MSDS Material Safety Data Sheet


File Name: 1424712873.asp

May 30, 2007

Part III

Protection Agency
40 CFR Part 82
Protection of Stratospheric Ozone: Listing
of Substitutes for Ozone-Depleting
Substances-n-Propyl Bromide in Solvent
Cleaning; Protection of Stratospheric
Ozone: Listing of Substitutes for Ozone-
DepletingSubstances-n-Propyl Bromide in
Adhesives, Coatings, and Aerosols; Final
Rule and Proposed Rule
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G. Executive Order 13045: Protection of
Children from Environmental Health and
Margaret Sheppard, Stratospheric
Safety Risks
Protection Division, Office of
H. Executive Order 13211: Actions That
40 CFR Part 82 Atmospheric Programs, Mail Code
Significantly Affect Energy Supply,
6205J, Environmental Protection Distribution, or Use
[EPA璈Q璒AR?002?064; FRL?316?]
Agency, 1200 Pennsylvania Ave., NW., I. National Technology Transfer and
Washington, DC 20460; telephone
RIN 2060瑼O10 Advancement Act
number (202) 343?163; fax number J. Congressional Review Act
Protection of Stratospheric Ozone: (202) 343?362, e-mail address: VIII. References
Listing of Substitutes for Ozone- Notices
I. General Information
Depleting Substances-n-Propyl and rulemakings under the SNAP
Bromide in Solvent Cleaning program are available on EPA's A. Does this action apply to me?
Stratospheric Ozone World Wide Web
This final rule lists n-propyl bromide
Environmental Protection
site at
(nPB) as an acceptable substitute when
used as a solvent in industrial
ACTION: Final Rule.
SUPPLEMENTARY INFORMATION: Table of equipment for metals cleaning,
Contents: This action is divided into
SUMMARY: The Environmental Protection electronics cleaning, or precision
eight sections:
Agency (EPA) determines that n-propyl cleaning. General metals, precision, and
bromide (nPB) is an acceptable electronics cleaning includes cleaning
I. General Information
substitute for methyl chloroform and with industrial cleaning equipment
A. Does this action apply to me?
chlorofluorocarbon (CFC)?13 in the B. What is n-propyl bromide? such as vapor degreasers, in-line
C. What acronyms and abbreviations are
solvent cleaning sector under the cleaning systems, or automated
used in the preamble?
Significant New Alternatives Policy equipment used for cleaning below the
II. How does the Significant New
(SNAP) program under section 612 of boiling point. We understand that nPB
Alternatives Policy (SNAP) Program
the Clean Air Act. The SNAP program is used primarily for cleaning in vapor
reviews alternatives to Class I and Class degreasers. Manual cleaning, such as
A. What are the statutory requirements and
II ozone depleting substances and pail-and-brush, hand wipe, recirculating
authority for the SNAP Program?
approves use of alternatives which do over-spray (``sink-on-a-drum'') parts
B. How do the regulations for the SNAP
not present a substantially greater risk to washers, immersion cleaning into dip
Program work?
C. How does the SNAP Program list our
public health and the environment than tanks with manual parts handling, and
the substance they replace or than other use of squirt bottles, is not currently
D. Where can I get additional information
available substitutes. regulated under the SNAP program.
about the SNAP Program?
EPA also does not regulate the use of
DATES: This final rule is effective on July III. What is EPA's final listing decision on
solvents as carriers for flame retardants,
30, 2007. nPB in solvent cleaning?
dry cleaning, or paint stripping under
IV. What criteria did EPA use in making this
ADDRESSES: EPA has established a
the SNAP program.
Final Decision?
docket for this action under Docket ID
This final action does not address the
A. Availability of alternatives to ozone-
No. EPA璈Q璒AR?002?064. All
depleting substances use of n-propyl bromide as an aerosol
documents in the docket are listed on
B. Impacts on the Atmosphere and Local solvent or as a carrier solvent in
the Web Air Quality adhesives or coatings. We are issuing a
site. Although listed in the index, some C. Ecosystem and Other Environmental
proposed rule addressing these end uses
information is not publicly available, Impacts
in a separate Federal Register action.
i.e., Confidential Business Information D. Flammability and Fire Safety
Neither this final nor the proposed rule
(CBI) or other information whose E. Impact on Human Health
issue a decision on other end uses in
V. How is EPA responding to comments on
disclosure is restricted by statute.
which nPB was submitted as an ozone-
the June 2003 Notice of Proposed
Certain other material, such as
depleting substance (ODS) substitute,
copyrighted material, is not placed on
A. EPA's Acceptability Decision such as fire suppression or foam
the Internet and will be publicly
B. Toxicity blowing, because of insufficient
available only in hard copy form. C. Ozone Depletion Potential information.
Publicly available docket materials are D. Other Environmental Impacts
Affected users under this final rule
available either electronically in http:// E. Flammability
could include: or in hard copy at F. Legal Authority to Set Exposure Limits
?Businesses that clean metal parts,
the Air and Radiation Docket, EPA/DC, VI. How can I use nPB as safely as possible?
such as automotive manufacturers,
VII. Statutory and Executive Order Reviews
EPA West, Room 3334, 1301
machine shops, machinery
A. Executive Order 12866: Regulatory
Constitution Ave., NW., Washington,
Planning and Review manufacturers, and electroplaters.
DC. This docket facility is open from
B. Paperwork Reduction Act ?Businesses that manufacture
8:30 a.m. to 4:30 p.m., Monday through
C. Regulatory Flexibility Act
electronics or computer equipment.
Friday, excluding legal holidays. The D. Unfunded Mandates Reform Act
?Businesses that require a high level
telephone number for the Public E. Executive Order 13132: Federalism
Reading Room is (202) 566?744, and of cleanliness in removing oil, grease, or
F. Executive Order 13175: Consultation
the telephone number for the Air and wax, such as for aerospace applications
and Coordination with Indian Tribal
Radiation Docket is (202) 566?742. or for manufacture of optical equipment.
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NAICS code
Category Description of regulated entities
or subsector

Industry .......................................................................... 331 Primary Metal Manufacturing.
Industry .......................................................................... 332 Fabricated Metal Product Manufacturing.
Industry .......................................................................... 333 Machinery Manufacturing.
Industry .......................................................................... 334 Computer and Electronic Product Manufacturing.
Industry .......................................................................... 335 Equipment Appliance, and Component Manufacturing.
Industry .......................................................................... 336 Transportation Equipment Manufacturing.
Industry .......................................................................... 337 Furniture and Related Product Manufacturing.
Industry .......................................................................... 339 Miscellaneous Manufacturing.

CFC--chlorofluorocarbon NESHAP--National Emission Standard for
This table is not intended to be
cfm--cubic feet per minute Hazardous Air Pollutants
exhaustive, but rather a guide regarding
CFR--Code of Federal Regulations NIOSH--National Institute for Occupational
entities likely to be regulated by this
CNS--central nervous system Safety and Health
action. If you have any questions about DNA--deoxyribonucleic acid NOAEL--No Observed Adverse Effect Level
whether this action applies to a EDSTAC--The Endocrine Disruptor NOEL--No Observed Effect Level
particular entity, consult the person Screening and Testing Advisory nPB-n-propyl bromide, C3H7Br, CAS Reg. No.
listed in the preceding section, FOR Committee 106?4?; also called 1-bromopropane or
EPA--the United States Environmental 1-BP
Protection Agency NPRM--Notice of Proposed Rulemaking
B. What is n-propyl bromide? FR--Federal Register NTP--National Toxicology Program
GWP--global warming potential NTTAA--National Technology Transfer and
n-propyl bromide (nPB), also called 1-
HCFC-123--the ozone-depleting chemical Advancement Act
bromopropane, is a non-flammable
1,2-dichloro-1,1,2-trifluoroethane, CAS ODP--ozone depletion potential
organic solvent with a strong odor. Its Reg. No. 306?3? ODS--ozone-depleting substance
chemical formula is C3H7Br. Its HCFC-141b--the ozone-depleting chemical OEHHA--Office of Environmental Health
identification number in Chemical 1,1-dichloro-1-fluoroethane, CAS Reg. Hazard Assessment of the California
Abstracts Service's registry (CAS Reg. No. 1717?0? Environmental Protection Agency
HCFC-225ca/cb--the commercial mixture of
No.) is 106?4?. nPB is used to remove OMB--U.S. Office of Management and
the two ozone-depleting chemicals 3,3- Budget
wax, oil, and grease from electronics,
dichloro-1,1,1,2,2-pentafluoropropane, OSHA--the United States Occupational
metal, and other materials. It also is
CAS Reg. No. 422?6? and 1,3- Safety and Health Administration
used as a carrier solvent in adhesives. dichloro-1,1,2,2,3-pentafluoropropane, PCBTF--parachlorobenzotrifluoride, CAS
Some brand names of products using CAS Reg. No. 507?5? Reg. No. 98?6?
nPB are: Abzol, EnSolv, and Solvon HCFC--hydrochlorofluorocarbon PEL--Permissible Exposure Limit
cleaners; Pow-R-Wash NR Contact HEC--human equivalent concentration ppm--parts per million
HFC-245fa--the chemical 1,1,3,3,3-
Cleaner, Superkleen Flux Remover 2311 RCRA--Resource Conservation and Recovery
pentafluoropropane, CAS Reg. No. 460?br> and LPS NoFlash NU Electro Contact Act
Cleaner aerosols; and Whisper Spray RFA--Regulatory Flexibility Act
HFC-365mfc--the chemical 1,1,1,3,3- RfC--reference concentration
and Fire Retardant Soft Seam 6460 pentafluorobutane, CAS Reg. No. 405? SIP--state implementation plan
adhesives. 58? SNAP--Significant New Alternatives Policy
HFC-4310mee--the chemical
C. What acronyms and abbreviations are STEL--Short term exposure limit
1,1,1,2,3,4,4,5,5,5-decafluoropentane, TCA--the ozone-depleting chemical 1,1,1-
used in the preamble? CAS Reg. No. 138495?2? trichloroethane, CAS Reg. No. 71?5?;
Below is a list of acronyms and also called methyl chloroform, MCF, or
abbreviations used in this document. 1,1,1
HHE--health hazard evaluation TCE--the chemical 1,1,2-trichloroethene,
8-hr--eight hour ICF--ICF Consulting
CAS Reg. No. 79?1?, C2Cl3H; also call
ACGIH--American Conference of ICR--Information Collection Request
Governmental Industrial Hygienists iPB--isopropyl bromide, C3H7Br, CAS Reg.
TERA--Toxicological Excellence for Risk
AEL--acceptable exposure limit No. 75?6?, an isomer of n-propyl
ASTM--American Society for Testing and bromide; also called 2-bromopropane or
TLV--Threshold Limit ValueTM
Materials 2-BP
TSCA--Toxic Substances Control Act
BMD--benchmark dose Koc--organic carbon partition coefficient, for
TWA--time-weighted average
BMDL--benchmark dose lowerbound, the determining the tendency of a chemical
UMRA--Unfunded Mandates Reform Act
lower 95%-confidence level bound on to bind to organic carbon in soil
U.S.C.--United States Code
the dose/exposure associated with the LC50--the concentration at which 50% of test
VMSs--volatile methyl siloxanes
benchmark response animals die
VOC--volatile organic compound
BSOC--Brominated Solvents Consortium LOAEL--Lowest Observed Adverse Effect
WEL--workplace exposure limit
CAA--Clean Air Act Level
CAS Reg. No.--Chemical Abstracts Service Log Kow--logarithm of the octanol-water II. How does the Significant New
Registry Identification Number partition coefficient, for determining the
Alternatives Policy (SNAP) program
CBI--Confidential Business Information tendency of a chemical to accumulate in
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CEG--community exposure guideline lipids or fats instead of remaining
CERHR--Center for the Evaluation of Risks to dissolved in water A. What are the statutory requirements
Human Reproduction mg/l--milligrams per liter and authority for the SNAP program?
CFC-113--the ozone-depleting chemical MSDS--Material Safety Data Sheet
Section 612 of the Clean Air Act
1,1,2-trifluoro-1,2,2-trichloroethane, NAICS--North American Industrial
(CAA) authorizes EPA to develop a
C2Cl3F3, CAS Reg. No. 76?3? Classification System

