of data and information to make a risk determination on
Purpureocillium lilacinum strain PL11. For more information on the
human health risk assessment of Purpureocillium lilacinum strain PL11,
please see the supporting documentation provided in the associated
regulatory docket (search for ``EPA-HQ-OPP-2016-0079'' at
www.regulations.gov).

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or Tribal
Governments, on the relationship between the National Government and
the States or Tribal Governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian Tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as

described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 10, 2021.
Edward Messina,
Acting Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1382 to subpart D to read as follows:

Sec.  180.1382   Purpureocillium lilacinum strain PL11; exemption from
the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Purpureocillium lilacinum strain PL11 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2021-12610 Filed 6-15-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Notices]
[Page 65545]
[FR Doc No: 2012-26442]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL13-11-000; RD13-1-000]

Tri-State Generation and Transmission Association, Inc. v.
Western Electric Coordinating Council and North American Electric
Reliability Corporation; Notice of Complaint

    Take notice that on October 18, 2012, pursuant to sections
215(d)(6) and 206 of the Federal Power Act, 16 USC 824o(d)(6) and 824e
(2010), section 39.6 of the Federal Energy Regulatory Commission's
(Commission) regulations 18 CFR 39.6 (2011) and rule 206 of
Commission's Rules of Practice and Procedure, 18 CFR 385.206 (2011),
Tri-State Generation and Transmission Association, Inc. (Complainants)
filed a complaint and petition requesting resolution of the conflict
between Western Electric Coordinating Council and North American
Electric Reliability Corporation's (Respondent) implementation of
Regional Reliability Standard IRO-006-WECC-1 and the transmission
curtailment priorities specified in the Commission's pro forma Open
Access Transmission Tariff.
    The Complainant stated that copies of the complaint and petition
have been served on the Respondents as listed on the Certificate of
Service appended to the complaint and petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 8, 2012.

    Dated: October 22, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-26442 Filed 10-26-12; 8:45 am]
BILLING CODE 6717-01-P


Duly noted. The AG is working on the letter as we speak.  We hope to get

the final application up there as soon as possible after the permit

duration rule is effective (October 14).

>>><EMAIL_ADDRESS>10/5/2006 12:24 PM >>>

Jeff:   The MOA submitted on August 1, addressed the comment/request

successfully.  As for the cover letter, you wisely went back to

Bharat's

name as Tom left again.   Starting next week, however, Mary Gade will

become the new Regional Administrator.  You may want to note that for

the future.   It is not an issue for the MOA as it was dated August 1.

I think we can consider the MOA complete.

----- Forwarded by Gary Westefer/R5/USEPA/US on 10/05/2006 11:20 AM

-----

             Gary

             Westefer/R5/USEP

             A/US

                                                                     To

             01/18/2006 08:18<EMAIL_ADDRESS>

             AM                                                      cc

                                                                Subject

                                      ARA 7

Jeff:

I will give this to you in writing so you can refer to it easier.

The only comment we had was on the MOA and came from enforcement.

They

are asking to make one change on the MOA on Page 15, Section VII A, in

the indented paragraph we cite where EPA will take enforcement action.

We would like to add as follows "or; 3) detecting violations during a

designated lead federal inspection."

Adding this makes sense to me as we normally would do the enforcement

on

our own inspections.

The other item is not an error or comment, but simply since it was in

ORC so long, Tom Skinner came back and now the cover letter needs to

be

changed from Bharat's name to Tom's.

That's all.  Congratulations on a good application.

Gary


Response to EPA Comments Concerning the Creosote Pressure Treatment Worker Exposure Study Included in the Creosote Human Risk Characterization Preliminary Risk Assessment Documents Author Mark G. Bookbinder, Ph. D. 11157 Yellow Leaf Way Germantown, MD 20876 1377 Date Submitted:

02/ 21/ 2003 The EPA has made a number of comments on the 2001 creosote pressure treatment worker exposure study in their draft RED science chapter, which are repeated in the Creosote Human Exposure Executive Summary, Human Risk Characterization, and Review of Worker Exposure Study Sections. Each comment is presented below in italics, along with our response. The comments are presented in the order in which they appear in the Creosote Human Exposure Executive Summary.

1. The Study Sponsors made no attempt to relate inhalation levels found for PNAs and CTPVs to " total creosote"...

While we recognize the Agency's wish to consider creosote as a single " unit product" for the purposes of risk assessment, it must be noted that a working pressure treatment system does not spray creosote into the environment. Therefore, workers involved in pressure treatment will not be directly exposed to respirable droplets of creosote per se, but instead are more likely to inhale a mixture of individual creosote components volatilizing from hot treated materials. For this reason, this study monitored exposure to several of those individual components, representing a range of molecular weights and boiling temperatures.

The results of the study indicate that only the lighter components are likely to be present in the air in pressure treating areas. Chrysene and benzo[ a] pyrene ( the highest formula weight PNAs monitored) were not detected in any of 88 full day worker samples. In contrast, naphthalene ( with the smallest f. w. of any monitored PNA) was found in every sampling train. The percentage of worker samples containing each monitored PNA is shown in the table below:

A plot of the formula weight of each monitored PNA against the mean percentage of worker samples in which a PNA of that formula weight was detected, is shown below:

128.17 142.2 154.21 168.2 166.22 178.23 202.26 Formula weight 0 20 40 60 80 100 Mean % samples containing component Formula Representative analyte( s) monitored Avg. % of w eight Boiling Formula % w orker w orker range Chemical name pt. ( ° C) w eight samples*? samples < 130 Naphthalene 217.7 128.17 100.0% 100.0% 130 150 2 methylnaphthalene 241 242 142.2 98.9% 92.0% 1 methylnaphthalene 240 243 142.2 85.2% 150 170 Acenaphthene 279 154.21 68.2% 68.2% Dibenzofuran 154 155 168.20 54.5% 54.5% Fluorene 298 166.22 53.4% 53.4% 170 180 Phenanthrene 340 178.23 42.0% 22.2% Anthracene 340 178.23 2.3% 180 205 Pyrene 404 202.26 1.1% 1.14% > 205 Chrysene 448 228.29 0.0% 0.0% Benzo( a) pyrene 495 228.29 0.0% * Percent of w orker sampling trains containing this analyte. ** Average % of w orker samples containing analytes of this formula w eight range. Regression of the mean % samples vs. formula weight demonstrates that the presence of a creosote component in the air around pressure treatment systems is related to its formula weight ( r2 = 0.966), and strongly suggests that very large molecules such as chrysene and benzo[ a] pyrene will not be available for inhalation by treatment workers, possibly because they are not volatilized at typical wood treatment temperatures, and/ or because they may recondense very quickly after volatilization and do not remain airborne.

We believe that this relationship can be used to relate the quantity of PNAs found in worker sampling trains to that of " total airborne creosote" ( i. e., the sum of the individual components of total creosote that become airborne in the treatment area).

The components of P1/ P13 and P2 creosote were recently characterized ( Sparacino, 1999). Each known component can be placed into one of the formula weight categories listed in the table above. As those making up the " 0% sampled" formula weight group are unlikely to be present in treatment area air, the contribution of each of the remaining components to " total airborne creosote" can be estimated by dividing the original percentage of that component in standard creosote by that fraction of standard creosote consisting of the total of airborne components.

For example, if airborne creosote is assumed to contain only 74% of the components of standard creosote ( i. e., if components making up 26% of standard creosote fall into the " 0% airborne" weight group), then a detectable component making up 17% of standard creosote would make up 23% of " total airborne creosote." Then, to normalize the levels of creosote components found in an inhalation sample to total airborne creosote, the total found is divided by the sum of the fractions of all detected components in total airborne creosote, as shown in the simplified example below:

Eliminating % of each Components % of each % of each component in total found in in total Know n in standard d as non aerial w orker aerial components creosote airborne creosote samples creosote a 5 5 6.8% * 6.8% b 12 12 16.2% * 16.2% c 17 17 23.0% d 26  e 30 30 40.5% * 40.5% f 10 10 13.5% TOTAL 100 74 100.0% 63.5% Then a sample containing 67 ug residues w ould be considered to contain ( 67 ug / 0.635 =) 105.51 ug total airborne creosote. When this procedure is performed on the known components of P1/ P13 creosote typically used at monitored treatment plants, PNAs making up 16.1% of total creosote are eliminated from consideration as components of total airborne creosote. The calculated percentages of the monitored PNAs in total airborne creosote are shown in the table below:

The monitored PNAs ( excluding pyrene, chrysene, and benzo[ a] pyrene) together make up 52.1% of total airborne creosote.

Reference: Sparacino, C. M. 1999. Preliminary Analysis for North American CTM Creosote P1/ P13. Research Triangle Institute, Research Triangle Park, NC. 31 pp.

2. The amount of product applied and the amount of ai handled by each worker was not calculated because the creosote was applied in a closed system which recovered and retained excess treatment solution from the wood and treatment vessel while sealed.

