[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15195-15196]
[FR Doc No: 2020-05444]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2734]

Robert Richard Jodoin: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Robert Richard Jodoin for a period of 5 years from importing any drug
into the United States. FDA bases this order on a finding that Mr.
Jodoin was convicted, as defined in the FD&C Act, of one felony count
under Federal law for unlawfully importing and attempting to import a
controlled substance into the United States. The factual basis
supporting the conviction, as described below, is conduct relating to
the importation into the United States of a drug or controlled
substance. Mr. Jodoin was given notice of the proposed debarment and,
in accordance with the FD&C Act, was given an opportunity to request a
hearing to show why he should not be debarred. As of November 9, 2019
(30 days after receipt of the notice), Mr. Jodoin had not responded.
Mr. Jodoin's failure to respond and request a hearing constitutes a
waiver of his right to a hearing concerning this matter.

DATES: This order is applicable March 17, 2020.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(C) of the FD&C Act, that the individual has been
convicted of a felony for conduct relating to the importation into the
United States of any drug or controlled substance.
    On February 25, 2019, Mr. Jodoin was convicted as defined in
section 306(l)(1)(B) of the FD&C Act, in the United States District
Court for the Middle District of Florida, Jackson Division, when the
court accepted his plea of guilty and entered judgment against him for
multiple offenses, one of which is relevant to this debarment.
Specifically, FDA's finding that debarment is appropriate is based on
Mr. Jodoin's felony conviction for

knowingly and intentionally attempting to import into the United States
a mixture and substance containing a detectable amount of gamma-
Hydroxybutyric Acid, a Schedule I controlled substance in violation of
21 U.S.C. 952(a), 960(a)(1), 960(b)(3), and 963 on or about April 16,
2018, as described in the Superseding Indictment in his case dated
October 10, 2018.
    As a result of this conviction, FDA sent Mr. Jodoin by certified
mail on September 25, 2019, a notice proposing to debar him for 5 years
from importing or offering for import any drug into the United States.
The proposal was based on a finding under section 306(b)(3)(C) of the
FD&C Act that Mr. Jodoin's felony conviction was for conduct relating
to the importation into the United States of any drug or controlled
substance because he smuggled into the United States a Schedule I
controlled substance. In proposing a debarment period, FDA weighed the
considerations set forth in section 306(c)(3) of the FD&C Act that it
considered applicable to Mr. Jodoin's offense and concluded Mr.
Jodoin's felony offense warranted a 5-year period of debarment.
    The proposal informed Mr. Jodoin of the proposed debarment and
offered Mr. Jodoin an opportunity to request a hearing, providing him
30 days from the date of receipt of the letter in which to file the
request, and advised him that failure to request a hearing constituted
a waiver of the opportunity for a hearing and of any contentions
concerning this action. Mr. Jodoin received the proposal and notice of
opportunity for a hearing on October 8, 2019. Mr. Jodoin failed to
request a hearing within the timeframe prescribed by regulation and
has, therefore, waived his opportunity for a hearing and waived any
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Jodoin has been convicted of a felony under Federal law for conduct
relating to the importation into the United States of any drug or
controlled substance. FDA finds that this offense should be accorded a
debarment period of 5 years.
    As a result of the foregoing finding, Mr. Jodoin is debarred for a
period of 5 years from importing or offering for import any drug into
the United States, effective (see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for
import into the United States of any drug or controlled substance by,
with the assistance of, or at the direction of Mr. Jodoin is a
prohibited act.
    Any application by Mr. Jodoin for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-2734 and sent to the Dockets Management Staff (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05444 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Rules and Regulations]
[Pages 64375-64377]
[FR Doc No: 2020-22505]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 85, No. 198 / Tuesday, October 13, 2020 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0733; Project Identifier AD-2020-00990-E;
Amendment 39-21286; AD 2020-21-13]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain General Electric Company (GE) GE90-110B1 and GE90-115B model
turbofan engines. This AD was prompted by the detection of melt-related
freckles in the billet, which may reduce the life limits of certain
high-pressure turbine (HPT) rotor stage 2 disks and certain rotating
compressor discharge pressure (CDP) HPT seals. This AD requires the
replacement of the affected HPT rotor stage 2 disks and rotating CDP
HPT seals. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective November 17, 2020.

ADDRESSES: For service information identified in this final rule,
contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215;
phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>website:
www.ge.com. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0733.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0733; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Mehdi Lamnyi, Aerospace Engineer, ECO
Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7743; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain GE GE90-110B1
and GE90-115B model turbofan engines. The NPRM published in the Federal
Register on August 13, 2020 (85 FR 49322). The NPRM was prompted by the
detection of melt-related freckles in the billet, which may reduce the
life limits of certain HPT rotor stage 2 disks and certain rotating CDP
HPT seals. The NPRM proposed to require the replacement of certain HPT
rotor stage 2 disks and certain rotating CDP HPT seals. The FAA is
issuing this AD to address the unsafe condition on these products.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comments
received. Boeing Commercial Airplanes supported the NPRM. The Air Line
Pilots Association and United Airlines reviewed the NPRM and have no
objections.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed.