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program for evaluating alternatives to that described the process for end uses are available for their specific
ozone-depleting substances, referred to administering the SNAP program and application. We describe these
as the Significant New Alternatives issued the first acceptability lists for substitutes as ``acceptable subject to
Policy (SNAP) program. The major substitutes in the major industrial use narrowed use limits.'' If you use a
provisions of section 612 are: sectors. These sectors include: substitute that is acceptable subject to
?Rulemaking--Section 612(c) Refrigeration and air conditioning; foam narrowed use limits, but use it in
requires EPA to promulgate rules blowing; solvents cleaning; fire applications and end-uses which are not
making it unlawful to replace any class suppression and explosion protection; consistent with the narrowed use limit,
I (chlorofluorocarbon, halon, carbon sterilants; aerosols; adhesives, coatings you are using these substitutes in an
tetrachloride, methyl chloroform, and and inks; and tobacco expansion. These unacceptable manner and you could be
hydrobromofluorocarbon) or class II sectors comprise the principal industrial subject to enforcement for violation of
(hydrochlorofluorocarbon) substance sectors that historically consumed large section 612 of the Clean Air Act.
with any substitute that the The Agency publishes its SNAP
volumes of ozone-depleting substances.
Administrator determines may present Anyone who plans to market or program decisions in the Federal
produce a substitute for an ODS in one Register. For those substitutes that are
adverse effects to human health or the
of the eight major industrial use sectors deemed acceptable subject to use
environment where the Administrator
must provide the Agency with health restrictions (use conditions and/or
has identified an alternative that (1)
and safety studies on the substitute at narrowed use limits), or for substitutes
reduces the overall risk to human health
least 90 days before introducing it into deemed unacceptable, we first publish
and the environment, and (2) is
interstate commerce for significant new these decisions as proposals to allow the
currently or potentially available.
?Listing of Unacceptable/Acceptable use as an alternative. This requirement public opportunity to comment, and we
Substitutes--Section 612(c) also applies to the person planning to publish final decisions as final
introduce the substitute into interstate rulemakings. In contrast, we publish
requires EPA to publish a list of the
commerce, typically chemical substitutes that are deemed acceptable
substitutes unacceptable for specific
manufacturers, but may also include with no restrictions in ``notices of
uses. We must publish a corresponding
importers, formulators or end-users acceptability,'' rather than as proposed
list of acceptable alternatives for
when they are responsible for and final rules. As described in the rule
specific uses.
?Petition Process--Section 612(d) introducing a substitute into commerce. implementing the SNAP program (59 FR
grants the right to any person to petition 13044), we do not believe that
C. How does the SNAP program list our
EPA to add a substitute to or delete a rulemaking procedures are necessary to
list alternatives that are acceptable
substitute from the lists published in
The Agency has identified four without restrictions because such
accordance with section 612(c). EPA has
possible decision categories for listings neither impose any sanction nor
90 days to grant or deny a petition.
substitutes: Acceptable; acceptable prevent anyone from using a substitute.
Where the Agency grants the petition,
subject to use conditions; acceptable Many SNAP listings include
we must publish the revised lists within
subject to narrowed use limits; and ``comments'' or ``further information.''
an additional six months.
?90-day Notification--Section 612(e) unacceptable. Use conditions and These statements provide additional
narrowed use limits are both considered information on substitutes that we
requires EPA to require any person who
``use restrictions'' and are explained determine are either unacceptable,
produces a chemical substitute for a
below. Substitutes that are deemed acceptable subject to narrowed use
class I substance to notify the Agency
acceptable with no use restrictions (no limits, or acceptable subject to use
not less than 90 days before new or
use conditions or narrowed use limits) conditions. Since this additional
existing chemicals are introduced into
can be used for all applications within information is not part of the regulatory
interstate commerce for significant new
the relevant sector end-use. Substitutes decision, these statements are not
uses as substitutes for a class I
that are acceptable subject to use binding for use of the substitute under
substance. The producer must also
restrictions may be used only in the SNAP program. However, regulatory
provide the Agency with the producer's
accordance with those restrictions. It is requirements listed in this column are
health and safety studies on such
illegal to replace an ODS with a binding under other programs. The
?Outreach--Section 612(b)(1) states substitute listed as unacceptable. further information does not necessarily
After reviewing a substitute, the include all other legal obligations
that the Administrator shall seek to
Agency may make a determination that pertaining to the use of the substitute.
maximize the use of federal research
a substitute is acceptable only if certain However, we encourage users of
facilities and resources to assist users of
conditions of use are met to minimize substitutes to apply all statements in the
class I and II substances in identifying
risks to human health and the FURTHER INFORMATION column in their
and developing alternatives to the use of
environment. We describe such use of these substitutes. In many
such substances in key commercial
substitutes as ``acceptable subject to use instances, the information simply refers
?Clearinghouse--Section 612(b)(4) conditions.'' If you use these substitutes to sound operating practices that have
without meeting the associated use
requires the Agency to set up a public already been identified in existing
conditions, you use these substitutes in
clearinghouse of alternative chemicals, industry and/or building-code
an unacceptable manner and you could
product substitutes, and alternative standards. Thus, many of the comments,
be subject to enforcement for violation
manufacturing processes that are if adopted, would not require the
of section 612 of the Clean Air Act.
available for products and affected industry to make significant
For some substitutes, the Agency may
manufacturing processes which use changes in existing operating practices.
permit a narrowed range of use within
class I and II substances.
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D. Where can I get additional
a sector. For example, we may limit the
B. How do the regulations for the SNAP information about the SNAP program?
use of a substitute to certain end-uses or
program work? specific applications within an industry For copies of the comprehensive
On March 18, 1994, EPA published sector or may require a user to SNAP lists of substitutes or additional
the original rulemaking (59 FR 13044) demonstrate that no other acceptable information on SNAP, look at EPA's

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Ozone Depletion World Wide Web site available or potentially available of the comment period on the June 2003
at substitutes for ozone-depleting NPRM relevant to our proposed
index.html. For more information on the substances in these end uses. determinations for adhesive and aerosol
EPA is issuing today's listing in the
Agency's process for administering the solvent end uses in that same proposal,
form of a final rule, rather than in a
SNAP program or criteria for evaluation the Agency is issuing a new proposal for
notice of acceptability, in order to
of substitutes, refer to the SNAP final those end uses in a separate Federal
respond to the public comments
rulemaking published in the Federal Register action. The Agency is not
received on a Notice of Proposed
Register on March 18, 1994 (59 FR including a recommended AEL in this
Rulemaking (NPRM) that we issued on
13044), codified at Code of Federal final rule.
June 3, 2003 (68 FR 33284). In that rule,
Regulations at 40 CFR part 82, subpart
Table 2 contains the text pertaining to
we proposed listing n-propyl bromide
G. You can find a complete chronology
nPB use in solvent cleaning end-uses
(nPB) as an acceptable substitute for use
of SNAP decisions and the appropriate
that will be added to EPA's list of
in metals, precision, and electronics
Federal Register citations at http://
acceptable substitutes located on the
cleaning, and in aerosols and adhesives
SNAP Web site at
end-uses, subject to the use condition
III. What is EPA's final listing decision ozone/snap/lists/index.html. This and
that nPB used in these applications
on nPB in solvent cleaning? other listings for substitutes that are
contains no more than 0.05% by weight
acceptable without restriction are not
The Agency is listing nPB as an of isopropyl bromide. In addition, in
included in the Code of Federal
acceptable substitute in metals, that proposed rule, EPA indicated that
Regulations because they are not
precision and electronics cleaning end we also would recommend that users
regulatory requirements. The
uses. Based on the available adhere to a voluntary acceptable
information contained in the ``Further
information, we find that nPB can be exposure limit (AEL) of 25 parts per
Information'' column of those tables are
used with no substantial increase in million averaged over an eight-hour
non-binding recommendations on the
overall risks to human health and the time-weighted average (TWA). Based on
environment, compared to other new information received after the close safe use of substitutes.

End use Substitute Decision Further information

Metals cleaning, electronics n-propyl bromide (nPB) as Acceptable ......................... EPA recommends the use of personal protective
cleaning, and precision a substitute for CFC?13 equipment, including chemical goggles, flexible lami-
cleaning. and methyl chloroform. nate protective gloves and chemical-resistant cloth-
EPA expects that all users of nPB would comply with
any final Permissible Exposure Limit that the Occu-
pational Safety and Health Administration issues in
the future under 42 U.S.C. 7610(a).
nPB, also known as 1-bromopropane, is Number 106?br> 94? in the Chemical Abstracts Service (CAS) Reg-

IV. What criteria did EPA consider in applications such as electronics Our evaluation is based on the end use;
cleaning. In those consumer products for example, we compared nPB as a
making this final determination?
made using nPB, such as a computer, metal cleaning solvent against other
In the original rule implementing the
the nPB would have evaporated long available or potentially available metal
SNAP program (March 18, 1994; 59 FR
before a consumer would purchase the cleaning alternatives.
13044, at 40 CFR 82.180(a)(7)), the
Although EPA does not judge the
item. Therefore, we believe there is no
Agency identified the criteria we use in
effectiveness of an alternative for
consumer exposure risk in the end uses
determining whether a substitute is
purposes of determining whether it is
we evaluated for this rule.
acceptable or unacceptable as a
Section 612(c) of the Clean Air Act acceptable, we consider effectiveness
replacement for class I or II compounds:
directs EPA to publish a list of when determining whether alternatives
(i) Atmospheric effects and related
replacement substances (``substitutes'') that pose less risk are available in a
health and environmental impacts; [e.g.,
for class I and class II ozone depleting particular application within an end
ozone depletion potential]
substances based on whether the use. There are a wide variety of
(ii) General population risks from
Administrator determines they are safe acceptable alternatives listed for solvent
ambient exposure to compounds with
(when compared with other currently or cleaning, but not all are appropriate for
direct toxicity and to increased ground-
potentially available substitutes) for a specific application because of
level ozone;
specific uses or are to be prohibited for differences in soils, materials
(iii) Ecosystem risks [e.g.,
specific uses. EPA must compare the compatibility, degree of cleanliness
bioaccumulation, impacts on surface
risks to human health and the required, local environmental
and groundwater];
environment of a substitute to the risks requirements, and other factors. For
(iv) Occupational risks;
associated with other substitutes that example, aqueous cleaners are effective
(v) Consumer risks;
are currently or potentially available. In cleaners in many situations and are the
(vi) Flammability; and
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addition, EPA also considers whether substitute of choice for many in the
(vii) Cost and availability of the
the substitute for class I and class II metal cleaning end use. However, in
In this review, EPA considered all the ODSs ``reduces the overall risk to some specific precision cleaning
criteria above. However, n-propyl human health and the environment'' applications that require a high degree
bromide is used in industrial compared to the ODSs being replaced. of cleanliness and that have narrow