This is true. To reflect typical use practices, we monitored workers operating full sized treatment systems. Since the workers never directly handled the treatment solution prior to, during, or after application ( under normal circumstances) in the sense typically employed to describe worker exposure scenarios, it is impossible to assign an " amount handled" to any worker involved in the process. For each charge treated, we recorded the volume of treating solution added to the pressure vessel, the volume of wood treated, and the volume of treating solution recovered by the treating system following treatment. These data were summarized in Table XII of the study report. From this information we calculated the volume of creosote retained in/ on the wood ( as well as on the trams, cables, bands, and other exposed surfaces within the pressure vessel) during treatment. These results are presented on Page 55 of the study report.

3. The number of field fortification samples collected at the sites were less than the required number to satisfy Series 875 guidelines...

The number and types of field controls followed Guideline 875, Group B, Part C ( 3.1.1). Due to the complex nature of the study, one set of each type of field controls was produced at each field test site to support the replicates of monitoring done at the site. Ambient weather conditions varied only slightly during the monitoring period at each site, and stability of the compounds tested had been demonstrated during prefield testing. Percent of Percent of Formula total total aerial Monitored PNA w eight Creosote creosote naphthalene 128.2 9.00 10.6 I methylnaphthalene 142.2 2.30 2.71 2 methylnaphthalene 142.2 5.10 6.01 acenaphthene 154.2 6.10 7.18 dibenzofuran 168.2 3.10 3.65 fluorene 166.2 4.20 4.95 phenanthrene 178.2 12.2 14.4 anthracene 178.2 2.20 2.59 pyrene 202.3 6.00 0 chrysene 228.3 1.50 0 benzo[ a] pyrene 253.3 0.50 0 4. The overall inhalation field fortification percent recoveries for the coal tar pitch volatiles ( CTPVS) were poor...

The nature of CTPVs is such that any highly volatile component that was trapped by the collection filter could revolatilize during the 8 hr exposure period and be lost to the collection filter. Since no worker samples contained quantifiable levels of CTPVs, we did not correct results for field control recoveries. Any revolatalized PNAs were likely to be retained in the XAD 2 resin tubes, thus would be not be lost to the sampling systems.

5. There were some dermal fortification levels with extremely high recoveries for WBD's and some with unacceptable low recoveries for gloves...

It became apparent during the conduct of the study that the analytical method used to determine total creosote in dermal monitoring matrices was subject to some variability near the LOQ ( which could artifactually impact the results of field recoveries at that level), and that field control samples mainly monitored the comparative volatility of creosote components regardless of the spike level applied. In addition, outdoor prefield testing demonstrated that recoveries from samples fortified at LOQ were significantly more variable ( as indicated by standard errors) than those from samples spiked at either 100X LOQ or 1000X LOQ, and that the variability was of similar magnitude at the two higher rates.

We recognized, therefore, that variability of recovery of creosote from the LOQ level field control samples was greater than desired, and used the recoveries from high rate samples for correction of raw results, as described on page 51 of the study final report. Among the samples actually used for correcting dermal results:

  Recoveries from glove samples were between 68.4% and 89.1%, thus within the acceptable range.

  Recoveries from WBD samples were between 67.5 and 81.4% ( except for one Site D sample for which the recovery was 61.8%).

We believe that these results reflect the reality that testing under field conditions may exhibit slightly more variability than would be expected under more strictly controlled laboratory environments.

6. PMRA has indicated that there are calculation mistakes with inhalation data in the study.

PMRA indicated that a problem existed with the inhalation exposure calculation example that appears in the final study report ( on Page 53). In addition, EPA notes that following the calculation process was difficult. To alleviate these concerns, we have expanded the information provided for the calculation of inhalation exposure, and present it below:

Potential inhalation exposure to each creosote component monitored ( PNAs, CTPVs) was estimated from material collected in the appropriate air sampler. The unadjusted residue level ( in ) g) for each air sampler from each worker was corrected for the mean recovery of the appropriate analytical standard( s) from samples of the appropriate matrix fortified in the field at that test site. Inhalation exposure for each target compound was calculated from material found in the entire sampling train ( filter + front tube + rear tube). Calculated inhalation exposure levels were normalized by scaling up the pump flow rate of 1 L/ min to the U. S. EPA's recommended minute ventilation rate of 1,100 L/ hr (~ 18.34 L/ min) for " light activities" ( 4), then by adjustment for the standard EPA recommended adult weight of 71.8 kg.

The following example illustrates the results of this procedure for creosote components collected in the air sampling train worn by the Site C LLO during his first monitored work cycle ( Replicate 1).

Sample data:

AASI sample numbers: 3 F 1 ( filter), 3 S 1A ( front tube), and 3 S 1B ( rear tube) UEC sample numbers: PRM31824, 25, and 26 ( filter, front tube, and rear tube) Duration of monitoring period: 6: 36 (  0.826 standard work days; from Table XIII) Calibrated air flow rate: 0.980 L/ min during work cycle ( from Table XXIV)

Residues found ( from Table 2 of Appendix E of the final report):

Mean recovery of components from Site C field spikes ( for entire train; from Table XVI):

Naphthalene: 90.1% 2 Methylnaphthalene: 81.9% 1 Methylnaphthalene: 81.4% Acenaphthene: 72.1% Others: Not applicable ( components < LOD) Raw µ g analyte per sample Front tube Back tube Analyte Filter Front Back Front Back CTPVs 0.018 < LOD < LOD < LOD < LOD Naphthalene < LOD 73.8 20.5 < LOD < LOD 2 Methylnaphthalene < LOD 5.80 < LOD < LOD < LOD 1 Methylnaphthalene < LOD 8.20 < LOD < LOD < LOD Acenaphthene < LOD 8.30 < LOD < LOD < LOD Dibenzofuran < LOD < LOD < LOD < LOD < LOD Fluorene < LOD < LOD < LOD < LOD < LOD Phenanthrene < LOD < LOD < LOD < LOD < LOD Anthracene < LOD < LOD < LOD < LOD < LOD Pyrene < LOD < LOD < LOD < LOD < LOD Chrysene < LOD < LOD < LOD < LOD < LOD Benzo( a) pyrene < LOD < LOD < LOD < LOD < LOD Calculations:

1. Determination of the adjusted value of each analyte found in/ on samplers at quantifiable levels. The following example is presented for naphthalene. The procedure described below was followed for each component for which residues > LOQ were found ( 2 and 1 methyl naphthalene, and acenapthene:

Analyte level adjusted for recovery or LOD/ LOQ:

Filter: 0.41 ) g  2 = 0.205 ) g ( 50% of LOD) Front tube/ front sec.: 73.8 ) g  90.1% = ~ 81.93 ug Front tube/ rear sec.: 20.5 ) g  2 = 10.3 ) g ( 50% of LOQ) rear tube/ front sec.: 0.41 ) g  2 = 0.205 ) g ( 50% of LOD) Rear tube/ rear sec.: 0.41 ) g  2 = 0.205 ) g ( 50% of LOD) TOTAL: ~ 92.8 ) g Analyte level normalized to standard worker respiration rate, body weight, and work day length:

Corr. ) g/ sample = adj. ) g/ sample + ( RR  60) + ( 1  FR]) + ( 1  BW) + ( 1  DW)

Where FR = calibrated pump flow rate ( L/ min), RR = 1100 L/ hr ( EPA recommended " light work" respiration rate), DW = portion of 8 hr work day represented by work period, and BW = 71.8 kg ( EPA standard adult body weight).

x 92.8 ) g + ( 1100  60) + ( 1  0.98]) + ( 1  71.8) + ( 1  0.8258)

x 29.3 ) g naphthalene/ kg worker weight/ work day 2. Calculation of value for each analyte not detected in/ on samplers: The following example is presented for chrysene in the above noted samples.

Analyte level adjusted for LOD:

Filter: 0.36 ) g  2 = 0.18 ) g ( 50% of LOD) Front tube/ front sec.: 0.36 ) g  2 = 0.18 ) g ( 50% of LOD) Front tube/ rear sec.: 0.36 ) g  2 = 0.18 ) g ( 50% of LOD) rear tube/ front sec.: 0.36 ) g  2 = 0.18 ) g ( 50% of LOD) Rear tube/ rear sec.: 0.36 ) g  2 = 0.18 ) g ( 50% of LOD) TOTAL: 0.90 ) g Analyte level normalized to standard worker respiration rate, body weight, and work day length:

Corr. ) g/ sample = adj. ) g/ sample + ( RR  60) + ( 1  FR]) + ( 1  BW) + ( 1  DW)

Where FR = calibrated pump flow rate ( L/ min), RR = 1100 L/ hr ( EPA recommended " light work" respiration rate), DW = portion of 8 hr work day represented by work period, and BW = 71.8 kg ( EPA standard adult body weight).

x 0.90 ) g + ( 1100  60) + ( 1  0.98]) + ( 1  71.8) + ( 1  0.8258)

x 0.284 ) g chrysene/ kg worker weight/ work day For analytes present between LOD and LOQ, a residue level of 50% LOQ was assigned for each sampler.