Related Service Information

    The FAA reviewed GE Service Bulletin GE90-100 S/B 72-0845, Revision
1, dated July 17, 2020. The service information describes procedures
for the removal of affected HPT rotor stage 2 disks and rotating CDP
HPT seals from service.

Interim Action

    The FAA considers this AD an interim action. This issue is still
under investigation by the manufacturer and, depending on the results
of that investigation, the FAA may consider further rulemaking action.

Costs of Compliance

    The FAA estimates that this AD will affect 1 engine installed on an
airplane of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Remove and replace the HPT rotor stage  1,500 work-hours x $85          $565,600        $693,100        $693,100
 2 disk.                                 per hour = $127,500.
Remove and replace the rotating CDP     600 work-hours x $85 per         209,900         260,900               0
 HPT Seal.                               hour = $51,000.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2020-21-13 General Electric Company: Amendment 39-21286; Docket No.
FAA-2020-0733; Project Identifier AD-2020-00990-E.

(a) Effective Date

    This AD is effective November 17, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to General Electric Company GE90-110B1 and GE90-
115B model turbofan engines with:
    (1) A high-pressure turbine (HPT) rotor stage 2 disk, part
number (P/N) 2505M73P03, and serial number (S/N) TMT1BA38 or
TMT1BA41, installed; or
    (2) A rotating compressor discharge pressure (CDP) HPT seal, P/N
2479M03P01, and S/N GEE1H7GH or GEE1H7JJ, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7250, Turbine
Section.

(e) Unsafe Condition

    This AD was prompted by the detection of melt-related freckles
in the billet, which may reduce the life limits of certain HPT rotor
stage 2 disks and certain rotating CDP HPT seals. The FAA is issuing
this AD to prevent uncontained release of both the HPT rotor stage 2
disk and the rotating CDP HPT seal. The unsafe condition, if not
addressed, could result in damage to the engine and damage to the
aircraft.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) Before the affected HPT rotor stage 2 disk or the rotating
CDP HPT seal listed in Table 1 to paragraph (g) of this AD (``Table
1'') accumulates the cycles since new (CSN) threshold in Table 1, or
at the next engine shop visit, whichever occurs first after the
effective date of this AD, remove the affected part from service and
replace it with a part eligible for installation.
    (2) If the affected HPT rotor stage 2 disk or rotating CDP HPT
seal has already exceeded the CSN threshold in Table 1, remove the
affected part before further flight and replace with a part eligible
for installation.
[GRAPHIC] [TIFF OMITTED] TR13OC20.005

(h) Definitions

    (1) For the purpose of this AD, a part eligible for installation
is any HPT stage 2 disk or rotating CDP HPT seal with an S/N that is
not listed in Table 1.
    (2) For the purpose of this AD, an engine shop visit is the
induction of an engine into the shop for maintenance involving the
separation of pairs of major mating engine flanges, except that the
separation of engine flanges solely for the purposes of
transportation of the engine without subsequent engine maintenance
does not constitute an engine shop visit.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (j) of this AD. You may email your request
to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager

of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, contact Mehdi Lamnyi,
Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    None.

    Issued on October 6, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-22505 Filed 10-9-20; 8:45 am]
BILLING CODE 4910-13-P


-------------------------------------------------------------------------------- \* MERGEFORMAT

MEMORANDUM

DATE:		January 31, 2005

SUBJECT:	Evaluation of the Feasibility, Costs, and Impacts of Switching from a Halogenated Solvent with a High Cancer Unit Risk Value to a Halogenated Solvent with a Lower Cancer Unit Risk Value

FROM:	Chris Sarsony             Alpha-Gamma Technologies, Inc.

TO:		Lynn Dail             U.S. Environmental Protection Agency

1.0  	Overview       There are primarily three halogenated solvents being used for degreasing applications today:  Perchloroethylene (PCE)  Trichloroethylene (TCE)  Methylene Chloride (MC)

      Table 1 shows that switching from one halogenated solvent to another halogentated solvent can result in significant reductions in cancer risk.  For example, switching from PCE or TCE to MC reduces the cancer risk by 93% and 70%, respectively.  This reduction in risk is primarily the result of differences in the cancer unit risk values, which are discussed in Section 2.0.  Also, affecting the cancer risk are differences in solvent consumption rates, which are discussed in Section 3.0.                                           Table 1 - Change in Cancer Risk Resulting from Switching Halogenated Solvents[a]

                               Perchloroethylene

                               Trichloroethylene

                              Methylene Chloride

                                  PCE to TCE

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

                      77 Percent Decrease in Cancer Risk

                                   TCE to MC

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

                      70 Percent Decrease in Cancer Risk

                                   PCE to MC

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

                      93 Percent Decrease in Cancer Risk a - Considers differences in cancer unit risk values (Table 2) and differences in solvent consumption (Table 3).