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spaces that may trap water used in cleanliness in precision cleaning. Of the developed to attain the National
rinsing, aqueous cleaners may not be available substitutes, aqueous cleaners Ambient Air Quality Standards for
appropriate and thus are not available in or solvents for vapor degreasing such as ground-level ozone, which is a
those specific applications. TCE, blends of alcohols or trans-1,2- respiratory irritant. Users located in
EPA evaluated each of the criteria dichloroethylene and HFCs or HFEs, ozone non-attainment areas may need to
separately and then considered overall and HCFC?25ca/cb are most likely to consider using a substitute for cleaning
risk to human health and the be used in the same applications as nPB. that is not a VOC or if they choose to
environment in comparison to other nPB is already commercially available use a substitute that is a VOC, they may
available or potentially available in solvent cleaning, and is used mostly need to control emissions in accordance
alternatives. We concluded that overall, for vapor degreasing in the electronics with the SIP. Companies have
while there are a number of alternatives and precision cleaning end uses (IBSA, petitioned EPA, requesting that we
that reduce the risks from ozone 2002). exempt nPB from regulation as a VOC.
depletion or from smog production 1 However, unless and until EPA issues a
B. Impacts on the Atmosphere and
slightly more than nPB when used in final rulemaking exempting a
Local Air Quality
industrial solvent cleaning equipment, compound from the definition of VOC
As discussed in the June 2003
we found no single alternative that and states change their SIPs to exclude
proposal, nPB emissions from the
could work in all applications that such a compound from regulation, that
continental United States are estimated
clearly would reduce overall risks to compound is still regulated as a VOC.
to have an ozone depletion potential
human health and the environment in Other acceptable ODS-substitute
(ODP) of approximately 0.013?.018,
metals cleaning, electronics cleaning, solvents that are VOCs for state air
(Wuebbles, 2002) 4, lower than that of
and precision cleaning. Balancing the quality planning purposes include most
the ozone depletion potential of the
different criteria discussed below, nPB oxygenated solvents such as alcohols,
substances that nPB would replace--
used in solvent cleaning end-uses does ketones, esters, and ethers;
CFC?13 (ODP=1.0), and methyl
not pose a significantly greater risk than hydrocarbons and terpenes;
chloroform and HCFC?41b (ODPs =
other substitutes or than the ODS it is trichloroethylene; trans-1,2-
0.12) (WMO, 2002). Some other
replacing in these end uses. Thus, we dichloroethylene; monochlorotoluenes;
acceptable alternatives for these ODSs
are listing nPB as acceptable in metals and benzotrifluoride. Some VOC-
also have low ODPs. For example,
cleaning, electronics cleaning, and exempt solvents that are acceptable ODS
HCFC?25ca/cb has an ODP of 0.02?br> precision cleaning. substitutes include HFC?45fa for
0.03 (WMO, 2002) and is acceptable in aerosol solvents; HCFC?25ca/cb, HFC?br> A. Availability of Alternatives to Ozone- metals cleaning and aerosol solvents, 365mfc and HFC?310mee for metals
Depleting Substances and acceptable subject to use conditions electronics, and precision cleaning and
Other alternatives to methyl in precision cleaning and electronics aerosol solvents; and methylene
chloroform and CFC?13 are available cleaning. HCFC?23 has an ODP of 0.02 chloride, perchloroethylene, HFE?100,
for metals, electronics, and precision (WMO, 2002), and is an acceptable HFE?200, PCBTF, acetone, and methyl
cleaning that have already been found substitute in precision cleaning. There acetate for metals, electronics, and
acceptable or acceptable subject to use are other acceptable cleaners that precision cleaning, aerosol solvents,
conditions under the SNAP program essentially have no ODP--aqueous adhesives, and coatings.
including: Aqueous cleaners, semi- cleaners, HFEs, HFC?310mee, HFC?br> C. Ecosystem and Other Environmental
365mfc, HFC?45fa, hydrocarbons,
aqueous cleaners, alcohols, ketones,
VMSs, methylene chloride, TCE,
esters, ethers, terpenes, HCFC?25ca/cb,
perchloroethylene, and PCBTF. EPA considered the possible impacts
hydrofluoroethers (HFEs),
The global warming potential (GWP) of nPB if it were to pollute soil or water
hydrofluorocarbon (HFC)?310mee,
index is a means of quantifying the as a waste and compared these impacts
HFC?65mfc, heptafluorocyclopentane,
potential integrated climate forcing of to screening criteria developed by the
hydrocarbons, volatile methyl siloxanes
various greenhouse gases relative to Endocrine Disruptor Screening and
(VMSs), trans-1,2-dichloroethylene,
carbon dioxide. Earlier data found a Testing Advisory Committee (EDSTAC,
methylene chloride, trichloroethylene 2
direct 100-year integrated GWP (100yr 1998) (see Table 3). Available data on
(TCE), perchloroethylene,3
GWP) for nPB of 0.31 (Atmospheric and the organic carbon partition coefficient
parachlorobenzotrifluoride (PCBTF),
Environmental Research, Inc., 1995). (Koc), the breakdown processes in water
and alternative technologies like
More recent analysis that considers both and hydrolysis half-life, and the
supercritical fluids, plasma cleaning,
the direct and the indirect GWP of nPB volatilization half-life indicate that nPB
and ultraviolet/ozone cleaning. Some
found a 100-yr GWP of 1.57 (ICF, 2003a; is less persistent in the environment
alternatives are unlikely to be used in
ICF, 2006a). In either case, the GWP for than many solvents and would be of low
particular end uses because of
nPB is comparable to or below that of to moderate concern for movement in
constraints such as cleaning
previously approved substitutes in these soil. Based on the LC50, the acute
performance, materials compatibility,
end uses. concentration at which 50% of tested
cost, workplace exposure requirements,
Use of nPB may be controlled as a animals die, nPB's toxicity to aquatic
or flammability. For example, no-clean
volatile organic compound (VOC) under life is moderate, being less than that for
technology is used in electronics
state implementation plans (SIPs) some acceptable cleaners (for example,
cleaning and not in precision cleaning
trichloroethylene, hexane, d-limonene,
because of the need for a high degree of 4 nPB emissions in the tropics have an ODP of
and possibly some aqueous cleaners)
0.071 to 0.100; the portions of the U.S. outside the
and greater than that for some others
1 Smog, also known as ground-level ozone, is continental U.S., such as Alaska, Hawaii, Guam,
(methylene chloride, acetone, isopropyl
produced from emissions of volatile organic
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and the U.S. Virgin Islands, contain less than 1
compounds that react under certain conditions of alcohol, and some other aqueous
percent of the U.S.'s businesses in industries that
temperature and light. could use nPB. Thus, their potential impact on the cleaners). The LC50 for nPB is 67 mg/l,
2 Also called trichlorethene or TCE, C Cl H, CAS
ozone layer must be significantly less than that of
2 3
which is greater than 10 mg/l. Based on
Reg. No. 79?1?. the already low impact from nPB emissions in the
EPA's criteria for listing under the
3 Also called PERC, tetrachloroethylene, or continental U.S. (U.S. Economic Census, 2002a
Toxics Release Inventory (U.S. EPA,
tetrachloroethene, C2Cl4, CAS Reg. No. 172?8?. through f).

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1992), we believe that nPB would not be bioaccumulation. Table 3 summarizes a solvent used for metals, electronics,
sufficiently toxic to aquatic life to information on environmental impacts and precision cleaning; and methyl
warrant listing under the Toxics Release of nPB; trans-1,2-dichloroethylene, a chloroform, an ODS that nPB would
Inventory. Based on its relatively low commonly-used solvent in blends for replace.
bioconcentration factor and log Kow aerosol solvents, precision cleaning, and
value, nPB is not prone to electronics cleaning; trichloroethylene,

Value for trans- Value for trichloro- Value for methyl
Property Description of environmental property Value for nPB 1,2-dichloro-ethyl- ethylene chloroform

Koc, organic-carbon Degree to which a substance tends to 330 (Source: ICF, 32 to 49 (Source: 106 to 460 152 (Source: U.S.
partition coeffi- stick to soil or move in soil. Lower 2004a). ATSDR, 1996). (Source: EPA, 1994a).
cient. values (< 300)* indicate great soil ATSDR, 1997).
mobility; values of 300 to 500 indi-
cate moderate mobility in soil.
Break down in Mechanism and speed with which a Hydrolysis is sig- Photolytic decom- Volatilization and Volatilization most
water. compound breaks down in the envi- nificant. Hydrol- position, biodegradation significant; bio-
ronment. (Hydrolysis half-life values ysis half-life of dechlorination most significant, degradation and
> 25 weeks* are of concern.) 26 days and biodegrada- with hydrolysis hydrolysis also
(Source: ICF, tion are signifi- relatively insig- occur (Source:
2004a). cant; hydrolysis nificant. Hydrol- ATSDR, 2004).
not significant ysis half-life of
(Source: 10.7 to 30
ATSDR, 1996). months (Source:
ATSDR, 1997).
Volatilization half- Tendency to volatilize and pass from 3.4 hours-4.4 days 3 to 6.2 hours 3.4 hours to 18 Hours to weeks
life from surface water into the air. (Source: ICF, (Source: days (Source: (Source: U.S.
waters. 2004a). ATSDR, 1996). ATSDR, 1997). EPA, 1994a).
LC50 (96 hours) for Concentration at which 50% of ani- 67 mg/L (Source: 108 mg/L (Source: 40.7 to 66.8 mg/L 52.8 to 105 mg/L
fathead minnows. mals die from toxicity after expo- Geiger, 1988). U.S. EPA, 1980). (Source: NPS, (Source: U.S.
sure for 4 days. 1997). EPA, 1994a).
?.48 (Source:
log Kow .................. Logarithm of the octanol/water parti- 2.10 (Source: ICF, 2.38 (Source: 2.50 (Source:
tion coefficient, a measure of tend- 2004a). LaGrega et al., LaGrega et al., LaGrega et al.,
ency to accumulate in fat. Log Kow 2001, p. 1119). 2001, p. 1127). 2001, p. 1127).
values >3* indicate high tendency
to accumulate.
Bioconcentration High factors (>1000)* indicate strong 23 (Source: 5 to 23 (Source: 10 to 100 (Source: <9 (Source: U.S.
factor. tendency for fish to absorb the HSDB, 2004). ATSDR, 1996). ATSDR, 1997). EPA, 1994a).
chemical from water into body tis-
*Criteria from EDSTAC, 1998.

nPB is not currently regulated as a D93 Pensky-Martens closed cup lower flammability limits, it could catch
methods (BSOC, 2000; Miller, 2003;
hazardous air pollutant and is not listed fire in presence of a flame. Such a
Morford, 2003a, b and c; Shubkin, 2003;
as a hazardous waste under the situation is unusual, but users should
Weiss Cohen, 2003). We agree with the
Resource Conservation and Recovery take appropriate precautions in cases
commenters that by these standard test
Act (RCRA). nPB is not required to be where the concentration of vapor could
methods, nPB displayed no flash point.
reported as part of the Toxic Release fall between the flammability limits.
Thus under standard test conditions,
Inventory under Title III of the
E. Impact on Human Health
nPB is not flammable, and it should not
Superfund Amendments and
In evaluating potential human health
be flammable under normal use
Reauthorization Act. Despite this, large
impacts of nPB, EPA considered
conditions. With its low potential for
amounts of nPB might be harmful if
impacts on both exposed workers and
flammability, nPB is comparable to
disposed of in water. We recommend
on the general population because we
chlorinated solvents, HCFCs, HFEs,
that users dispose of nPB as they would
identified these groups of people as the
HFC?45fa, HFC?310mee, and
dispose of any spent halogenated
ones likely to be exposed to nPB when
aqueous cleaners, and is less flammable
solvent (F001 waste under RCRA). Users
than many acceptable substitutes, such it is used as a substitute for ozone-
should not dump nPB into water, and
as ketones, alcohols, terpenes, and depleting substances. EPA evaluated the
should dispose of it by incineration.
hydrocarbons. nPB exhibits lower and available toxicity data using EPA
D. Flammability and Fire Safety upper flammability limits of guidelines to develop health-based
A number of commenters on the June approximately 3% to 8% (BSOC, 2000). criteria to characterize human health
2003 proposal provided additional A number of other solvents that are risks (U.S. EPA, 1994b. RfC Guidelines;
information on the flammability of nPB typically considered to be non- U.S. EPA, 1991. Guidelines for
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using standard test methods for flammable also have flammability limits Developmental Toxicity Risk
determining flash point, such as the (for example, methylene chloride, Assessment; U.S. EPA, 1995b.
American Society for Testing and HCFC?41b, and methyl chloroform). If Benchmark Dose guidelines; U.S. EPA,
Materials (ASTM) D 92 open cup, the concentration of vapor of such a 1996. Guidelines for Reproductive
ASTM D56 Tag closed cup, and ASTM solvent falls between the upper and Toxicity Risk Assessment).