3. Determination of total adjusted analytes in/ on samplers. Individual and total values shown below are found in Table XXVII ( LLO, Replicate 1).

CTPVs: 3.16 ) g ( by adjustment for 50% LOD) Naphthalene: ~ 29.3 ) g ( by calculation from quantifiable residues) 2 Methylnaphthalene: ~ 3.78 ) g ( by calculation from quantifiable residues) 1 Methylnaphthalene: ~ 3.51 ) g ( by calculation from quantifiable residues) Acenapthene: ~ 3.88 ) g ( by calculation from quantifiable residues) Dibenzofuran: 0.54 ) g ( by adjustment for 50% LOD) Fluorine: 0.38 ) g ( by adjustment for 50% LOD) Phenanthrene: 0.28 ) g ( by adjustment for 50% LOD) Anthracene: 0.402 ) g ( by adjustment for 50% LOD) Pyrene: 0.371 ) g ( by adjustment for 50% LOD) Chrysene: 0.284 ) g ( by adjustment for 50% LOD) Benzo a pyrene: 0.402 ) g ( by adjustment for 50% LOD)

TOTAL: ~ 46.3 ) g ( total of all above listed individual values)

Due to the number of separate calculations required for analyte level determination in/ on each sampler, the procedures described above were performed using linked electronic spreadsheets and calculated using the native precision of the spreadsheet software ( Lotus ® 123   Release 9.5): therefore, calculation results may differ slightly from those derived by hand from the same raw data, due to rounding of intermediate values.

While reviewing the exposure study results, we noted the following additional items: corrections to raw data values for two samples ( Site B, Replicate 1, front section of the front tube, for naphthalene; and Site C, Replicate 5, front section of the front tube, for 1 methylnaphthalene) that had been provided by the analytical laboratory were inadvertently not applied to the data during processing. In addition, corrections for storage stability were incorrectly applied to certain samples collected at Site C. Revised tables and figures reflecting these corrections are appended to this report. Dose levels and MOEs calculated from the revised data, shown in the following table, do not differ appreciably from those calculated by EPA's reviewers.

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

The bar graphs shown on pages 71 73 of the final report were generated from the data shown in Tables XXVI XXVIII ( pages 144 146) by means of intermediate steps which were shown as separate tables ( including only partial headings and identification) on the QAU audited electronic data file submitted with the study raw data, but which were not included in the report ( to conserve space). Those intermediate tables ( with rows and columns resized and reformatted for clarity; including complete headings and doubleletter rather than numeric, identifiers; and reflecting the data corrections noted in item # 6 above) are included in Appendix 1.

For each replicate of monitoring of each subject, the calculated inhalation exposure values for the individual creosote components shown in table XXVI, XXVII, or XXVIII were summed, to generate a value representing the total calculated exposure to all target residues. This appears in the far right column of the table, which was not reproduced in the final report. The complete version of each table is included in Appendix 1. Summary of inhalation exposure and risk derived from revised* sample data. Daily exposure Daily dose Lifetime a. d. d. Job mg/ day mg/ kg/ day mg/ kg/ day MOE class G. M.** Max** G. M. Max G. M. Max G. M. Max TO 8.2 30.0 0.117 0.429 0.021 0.078 10.3 2.80 TA 4.8 7.3 0.069 0.104 0.013 0.019 17.3 11.5 TB 6.5 16.6 0.092 0.237 2.36 6.05 13.0 5.07 LLO 3.6 22.1 0.051 0.316 1.30 8.09 23.5 3.79 LLO( F) 7.6 18.6 0.109 0.266 2.78 6.81 11.0 4.51 LH 1.3 1.7 0.018 0.024 0.471 0.614 65.1 50.0 CLO 15.5 48.6 0.221 0.695 5.65 17.8 5.43 1.73 CH 19.7 76.6 0.281 1.094 7.20 28.0 4.26 1.10 WO 7.7 9.1 0.110 0.130 2.81 3.33 10.9 9.22 CK 3.0 7.0 0.042 0.099 1.09 2.54 28.3 12.1 OU 11.6 18.2 0.166 0.260 4.24 6.64 7.24 4.62 DP 4.3 12.0 0.061 0.172 1.55 4.40 19.7 6.98 * Storage stability corrections applied to Site C replicates 28 34 and removed elsew here; raw data values corrected for Site B Rep. 1 and Site C Rep 5. ** G. M. = calculated using geometric mean of individual w orker replicate The individual replicate exposures shown in the numbered tables were rearranged to permit the calculation of exposures for each job class, averaged over all test sites, shown in in Table AA. The geometric mean exposures calculated in Table AA were summarized in Table BB, which was used to generate the figure shown on Page 71 of the final report.