      In the preliminary risk analysis conducted by ICF, 32 facilities using PCE or TCE were found to have a cancer risk above 1 x 10[-6].  All 5 of the facilities using only PCE and half of the 25 facilities using only TCE could reduce their risk to below 1 x 10[-6] by switching to MC.  Another 25% of the facilities using TCE could lower their risk to below 1 x 10[-6] by switching to MC and reducing their solvent emissions by 10% or less.  Therefore, 80 percent of the facilities with risk above 1 x 10[-6] could lower their risk to below 1 x 10[-6] simply by switching to MC and decreasing their emissions by 10% or less.

      Each of the three halogenated solvents has advantages and disadvantages, which are discussed in Section 4.0.  As a result, some halogenated solvents may not be appropriate for some specific cleaning applications.  Since solvent cleaning is application specific, each facility would need to determine whether switching to another halogenated solvent is a viable option for their particular cleaning application.  However, Dow Chemical Corporation, one of the largest manufacturers of halogenated solvents, states that in general:

      "Most vapor degreasing operations can be performed with any of the three solvents (PCE, TCE, and MC), so the choice is often based on other performance characteristics, safety, environmental considerations, or cost."[1]

      Costs of the solvent switching options are discussed in Section 5.0.  Costs related to switching from one halogenated solvent to another halogenated solvent include:  Changes in the cost of the solvent  Changes in solvent consumption  Changes in energy requirements  Costs for equipment modifications  Changes in productivity

      Costs were evaluated for each solvent switching option using a large (1.5 m[2]) model open top cleaning machine.  The costs were calculated to be as follows:  PCE to TCE = Savings of $5,125 per year  PCE to MC = Savings of $1,719 per year  TCE to MC = Cost of $2,825 per year

2.0	Cancer Unit Risk       Since the cancer unit risk values for the three solvents are different, a facility could achieve a substantial decrease in cancer risk simply by switching from one halogenated solvent to another.  Table 2 shows that, when looking at cancer unit risk alone, switching from PCE to TCE or MC reduces the cancer risk by 66% or 92%, respectively.  Switching from TCE to MC reduces the cancer risk by 76.5%.                                               Table 2 - Relative Cancer Unit Risk Values for Halogenated Solvents

                               Perchloroethylene

                               Trichloroethylene

                              Methylene Chloride

                            Cancer Unit Risk Value

                                 5.9 x 10[-6]

                                 2.0 x 10[-6]

                                 4.7 x 10[-7]

                                  PCE to TCE

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

                    66 Percent Decrease in Cancer Unit Risk

                                   TCE to MC

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

                   76.5 Percent Decrease in Cancer Unit Risk

                                   PCE to MC

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

                    92 Percent Decrease in Cancer Unit Risk

3.0	Solvent Consumption       Solvent is consumed when it is emitted to the atmosphere from the solvent cleaning machine.  Dow Corporation conducted solvent consumption tests on an idling (i.e., the machine is turned on and ready to operate) open-top degreaser with a 24" x 58" opening using PCE, TCE, and MC.  The comparison of the resulting solvent consumption rates is shown in Table 3.

    Table 3 - Relative Solvent Consumption Rates for Halogenated Solvents                (based on the vapor loss from an idling degreaser)

                               Perchloroethylene

                               Trichloroethylene

                              Methylene Chloride

                            Solvent Consumption[a]

                                0.293 lb/ft2/hr

                                0.201 lb/ft2/hr

                                0.260 lb/ft2/hr

                                  PCE to TCE

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

                  31 Percent Decrease in Solvent Consumption

                                   TCE to MC

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

                  29 Percent Increase in Solvent Consumption

                                   PCE to MC

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

                  11 Percent Decrease in Solvent Consumption a - Reference 1.

      Air/solvent vapor interface loses during idling (i.e., when the machine is turned on and ready to operate) consist of solvent vapor diffusion (or evaporation from liquid solvent in a cold cleaner) and solvent vapor convection induced by warm freeboards.  Diffusion occurs because molecules of solvent move from higher concentrations in the vapor zone to lower concentrations in the air.  Because molecular activity increases at higher temperatures, diffusion rates are temperature-dependent.[2]  The rate of diffusion is also dependent on the vapor density of the solvent and the boiling point of the solvent.  The lower the vapor density, the more susceptible the solvent is to losses due to air disturbances and work transfer.[1]  The higher the boiling point of the solvent, and thus, the higher the solvent temperature, the greater the diffusion losses.[2]  Table 4 shows the vapor density and boiling point for each of the three halogenated solvents.

       Table 4 - Vapor Density and Boiling Point of PCE, TCE, and MC[a]

                                    Solvent

                                 Vapor Density

                           Boiling Point (degrees F)

                               Perchloroethylene

                                     5.76

                                      250

                               Trichloroethylene

                                     4.53

                                      189

                              Methylene Chloride

                                     2.93

                                      104 a - Reference 1

      Table 3 shows that PCE had the highest solvent consumption rate at 0.293 lb/ft2/hr.  Although PCE has a high vapor density, the high consumption rate of PCE relative to the other solvents is due to its very high boiling point.  Methylene Chloride had the second highest solvent consumption rate at 0.260 lb/ft2/hr.  The high consumption rate of MC relative to TCE is due to the very low vapor density of MC.