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30148 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

AEL. These documents assigned
In the June 2003 NPRM, EPA al., 2002, NTP, 2003; Sohn et al. 2002,
uncertainty factors in a manner
proposed that an exposure limit of 25 Wang et al., 2003).
?Case reports of nPB exposure in the inconsistent with EPA's guidance. This
ppm would be protective of a range of
would result in a higher AEL than we
effects observed in animal and human workplace indicate that severe, possibly
would determine following the
studies, including reproductive and irreversible, neurological effects may
approach EPA has used on other
developmental toxicity, neurotoxicity, occur at sustained concentrations of
chemicals, as well as an AEL that in our
and hepatotoxicity. Reduction of sperm approximately 100 ppm or greater (Beck
view would not sufficiently protect
motility in rats, noted across multiple and Caravati, 2003; Majersik et al., 2004;
human health from nPB's effects
studies at relatively low exposures, was Majersik et al., 2005; Ichihara et al.,
because of multiple sources of
determined to be the most sensitive 2002; Miller, 2005; Raymond and Ford,
uncertainty in available data (i.e.,
effect. The Agency derived an exposure 2005). In other cases, similar or higher
variability within the working
limit of 18 ppm from a dose response concentrations up to 170 ppm caused
population and differences between
relationship in male rat offspring (``F1 less severe nervous system effects
animals and humans in how nPB affects
generation'') whose parents were (Nemhauser, 2005; NIOSH, 2003a;
the reproductive system).
exposed to nPB from prior to mating Ichihara, 2004a). Some neurological
?TERA (2004) reviews other AEL
through birth and weaning of the litters effects occurred in workers at levels of
derivations for nPB, performs a
(WIL Research Laboratories, 2001). We less than 50 ppm (Ichihara et al., 2004b).
benchmark dose (BMD) analysis, and
then proposed to adjust this value Because of design and methodological
recommends an AEL of 20 ppm based
upwards to 25 ppm based on principles limitations, such as small numbers of
on live litter size. This document is
of risk management consistent with one subjects and limited exposure
consistent with EPA guidance for BMD
of the original ``Guiding Principles'' of information, these studies do not
modeling and for assigning uncertainty
the SNAP program (59 FR 13046, March provide a sufficient quantitative basis to
factors. A review of this document is
18, 1994). As we discussed in the June derive an acceptable exposure limit.
available in the public docket (ICF,
?Data on female rats indicate that
2003 NPRM, EPA noted that adhesives
users should be able to achieve an AEL nPB affects the maturation of ovarian
?ICF (2004c, 2006b) derived an AEL
of 25 ppm and that 25 ppm was between follicles and the ovarian cycle (Yamada
for nPB based upon female reproductive
the level based on the most sensitive et al., 2003), consistent with previously
effects. ICF (2004c, 2006b) discussed the
endpoint (sperm motility in the F1 reviewed data (WIL, 2001; Sekiguchi et
relevant literature (Ichihara et al., 1999,
offspring generation) and the second al., 2002).
2002, 2004a, 2004b; Sekiguchi, 2002;
?Some data on occupation exposure
most sensitive endpoint (sperm motility
Yamada et al., 2003; WIL, 2001) and
in the F0 parental generation). suggest that workers exposed to nPB
calculated mean estrous cycle length
Following SNAP program principles, we may have experienced menstrual
and the mean number of estrous cycles
noted that ``a slight adjustment of the disorders (Ichihara et al., 2002; Ichihara
occurring during a three-week period at
AEL may be warranted after applying et al., 2004b). However, the data are not
different exposure levels in the WIL,
judgment based on the available data statistically significant and are not
2001 2-generation study. ICF (2004c,
and after considering alternative sufficient to conclude that nPB exposure
2006a) found statistically significant
derivations'' (69 FR 33295). We stated caused these female reproductive
reductions in the number of estrous
further that ``18 ppm is a reasonable but effects.
cycles in a three-week period, both
?Data on DNA damage in workers
possibly conservative starting point, and
including and excluding females that
that exposure to 25 ppm would not pose exposed to nPB was not statistically
had stopped their estrous cycles, at 250,
substantially greater risks, while still significant (Toraason et al., 2006). 500, and 750 ppm in the F0 parental
?Metabolic data on mice and rats
falling below an upper bound on the generation and at 500 and 750 ppm in
occupation[al] exposure limit.'' indicate some species differences. the F1 generation. ICF (2004c, 2006a)
Metabolism of nPB appears to be
As part of this final rulemaking, the conducted BMD modeling and
primarily through cytochrome P450
Agency has reviewed both information calculated benchmark dose lowerbound
enzymes, particularly in mice;
available at the time of the 2003 NPRM (BMDL) values of the number of estrous
glutathione conjugation also plays a
related to the health risks associated cycles in a three-week period that varied
role, and a bigger role for rats than for
with nPB use, as well as more recent from 102 to 208 ppm, depending upon
mice (RTI, 2005).
case studies of nPB exposures and the model used and the benchmark
effects in the workplace, newly These more recent studies do not cause criteria selected. All data were
published toxicological studies, us to change our acceptability calculated based on the mean
comments to the NPRM, new risk determination for solvent cleaning. reductions in estrous cycle number
assessments on nPB, and a new In addition, we considered new calculated from the WIL, 2001 study.
threshold limit value (TLV) issued by evaluations of the toxicity of nPB from Values were calculated for the F0
the American Council of Government Stelljes and Wood (2004), Toxicological generation; the number of data for the
and Industrial Hygienists (ACGIH). The Excellence in Risk Assessment (TERA, F1 generation was too small for
new information is reviewed in greater 2004), ICF (2004a, 2006a), and the TLV statistical analysis. The BMDLs that ICF
detail in EPA's proposal specific to the documentation from the ACGIH calculated for the number of estrous
use of nPB in aerosol solvents, (ACGIH, 2005). cycles in a three-week period were 162
?Stelljes and Wood (2004) is similar
adhesives, and coatings. ppm and 208 ppm, depending on the
Some general conclusions we draw in its results to SLR International (2001), benchmark response criteria (10%
from the new studies include: a study by the same authors. EPA change in response vs. one standard
?New data from toxicological studies previously reviewed SLR International, deviation) and using a linear-
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on nervous system effects remain 2001 in developing the June 2003 heterogeneous model.
?The ACGIH issued a recommended
inconsistent and equivocal concerning NPRM. Both these studies concluded
the level at which nervous system with a recommended AEL of 156 ppm, TLV of 10 ppm (time-weighted average)
effects occur (Fueta et al., 2002; Fueta et based on male reproductive effects and for nPB (ACGIH, 2005). ACGIH
al., 2004; Honma et al., 2003; Ishidao et uncertainty factors of 1 in driving the summarized numerous studies showing

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different effects of nPB and identified from one litter in this study and the complete body of literature as
no observed effect levels (NOELs) of 200 calculated a BMDL greater than 300 several studies discussing neurotoxicity
ppm for hepatotoxicity (ClinTrials, ppm for this endpoint after removing and female reproductive effects were
1997b) and less than 100 ppm for those outlier data (CERHR, 2002a, omitted from the list of references. A
developmental toxicity, as evidenced by 2003a, and 2004a). TERA calculated a number of reviews of this document are
decreased fetal weight (Huntingdon Life BMDL similar to that of the CERHR available in the public docket (ICF,
Sciences, 2001). expert panel when analyzing the same 2004d; O'Malley, 2004). Despite some
The Occupational Safety and Health data set (TERA, 2004). Further, the flaws in its derivation, the TLV of 10
Administration (OSHA) has not reference list in the documentation on ppm is less than two-fold lower than the
developed a permissible exposure limit the TLV indicates that ACGIH did not low end of the range of acceptable
(PEL) for nPB that EPA could use to review and evaluate all the studies exposure levels based on the most
evaluate toxicity risks 5 from workplace available prior to the development of sensitive reproductive endpoints (see
exposure. In prior SNAP reviews, EPA the recommended exposure limit. For below). This small difference is well
has used ACGIH TLVs where available example, key supporting articles that within the uncertainty we see when
in assessing a chemical's risks and reported disruption of estrous cycles extrapolating a benchmark dose from an
determining its acceptability if OSHA (Yamada et al., 2003 and Sekiguchi et experimental study in rats to an
has not set a PEL. ACGIH is recognized al., 2002) were not discussed in the TLV occupational exposure limit in humans.
as an independent, scientifically documentation. Further, ACGIH did not We summarize the data for a number
knowledgeable organization with provide sufficient reasoning for the of end points found in these analyses in
expertise in issues of toxicity and selection of the chosen endpoint over Table 4 below. We examined these data
industrial hygiene. However, in this others (e.g., reproductive toxicity and/or to assess the acceptability of nPB use in
case, EPA believes that ACGIH's TLV for neurotoxicity). The lack of discussion of the metals, electronics, and precision
nPB of 10 ppm has significant applied uncertainty factors also cleaning end uses reviewed in this final
limitations as a reliable basis for an prevents a determination of how ACGIH rule. These data indicate that, once
acceptable exposure limit, especially arrived at a TLV of 10 ppm. In uncertainty factors are applied
given the availability of other, more summary, EPA is not basing its consistent with EPA guidelines, the
comprehensive analyses described in proposed acceptability determination lowest levels for acceptable exposures
this preamble. First, according to the for nPB on the ACGIH TLV because: (1) would be derived for reproductive
authors of the Huntingdon Life Sciences Other scientists evaluating the database effects.6 The data also indicate that a
study, the decrease in fetal weight was for nPB did not find the reduced pup level sufficient to protect against male
an artifact of sampling procedure that weight to be the most sensitive reproductive effects (e.g., reduced sperm
biased the data (test animals were only endpoint; (2) BMD analysis of the motility) would be in a range from 18
sacrificed at the end of the day rather reduced pup weight data (CERHR, to 30 ppm, in the range of 17 to 22 ppm
than at random). The Center for the 2002a; TERA, 2004) results in a higher to protect against female reproductive
Evaluation of Risks to Human BMDL (roughly 300 ppm) than those for effects (e.g., estrous cycle length), and at
Reproduction (CERHR) expert panel sperm effects and estrous cycle changes; approximately 20 ppm for effects related
excluded ``aberrantly low'' fetal weights and (3) ACGIH may not have reviewed to reproductive success (live litter size).

BMDLb concentra-
Endpoint a Study (ppm) tion

Liver Effects d

Liver vacuolation in males (F1 off- WIL, 2001 as analyzed in ICF, 2002 .............................................................. 110 116
spring generation).
Liver vacuolation in males (F0 parent WIL, 2001 as analyzed in ICF, 2002 .............................................................. 143 150
Liver vacuolation ................................ ClinTrials, 1997b as analyzed in ICF, 2002 and Stelljes & Wood, 2004 ....... 226 170

Reproductive Effects--Male

Sperm motility (F1 offspring genera- WIL, 2001 as analyzed in ICF, 2002 .............................................................. 169 177
WIL, 2001 as analyzed in Stelljes & Wood, 2004 .......................................... 156 164
Sperm motility (F0 parent generation) WIL, 2001 as analyzed in ICF, 2002 .............................................................. 282 296
WIL, 2001 as analyzed in Stelljes & Wood, 2004 .......................................... 263 276
Prostate weight (F0 parent genera- WIL, 2001 as analyzed in TERA, 2004 .......................................................... 190 200
Sperm count ....................................... Ichihara et al., 2000b as analyzed in Stelljes & Wood, 2004 ........................ 232 325
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5 Vendors of nPB-based products have 6 By EPA guidelines, we would apply an necessarily screen out an individual from being able
uncertainty factor of 10, or approximately 3, for
recommended a wide range of exposure limits, from to work, unlike for liver or nervous system effects.
differences between species for all health effects.
5 ppm to 100 ppm (Albemarle, 2003; Chemtura, Therefore, for reproductive and developmental
We would also apply an uncertainty factor of 10
2006; Docket A?001?7, item II璂?9; Enviro effects, we use a composite uncertainty factor of 10.
(3) for variability within the working population for
Tech International, 2006; Farr, 2003; Great Lakes See further discussion of uncertainty factors in
reproductive and developmental effects, because,
Chemical Company, 2001). section V.B.3 below.
among other reasons, these conditions would not

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BMDLb concentra-
Endpoint a Study (ppm) tion

Sperm deformities (F0 parent genera- WIL, 2001 as analyzed in Stelljes & Wood, 2004 .......................................... 296 311

Reproductive Effects--Female

Number of estrus cycles during a 3 WIL, 2001 as analyzed in ICF, 2006a ............................................................ 162 170
week period (F0 parent generation).
WIL, 2001 as analyzed in ICF, 2006a ............................................................ 208 218
Estrous cycle length (F1 offspring WIL, 2001 as analyzed in TERA, 2004 .......................................................... 400 420
generation) d.
Estrous cycle length (F0 parent gen- WIL, 2001 as analyzed in TERA, 2004 .......................................................... 210 220
eration) e.
No estrous cycle incidence (F1 off- WIL, 2001 as analyzed in TERA, 2004 .......................................................... 180 189
spring generation).
No estrous cycle incidence (F0 parent WIL, 2001 as analyzed in TERA, 2004 .......................................................... 480 504

Reproductive Effects--Reproductive Success

Decreased live litter size (F1 offspring WIL, 2001 as analyzed in TERA, 2004 .......................................................... 190 200
Decreased live litter size (F2 offspring WIL, 2001 as analyzed in TERA, 2004 .......................................................... 170 179
Pup weight gain, post-natal days 21 WIL, 2001 as analyzed in TERA, 2004 .......................................................... 180 189
to 28 (F1 offspring generation).