I n addition, the geometric means of the total exposures for all analytes ( new column) of Tables XXVI XXVIII were summarized by job class within test sites as Table GG, which itself was the source of the values shown in the figures presented on Pages 72 73 for Test Sites B, C, and D. These tables and graphs, reflecting the data revisions noted in Item # 6 above, are included in Appendix 1. The original electronic file ( based on uncorrected data), as well as a revised version of the original electronic file, including the data corrections, is available for review. Appendix 1 Revised inhalation tables and graphs based on corrected worker exposure data. Table XXVI. Inhalation exposure of pressure treatment w orkers to creosote components: Site B. Mean daily inhalation exposure ( µ g/ kg body w eight/ w ork day) of pressure treatment w orkers to: µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g Job Rep. CTPV N 2 MN 1 MN Ac DBF F Ph An Py C BAP TOTAL WO 1 11.3 29 44.8 29.6 3.50 3.41 3.25 0.256 0.363 0.335 0.256 0.363 127 7 2.83 82.9 13.7 9.25 0.33 0.49 0.340 0.255 0.361 0.333 0.255 0.361 111 13 11.5 61.3 12.3 8.02 3.59 0.50 0.351 0.263 0.373 0.343 0.263 0.373 99.2 19 10.8 61.8 9.3 6.45 3.37 0.47 0.329 0.247 0.349 0.322 0.247 0.349 94.0 Mean: 9.11 59 20.0 13.3 2.70 1.22 1.07 0.255 0.362 0.333 0.255 0.362 108 S. D.: 4.20 22.1 16.6 10.9 1.58 1.46 1.46 0.007 0.010 0.009 0.007 0.010 15 G. M. 7.94 55.1 16.3 10.9 1.94 0.79 0.598 0.255 0.362 0.333 0.255 0.362 107 Median: 11.0 61.5 13.0 8.64 3.43 0.50 0.345 0.256 0.362 0.334 0.256 0.362 105 LH 2 2.99 6.62 3.59 3.33 0.35 0.52 0.359 0.269 0.382 0.352 0.269 0.382 19.4 8 12.5 3.49 3.78 0.42 0.37 0.54 0.379 0.284 0.402 0.371 0.284 0.402 23.2 14 2.96 7.49 3.55 3.29 3.63 0.51 0.355 0.266 0.377 0.348 0.266 0.377 23.4 20 2.98 3.30 0.35 0.39 0.35 0.51 0.357 0.268 0.380 0.350 0.268 0.380 9.9 Mean: 5.35 5.23 2.82 1.86 1.18 0.52 0.363 0.272 0.385 0.355 0.272 0.385 19.0 S. D.: 4.74 2.14 1.65 1.67 1.64 0.02 0.011 0.008 0.012 0.011 0.008 0.012 6.33 G. M. 4.26 4.89 2.03 1.16 0.64 0.52 0.362 0.272 0.385 0.355 0.272 0.385 18.0 Median: 2.99 5.06 3.57 1.85 0.36 0.52 0.358 0.269 0.381 0.351 0.269 0.381 21.3 LLO 3 11.9 3.34 3.62 0.40 3.71 0.52 0.362 0.271 0.385 0.354 0.271 0.385 25.5 9 12.0 3.36 3.64 3.38 3.73 0.52 0.365 0.273 0.387 0.357 0.273 0.387 28.7 15 10.9 3.07 3.32 0.37 0.33 0.48 0.332 0.249 0.353 0.325 0.249 0.353 20.4 21 12.3 3.45 3.74 0.41 0.37 0.54 0.374 0.280 0.397 0.366 0.280 0.397 22.9 Mean: 11.8 3.30 3.58 1.14 2.03 0.51 0.358 0.269 0.381 0.351 0.269 0.381 24.4 S. D.: 0.591 0.17 0.18 1.49 1.95 0.03 0.018 0.013 0.019 0.018 0.013 0.019 3.57 G. M. 11.8 3.30 3.58 0.67 1.13 0.51 0.358 0.268 0.380 0.350 0.268 0.380 24.2 Median: 12.0 3.35 3.63 0.41 2.04 0.52 0.363 0.272 0.386 0.356 0.272 0.386 24.2 TA 4 3.11 49.7 10.61 3.45 3.82 0.54 3.55 0.280 0.396 0.365 0.280 0.396 76.5 10 2.96 64.4 15.67 9.12 3.64 0.51 3.38 0.267 0.378 0.348 0.267 0.378 101 16 2.94 14.4 3.53 3.27 0.35 0.51 0.35 0.265 0.375 0.346 0.265 0.375 26.9 22 12.2 70.4 7.28 3.44 3.80 0.53 0.37 0.278 0.394 0.363 0.278 0.394 100 Mean: 5.31 49.7 9.27 4.82 2.90 0.52 1.91 0.272 0.386 0.356 0.272 0.386 76.1 S. D.: 4.60 25.1 5.15 2.87 1.71 0.01 1.79 0.008 0.011 0.010 0.008 0.011 34.7 G. M. 4.27 42.4 8.08 4.34 2.07 0.52 1.12 0.272 0.386 0.356 0.272 0.386 67.5 Median: 3.04 57.1 8.94 3.44 3.72 0.52 1.88 0.273 0.386 0.356 0.273 0.386 88.1 TO 5 4.28 25.2 5.13 4.76 0.50 0.74 0.51 0.385 0.546 0.503 0.385 0.546 43 11 2.68 40.6 3.21 2.98 0.32 0.46 0.32 0.241 0.342 0.315 0.241 0.342 52 17 2.86 16.3 3.43 3.18 0.34 0.49 0.34 0.257 0.365 0.336 0.257 0.365 29 23 3.21 26.1 3.85 3.57 0.38 0.55 0.39 0.289 0.410 0.378 0.289 0.410 40 Mean: 3.26 27.0 3.91 3.62 0.38 0.56 0.39 0.293 0.416 0.383 0.293 0.416 41.0 S. D.: 0.72 10.1 0.86 0.80 0.08 0.12 0.09 0.064 0.091 0.084 0.064 0.091 9.74 G. M. 3.21 25.7 3.84 3.56 0.38 0.55 0.38 0.288 0.409 0.377 0.288 0.409 40.0 Median: 3.04 25.6 3.64 3.37 0.36 0.52 0.36 0.273 0.387 0.357 0.273 0.387 41.6 CLO 6 3.16 15.2 3.78 3.51 3.88 0.54 0.38 0.284 0.402 0.371 0.284 0.402 32 12 2.99 45.0 12.7 6.66 3.68 0.52 3.42 0.269 0.382 0.352 0.269 0.382 77 18 10.1 36.8 10.6 5.66 3.15 3.08 0.31 2.88 0.327 0.302 0.231 0.327 74 24 11.3 13.9 3.44 3.19 3.52 0.49 0.34 0.258 0.366 0.337 0.258 0.366 38 Mean: 6.90 27.7 7.64 4.75 3.56 1.16 1.11 0.923 0.369 0.340 0.261 0.369 55.1 S. D.: 4.45 15.6 4.74 1.68 0.31 1.28 1.54 1.30 0.032 0.029 0.022 0.032 23.4 G. M. 5.74 24.3 6.48 4.53 3.55 0.81 0.61 0.488 0.368 0.339 0.260 0.368 51.2 Median: 6.65 26.0 7.20 4.58 3.60 0.53 0.36 0.277 0.374 0.344 0.264 0.374 55.8 * CLO = cylinder area loader operator; LLO = load out area loader operator; LH = load out area helper; TA = treating assistant; TO = treating operator; WO = w ater treatment system operator. Table XXVII. Inhalation exposure of pressure treatment w orkers to creosote components: Site C. Mean daily inhalation exposure ( µ g/ kg body w eight/ w ork day) of pressure treatment w orkers to: µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g Job Rep. CTPV N 2 MN 1 MN Ac DBF F Ph An Py C BAP TOTAL LLO 1 3.16 29.3 3.78 3.51 3.88 0.54 0.38 0.28 0.402 0.371 0.284 0.402 46.3 7 11.2 164 60.0 25.5 28.4 11.9 3.24 3.19 0.362 0.334 0.256 0.362 308 14 2.88 75.3 23.9 10.2 12.9 3.45 3.28 3.23 0.367 0.338 0.259 0.367 137 21 2.93 45.3 15.7 3.26 3.60 3.51 3.34 0.264 0.374 0.344 0.264 0.374 79 28 3.36 73.3 25.5 11.19 14.2 4.03 3.84 3.77 0.429 0.395 0.303 0.429 141 Mean: 4.71 77.4 25.8 10.7 12.6 4.69 2.82 2.15 0.387 0.356 0.273 0.387 142 S. D.: 3.65 52.0 21.0 9.0 10.1 4.28 1.38 1.73 0.028 0.026 0.020 0.028 101 G. M. 3.98 65.4 18.5 8.03 9.39 3.16 2.20 1.24 0.386 0.356 0.272 0.386 117 Median: 3.16 73.3 23.9 10.24 12.9 3.51 3.28 3.19 0.374 0.344 0.264 0.374 137 CLO 2 3.16 94 32 13.4 16.4 3.78 3.60 3.54 0.402 0.371 0.284 0.402 172 8 2.87 286 116 51.0 66.5 27.9 20.2 11.4 0.366 0.337 0.258 0.366 584 15 11.4 343 124 54.8 73.0 31.2 23.1 13.4 3.173 0.338 0.259 0.367 677 22 2.94 255 98 43.3 60.1 25.9 19.3 11.0 0.375 0.346 0.265 0.375 517 29 3.32 358 122 53.0 73.3 30.0 22.9 13.23 0.423 0.390 0.299 0.423 676 Mean: 4.73 267 98 43.10 57.84 23.75 17.82 10.51 0.95 0.356 0.273 0.387 525 S. D.: 3.72 105 38 17.18 23.82 11.35 8.12 4.04 1.24 0.023 0.018 0.025 209 G. M. 3.99 243 89 38.62 51.14 19.12 14.93 9.53 0.59 0.356 0.273 0.386 473 Median: 3.16 286 116 51.01 66.47 27.94 20.25 11.43 0.40 0.346 0.265 0.375 584 CH 3 3.15 57.1 19.3 3.50 10.5 3.77 3.59 0.283 0.401 0.370 0.283 0.401 103 9 2.92 216 83.1 35.4 47.4 19.9 14.5 3.281 0.373 0.344 0.263 0.373 424 16 2.89 221 83.4 37.4 51.6 22.1 16.8 10.0 0.368 0.339 0.260 0.368 447 23 2.91 283 117 51.9 75.8 32.8 24.7 14.9 3.207 0.342 0.262 