      Differences in the rates of solvent consumption between the halogenated solvents directly affect the level of cancer risk.   Table 3 shows that, when looking at solvent consumption alone, switching from PCE or TCE to MC reduces the cancer risk by 31% and 11%, respectively.  Switching from TCE to MC increases the cancer risk by 29%.

4.0	Advantages and Disadvantages of PCE, TCE, and MC       Each of the three halogenated solvents has advantages and disadvantages, some of which are illustrated in Table 5.  As a result, some halogenated solvents may not be appropriate for some specific cleaning applications.  Since solvent cleaning is application specific, each facility would need to determine whether switching to another halogenated solvent is a viable option for their particular cleaning application.  However, Dow Chemical Corporation, one of the largest manufacturers of halogenated solvents, states that in general:       "Most vapor degreasing operations can be performed with any of the three solvents (PCE, TCE, and MC), so the choice is often based on other performance characteristics, safety, environmental considerations, or cost."[1]

      The Kauri Butanol (KB) number is an indication of solvency power that is measured by the formation of turbidity with solvent mixed with Kauri resin and n-butanol.  The higher the KB number the greater the solvency.  Table 6 shows the KB number for each of the three halogenated solvents.

      In general, PCE's high boiling point makes it an excellent choice for drying wet parts, for removing high-melting pitches and waxes, and cleaning light-gauge metals without staining.  However, because of PCE's high boiling point: a greater heat input is required; it can damage aircraft aluminum alloys, printed circuit boards, and plastic materials; and a longer cooling time is required.[1]

      Trichloroethylene has a high solvency power (KB number of 129), which makes it excellent for removing oils, greases, waxes, tars, lubricants, coolants, semicured varnish, paint films, heavy rosins, and buffing compounds.  However, TCE does attack some plastics, is reactive with caustic soda forming dichloroacetylene (toxic and spontaneously combustible), and degrades in UV light creating phosgene (a highly toxic and reactive gas).[1]

      Methylene chloride has the highest solvency power of the three solvents (KB number of 136), and therefore, can perform well in a diverse range of cleaning applications.  Due to its low boiling point, methylene chloride is the best choice for cleaning temperature sensitive parts.  In addition, MC is low in cost compared to alternative (non-halogenated) low-temperature solvents.  Due to its low vapor density and high evaporation rate, cleaning machines using MC must have a higher freeboard height, additional freeboard chilling capacity, and covers in order to prevent excessive solvent emissions.[1]

      All three of the halogenated solvents are considered to be nonflammable.  Therefore, flammability is not an issue when choosing among the three halogenated solvents. 	                 Table 5 - Advantages and Disadvantages of PCE, TCE, and MC[a]

                                    Solvent

                                  Advantages

                                 Disadvantages

                                      PCE

Effective with Wet Metals - High boiling point allows complete drying of moisture on parts.

High Heat Required - High boiling point requires additional heat, and thus, higher utility costs to bring work up to the solvent vapor temperature.

Reduced Staining - High boiling point allows a longer and more thorough rinsing action and may reduce staining in cleaning operations employing vapor exposure only (esp. for light-gauge metals).

Steam Stripping - Steam stripping is commonly practiced to recover  solvent without causing thermal degradation.  Results in undesirable water contamination and requires operator attention.

Removes Stubborn Soils - High boiling point makes PCE effective for removing high-melting pitches and waxes and for cleaning grossly contaminated parts.

Heat Effects - Certain aircraft aluminum alloys, printed circuit boards, and plastic materials cannot handle the 250 degree temperature.

Stability - Shows little tendency to hydrolyze (degrade with water), but can decompose in the presence of UV light, releasing phosgene.

Additional Insulation May Be Needed to Reduce Heat Loss

Decreased Corrosion - DOW's double stabilized PCE contains an inhibitor system that provides extra corrosion protection for cleaned parts and the degreaser.

Not Recommended for Cold Cleaning

Vapor Recoverable by Carbon Adsorption

Longer Cooling Time

                                      TCE

High Solvent Power - High solvency for oils, greases, waxes, tars, lubricants, and coolants generally found in the metal processing industries.  Often chosen for removing difficult soils, such as semicured varnish or paint films, heavy rosins, buffing compounds, etc.

Steam Stripping - Steam stripping is commonly practiced to recover solvent without causing thermal degradation.  Results in undesirable water contamination and requires operator attention.

No Conversion Costs - Most equipment was originally designed for TCE.

Reactive with Caustic Soda (NaOH) - Forms toxic and spontaneously combustible, dichloroacetylene

Recoverable by Carbon Adsorption

Attacks Some Plastics

Energy Efficient

Degrades in UV Light creating phosgene

                                      MC

High Solvent Power - MC is the strongest of the common vapor degreasing solvents. Can perform effectively in such diverse tasks as paint mask cleaning and removing excess impregnating resin from castings.

Rapid Evaporation Rate - MC evaporates more rapidly than other vapor degreasing solvents.  Covering the degreaser during non-operating periods is imperative to prevent excessive solvent losses.

Good for Temperature-Sensitive Parts - Low boiling point makes it possible to degrease thermal switches, thermometers, etc., which would be damaged by higher temperatures.  MC is also chosen when parts must be near room temperature after cleaning, such as for immediate handling.