Developmental Effects

Fetal body weight ............................... WIL, 2001 as analyzed in TERA, 2004 .......................................................... 310 326
Fetal body weight ............................... WIL, 2001 as analyzed in CERHR, 2002a ..................................................... 305 320

Nervous System Effects

Hindlimb strength ............................... Ichihara et. al., 2000a as analyzed in Stelljes and Wood, 2004 ................... 214 300
a Unless explicitly stated, data are from a parental generation. Of the studies analyzed, only the WIL, 2001 study has multiple generations to
be analyzed.
b The benchmark response value represents a specified level of excess risk above a control response.
c When considering workplace exposures, the human equivalent concentration is the BMDL, adjusted to apply to a 40-hour work week in which
workers are exposed for 8 hours a day for five days per week. Animals in the WIL, 2001 study were exposed for 6 hours a day, 7 days a week.
Animals in the Ichihara, 2000a and 2000b studies were exposed for 8 hours a day, 7 days a week. Animals in the ClinTrials, 1997b study were
exposed for 6 hours a day, 5 days a week.
d After applying an uncertainty factor of 3 for animal to human extrapolation, acceptable levels of exposure to protect against liver effects would
be in the range of 39 to 57 ppm.
e Omits data from those animals that have stopped estrous cycling altogether (TERA, 2004).

These more recent evaluations do not Based on review of the previously 1. Workplace Risks
available information and information
change EPA's acceptability
EPA believes that the great majority of
submitted in comments to the NPRM,
determination for solvent cleaning. As
users of nPB in metals cleaning,
the Agency believes that its derivation
discussed below, users of solvent
electronics cleaning, and precision
of 18 ppm as a starting point in the
cleaning equipment are reliably able to
cleaning have been able to attain
development of a recommended
achieve exposure levels well below our
exposure levels of well below 25 ppm,
acceptable exposure level is still valid.
proposed AEL of 25 ppm in the June
the proposed AEL in the 2003 NPRM,
For purposes of assessing the
2003 NPRM and therefore we expect
with their existing equipment. Recently
acceptability of nPB use in solvent
nPB users in the metals, electronics, and
measured exposure levels for nPB are
cleaning applications, the Agency
precision cleaning end uses to be able much lower than historic exposure data
evaluated whether exposure levels
to achieve acceptable exposure levels. from the 1970s and 1980s for metals
expected to result from solvent cleaning
Concentrations of nPB emitted from cleaning and electronics cleaning (ICF,
would approach either the 2003
industrial solvent cleaning equipment 2006a); this reflects both improvements
proposed recommended AEL of 25 ppm,
were found to be below 25 ppm in in industrial hygiene practices and
or the more conservative starting point
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roughly 88% of 500 samples on an 8-hr improvements in cleaning equipment
of 18 ppm which was derived from the
time-weighted average, below 18 ppm in since 1994 spurred by the National
Agency's original risk analysis. We also
81% of these samples, and below 10 Emission Standard for Hazardous Air
evaluated any potential risks to the
ppm in roughly 70% of these samples Pollutants for Halogenated Solvent
general population associated with nPB
(U.S. EPA, 2003). use as a solvent. Cleaning (59 FR 61801). Concentrations

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of nPB emitted from industrial solvent adhesives would have exposures below uses. Another commenter stated that
cleaning equipment were found to be the community exposure guideline of nPB is dangerous to the ozone layer and
below 25 ppm in roughly 88% of 500 1 ppm (68 FR 33300?3301). The workers and urged EPA to find a safe
samples on an 8-hr time-weighted community exposure guideline was substitute.
Response: EPA believes nPB may be
average, below 18 ppm in 81% of these derived considering both sperm motility
found acceptable under the SNAP
samples, and below 10 ppm in roughly and liver effects in the WIL (2001) 2-
program only in those end uses where
70% of these samples (U.S. EPA, 2003). generation study using EPA's reference
One nPB supplier provided evidence it has been shown to be used safely, as
concentrations (RfC) guidelines (U.S.
that on the few occasions when nPB compared with other substitutes that are
EPA, 1994b). Since the general
concentrations from vapor degreasers currently or potentially available. We
population would not be exposed in
were higher than the company's find this to be the case for metals
excess of the community exposure
recommended AEL of 25 ppm, users cleaning, electronics cleaning, and
guideline from a highly emissive
were able to reduce exposure easily and precision cleaning.
application, the less emissive uses such
Comment: Several commenters agreed
inexpensively by changing work as metals, electronics, and precision
with EPA's proposed approval for nPB
practices, such as reducing drafts near cleaning would create insignificant
in metal cleaning, electronics cleaning,
the cleaning equipment (Kassem, 2003). exposures (well below 1 ppm). Thus, we
and precision cleaning end uses. One
The ability to meet the workplace believe that proper use of nPB in solvent
specifically reported that his company's
exposure limit depends on: (1) The cleaning would not pose measurable
industrial hygiene program for nPB-
features of the cleaning equipment used, risks to the general population.
based solvents in metal and electronics
such as the presence of secondary
V. How is EPA responding to comments cleaning has conducted extensive air
cooling coils; and (2) the work practices,
on the June 2003 NPRM? sampling, and that the majority of the
such as avoiding drafts near cleaning
In this section, EPA responds to samples have shown values well below
equipment and lifting cleaned pieces
comments on the major issues in the 25 ppm. This commenter also noted
out slowly from the cleaning equipment.
June 2003 NPRM. A complete response that, in those few workplaces where
Workplace controls could include, but
to comments is in docket EPA璈Q? higher levels were found, adoption of
are not limited to, the use of the
OAR?002?064. recommended workplace ventilation
following: Covers on cold-cleaning and
and handling practices produced
vapor degreasing equipment when not A. EPA's Acceptability Decision
acceptable subsequent sample values.
in use; devices to limit air movement
There was no consensus among Thus, this commenter believes that
over the degreaser; and/or a lip-vent
commenters about whether EPA should exposures can be controlled to
exhaust system to capture vapors and
find nPB acceptable, acceptable subject protective levels.
vent them out of the room. Training
to use conditions, or unacceptable in the One commenter expressed concerns
workers in industrial hygiene practices
various end uses listed in the proposal. over the approval of nPB as acceptable
and in the proper use of cold cleaning
Some commenters raised concerns for use in solvent cleaning, maintaining
and vapor degreasing equipment, as
about specific end uses, particularly that toxicity data is insufficient to be
well as warning workers of the
aerosols and adhesives. Others convincing that long-term effects will
symptoms that may occur from over-
supported finding nPB acceptable in not be a concern. Two other
exposure to nPB, will also help reduce
solvents cleaning and in adhesives. We commenters did not support EPA's
exposure. Therefore, we expect that
are not taking final action in this rule proposal to find nPB acceptable. One of
users of nPB in the solvent cleaning
with respect to nPB as a substitute in the commenters concurred with EPA
sector following typical industry
aerosols or adhesives. We will respond that exposures from manual wipe
practices and using typical equipment
to any comments regarding those end cleaning will not be acceptable and that
for vapor degreasing will continue to
uses at the time we take final action for nPB should not be used in such
meet acceptable exposure levels and to
aerosols and adhesives. operations. Another commenter
use nPB safely without regulatory
Comment: Several commenters opposed EPA's proposed acceptability
requirements. This is the approach the
supported EPA's proposed approval of determination for solvent cleaning,
SNAP program has taken with many
nPB under the SNAP program in various stating that use of nPB in applications
other solvents where users are readily
end uses. In contrast, two commenters such as electronics and metals cleaning,
able to meet workplace exposure limit
opposed EPA's proposed acceptability label removal, and spray cleaning is not
that will protect human health and there
determination in all end uses, including appropriate.
is no enforceable OSHA PEL (e.g., HFC?br> solvent cleaning, citing concerns about Response: EPA agrees with those
365mfc, HFC?45fa,
exposure and the toxicity of nPB. commenters who said nPB should be
heptafluorocyclopentane, ketones,
Another commenter stated that acceptable for use in metal cleaning,
alcohols, esters, hydrocarbons, etc.).
applications cited in the proposal (e.g., electronics cleaning, and precision
Based on the available exposure data
electronics and metals cleaning, label cleaning. By our definition of the
and current industry practices, EPA
removal and spray cleaning) are not solvent cleaning sector, such users are
believes that users of nPB as an
suitable for use of nPB. This commenter cleaning using industrial cleaning
industrial solvent for metals cleaning,
reasoned that if nPB provides unique equipment. For an organic solvent, this
electronics cleaning, and precision
performance characteristics, its uses means a vapor degreaser or an
cleaning are likely to be exposed to
should be limited to non-emissive and automated cold cleaning machine.
concentrations of nPB well below the
low-volume applications. A commenter Emissions from vapor degreasers can be
proposed AEL of 25 ppm from the 2003
from a company that markets nPB as a controlled both through improving
chemical intermediate but not as a equipment (increasing the freeboard,
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2. General Population Risks solvent, noted that his company adding cooling coils, or adding a lift that
In the 2003 NPRM, the Agency recognizes the health concerns raises cleaned pieces slowly) and
provided analyses demonstrating that associated with nPB, and thus his through improved work practices
people living in the immediate vicinity company continues to prohibit the sale (leaving the vicinity of the vapor
of a facility using nPB in spray of nPB to customers with dispersive degreaser when done with work, tipping