0.371 607 30 3.38 286 101 44.0 61.4 25.1 19.4 11.69 0.431 0.397 0.304 0.431 553 Mean: 3.05 213 81 34.4 49.3 20.7 15.8 8.03 0.96 0.36 0.27 0.39 427 S. D.: 0.21 93.1 37.1 18.5 24.3 10.7 7.82 6.07 1.26 0.03 0.02 0.03 196 G. M. 3.04 186 69.1 25.4 41.3 16.9 13.3 4.38 0.60 0.36 0.27 0.39 366 Median: 2.92 221 83.4 37.4 51.6 22.1 16.8 9.98 0.40 0.34 0.26 0.37 447 CK 4 13.5 3.78 4.09 0.452 0.401 0.588 0.409 0.307 0.435 0.401 0.307 0.435 25 10 2.63 14.9 19.4 7.33 3.23 3.152 3.00 2.95 0.336 0.309 0.237 0.336 58 17 2.89 28.9 30.0 11.6 12.3 3.47 3.30 3.25 0.369 0.340 0.260 0.369 97 24 3.18 3.52 3.81 0.421 3.91 0.548 0.381 0.286 0.405 0.374 0.286 0.405 18 31 2.82 16.3 18.5 3.13 3.46 3.37 0.338 0.253 0.359 0.331 0.253 0.359 49 Mean: 5.00 13.5 15.1 4.59 4.65 2.23 1.49 1.41 0.38 0.35 0.27 0.38 49.4 S. D.: 4.74 10.5 11.2 4.84 4.48 1.52 1.52 1.55 0.04 0.04 0.03 0.04 31.4 G. M. 3.91 9.9 11.1 2.19 2.93 1.64 0.88 0.73 0.38 0.35 0.27 0.38 41.4 Median: 2.89 14.9 18.5 3.13 3.46 3.15 0.41 0.31 0.37 0.34 0.26 0.37 49.5 TB 5 18.0 175 21.2 3.506 3.878 3.78 3.60 0.284 0.402 0.371 0.284 0.402 231 11 3.05 83.5 25.9 9.7 10.6 3.65 3.48 3.42 0.388 0.358 0.274 0.388 145 18 3.09 73.2 30.5 12.5 16.1 3.70 3.53 3.47 0.394 0.363 0.278 0.394 148 25 3.12 55.4 13.5 3.46 3.83 0.537 0.374 0.280 0.397 0.366 0.280 0.397 82 32 2.87 83.2 29.2 11.02 3.53 3.44 3.279 0.259 0.366 0.338 0.259 0.366 138 Mean: 6.02 94 24.1 8.04 7.59 3.02 2.85 1.54 0.39 0.36 0.28 0.39 149 S. D.: 6.69 46.7 6.92 4.28 5.62 1.39 1.39 1.74 0.01 0.01 0.01 0.01 53.2 G. M. 4.33 86.8 23.1 6.95 6.17 2.48 2.22 0.75 0.39 0.36 0.27 0.39 141 Median: 3.09 83.2 25.9 9.68 3.88 3.65 3.48 0.28 0.39 0.36 0.28 0.39 145 TO 6 3.04 279 74.2 27.9 23.0 3.64 3.47 3.409 0.387 0.357 0.273 0.387 419 12 11.0 116 32.8 12.2 11.9 3.34 3.18 3.124 0.355 0.327 0.251 0.355 195 19 3.35 149 37.0 14.5 14.5 4.02 3.8 3.764 0.428 0.394 0.302 0.428 232 26 3.36 112 77.3 29.3 23.8 10.7 3.836 3.772 0.429 0.395 0.303 0.429 266 33 3.85 59.4 21.0 4.28 4.74 4.62 0.462 0.347 0.491 0.453 0.347 0.491 100 Mean: 4.92 143.1 48.47 17.64 15.57 5.27 2.95 2.88 0.42 0.39 0.30 0.42 242 S. D.: 3.41 82 25.63 10.72 7.98 3.09 1.42 1.44 0.05 0.05 0.04 0.05 116 G. M. 4.29 126 42.96 14.40 13.48 4.75 2.37 2.21 0.42 0.38 0.29 0.42 219 Median: 3.36 116 37.04 14.49 14.51 4.02 3.47 3.41 0.43 0.39 0.30 0.43 232 DP 13 6.48 94 32.8 7.20 7.96 7.76 7.39 0.583 0.826 0.761 0.583 0.826 168 20 3.59 15.1 4.30 3.99 4.41 0.619 0.431 0.323 0.458 0.422 0.323 0.458 34 27 4.70 22.2 5.63 0.62 5.77 0.810 0.564 0.423 0.599 0.552 0.423 0.599 43 34 7.96 23.6 9.55 1.06 0.936 1.37 0.956 0.717 1.015 0.936 0.717 1.015 50 Mean: 5.68 38.8 13.1 3.22 4.77 2.64 2.33 0.511 0.724 0.668 0.511 0.724 74 S. D.: 1.93 37.2 13.3 3.05 2.94 3.43 3.38 0.174 0.246 0.227 0.174 0.246 62.9 G. M. 5.43 29.4 9.33 2.08 3.71 1.52 1.14 0.489 0.692 0.638 0.489 0.692 59.3 Median: 5.59 22.9 7.59 2.52 5.09 1.09 0.760 0.503 0.712 0.656 0.503 0.712 46.4 * CH = cylinder area loader helper; CH = checker; CLO = cylinder area loader operator; DP = drip pad labor; LLO = load out area loader operator; TB = test borer; TO = treating operator; Table XXVIII. Inhalation exposure of pressure treatment w orkers to creosote components: Site D. Mean daily inhalation exposure ( µ g/ kg body w eight/ w ork day) of pressure treatment w orkers to: µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g Job* Rep. CTPV N 2 MN 1 MN Ac DBF F Ph An Py C BAP TOTAL TO 1 6.28 52.5 7.5 6.98 7.72 1.083 0.754 0.565 0.801 0.738 0.565 0.801 86.4 7 3.41 56.6 14.6 3.78 4.19 4.08 0.409 0.306 0.434 0.400 0.306 0.434 88.9 13 2.75 156 20.7 7.74 3.38 3.29 3.14 3.084 0.350 0.323 0.247 0.350 201 19 5.91 92.7 17.3 6.57 7.27 7.09 6.75 0.532 0.754 0.695 0.532 0.754 147 25 3.16 147 23.8 9.58 11.71 3.79 3.61 3.551 0.403 0.372 0.285 0.403 208 Mean: 4.30 101 16.8 6.93 6.85 3.87 2.93 1.61 0.55 0.51 0.39 0.55 146 S. D.: 1.66 48.8 6.24 2.10 3.31 2.15 2.56 1.57 0.21 0.20 0.15 0.21 58.5 G. M. 4.06 91.2 15.6 6.63 6.22 3.30 1.88 1.00 0.52 0.48 0.37 0.52 136 Median: 3.41 93 17.3 6.98 7.27 3.79 3.14 0.57 0.43 0.40 0.31 0.43 147 LLO 2 4.05 9.5 4.9 4.50 0.48 0.70 0.486 0.364 0.516 0.476 0.364 0.516 26.8 ( F) 8 11.6 128 23.4 9.9 11.7 3.51 3.34 3.29 0.374 0.344 0.264 0.374 196 14 11.9 107 20.3 8.4 10.1 3.62 3.45 3.39 0.386 0.355 0.272 0.386 169 20 3.13 164 38.7 14.7 20.7 9.41 3.57 3.51 0.399 0.368 0.282 0.399 260 26 11.8 23.6 3.6 3.31 3.66 3.57 3.40 3.34 0.380 0.350 0.268 0.380 57.6 Mean: 8.49 86.5 18.2 8.17 9.32 4.16 2.85 2.78 0.41 0.38 0.29 0.41 142 S. D.: 4.49 67.3 14.5 4.55 7.84 3.19 1.32 1.35 0.06 0.05 0.04 0.06 97 G. M. 7.29 55.1 12.6 7.11 5.31 3.13 2.33 2.17 0.41 0.38 0.29 0.41 106 Median: 11.6 107 20.3 8.4 10.1 3.57 3.40 3.34 0.39 0.36 0.27 0.39 169 LLO 3 4.19 4.6 5.0 0.55 5.14 0.72 0.502 0.377 0.534 0.492 0.377 0.534 23.1 9 3.20 18.1 3.8 3.55 3.93 0.55 0.383 0.288 0.407 0.376 0.288 0.407 35.3 15 3.08 18.1 3.7 3.43 3.79 0.53 0.370 0.278 0.393 0.362 0.278 0.393 34.7 21 3.02 74.1 17.6 7.58 11.94 3.62 3.45 3.392 0.385 0.355 0.272 0.385 126 27 3.12 7.4 3.74 0.41 3.84 0.54 0.375 0.281 0.398 0.367 0.281 0.398 21 Mean: 3.32 24.5 6.78 3.10 5.73 1.19 1.02 0.92 0.42 0.39 0.30 0.42 48.1 S. D.: 0.49 28.4 6.08 2.92 3.52 1.36 1.36 1.38 0.06 0.06 0.04 0.06 44.1 G. M. 3.30 15.3 5.42 1.84 5.12 0.84 0.62 0.49 0.42 0.39 0.30 0.42 37.6 Median: 3.12 18.1 3.83 3.43 3.93 0.55 0.38 0.29 0.40 0.37 0.28 0.40 34.7 CLO 4 5.61 13.4 6.7 0.74 0.66 0.97 0.674 0.505 0.716 0.660 0.505 0.716 31.9 10 12.1 108 20.5 8.22 9.98 3.67 3.49 3.43 0.390 0.360 0.276 0.390 171 16 3.34 46.0 8.2 3.71 4.10 0.58 0.400 0.300 0.425 0.392 0.300 0.425 68.2 22 3.22 97 20.4 8.6 11.5 3.86 3.68 3.616 0.411 0.379 0.290 0.411 153 28 3.10 105 19.8 8.3 11.6 3.72 3.54 3.479 0.395 0.364 0.279 0.395 160 Mean: 5.47 73.9 15.1 5.91 7.56 2.56 2.36 2.27 0.47 0.43 0.33 0.47 117 S. D.: 3.84 42.1 7.02 3.52 4.92 1.64 1.67 1.70 0.14 0.13 0.10 0.14 62.6 G. M. 4.69 58.4 13.6 4.38 5.14 1.97 1.65 1.46 0.45 0.42 0.32 0.45 98 Median: 3.34 97 19.8 8.2 10.0 3.67 3.49 3.43 0.41 0.38 0.29 0.41 153 CH 5 3.94 10.1 4.7 0.52 0.46 0.680 0.473 0.355 0.503 0.463 0.355 0.503 23.1 11 3.11 747 120 50.51 62.0 29.0 25.6 18.7 6.45 3.56 0.280 0.396 1,066 17 3.23 69.4 10.3 3.59 3.97 0.557 0.388 0.291 0.412 0.380 0.291 0.412 93 23 3.24 447 120 53.9 69.6 33.2 25.2 18.4 3.57 3.70 0.291 0.413 779 29 3.28 142 27.2 9.4 12.93 3.93 3.75 3.683 0.419 0.386 0.295 0.419 208 Mean: 3.36 283 56.43 23.59 29.79 13.48 11.09 8.27 2.27 1.70 0.30 0.43 434 S. D.: 0.33 309 58.61 26.33 33.29 16.22 13.15 9.45 2.70 1.76 0.03 0.04 462 G. M. 3.35 127 28.57 8.64 10.05 4.28 3.38 2.65 1.15 0.98 0.30 0.43 206 Median: 3.24 142 27.16 9.44 12.93 3.93 3.75 3.68 0.50 0.46 0.29 0.41 208 OU 6 8.29 180.6 