Low Vapor Density - MC's low vapor density makes it more susceptible to losses from air movement around the equipment.  Specialized equipment design, with a higher freeboard and adequate chilling is recommended for efficient use.

Low Cost - Low in cost compared to alternative low-temperature solvents used for similar applications.

High Throughput - Due to the low boiling point MC has the highest work throughput potential.

a - Adapted from Reference 1.

           Table 6 - Kauri Butanol Numbers for Halogenated Solvents

                                    Solvent

                             Kauri Butanol Number

                                      PCE

                                      90

                                      TCE

                                      129

                                      MC

                                      136

5.0	Costs       Costs related to switching from one halogenated solvent to another halogenated solvent include:  Changes in the cost of the solvent  Changes in solvent consumption  Changes in energy requirements  Costs for equipment modifications  Changes in productivity

      Table 7 shows the solvent costs, solvent consumption rates, and energy usage rates for PCE, TCE, and MC.  Trichloroethylene has the highest cost per gallon, PCE has the second highest cost per gallon, and MC has the lowest cost per gallon.  The solvent consumption rates are explained in more detail in section 3.0.  The energy usage values are derived from tests conducted by Dow Chemical Corporation.[1]  "During the tests the degreasers cleaned five loads of steel (100 lbs each) and provided 20 gallons of solvent spray per hour."[1]  The energy requirements for MC include the energy required to provide extra cooling capacity for adequate vapor condensation.

      The solvent costs per gallon, solvent consumption rates, and energy usage rates for PCE, TCE and MC are shown in Table 7.  Using the values in Table 7 and Appendix A, the solvent costs, energy costs, and equipment costs were calculated for a large (1.5 m2) model open top vapor degreaser (Table 8).  For the PCE and TCE base units it was assumed that the unit operated 8,760 hrs per year (24 hrs/day for 365 days/year) and that 1,350 gallons of solvent were used per year.  The solvent usage value of 1,350 gallons per year represents the average solvent usage for units using PCE and TCE with risk above 10[-6] in the preliminary risk analysis.  The annual solvent cost of the base units was calculated by multiplying 1,350 gallons by the cost of the solvent per gallon.  The annual energy cost for the base units was calculated by multiplying the energy usage by the electricity cost per kWh.  The solvent cost for switching from one solvent to another was calculated as follows: 	       Annual Solvent Cost = (base solvent volume) * (new solvent consumption/base solvent consumption) * (new solvent price)

In all cases, a savings in solvent costs results from switching from one solvent to another.

      The energy cost for switching from one solvent to another was calculated by taking the difference between the base unit energy requirements and the energy requirements of the unit with the new solvent.  When switching from PCE to TCE there is a savings in energy costs, whereas, when switching from PCE or TCE to MC there is a higher energy cost.  This is a result of the additional freeboard chilling capacity that is required when using MC.

      There are no equipment costs when switching from PCE to TCE.  However, when switching from PCE or TCE to MC the unit must have additional freeboard height (1.0 freeboard ratio) and additional freeboard chilling capacity (freeboard refrigeration device).  Capital and operational costs were estimated for these devices and are shown in the tables in Appendix A.

      The final column of Table 8 shows the total annual costs for each solvent switching option.  Switching from PCE to TCE or MC both result in an annual cost savings.  Switching from TCE to MC results in an increase in annual costs.  Since MC has a low boiling point, the cleaning cycle is shorter for MC than the other solvents.  A shorter cleaning cycle means increased productivity.  Therefore, some of the additional cost of using MC may be offset by productivity gains.          Table 7 - Solvent costs, solvent consumption, and energy usage for PCE, TCE and MC

                                   Cost Item

                                      PCE

                                      TCE

                                      MC

                     2004 Cost of Solvent per Gallon[3][a]

                                    $11.10

                                    $12.83

                                     $8.86

                     Solvent Consumption During Idling[1]

                                0.293 lb/ft2/hr

                                0.201 lb/ft2/hr

                                0.260 lb/ft2/hr

                              Energy Usage[1][b]

                                   20.8 kWh

                                   16.3 kWh

                                   21.47 kWh a - Based on purchase in 55 gallon drums. b - For MC the energy usage includes the additional energy used by a freeboard refrigeration device.

         Table 8 - Estimates of Solvent, Energy, and Equipment Costs                           for Solvent Switching Options

                                                                            Option

                                 Solvent Costs

                                 Energy Costs

                                                                   Annualized Equipment Cost

                                                                Total Annual  Costs for Option

                            Annual Solvent Cost[a]

                            Annual Change in Costs

                              Annual Energy Cost

                            Annual Change in Costs

Base PCE Unit

                                    $14,985

                                      NA

                                    $9,347

                                      NA

                                      NA

                                      NA

PCE to TCE

                                    $11,882

                                   ($3,103)

                                    $7,325

                                   ($2,022)

                                     None

                                   ($5,125)

PCE to MC

                                    $10,614

                                   ($4,371)

                                    $9,648

                                     $301

                                    $2,351

                                   ($1,719)

Base TCE Unit

                                    $17,321

                                      NA

                                    $7,325

                                      NA

                                      NA

                                      NA

TCE to MC

                                    $15,472

                                   ($1,849)

                                    $9,648

                                    $2,323

                                    $2,351

                                    $2,825 a - Calculated using the following equation: (Base solvent volume) * (New solvent consumption/Base solvent consumption) * (New solvent price)

References

1 - "Degreasing: Economical and Efficient Degreasing with Chlorinated Solvents from Dow", Dow Chemical Company, November 1999.