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work-pieces so they do not catch relevant. Other studies examining Others stated that sperm motility effects
neurological effects of nPB showed on the F1 generation are appropriate to
solvent, or lifting cleaned pieces out
those effects to be transient and consider (Risotto, 2003; Farr, 2003),
In solvent cleaning equipment, reversible at and above 200 ppm particularly because of the potential for
exposure data show that nPB can meet (Ichihara et al., 2000a). Exposures of 200 in utero effects and because of the
an exposure level well below 25 ppm, ppm and above for three weeks had no consistent presence of these
effect on memory, learning function, or reproductive effects in both generations
even at levels of 5 ppm or less, the
coordination of limbs (Honma, 2003); and at multiple levels.
majority of the time (U.S. EPA 2003;
Response: EPA is not finalizing a
the effect of spontaneous locomotor
ICF, 2006a). Concentrations of nPB
specific AEL for the purposes of this
activity seen in this study at 50 ppm
emitted from industrial solvent cleaning
final rule. EPA acknowledges that using
and above was not considered adverse
equipment were measure to be below 25
data from the F1 offspring generation
by the authors. In other studies,
ppm in roughly 88% of more than 500
may be conservative because the pups
neurological effects were absent after
samples, below 18 ppm in 81% of these
in the F1generation were exposed to
extended periods of exposure--after 28
samples, and at or below 5 ppm in 56%
nPB between weaning and sexual
days of exposure at concentrations >
of these samples (U.S. EPA, 2003). In
maturity (WIL, 2001). During
400 ppm (ClinTrials, 1997a) and after 90
cases where exposure levels are higher,
occupational exposure, this period of
days of exposure at concentrations up to
there are simple, cost-effective changes
exposure would not occur because
600 ppm (ClinTrials, 1997b). Thus,
that can be made to reduce emissions
children under age 16 are not allowed
although neurological effects have been
(Kassem, 2003). We agree that manual
to work in industrial settings. However,
associated with nPB exposure, the data
cleaning using nPB is inappropriate,
EPA believes that because of the
are currently insufficient to quantify
because of the difficulty of controlling
potential for in utero effects that would
and set an AEL based on this endpoint.
emissions, but manual cleaning is
only be seen in the offspring generation,
More recent data does not change EPA's
currently beyond the scope of the SNAP
looking only at the F0 parental
acceptability determination for solvent
Program. EPA plans to address spray
generation could underestimate the
cleaning using aerosols in a new
Comment: One commenter on the adverse health impacts of a chemical.
June 2003 NPRM requested that EPA Therefore, it was appropriate for us to
B. Toxicity evaluate a study by Yamada et al (2003), consider effects seen in both the F0
a study published just prior to the June parental generation and the F1 offspring
1. Health Endpoints
2003 NPRM. generation. Further, effects on sperm
Comment: A number of commenters Response: EPA reexamined Yamada et motility in the parental and offspring
on the June 2003 NPRM suggested that al., 2003 and re-evaluated the literature generations are seen at levels generally
EPA should consider neurotoxicity as (Ichihara et al., 1999, 2002, 2004a,b; consistent with multiple reproductive
the endpoint in deriving the AEL for Sekiguchi, 2002, Yamada et al., 2003; effects seen in both generations and
nPB (Linnell, 2003; Werner, 2003; WIL, 2001). Multiple benchmark both sexes exposed to nPB, such as
Rusch and Bernhard, 2003; Rusch, analyses found a statistically significant estrous cycle length, lack of estrous
2003). In particular, they requested that decrease in the number of estrous cycles cycling, the number of estrous cycles in
EPA consider the study conducted by and increase in estrous cycle length a given period of time, fertility indices,
Wang (2003) and epidemiological data associated with nPB exposure, and the number of live pup births
on neurotoxic effects of nPB. consistent with other reproductive (TERA, 2004; ICF, 2006a; SLR
Response: Recent data collected from endpoints, namely reductions in sperm International, 2001).
occupational settings indicate that motility, decreased live litter size, and We also note that different substances
severe, possibly irreversible, change in prostate weight (ICF, 2002a; have different toxicological effects and
neurological effects may occur at ICF, 2006a; Stelljes and Wood, 2004; those effects must be considered based
sustained concentrations of TERA, 2004). These more recent on the best scientific information and
approximately 100 ppm or greater (Beck evaluations, which could lead to an methodologies available. It is incorrect
and Caravati, 2003; Majersik, 2004; HEC of 170 ppm and an AEL of 17 ppm, to claim that such reviews, which focus
Majersik, 2005), with variability in do not change EPA's acceptability on the effects of different substances,
effects observed in different studies, determination for solvent cleaning, resulted in disparate treatment of nPB 7.
although in most cases exposures may since the evidence supports the ability
2. Adjustments to Acceptable Exposure
have been much higher. Other studies of users in this end use to consistently
Level Based on Risk Management
with human data are discussed above in meet such a level.
section IV.E. Because of design and Comment: Some commenters stated
methodological limitations, such as that data from the F1 generation is In the 2003 NPRM, EPA derived 18
small numbers of subjects and limited inappropriate for calculating ppm as the starting point for an
occupational exposure, citing
exposure information, none of the acceptable exposure level based on
statements from some toxicologists that
recent studies individually provides a reduced sperm motility in the offspring
use of effects on adult F1 generation
sufficient quantitative basis to derive an generation of animals exposed to nPB
animals is inappropriate. They also
AEL. (WIL, 2001). Following a SNAP program
In the study on rats by Wang et al. stated that EPA has not required this for principle that alternatives should be
(2003), measurements found a decrease other chemicals and that the resulting restricted only where it is ``clearly more
in enzymes in the spinal cord and brain value is more conservative than what is harmful to human health and the
at 200, 400, and 800 ppm, but the normal and appropriate for industrial
animals displayed no physical or toxicology (Morford, 2003d and e;
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7 We interpret the commenter's use of the term

behavioral changes. Because of the lack Ruckriegel, 2003). One commenter ``equal protection'' to mean that the commenter
beleives that EPA has performend a harsher review
of physical symptoms or behavioral claims that because EPA's review of nPB
of nPB than it has for other substitutes and not a
changes, EPA does not believe that the differed from EPA's review of other claim that EPA has violated the 14th Amendment
decrease in enzyme levels in the central SNAP alternatives, the process violates of the Constitution, which applies only to the states
nervous system are toxicologically equal protection (Morford, 2003d and e). and not the Federal Government.

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environment than other alternatives,'' uncertainty factors of up to 10 may be recommended with default dosimetric
we noted that ``a slight adjustment of applied to the ``human equivalent adjustments.'' (U.S. EPA, 1994b, p. 4?br> the AEL may be warranted after concentrations (which accounts for 73). By EPA RfC guidelines (US EPA,
applying judgment based on the worker exposure patterns of 8 hours per 1994b), no adjustment for differences in
available data and after considering day for 5 days a week), for each of the pharmacokinetics is necessary in this
alternative derivations''(69 FR 33294, following conditions: instance because the blood/air partition
(1) Data from animal studies are used
33295). The Agency proposed an coefficient 10 for nPB in the human (7.1)
to estimate effects on humans;
upward adjustment of the AEL to 25 is less than in the rat (11.7), indicating
(2) Data on healthy people or animals
ppm based on principles of risk that the delivered dose of nPB into the
are adjusted to account for variations in
management, and based, among other bloodstream in rats is slightly higher
sensitivity among members of the
things, on a determination that 25 ppm than in humans. EPA has seen no data
human population (inter-individual
was between the level based on the most to indicate that (1) the toxicity is not
sensitive endpoint (sperm motility in directly related to the inhaled parent
(3) Data from subchronic studies are
the F1 offspring generation) and the compound in the arterial blood, or that
used to provide estimates for chronic
second most sensitive endpoint (sperm (2) the critical metabolic pathways do
motility in the F0 parental generation). not scale across species, with respect to
(4) Studies that only provide a LOAEL
We stated further that ``18 ppm is a body weight, in the same way as the
rather than a NOAEL or BMD; or
reasonable but possibly conservative ventilation rate. Consistent with
(5) An incomplete database of toxicity
starting point, and that exposure to 25 Appendix J of EPA's RfC guidelines for
information exists for the chemical.
ppm would not pose substantially an inhaled compound that exerts its
Comment: Some commenters on the
greater risks, while still falling below an effects through the bloodstream, EPA
June 2003 NPRM stated that EPA should
upper bound on the occupation[al] applies an uncertainty factor of 1 for
use an uncertainty factor of 1 or 2 to
exposure limit.'' pharmacokinetics and an uncertainty
extrapolate from animals to humans
Comment: Commenters responded factor of 3 for differences between
(Weiss Cohen, 2003), while others
that: (1) The SNAP program does not animals and humans.
suggested uncertainty factors of 2 or 3
create a presumption in favor of Recent studies provide additional
for pharmacokinetics, or an overall
substances that are already available on data regarding metabolism of nPB in rats
uncertainty factor of 10 for rat to human
the market, especially where other and mice (RTI, 2005), but data on
extrapolation because of a lack of
alternatives exist (Linnell, 2003; human metabolism are still lacking. One
information on the metabolism and
Werner, 2003); (2) EPA's AEL derivation analysis of these metabolic data
mode of action of nPB and because the
of 18 ppm is not conservative enough suggested that mice are less sensitive to
rat is an insensitive model for effects on
(Werner, 2003; Risotto, 2003) and the effects of nPB than rats and
male reproduction in humans (Werner,
further adjustment upward further hypothesized that humans would also
2003; Rusch and Bernhardt, 2003).
reduces protection; (3) the data do not be less sensitive than rats (Stelljes,
Response: EPA believes that two
support adjusting the AEL upward 2005). This analysis makes numerous
uncertainty factors are appropriate for
(EPA璈Q璒AR?002?064?003); (4) assumptions about toxic nPB
this database to account for (1)
EPA should first use the same metabolites and metabolic activation
physiological differences between
methodology in establishing an AEL as pathways that have not been confirmed
humans and rats; and (2) variability
for other chemicals to ensure that the by experimental data. A review of this
within the working population. EPA RfC
program's guiding principle in analysis is available in the public docket
guidelines state that an uncertainty
comparing risks is not compromised (ICF, 2006c). Despite the difference in
factor of 10 may be used for potential
(Werner, 2003); and (5) EPA should metabolic pathways for nPB in mice and
differences between study animals and
reconsider whether industrial exposures rats (RTI, 2005), EPA finds no
humans. This factor of 10 consists in
consistently occur or can be controlled significant species-specific differences
turn of two uncertainty factors of 3--the
at 25 ppm (Werner, 2003). No in toxicity exist between rats and mice
first to account for differences in
commenters specifically supported at inhaled concentrations <500 ppm for
pharmacodynamics8 and the second to
adjusting the AEL upward. 13 weeks (NTP, 2003; ICF, 2006c).
account for differences in
Response: EPA is not finalizing a However, these metabolic and
pharmacokinetics9 between the study
specific AEL for the purposes of this subchronic inhalation studies
animal and humans. (The value of three
final rule. In a separate proposed conducted under the National
is the square root of 10 rounded to one
rulemaking for the aerosol, adhesive and Toxicology Program did not specifically
digit, with 10 representing an order of
coatings end uses, we will be providing examine for reproductive toxicity or
magnitude [EPA,1994a, pp. 1?, 4?3].
the public an opportunity to comment nPB metabolism in target organs that
In practice, EPA uses the square root of
on a range of exposure level values that control reproductive function. In
10 when there are two or four
are comparable to the levels discussed summary, there is little available data
uncertainty factors of 3, yielding a total
in the June 2003 proposal (69 FR 33295) about the metabolic activation or
uncertainty factor of 10 or 100, and we
that the Agency would consider to be reactive metabolites responsible for
use a value of 3 when multiplying by
acceptable. Because we have concluded reproductive toxicity in rodents.
other uncertainty factors.) In general,
that end users in the solvent sector are Similarly, for nPB, there is little
EPA's RfC guidelines state that for the
routinely able to meet even the lowest information available about differences
uncertainty factor extrapolating from
exposure level we considered and similarities between rodents and
animal to human data, ``Use of a 3 is
recommending (U.S. EPA, 2003), we do humans. Given this circumstance, EPA
not need to make a final determination assumes, in the absence of evidence to
as to the appropriate level for purposes 8 Pharmacodynamics refers to the biochemical
rwilkins on PROD1PC63 with RULES_2

the contrary, that nPB toxicity is
and physiological effects of chemicals in the body
of this rulemaking. directly related to the inhaled parent
and the mechanism of their actions.
3. Uncertainty Factors 9 Pharmacokinetics refers to the activity or fate of

chemicals in the body, including the processes of 10 The blood/air partition coefficient is the ratio
According to EPA risk assessment absorption, distribution, localization in tissues, of a chemical's concentration between blood and air
guidance for RfC (EPA 1994a), biotransformation, and excretion. when at equilibrium.