29.4 9.21 10.19 9.93 0.995 0.746 1.057 0.974 0.746 1.057 253 12 2.95 123.6 21.3 8.45 8.43 3.53 3.37 3.31 0.376 0.347 0.265 0.376 176 18 3.02 99.2 15.5 3.36 3.72 3.62 3.45 3.39 0.385 0.355 0.272 0.385 137 24 3.06 95.8 15.7 3.40 3.76 3.67 3.49 3.43 0.390 0.360 0.275 0.390 134 30 4.19 94.4 14.5 4.65 5.15 5.02 4.78 0.377 0.534 0.492 0.377 0.534 135 Mean: 4.30 119 19.27 5.81 6.25 5.15 3.22 2.25 0.55 0.51 0.39 0.55 167 S. D.: 2.29 36.6 6.25 2.81 2.92 2.74 1.37 1.55 0.29 0.27 0.21 0.29 51 G. M. 3.94 115 18.56 5.29 5.73 4.72 2.86 1.61 0.50 0.46 0.35 0.50 162 Median: 3.06 99 15.65 4.65 5.15 3.67 3.45 3.31 0.39 0.36 0.28 0.39 137 * CH = cylinder area loader helper; CLO = cylinder area loader operator; LLO( F) = load out forklift operator; LLO = load out area loader operator; OU = oil unloader; TO = treating operator. Table AA. Summary of daily inhalation exposure to creosote components of pressure treatment workers, by job classification. Mean daily inhalation exposure ( µ g/ kg body w eight/ work day) of pressure treatment w orkers to: Job Test µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g Total class site CTPV N 2 MN 1 MN Ac DBF F Ph An Py C BAP analytes TO B 4.28 25.16 5.13 4.76 0.503 0.738 0.514 0.385 0.546 0.503 0.385 0.546 43.4 2.68 40.59 3.21 2.98 0.315 0.462 0.322 0.241 0.342 0.315 0.241 0.342 52.0 2.86 16.31 3.43 3.18 0.336 0.493 0.343 0.257 0.365 0.336 0.257 0.365 28.5 3.21 26.08 3.85 3.57 0.378 0.554 0.386 0.289 0.410 0.378 0.289 0.410 39.8 C 3.04 279 74.2 27.9 23.0 3.64 3.47 3.41 0.387 0.357 0.273 0.387 419 11.0 116 32.8 12.2 11.9 3.34 3.18 3.12 0.355 0.327 0.251 0.355 195 3.35 149 37.0 14.5 14.5 4.02 3.8 3.76 0.428 0.394 0.302 0.428 232 3.36 112 77.3 29.3 23.8 10.7 3.84 3.77 0.429 0.395 0.303 0.429 266 3.85 59.4 21.0 4.3 4.7 4.62 0.46 0.35 0.491 0.453 0.347 0.491 100.5 D 6.28 52.5 7.53 6.98 7.72 1.08 0.75 0.57 0.80 0.74 0.57 0.80 86.4 3.41 56.6 14.6 3.78 4.19 4.08 0.41 0.31 0.43 0.40 0.31 0.43 88.9 2.75 156 20.7 7.74 3.38 3.29 3.14 3.08 0.35 0.32 0.25 0.35 201 5.91 93 17.3 6.57 7.27 7.09 6.75 0.53 0.75 0.69 0.53 0.75 147 3.16 147 23.8 9.6 11.7 3.79 3.61 3.55 0.40 0.37 0.28 0.40 208 Mean 4.23 95 24.4 9.8 8.12 3.42 2.21 1.69 0.464 0.428 0.327 0.464 150 S. D. 2.24 71.9 24.3 8.7 7.96 2.88 2.0 1.60 0.144 0.133 0.102 0.144 110 G. M. 3.87 71.3 15.0 7.32 3.68 2.26 1.30 0.931 0.447 0.412 0.316 0.447 114 Median 3.36 76.1 19.0 6.77 6.00 3.49 1.94 0.549 0.419 0.386 0.296 0.419 124 n 14 14 14 14 14 14 14 14 14 14 14 14 14 TA B 3.11 49.7 10.6 3.45 3.82 0.54 3.55 0.280 0.396 0.365 0.280 0.396 76.5 2.96 64.4 15.7 9.12 3.64 0.51 3.38 0.267 0.378 0.348 0.267 0.378 101 2.94 14.4 3.53 3.27 0.35 0.51 0.353 0.265 0.375 0.346 0.265 0.375 26.9 12.2 70.4 7.28 3.44 3.80 0.53 0.371 0.278 0.394 0.363 0.278 0.394 100 Mean 5.31 49.71 9.27 4.82 2.90 0.52 1.91 0.27 0.39 0.36 0.27 0.39 76.1 S. D. 4.60 25.11 5.15 2.87 1.71 0.01 1.79 0.01 0.01 0.01 0.01 0.01 34.7 G. M. 4.27 42.41 8.08 4.34 2.07 0.52 1.12 0.27 0.39 0.36 0.27 0.39 67.5 Median 3.04 57.06 8.94 3.44 3.72 0.52 1.88 0.27 0.39 0.36 0.27 0.39 88.1 n 4 4 4 4 4 4 4 4 4 4 4 4 4 CLO* B 3.16 15.23 3.78 3.51 3.88 0.54 0.38 0.28 0.40 0.37 0.28 0.40 32.22 2.99 45.00 12.74 6.66 3.68 0.52 3.42 0.27 0.38 0.35 0.27 0.38 76.67 10.14 36.77 10.61 5.66 3.15 3.08 0.31 2.88 0.33 0.30 0.23 0.33 73.79 11.33 13.91 3.44 3.19 3.52 0.49 0.34 0.26 0.37 0.34 0.26 0.37 37.81 TB* C 17.99 175.14 21.21 3.51 3.88 3.78 3.60 0.28 0.40 0.37 0.28 0.40 230.85 3.05 83.48 25.94 9.68 10.60 3.65 3.48 3.42 0.39 0.36 0.27 0.39 144.69 3.09 73.24 30.53 12.52 16.12 3.70 3.53 3.47 0.39 0.36 0.28 0.39 147.64 3.12 55.38 13.53 3.46 3.83 0.54 0.37 0.28 0.40 0.37 0.28 0.40 81.94 2.87 83.24 29.24 11.02 3.53 3.44 3.28 0.26 0.37 0.34 0.26 0.37 138.21 Mean 6.41 64.60 16.78 6.58 5.80 2.19 2.08 1.27 0.38 0.35 0.27 0.38 107.09 S. D. 5.48 49.05 10.37 3.63 4.51 1.60 1.64 1.50 0.02 0.02 0.02 0.02 63.65 G. M. 4.91 49.33 13.14 5.75 4.83 1.51 1.25 0.62 0.38 0.35 0.27 0.38 89.94 Median 3.12 55.38 13.53 5.66 3.83 3.08 3.28 0.28 0.39 0.36 0.27 0.39 81.94 n 9 9 9 9 9 9 9 9 9 9 9 9 9 * These positions w ere nearly equivalent, so are considered together here. Table AA, continued. Mean daily inhalation exposure ( µ g/ kg body w eight/ w ork day) of pressure treatment w orkers to: Job Test µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g Total class site CTPV N 2 MN 1 MN Ac DBF F Ph An Py C BAP analytes LLO B 11.91 3.34 3.62 0.40 3.71 0.52 0.36 0.27 0.38 0.35 0.27 0.38 25.5 12.00 3.36 3.64 3.38 3.73 0.52 0.36 0.27 0.39 0.36 0.27 0.39 28.7 10.94 3.07 3.32 0.37 0.33 0.48 0.33 0.25 0.35 0.33 0.25 0.35 20.4 12.31 3.45 3.74 0.41 0.37 0.54 0.37 0.28 0.40 0.37 0.28 0.40 22.9 C 3.16 29.28 3.78 3.51 3.88 0.54 0.38 0.28 0.40 0.37 0.28 0.40 46.3 11.23 163.6 60.0 25.5 28.4 11.94 3.24 3.19 0.36 0.33 0.26 0.36 308.4 2.88 75.3 23.9 10.2 12.9 3.45 3.28 3.23 0.37 0.34 0.26 0.37 136.5 2.93 45.3 15.7 3.3 3.6 3.51 3.34 0.26 0.37 0.34 0.26 0.37 79.3 3.36 73.3 25.5 11.2 14.2 4.03 3.84 3.77 0.43 0.40 0.30 0.43 140.8 D 4.19 4.63 5.02 0.55 5.14 0.72 0.50 0.38 0.53 0.49 0.38 0.53 23.1 3.20 18.11 3.83 3.55 3.93 0.55 0.38 0.29 0.41 0.38 0.29 0.41 35.3 3.08 18.09 3.70 3.43 3.79 0.53 0.37 0.28 0.39 0.36 0.28 0.39 34.7 3.02 74.08 17.61 7.58 11.94 3.62 3.45 3.39 0.39 0.36 0.27 0.39 126.1 3.12 7.44 3.74 0.41 3.84 0.54 0.37 0.28 0.40 0.37 0.28 0.40 21.2 Mean 6.24 37.31 12.65 5.27 7.13 2.25 1.47 1.17 0.40 0.37 0.28 0.40 74.9 S. D. 4.23 45.99 15.86 6.84 7.51 3.14 1.52 1.46 0.04 0.04 0.03 0.04 80.9 G. M. 5.08 16.58 7.46 2.34 4.13 1.17 0.83 0.58 0.40 0.37 0.28 0.40 49.7 Median 3.28 18.10 3.81 3.40 3.86 0.55 0.38 0.28 0.39 0.36 0.28 0.39 35.0 n 14 14 14 14 14 14 14 14 14 14 14 14 14 CLO C 3.16 94.5 32.1 13.4 16.4 3.78 3.60 3.54 0.40 0.37 0.28 0.40 172 2.87 286.1 116.1 51.0 66.5 27.9 20.2 11.4 0.37 0.34 0.26 0.37 584 11.37 342.7 123.8 54.8 73.0 31.2 23.1 13.4 3.17 0.34 0.26 0.37 677 2.94 255.4 97.5 43.3 60.1 25.9 19.3 11.0 0.38 0.35 0.27 0.38 517 3.32 357.6 121.6 53.0 73.3 30.0 22.9 13.2 0.42 0.39 0.30 0.42 676 D 5.61 13.43 6.73 0.74 0.66 0.97 0.67 0.51 0.72 0.66 0.51 0.72 31.9 12.09 108.25 20.49 8.22 9.98 3.67 3.49 3.43 0.39 0.36 0.28 0.39 171 3.34 46.03 8.22 3.71 4.10 0.58 0.40 0.30 0.43 0.39 0.30 0.43 68.2 3.22 96.52 20.45 8.59 11.48 3.86 3.68 3.62 0.41 0.38 0.29 0.41 153 3.10 105.10 19.83 8.27 11.58 3.72 3.54 3.48 0.40 0.36 0.28 0.40 160 Mean 5.10 170.56 56.68 24.50 32.70 13.15 10.09 6.39 0.71 0.39 0.30 0.43 321 S. D. 3.59 126.85 50.93 22.82 31.07 13.53 9.85 5.23 0.87 0.10 0.07 0.10 260 G. M. 4.32 119.10 34.68 13.00 16.21 6.13 4.97 3.72 0.52 0.39 0.30 0.42 216 Median 3.27 106.67 26.30 10.99 13.97 3.82 3.64 3.58 0.41 0.37 0.28 0.40 171 n 10 10 10 10 10 10 10 10 10 10 10 10 10 CH