2 - "National Emission Standards for Hazardous Air Pollutants: Halogenated Solvent Cleaning - Background Information Document", U.S. EPA, EPA-453/R-93-054, November 1993.

3 - Price quote from Univar USA Inc., Charlotte, NC.  Univar is a direct distributor for Dow Chemicals Company.   January 25, 2005.

                         Appendix A - Equipment Costs

                     Freeboard Refrigeration Device Costs

1.  Capital Costs

1990 Installed Capital Costs [1, 2]

                                    $9,000

Scaling Factor from 1990 to 2004 Based on the PPI

                                     1.30

2004 Installed Capital Costs

                                    $11,717

Cost of Additional Floor Space[3]

                                     $315

Total Capital Costs

                                    $12,032

Annualized Total Capital Costs (15yr @ 7%)

                                    $1,324

2. Annual Operation Costs

Labor [4]

                                     $146

Misc. Operating Costs [5]

                                     $481

Total Annual Operation Costs

                                     $627

3.  Total Annualized Cost (Annualized Total Capital Cost plus Total Annual Operating Costs)

                                    $1,950

[1] - C. Sarsony, Radian Corp. to Paul Almodovar, U.S. EPA. "Revised Cost and Cost Effectiveness Values Associated with Emission Reductions for Selected Control Techniques for Halogenated Solvent Cleaners."  August 19, 1994.  Docket A-92-39, Item Number IV-B-3.

[2] - Based on the Large Open Top Vapor Cleaner Size (1.5 m[2]).  This is the closest to the average size of the units using PCE and TCE with risk above 10-6 (2.92 m[2]).

[3] - Scaled from 1990 (Source 1) using the PPI.

[4] - Assumed operating 8,760 hrs per year.  1,095 shifts/year * $13.29/hr * 0.01 hrs/shift = labor cost.  Labor rate was obtained from BLS - Private Industry Blue Collar Machine Operators, July 2003.

[5] - Calculated as 4% of capital costs (Source 1).

                           1.0 Freeboard Ratio Costs

1.  Capital Costs

1990 Installed Capital Costs [1, 2]

                                    $2,800

Scaling Factor from 1990 to 2004 Based on the PPI

                                     1.30

2004 Installed Capital Costs

                                    $3,645

Cost of Additional Floor Space[3]

                                      $0

Total Capital Costs

                                    $3,645

Annualized Total Capital Costs (15yr @ 7%)

                                     $401

2. Annual Operation Costs

Labor [4]

                                      $0

Misc. Operating Costs [5]

                                      $0

Total Annual Operation Costs

                                      $0

3.  Total Annualized Cost (Annualized Total Capital Cost plus Total Annual Operating Costs)

                                     $401

[1] - C. Sarsony, Radian Corp. to Paul Almodovar, U.S. EPA. "Revised Cost and Cost Effectiveness Values Associated with Emission Reductions for Selected Control Techniques for Halogenated Solvent Cleaners."  August 19, 1994.  Docket A-92-39, Item Number IV-B-3.

[2] - Based on the Large Open Top Vapor Cleaner Size (1.5 m[2]).  This is the closest to the size of the units using PCE and TCE with risk above 10-6 (average of 2.93 m2, median of 1.67m[2]).

[3] - Scaled from 1990 (Source 1) using the PPI.

[4] - Assumed operating 8,760 hrs per year.  1,095 shifts/year * $13.29/hr * 0.01 hrs/shift = labor cost.  Labor rate was obtained from BLS - Private Industry Blue Collar Machine Operators, July 2003.

[5] - Calculated as 4% of capital costs (Source 1).


[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18672-18673]
[FR Doc No: 2013-07035]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA 2013-0002-N-6]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following currently
approved information collection activities. Before submitting these
information collection requirements (ICRs) for clearance by the Office
of Management and Budget (OMB), FRA is soliciting public comment on
specific aspects of the activities identified below.