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30154 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

compound in the arterial blood and that factors in the past to protect sensitive default value for an uncertainty factor
the critical metabolic pathways scale subpopulations on other chemicals where there is indication that a value
across species in a manner similar to the reviewed under the SNAP program (e.g., less than an order of magnitude (10) but
ventilation rate (U.S. EPA, 1994b). trifluoroiodomethane at 60 FR 31092, 61 greater than one is appropriate, and
Therefore, the Agency applied an FR 25585 and IoGasTM Sterilant Blends where the available data are not
uncertainty factor of 1 to account for at 69 FR 58903). For deriving AELs from sufficiently quantified to select a
interspecies differences in health endpoints such as liver effects specific value.
pharmacokinetics. and neurotoxicity, the SNAP program
4. Other Analyses of nPB's Toxicity
Given the available data on the blood/ typically has assigned an uncertainty
Comment: One commenter stated that
air partition coefficient and EPA RfC factor of 1 for sensitive subpopulations
documents by Drs. Doull, Rozman,
guidance in the absence of other because we assume that individuals
Stelljes, Murray, Rodricks, and the KS
information, EPA is applying the same who are especially susceptible to these
Crump Group were not acknowledged
rationale used for other compounds effects will have greater difficulty
(Morford, 2003d,e, and f). Another
reviewed under EPA's SNAP program working than most people. However,
commenter requested that EPA take into
with a comparable amount of data there is no connection between the
account the scientific presentations
where an uncertainty factor of 1 for ability to reproduce and the ability to
presented by Drs. Doull, Rozman and
pharmacokinetics was applied. To work in the industrial sectors discussed
Stelljes and mentions a review by Dr.
account for uncertainty in in this rule. Thus, we find it appropriate
Rodricks (Weiss Cohen, 2003).
pharmacodynamics of nPB, EPA is to require an uncertainty factor greater
Response: EPA specifically mentioned
applying the default uncertainty factor than 1 for reproductive effects for
and responded to the occupational
of 3. This follows the procedures in variability within the working
exposure limit recommendations from
EPA's RfC guidelines for situations population.
Drs. Rozman, Doull, and Stelljes in the
where there are no data to compare Comment: Some commenters said that
preamble to the June 2003 NPRM at 68
pharmacodynamics in rats versus an uncertainty factor of 1 is appropriate
FR 33298?3299. In addition, EPA
humans (U.S. EPA, 1994b). Recently for variability within the working
included more detailed written
published data on humans and rodents population because sensitive
responses to these derivations and the
do not decrease the uncertainty subpopulations will not be present in
evaluation by Dr. Rodricks in the online
regarding the pharmacodynamics of the working population (Stelljes, 2003,
docket prior to proposal (EPA璈Q?br> nPB; therefore, modification of the Morford, 2003e). Other commenters
OAR?002?064?017, ?018, and
uncertainty factor of 3 for differences stated that there will be very little
?019). Here are abbreviated responses
between species was not justified. difference in variability between the
to the various documents cited by the
Comment: One commenter stated that worker population and the general
EPA did not cite any data that describes population and that it is unclear why
?Drs. Doull and Rozman's letter
the size, condition, or existence of a EPA selected an uncertainty factor of 3
dated August 24, 2001, stating that a
subpopulation of men especially instead of 10 (Werner, 2003).
two-generational reproductive study is
sensitive to the effects of nPB. In Commenters suggested uncertainty
not appropriate (Docket A?001?7,
addition, this commenter asserted that factors for variability in the working
item II璂?6)--Drs. Doull and Rozman
sensitive populations are not population of 1, 2, and 5 (Stelljes, 2003,
do not provide a rationale for their
traditionally considered when deriving Weiss Cohen, 2003, Werner, 2003).
statement. Their statement is in conflict
an OEL, and that EPA has never Response: EPA disagrees with the
with their AEL derivation, in which
mentioned a concern with sensitive commenters. EPA's RfC guidelines
they consider use of the F1 generation
subpopulations in previous SNAP recommend an uncertainty factor of 10
of the WIL Laboratories two-generation
reviews. Another commenter said that to account for intraspecies variability
study. As discussed above in section
there is no evidence to support the within the general population. However,
V.B.1, EPA believes that data from a
assertion that nPB exposure below a 100 in developing an AEL, EPA's focus is on
two-generation reproductive study are
ppm average will further reduce sperm worker exposure, which excludes some
appropriate in developing a guideline
count or that the removal of nPB particularly vulnerable populations,
for the workplace in order to assure that
exposure will improve sperm count. such as children, most adolescents, and
workers and their children are protected
Response: EPA disagrees with the the elderly. Thus, we believe that a full
from any adverse health effects of
comments. There are preexisting uncertainty factor of 10, as for the
workplace exposure, including exposure
reproductive conditions as well as general population, may be higher than
significant variability in fertility among in utero. We acknowledge that this
necessary to protect workers. Certain
otherwise healthy adults in the value may be more conservative than
individuals in the general population
workplace. Both male and female considering data only from the parental
but not in the working population that
reproduction have been shown to be generation.
might be particularly vulnerable would
?Drs. Doull and Rozman's critique of
adversely affected by aging, with effects include children and adolescents under
ICF's AEL derivation (II-D?1b)--Drs.
on the ovarian cycle and on sperm age 16 and individuals with immune
Doull and Rozman's primary stated
motility as major factors changing with deficiency disorders. However, because
reason for rejecting ICF Consulting's
increasing age for women and men, of variability in reproductive function
respectively (Dunson et al., 2002). evaluation is that it does not reflect their
due to factors present among workers,
Adding damage from other factors, such own AEL derivation. They reiterate that
such as aging, smoking, and sexually
as smoking or occupational exposure to they find neurotoxicity to be the
transmitted disease (Dunson et al.,
chemicals such as nPB, therefore, can appropriate basis for an AEL without
2002), and because there is no screening
potentially harm an individual's ability addressing the reasons that ICF's
of workers that would make workers
rwilkins on PROD1PC63 with RULES_2

to reproduce further (Dunson, et al. derivation provides for finding
more likely to have healthy
2002). EPA did not issue a proposal reproductive toxicity to be of greater
reproductive systems than non-workers
based on sperm count, so that comment of the same age, we believe than an concern than neurotoxicity. We disagree
is not relevant to this rule. In addition, uncertainty factor of 1 is not sufficiently with Doull and Rozman's conclusion
we note that EPA has used uncertainty protective. Under EPA guidelines, 3 is a that neurotoxicity is the more

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appropriate endpoint for several survey, selecting an endpoint of 190 EPA disagrees in part with Dr. Stelljes's
reasons: (1) The human data are ppm. However, the data in the final reasoning. Data from F0 animals may
insufficient to draw conclusions survey were not sufficient to detect any not be sufficiently protective because
because of a small number of subjects, dose-response with any statistical effects on the F0 animals will not reflect
limited exposure information, and lack significance (Custom Products HHE, II? effects of in utero exposure. However,
of statistical significance; (2) the animal A?9). Further, more recent studies on we agree that exposure during weaning
data on neurotoxicity are inconsistent human exposure to nPB have found is not reflective of workplace exposure,
and equivocal concerning the level at neurotoxic effects occurring at levels at and thus, data from F1 animals may be
which nervous system effects occur, and least as low as 86 ppm, and possibly conservative. EPA proposed 25 ppm
they indicate that neurotoxic effects lower than 60 ppm (Ichihara 2004a, instead of 18 ppm in part to take this
may be reversible; and (3) neurotoxicity Beck and Caravati 2003). These data conservatism into account.
?Dr. Stelljes's (SLR International's)
is a less sensitive endpoint than would indicate that an AEL of 60 to 90
AEL derivation (II璂?3)--EPA
reproductive effects. However, if we had ppm is not sufficiently protective
discussed this AEL derivation at length
used neurotoxicity as the endpoint for against neurotoxic effects. Drs. Rozman
in the preamble to the proposed rule at
an AEL, we would have reached the and Doull themselves now suggest that
68 FR 33298. We agreed with Dr.
same acceptability determination for an AEL of 25 ppm may be more
Stelljes's BMD modeling and his
solvent cleaning. appropriate for protecting against
The basis of EPA's June 2003 NPRM selection of reduced sperm motility in
neurotoxic effects (Rozman and Doull,
is different from either one of these the F1 offspring generation of the WIL
?Dr. Rodricks' AEL derivation and
documents because it uses a different Laboratories study as the most sensitive
endpoint from Doull and Rozman's comments on ICF's derivation (II璂? endpoint. However, we disagree with
derivation (2001) and an uncertainty 65)--EPA reviewed Rodricks (2002) in Dr. Stelljes's selection of uncertainty
factor of 3 instead of 2 to 3 for developing its June 2003 NPRM, factors. There is no information showing
variability within the working although the study was not explicitly that human sex cells are less sensitive
population (Doull and Rozman, 2001; mentioned in that preamble. Rodricks to nPB than rat sex cells, and there is
ICF, 2002a). According to EPA guidance (2002) suggests an AEL of 60 to 88 ppm considerable evidence that human
on establishing uncertainty factors, if a for nPB, based on male reproductive males have less reproductive capacity
uncertainty factor is between 1 and 10 effects. Dr. Rodricks says that the most than male rats (U.S. EPA, 1996).
and the data are not sufficient to sensitive endpoint that is relevant for Therefore, it is appropriate to add an
quantify the uncertainty between those occupational exposure is data from the uncertainty factor of at least 3 to
values, the default uncertainty factor to parent generation of the two-generation account for differences between rats and
be used is 3 (U.S. EPA, 1994b). reproductive study. Dr. Rodricks humans. Further, Stelljes dismisses the
?Drs. Rozman and Doull's derivation suggests that an uncertainty factor of use of an uncertainty factor for
of an AEL (II璂?3)--EPA discussed only 1 to 2 is necessary for animal to differences within the human
our evaluation of this document at human extrapolation because one population. Although we agree that
length in the preamble of the June 2003 should consider animals and workers of children and the elderly would not be
NPRM at 68 FR 33298. In particular, we average sensitivity; although such an present in the workplace as sensitive
disagree with Rozman and Doull's argument presumably could be made for subpopulations, there certainly is
selection of the most sensitive endpoint. any chemical used in the workplace, variability in the reproductive abilities
Rozman and Doull concluded that EPA has not seen other AEL derivations of different working-age people that
reproductive toxicity should not be that use this approach. Dr. Rodricks would have no impact on the
considered the most sensitive endpoint, appears to agree with ICF that an individual's ability to be hired or to
stating that a National Institute for uncertainty factor for variability in work; therefore, EPA expects there is
Occupational Safety and Health reproductive function in the human some variability in the susceptibility of
(NIOSH) evaluation found that no population is reasonable, although he working individuals to the effects of
human beings at a facility using nPB- suggests a factor of 2 instead of the reproductive toxicants. EPA believes
based adhesives experienced range of 2 to 3 in ICF's derivation. Dr. that male reproductive capacity is very
reproductive health effects from the Rodricks and colleagues previously susceptible to chemical insult (U.S.
nPB. However, the NIOSH study in fact recommended an AEL for nPB of less EPA, 1996).
?Dr. Murray's opinion on parent and
concluded that the survey questions than 10 ppm, and at that time suggested
would not be sufficient to determine if offspring generations (II璂?8)--Dr.
an uncertainty factor of 10 for variability
there were reproductive health effects, Murray says that because the offspring
in reproductive function in the human
which is significantly different from generation will not yet have developed
population (A?1?2, X瑽?3). We
saying that there was no health effect. sperm while in utero, it is more
discussed above the use of data from
The expert panel for the CERHR looked appropriate to use data from the parent
both the F0 and F1 generations and the
at the NIOSH report and a wide range generation of the two-generation study.
use of an uncertainty factor of 3 for
of human and animal studies on nPB; in However, Dr. Murray does not address
variability within the working
contrast to Rozman and Doull, the the possibility that nPB exposure during
?Dr. Stelljes's critique of ICF's AEL
expert panel concluded that there was pregnancy could influence the
derivation (II璂?1a)--Dr. Stelljes states
insufficient information on reproductive production of hormones that eventually
that ICF should have used data from the
effects of nPB on humans and that the would result in sperm production.
parent generation rather than from the
results of tests on animals were Further, Dr. Murray's response does not
offspring generation because ``data from
considered appropriate for evaluating address potential effects on ova, which
F1 animals is not directly applicable to
potential reproductive health effects on would be present while a fetus is still
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a workplace exposure setting because
humans. in its mother's womb.
?Report on uncertainty factors used
Further, EPA disagrees with the both parents would not be exposed to
specific AEL value of 60 to 90 ppm that nPB on a daily basis over the by ACGIH from K.S. Crump Group (IV?br> Rozman and Doull derived. They used reproductive cycle, and also have their D?6/OAR?002?064?047 and ?8)--
data on headaches from a draft NIOSH offspring exposed daily from weaning.'' This report concluded that EPA's