C 3.15 57.06 19.27 3.50 10.52 3.77 3.59 0.28 0.40 0.37 0.28 0.40 103 2.92 216.13 83.11 35.36 47.37 19.85 14.47 3.28 0.37 0.34 0.26 0.37 424 2.89 221.29 83.45 37.40 51.56 22.13 16.80 9.98 0.37 0.34 0.26 0.37 447 2.91 283.29 116.69 51.95 75.82 32.83 24.74 14.91 3.21 0.34 0.26 0.37 607 3.38 285.87 100.93 43.96 61.42 25.07 19.35 11.69 0.43 0.40 0.30 0.43 553 D 3.94 10.07 4.73 0.52 0.46 0.68 0.47 0.35 0.50 0.46 0.35 0.50 23 3.11 746.73 119.78 50.51 61.99 29.03 25.64 18.68 6.45 3.56 0.28 0.40 1066 3.23 69.43 10.29 3.59 3.97 0.56 0.39 0.29 0.41 0.38 0.29 0.41 93 3.24 446.98 120.20 53.86 69.60 33.18 25.21 18.36 3.57 3.70 0.29 0.41 779 3.28 142.28 27.16 9.44 12.93 3.93 3.75 3.68 0.42 0.39 0.30 0.42 208 Mean 3.21 247.91 68.56 29.01 39.56 17.10 13.44 8.15 1.61 1.03 0.29 0.41 430 S. D. 0.31 218.29 47.96 22.19 29.35 13.50 10.50 7.49 2.10 1.37 0.03 0.04 335 G. M. 3.19 153.65 44.43 14.81 20.37 8.50 6.71 3.41 0.83 0.59 0.29 0.41 274 Median 3.19 218.71 83.28 36.38 49.47 20.99 15.63 6.83 0.42 0.38 0.29 0.41 435 n 10 10 10 10 10 10 10 10 10 10 10 10 10 Table AA, continued. Mean daily inhalation exposure ( µ g/ kg body w eight/ work day) of pressure treatment w orkers to: Job Test µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g Total class site CTPV N 2 MN 1 MN Ac DBF F Ph An Py C BAP analytes WO B 11.26 29.37 44.84 29.63 3.50 3.41 3.25 0.26 0.36 0.33 0.26 0.36 127 2.83 82.88 13.71 9.25 0.33 0.49 0.34 0.26 0.36 0.33 0.26 0.36 111 11.54 61.27 12.31 8.02 3.59 0.50 0.35 0.26 0.37 0.34 0.26 0.37 99 10.82 61.76 9.27 6.45 3.37 0.47 0.33 0.25 0.35 0.32 0.25 0.35 94 Mean 9.11 58.82 20.03 13.34 2.70 1.22 1.07 0.26 0.36 0.33 0.26 0.36 108 S. D. 4.20 22.07 16.64 10.92 1.58 1.46 1.46 0.01 0.01 0.01 0.01 0.01 15 G. M. 7.94 55.09 16.27 10.92 1.94 0.79 0.60 0.26 0.36 0.33 0.26 0.36 107 Median 11.04 61.51 13.01 8.64 3.43 0.50 0.35 0.26 0.36 0.33 0.26 0.36 105 n 4 4 4 4 4 4 4 4 4 4 4 4 4 CK C 13.48 3.78 4.09 0.45 0.40 0.59 0.41 0.31 0.43 0.40 0.31 0.43 25.1 2.63 14.85 19.36 7.33 3.23 3.15 3.00 2.95 0.34 0.31 0.24 0.34 57.7 2.89 28.86 29.96 11.64 12.27 3.47 3.30 3.25 0.37 0.34 0.26 0.37 97 3.18 3.52 3.81 0.42 3.91 0.55 0.38 0.29 0.41 0.37 0.29 0.41 17.5 2.82 16.34 18.48 3.13 3.46 3.37 0.34 0.25 0.36 0.33 0.25 0.36 49.5 Mean 5.00 13.47 15.14 4.59 4.65 2.23 1.49 1.41 0.38 0.35 0.27 0.38 49.4 S. D. 4.74 10.49 11.17 4.84 4.48 1.52 1.52 1.55 0.04 0.04 0.03 0.04 31.4 G. M. 3.91 9.86 11.08 2.19 2.93 1.64 0.88 0.73 0.38 0.35 0.27 0.38 41.4 Median 2.89 14.85 18.48 3.13 3.46 3.15 0.41 0.31 0.37 0.34 0.26 0.37 49.5 n 5 5 5 5 5 5 5 5 5 5 5 5 5 OU D 8.29 180.56 29.37 9.21 10.19 9.93 0.99 0.75 1.06 0.97 0.75 1.06 253 2.95 123.59 21.34 8.45 8.43 3.53 3.37 3.31 0.38 0.35 0.27 0.38 176 3.02 99.16 15.49 3.36 3.72 3.62 3.45 3.39 0.39 0.36 0.27 0.39 137 3.06 95.77 15.65 3.40 3.76 3.67 3.49 3.43 0.39 0.36 0.28 0.39 134 4.19 94.37 14.50 4.65 5.15 5.02 4.78 0.38 0.53 0.49 0.38 0.53 135 Mean 4.30 118.69 19.27 5.81 6.25 5.15 3.22 2.25 0.55 0.51 0.39 0.55 167 S. D. 2.29 36.57 6.25 2.81 2.92 2.74 1.37 1.55 0.29 0.27 0.21 0.29 51.4 G. M. 3.94 114.87 18.56 5.29 5.73 4.72 2.86 1.61 0.50 0.46 0.35 0.50 162 Median 3.06 99.16 15.65 4.65 5.15 3.67 3.45 3.31 0.39 0.36 0.28 0.39 137 n 5 5 5 5 5 5 5 5 5 5 5 5 5 DP C 6.48 94.43 32.78 7.20 7.96 7.76 7.39 0.58 0.83 0.76 0.58 0.83 168 3.59 15.12 4.30 3.99 4.41 0.62 0.43 0.32 0.46 0.42 0.32 0.46 34.5 4.70 22.15 5.63 0.62 5.77 0.81 0.56 0.42 0.60 0.55 0.42 0.60 42.8 7.96 23.63 9.55 1.06 0.94 1.37 0.96 0.72 1.02 0.94 0.72 1.02 49.9 Mean 5.68 38.83 13.07 3.22 4.77 2.64 2.33 0.51 0.72 0.67 0.51 0.72 73.7 S. D. 1.93 37.25 13.33 3.05 2.94 3.43 3.38 0.17 0.25 0.23 0.17 0.25 62.9 G. M. 5.43 29.40 9.33 2.08 3.71 1.52 1.14 0.49 0.69 0.64 0.49 0.69 59.3 Median 5.59 22.89 7.59 2.52 5.09 1.09 0.76 0.50 0.71 0.66 0.50 0.71 46.4 n 4 4 4 4 4 4 4 4 4 4 4 4 4 LH B 2.99 6.62 3.59 3.33 0.35 0.52 0.36 0.27 0.38 0.35 0.27 0.38 19.4 12.46 3.49 3.78 0.42 0.37 0.54 0.38 0.28 0.40 0.37 0.28 0.40 23.2 2.96 7.49 3.55 3.29 3.63 0.51 0.35 0.27 0.38 0.35 0.27 0.38 23.4 2.98 3.30 0.35 0.39 0.35 0.51 0.36 0.27 0.38 0.35 0.27 0.38 9.9 Mean 5.35 5.23 2.82 1.86 1.18 0.52 0.36 0.27 0.39 0.36 0.27 0.39 19.0 S. D. 4.74 2.14 1.65 1.67 1.64 0.02 0.01 0.01 0.01 0.01 0.01 0.01 6.33 G. M. 4.26 4.89 2.03 1.16 0.64 0.52 0.36 0.27 0.39 0.35 0.27 0.39 18.0 Median 2.99 5.06 3.57 1.85 0.36 0.52 0.36 0.27 0.38 0.35 0.27 0.38 21.3 n 4 4 4 4 4 4 4 4 4 4 4 4 4 LLO( F) D 4.05 9.52 4.85 4.50 0.48 0.70 0.49 0.36 0.52 0.48 0.36 0.52 26.81 11.58 128.24 23.37 9.92 11.67 3.51 3.34 3.29 0.37 0.34 0.26 0.37 196.28 11.95 106.89 20.27 8.40 10.08 3.62 3.45 3.39 0.39 0.36 0.27 0.39 169.45 3.13 164.45 38.72 14.71 20.69 9.41 3.57 3.51 0.40 0.37 0.28 0.40 259.64 11.77 23.58 3.57 3.31 3.66 3.57 3.40 3.34 0.38 0.35 0.27 0.38 57.58 Mean 8.49 86.54 18.16 8.17 9.32 4.16 2.85 2.78 0.41 0.38 0.29 0.41 141.95 S. D. 4.49 67.30 14.53 4.55 7.84 3.19 1.32 1.35 0.06 0.05 0.04 0.06 97.38 G. M. 7.29 55.06 12.60 7.11 5.31 3.13 2.33 2.17 0.41 0.38 0.29 0.41 105.92 Median 11.58 106.89 20.27 8.40 10.08 3.57 3.40 3.34 0.39 0.36 0.27 0.39 169.45 n 5 5 5 5 5 5 5 5 5 5 5 5 5 Table BB. G. M. daily inhalation exposure of pressure treatment w orkers to creosote components; by job class over all monitored test sites. Geometric mean daily inhalation exposure ( µ g/ kg bw / day) to: Job µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g µ g Total class CTPV N 2 MN 1 MN Ac DBF F Ph An Py C BAP residues TO 3.87 71.3 15.0 7.32 3.68 2.26 1.30 0.931 0.447 0.412 0.316 0.447 114 TA 4.27 42.4 8.08 4.34 2.07 0.522 1.12 0.272 0.386 0.356 0.272 0.386 67.5 TB 4.91 49.3 13.1 5.75 4.83 1.51 1.25 0.622 0.380 0.350 0.268 0.380 89.9 LLO 5.08 16.6 7.46 2.34 4.13 1.17 0.834 0.575 0.396 0.365 0.280 0.396 49.7 LLO( F) 7.29 55.1 12.6 7.11 5.31 3.13 2.33 2.17 0.408 0.376 0.288 0.408 106 LH 4.26 4.89 2.03 1.16 0.64 0.52 0.362 0.272 0.385 0.355 0.272 0.385 18.0 CLO 4.32 119 34.7 13.0 16.2 6.13 4.97 3.72 0.519 0.386 0.296 0.419 216 CH 3.19 154 44.4 14.8 20.4 8.50 6.71 3.41 0.828 0.591 0.287 0.407 274 WO 7.94 55.1 16.3 10.92 1.94 0.79 0.598 0.255 0.362 0.333 0.255 0.362 107 CK 3.91 9.9 11.1 2.19 2.93 1.64 0.878 0.734 0.379 0.349 0.268 0.379 41.4 OU 3.94 115 18.6 5.29 5.73 4.72 2.86 1.61 0.502 0.463 0.354 0.502 162 DP 5.43 29.40 9.33 2.08 3.71 1.52 1.14 0.49 0.692 0.638 0.489 0.692 59.3 Table GG. Summary of inhalation exposure ( µ g total residues per kg w orker w t. per w ork day). G. M Test Job total site class residue B WO 67.5 LH 40.0 LLO 107.1 TA 51.2 TO 24.2 CLO 18.0 C LLO 219.1 CLO 141.1 CH 473.3 CK 365.6 TB 116.8 TO 59.3 DP 41.4 D TO 136.4 LLO( F) 161.5 LLO 98.2 CLO 206.0 CH 37.6 OU 105.9 Revised summary graph from study report Pages 16 and 71:

Revised Site B inhalation exposure graph from study report Page 72: TO TA TB LLO LLO( F) LH CLO CH WO CK OU DP Job class 0 50 100 150 200 G. M. inhal. exposure ( µ g/ kg bw/ day)

CTPVs N 2 MN TA TO WO CLO LLO LH Job class 0 20 40 60 80 100 120 ( µ g/ kg/ day)

GM daily inhalation exposure Revised Site C inhalation exposure graph from study report Page 72:

Revised Site D inhalation exposure graph from study report Page 73: TO TB CLO CH LLO DP CK Job class 0 100 200 300 400 500 ( µ g/ kg/ day)

GM daily inhalation exposure TO OU CLO CH LLO LLO( F)

Job class 0 50 100 150 200 250 ( µ g/ kg/ day)

GM daily inhalation exposure


[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Notices]
[Pages 43025-43026]
[FR Doc No: 2017-19435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5297]

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study
Recommendations; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Microdose
Radiopharmaceutical Diagnostic Drugs: Nonclinical Study
Recommendations.'' This draft guidance is intended to assist developers
of microdose radiopharmaceutical diagnostic drugs on the nonclinical
studies recommended to support human clinical trials and marketing
authorization. The draft guidance discusses how to refine nonclinical
study recommendations for this class of drug given its unique
characteristics. This draft guidance is intended to provide
recommendations for a pathway to full drug development (marketing
authorization) for microdose radiopharmaceutical diagnostic drugs.

DATES: Submit either electronic or written comments on the draft
guidance by November 13, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that

identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5297 for ``Microdose Radiopharmaceutical Diagnostic Drugs:
Nonclinical Study Recommendations; Draft Guidance for Industry;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Adebayo Laniyonu, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5400, Silver Spring, MD 20993-0002, 301-
796-1392.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical
Study Recommendations.'' This draft guidance is intended to assist
developers of microdose radiopharmaceutical diagnostic drugs on the
nonclinical studies recommended to support human clinical trials and
marketing authorization. The draft guidance discusses how to refine
nonclinical study recommendations for this class of drug given its
unique characteristics. This draft guidance is intended to provide
recommendations for a pathway to full drug development (marketing
authorization) for microdose radiopharmaceutical diagnostic drugs.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on nonclinical
studies recommended for microdose radiopharmaceutical diagnostic drugs.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively. The collection of information for radioactive drug
research committees in 21 CFR 361.1 has been approved under OMB control
number 0910-0053. The collection of information for the regulations on
in vivo radiopharmaceuticals used for diagnosis and monitoring in 21
CFR 315.4, 315.5, and 315.6 has been approved under OMB control number
0910-0409.

II. Electronic Access

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

    Dated: September 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19435 Filed 9-12-17; 8:45 am]
 BILLING CODE 4164-01-P