DATES: Comments must be received no later than May 28, 2013.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave. SE., Mail Stop 17, Washington, DC
20590, or Ms. Kimberly Toone, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB control number ----------
--.'' Alternatively, comments may be transmitted via facsimile to (202)
493-6216 or<PHONE_NUMBER>, or via email to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Toone at<EMAIL_ADDRESS>Please
refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave. SE., Mail Stop 17, Washington, DC 20590 (telephone:
(202) 493-6292) or Ms. Kimberly Toone, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-
6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION:
    The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, Sec.
2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520),
and its implementing regulations, 5 CFR part 1320, require Federal
agencies to provide 60-days notice to the public for comment on
information collection activities before seeking approval for
reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR
1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA invites
interested respondents to comment on the following summary of proposed
information collection activities regarding (i) Whether the information
collection activities are necessary for FRA to properly execute its
functions, including whether the activities will have practical
utility; (ii) the accuracy of FRA's estimates of the burden of the
information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)-(iv); 5 CFR
1320.8(d)(1)(I)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below are brief summaries of three currently approved information
collection activities that FRA will submit for clearance by OMB as
required under the PRA:
    Title: Filing of Dedicated Cars.
    OMB Control Number: 2130-0502.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Businesses.
    Form(s): N/A.
    Abstract: Title 49, Part 215 of the Code of Federal Regulations,
prescribes certain conditions to be followed for the movement of
freight cars that are not in compliance with this Part. Dedicated
service means the exclusive assignment of railroad cars to the
transportation of freight between specified points under the following
conditions: (1) The cars are operated primarily on track that is inside
an industrial or other non-railroad installation; and only occasionally
over track of a railroad; (2) The cars are not operated at speeds of
more than 15 miles per hour; and over track of a railroad--(A) for more
than 30 miles in one direction; or (B) on a round trip for more than 60
miles; (3) The cars are not freely interchanged among railroads; (4)
The words ``Dedicated Service'' are stenciled, or otherwise displayed,
in clear legible letters on each side of the car body; and (5) The cars
have been examined and found safe to operate in dedicated service.
These cars must be identified in a written report to FRA before they
are assigned to dedicated service, and these reports must be filed with
FRA 30 days before the cars operate in dedicated service. FRA uses the
information collected under Sec.  215.5(d) to determine the number of
railroads affected, the number and type of cars involved, the
commodities being carried, and the territorial and speed limits within
which the cars will be operated. FRA reviews these reports to determine
if the equipment is safe to operate and if the operation qualifies for
dedicated service. The information collected indicates to FRA
inspectors that the particular or ``dedicated'' car is in special
service and that certain exceptions have been provided for

regarding the application of this regulation spelled out in Sec.
215.3. Cars not in compliance with Sec.  215.5(d) will be cited for
violations by FRA inspectors. The information collected is also used by
railroads to provide identification and control so that dedicated cars
remain in the prescribed service.
    Total Annual Estimated Responses: 4.
    Total Annual Estimated Burden: 4 hours.
    Title: Special Notice for Repairs.
    OMB Control Number: 2130-0504.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Businesses.
    Form(s): FRA F 6180.8; FRA F 6180.8A.
    Abstract: The Special Notice for Repairs is issued to notify the
carrier in writing of an unsafe condition involving a locomotive, car,
or track. The carrier must return the form after repairs have been
made. The collection of information is used by State and Federal
inspectors to remove freight car or locomotives until they can be
restored to a serviceable condition. It is also used by State and
Federal inspectors to reduce the maximum authorized speed on a section
of track until repairs can be made.
    Total Annual Estimated Responses: 32.
    Total Annual Estimated Burden: 10 hours.
    Title: Remotely Controlled Switch Operations.
    OMB Control Number: 2130-0516.
    Abstract: Title 49, Section 218.30 of the Code of Federal
Regulations (CFR), ensures that remotely controlled switches are lined
to protect workers who are vulnerable to being struck by moving cars as
they inspect or service equipment on a particular track or,
alternatively, occupy camp cars. FRA believes that production of
notification requests promotes safety by minimizing mental lapses of
workers who are simultaneously handling several tasks. Sections 218.30
and 218.67 require the operator of remotely controlled switches to
maintain a record of each notification requesting blue signal
protection for 15 days. Operators of remotely controlled switches use
the information as a record documenting blue signal protection of
workers or camp cars. This record also serves as a valuable resource
for railroad supervisors and FRA inspectors monitoring regulatory
compliance.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Respondent Universe: 728 railroads.
    Frequency of Submission: On occasion.

----------------------------------------------------------------------------------------------------------------
                                                                                Average time
            CFR section              Respondent universe        Total annual       per response    Total annual
                                                                 responses           (minute)      burden hours
----------------------------------------------------------------------------------------------------------------
218.30--Blue signal protection of   70 railroads.........  3,600,000                           1          60,000
 workmen.                                                   notifications.
218.77--Protection of occupied      4 railroads..........  2,300 notifications..               1              38
 camp cars.
----------------------------------------------------------------------------------------------------------------

    Total Estimated Responses: 3,602,300.
    Total Estimated Annual Burden: 60,038 hours.
    Status: Regular Review.
    Title: Bad Order and Home Shop Card.
    OMB Control Number: 2130-0519.
    Abstract: Under 49 CFR part 215, each railroad is required to
inspect freight cars placed in service and take the necessary remedial
action when defects are identified. Part 215 defects are specific in
nature and relate to items that have or could have caused accidents or
incidents. Section 215.9 sets forth specific procedures that railroads
must follow when it is necessary to move defective cars for repair
purposes. For example, railroads must affix a ``bad order'' tag
describing each defect to each side of the freight car. It is
imperative that a defective freight car be tagged ``bad order'' so that
it may be readily identified and moved to another location for repair
purposes only. At the repair point, the ``bad order'' tag serves as a
repair record. Railroads must retain each tag for 90 days to verify
that proper repairs were made at the designated location. FRA and State
inspectors review all pertinent records to determine whether defective
cars presenting an immediate hazard are being moved in transportation.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Frequency of Submission: On occasion.

----------------------------------------------------------------------------------------------------------------
                                                                                Average time
            CFR section              Respondent universe        Total annual       per response    Total annual
                                                                 responses           (minutes)     burden hours
----------------------------------------------------------------------------------------------------------------
215.9--Movement of Defective Cars   728 railroads........  150,000 tags.........               5          12,500
 for Repair--Tagging.
--Notifications of Removal of       728 railroads........  75,000 notifications.               2           2,500
 Defective Car Tags.
215.11--Designated Inspectors--     718 railroads........  45,000 records.......               1             750
 Records.
----------------------------------------------------------------------------------------------------------------

     Respondent Universe: 728 railroads.
    Total Estimated Responses: 270,000.
    Total Estimated Annual Burden: 15,750 hours.
    Status: Regular Review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on March 21, 2013.
Rebecca Pennington,
Chief Financial Officer, Federal Railroad Administration.
[FR Doc. 2013-07035 Filed 3-26-13; 8:45 am]
BILLING CODE 4910-06-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD (HSRB)

PUBLIC TELECONFERENCE MEETING

Monday, December 13, 2010

3:00 pm -5:00 pm (Eastern Time)*

HSRB MEETING FOR REVIEW AND APPROVAL OF THE

DRAFT OCTOBER 27/28, 2010 HSRB MEETING REPORT

HSRB WEB SITE http://www.epa.gov/osa/hsrb/

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA–HQ–ORD–2010–0919

Meeting location via telephone only

Dial in number<PHONE_NUMBER>; conference code<PHONE_NUMBER>

3:00 PM	Convene Meeting and Identification of Board Members – Jim
Downing (Designated Federal Officer, HSRB, OSA, EPA)

3:10 PM*	Meeting Administrative Procedures – Jim Downing, DFO

3:15 PM	Meeting Process –Sean Philpott, Ph.D. (HSRB Chair)

3:20 PM	Public Comments

3:30 PM	Board Discussion and Decision on Final Report – Sean Philpott,
Ph.D. (HSRB Chair)

The Board’s response to EPA charge questions presented at the October
27/28, 2010 meeting.

Carroll-Loye Biological Research, Inc. Protocol No Mas 003, a Field
Efficacy Test of PMD and Lemongrass Oil-based Repellent “No Mas”
Against Mosquitoes.

Charge to the Board:

If the proposed field repellency study protocol No Mas 003 is revised as
suggested in EPA’s review and if the research is performed as
described:

Is the research likely to generate scientifically reliable data, useful
for assessing the efficacy of the tested material in repelling
mosquitoes?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

A new scenario design and associated protocol from the Agricultural
Handler Exposure Task Force (AHETF) to measure dermal and inhalation
exposure to applicators who use backpack sprayers or hand gun sprayers
to apply pesticides in utility rights-of-way.

Charge to the Board:

If the proposed Agricultural Handler Exposure Task Force (AHETF)
Right-of-Way application scenario and field study protocol AHE400 is
revised as suggested in EPA’s review and if it is performed as
described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of workers who apply pesticides in utility
rights-of-way with backpack or hand gun sprayers?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

Completed scenario monograph and study report from the Antimicrobial
Exposure Assessment Task Force II (AEATF–II): Dermal and Inhalation
Exposure of Professional Janitorial Workers Applying Liquid
Antimicrobial Products to Indoor Floors Using Bucket and Mop

Charge to the Board:

In the completed scenario monograph and study report AEA03 from the
Antimicrobial Exposure Assessment Task Force II (AEATF–II):

Was the research reported in the Antimicrobial Exposure Assessment Task
Force II (AEATF–II) completed study report AEA03 and associated
supplemental reports faithful to the design and objectives of the
protocol and governing documents of AEATF-II?

Has the Agency adequately characterized, from a scientific perspective,
the limitations on these data that should be considered when using the
data in estimating exposure of those who apply antimicrobial
floor-cleaning products with mop and bucket?

Does available information support a determination that the study was
conducted in substantial compliance with subparts K and L of 40 CFR Part
26?

Revised scenario design and associated protocol from the Agricultural
Handler Exposure Task Force (AHETF) describing proposed research to
monitor exposure of workers who mix and load pesticides formulated as
wettable powders in water-soluble packaging

Charge to the Board:

If the revised AHETF scenario and field study proposal AHE120 is revised
as suggested in EPA’s review, and if it is performed as described:

Is the research likely to generate scientifically reliable data, useful
for assessing the exposure of handlers who mix and load pesticides in
water-soluble packaging?

Is the research likely to meet the applicable requirements of 40 CFR
part 26, subparts K and L?

4:55 PM	Summary and Next Steps – Sean Philpott, Ph.D. (HSRB Chair) and
Jim Downing (DFO)

5:00 PM 	Adjournment

* Please be advised that agenda times are approximate. For further
information, please contact the Designated Federal Officer for this
meeting, Jim Downing via telephone:<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>
  PAGE  1