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approach to selecting uncertainty factors notation, and proposed that this was not 7. Iso-Propyl Bromide Limit
for use in risk assessment was more necessary (68 FR 33295). In the June 2003 proposed rule, we
transparent, with justification for each Comment: Several commenters on the proposed as a use condition that nPB
value selected, and was more consistent June 2003 proposal stated that a skin formulations contain no more than
than the values apparently used by the notation for nPB is appropriate, while 0.05% isopropyl bromide (iPB) 11 by
ACGIH in deriving TLVs. EPA agrees another commenter agreed with EPA's weight because of potential health
with these conclusions. proposal that no skin notation was effects associated with this isomer (68
Comment: A commenter states that necessary (Smith, 2003; HESIS, 2003; FR 33301?3302).
``an uncertainty factor of 10 is NOT Werner, 2003, Weiss Cohen, 2003). One Comment: Two commenters said that
`generally' used to derive occupational commenter said that EPA should require 0.05% iPB is an appropriate and
exposure limits and that in fact, manufacturers, distributors, and achievable limit. (Smith, 2003; Weiss
uncertainty factors of 3 or less or more marketers of nPB-containing products to Cohen, 2003). One of these commenters
commonly used,'' citing the K. S. Crump communicate such information on the stated that industry test studies showed
Group's report. Material Safety Data Sheets (MSDS) and that lower limits were neither
Response: In the case of the TLV that the product label. toxicologically justified nor economical.
ACGIH established for nPB, ACGIH Response: We agree with the Another commenter opposed the
appears to set an AEL that is a factor of commenter that said a skin notation is implementation of the proposed use
10 lower than the endpoint cited as not necessary. However, today's restriction, stating that it places an
lowest (100 ppm for effects on pup decision includes a recommendation for undue legal burden on end users, rather
weight) (ACGIH, 2005). Thus, ACGIH users to wear protective clothing and than the manufacturers of raw materials,
has used an approach for nPB consistent flexible laminate gloves when using nPB and would not benefit worker safety.
with the total uncertainty factor of 10 to address the concerns about dermal This commenter also stated that this is
assigned by EPA. exposure. the only instance that SNAP has
Rat studies indicate that dermal
5. Overall Stringency of the Acceptable regulated residual contaminants. This
exposure to nPB results in neither
Exposure Limit commenter also suggested that EPA
appreciable absorption through the skin defer to an AEL of 1 ppm for iPB
Comment: Some commenters
(RTI, 2005) nor systemic toxicity (Elf established by the government of Korea
supported the proposed AEL of 25 ppm,
Atochem, 1995). Unlike methyl chloride and the Japan Society for Occupational
stating that it was derived using
and dichlorvos, which are absorbed Health. Moreover, this commenter said
appropriate conservative and cautious
through the skin and could contribute to that the difference between the
scientific processes. Other commenters
systemic toxicity (ACGIH, 1991), EPA is acceptable iPB exposure determined by
said that the proposed AEL of 25 ppm
not including a skin notation for nPB in EPA and that determined by ASTM?br> was too high, citing uncertainties in the
the information provided to users D6368?0 is very small and, thus, EPA's
data, the inappropriateness of adjusting
associated with this rulemaking because proposed regulation does not add any
the AEL upward from 18 ppm, reports
of the relatively low level of absorption. value to existing standards. Finally, this
of health effects on humans, and a need
The ACGIH provides no skin notation in commenter noted that epidemiological
for higher uncertainty factors. Other
its TLV documentation for several data found no adverse effect on human
commenters said that the proposed AEL
solvents, including nPB (ACGIH, 2005), workers exposed to 110 ppm of iPB
of 25 ppm was too low, citing higher
methylene chloride, and (Ichihara, specific study not identified
AELs derived by Drs. Stelljes, Doull,
perchloroethylene, and there is no by the commenter). (Morford, 2003g and
Rozman, and Rodricks, NIOSH studies,
evidence that absorption through the h).
and a need for lower uncertainty factors.
skin is greater for nPB than for the other
Commenters suggested alternate AEL Response: We agree that industry has
halogenated compounds. The TLV
values ranging from 1 ppm to 156 ppm. achieved this contamination limit for
documentation for nPB states, ``There is
Response: In this final rule, EPA is several years without regulation. We
no basis for a skin notation because the
not recommending an acceptable also agree that the concentration of iPB
dermal LD50 of 1-BP was >2 g/kg.''
exposure limit. We have based our likely to be breathed in by workers
Further, including a statement giving
determination of acceptability by would be below 1 ppm even if workers
advice about how to reduce skin
comparing measured exposure levels were exposed to concentrations of nPB
exposure in the ``Further Information''
from workers using nPB in solvent at 100 ppm or more, provided that the
column of listings is likely to be more
cleaning to exposure levels discussed by iPB content meets the ASTM璂6368?0
informative to workers than a skin
EPA in the proposal (see section IV.E). standard for nPB used in vapor
At the levels discussed in the NRPM or degreasing. Further, even if iPB were
Given the possibility that some nPB
higher, we find nPB acceptable for present in nPB formulations in
can be absorbed through the skin in
solvent cleaning. After considering the concentrations as high as 1%, if
humans, and that the solvent can irritate
available scientific studies on toxicity, industry meets the AEL for nPB
the skin, EPA encourages users to wear
exposure data, and alternative proposed in 2003 of 25 ppm, or lower,
protective clothing and flexible laminate
derivations of the acceptable exposure exposures still would be at most 0.25
gloves when using nPB and encourages
limit, we find that the exposure levels ppm. This is below the level of 1 ppm
manufacturers, distributors, and
discussed in 2003 provide sufficient established by the Korean government
marketers of nPB-containing products to
protection for human health and are and by the Japan Society for
include such precautions in their
consistent with EPA's derivations of Occupational Health (Morford, 2003h).
MSDSs. EPA believes that our
AELs for other chemicals reviewed Therefore, we are not adopting a use
regulatory authority for the SNAP
under the SNAP program and EPA condition for iPB for the solvent
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program is over the substitution (use) of
guidance for risk assessment. cleaning end uses.
ozone-depleting substances, and thus,
6. Skin Absorption we do not believe we have sufficient 11 iPB is also referred to as 2-bromopropane, 2-
In the June 2003 NPRM, EPA authority to regulate the manufacturers, propyl bromide, or 2-BP. Its CAS registry number
discussed listing nPB with a skin distributors and marketers of nPB. is 75?6?.

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8. Short-Term Exposure Limit (STEL) larger if all emissions were to occur in Working Group for the consideration of
the Nineteenth Meeting of the Parties.
the equatorial region. (Morford, 2003f).
In the June 2003 NPRM, EPA
Response: EPA agrees that, based on (MOP 18, 2006)
recommended a short-term exposure
the current usage of nPB and its ODP in
limit of 75 ppm (three times the AEL). D. Other Environmental Impacts
the U.S., there is not a significant
Comment: One commenter noted that With respect to environmental effects
impact on the ozone layer.
there was no indication in the various other than ozone depletion potential, we
Comment: Comments on the June
applications as to how the exposures stated in the June 2003 NPRM that users
2003 NPRM expressed concern that
from those operations compared to the should observe existing Federal, state,
other countries, particularly those in
EPA recommendation for a STEL at 75 and local regulations such as those
equatorial regions, might assume that
ppm. This commenter asserted that the under the Resource Conservation and
nPB does not pose a danger to the
potential for exceeding the STEL in Recovery Act or those for compliance
stratospheric ozone layer if the U.S.
solvent cleaning applications appears with the National Ambient Air Quality
EPA's SNAP program finds nPB
high and should, therefore, be Standards (68 FR 33304).
acceptable (Linnell, 2003; Steminiski,
investigated by EPA. This commenter Comment: Commenters stated that,
also stated that, depending on the until the safety of nPB has been
Response: Because the ODP for nPB is
results of this investigation, EPA may demonstrated conclusively, more
higher when used in the tropics (see
choose to find nPB unacceptable in stringent controls are necessary to
footnote 3 above in section IV.2), we
metals cleaning or restrict its use to protect the public and the environment.
recognize the concerns raised by these
where ventilation is employed and/or In particular, these commenters said
commenters. However, EPA is
personal protective equipment is worn. that the potential for cross-media
regulating use in the U.S. and cannot
Response: EPA disagrees that it is impacts was not given adequate
dictate actions taken by other countries.
necessary to use a short-term exposure consideration in the proposed rule.
For example, other countries could
limit in determining the acceptability of They also stated that EPA did not
choose to continue to use nPB even if
nPB in solvent cleaning. Acute, short- address the potential for nPB to
EPA were to find it unacceptable in the
term exposures of nPB are not of bioaccumulate in the environment or its
U.S. We believe the more appropriate
significant health concern, so long as impact on sensitive species. One
forum to address this concern is through
long-term exposures are below the 8- commenter said that he thought it was
the Parties to the Montreal Protocol.
hour TWA limit (ERG, 2004). EPA appropriate to ensure that nPB be kept
At the most recent Meeting of the
provided the STEL recommendation in out of wastewater, and an independent
Parties to the Montreal Protocol, the
the June 2003 proposal to give guidance contractor also mentioned concerns
Parties made the following decision
to the user community, consistent with about water pollution. Another
with regard to n-propyl bromide, in
the following recommendation of the commenter said that nPB hydrolyzes
order to ``allow Parties to consider
American Conference of Governmental more quickly than the chlorinated
further steps regarding n-propyl
Industrial Hygienists (ACGIH): solvents, and so would have less impact
bromide, in the light of available
``Excursions in worker exposure levels on water quality. Currently, the
alternatives'' (Decision XVIII/11):
may exceed 3 times the [threshold limit representative's company recommends
1. To request the Scientific
value] TLV璗WA for no more than a that spent solvents be incinerated, and
Assessment Panel to update existing
total of 30 minutes during a workday'' offers free pickup and disposal of spent
information on the ozone depletion
(ACGIH 1999). We note that when the solvent to its customers.
potential of n-propyl bromide, including
Response: EPA agrees that it should
ACGIH developed a TLV for nPB, they ozone depleting potential depending on
not be standard practice to dispose of
said there were no data to support a the location of the emissions and the
spent nPB in water, and that nPB should
short-term exposure limit (ACGIH, season in the hemisphere at that
be kept out of wastewater to the extent
2005). location;
possible. This may be achieved by
2. To request the Technology and
C. Ozone Depletion Potential recycling or through incineration. These
Economic Assessment Panel to continue
We proposed that, since the ODP of also are good practices with other spent
its assessment of global emissions of n-
nPB in the continental U.S. is only halogenated solvents, whether or not
propyl bromide, * * * paying particular
0.013 to 0.018 relative to an ODP of 0.8 they are specifically listed as hazardous
attention to:
for CFC-113, 0.1 for methyl chloroform, wastes.
(a) Obtaining more complete data on
EPA's PBT (persistence/
and 0.1 for HCFC-141b, nPB should not production and uses of n-propyl
bioaccumulation/toxicity) profiler tool
be found unacceptable because of its bromide as well as emissions of n-
suggested that, based on its structure,
ODP (68 FR 33303). The Agency propyl bromide from those sources;
nPB would not be considered persistent
recognized that nPB's ODP could be (b) Providing further information on
in water or soil and that nPB would
much higher in tropical regions, as high the technological and economical
have a low tendency to bioaccumulate
as 0.071 to 0.100, but since EPA is availability of alternatives for the
(8.3, where 1000 is considered
regulating nPB used in the U.S., we different use categories of n-propyl
bioaccumulative and greater than 5000
made our decision based on the ODP in bromide and information on the toxicity
is considered very bioaccumulative).
the continental U.S. of and regulations on the substitutes for
Comment: One commenter on the Further, the calculated bioconcentration
n-propyl bromide;
June 2003 NPRM provided information factor for nPB is only in the range of 18
(c) Presenting information on the
(Wuebbles, 2002) and stated that ``even to 23 (HSDB, 2004; ICF, 2004a). Under
ozone depletion potential of the
if the entire amount of nPB produced in EPA's criteria for listing chemicals on
substances for which n-propyl bromide
2002 was emitted across North the Toxics Release Inventory, this
is used as a replacement;
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American, European and Asian 3. To request that the Technology and would not be a level of concern (ICF
latitudes, the resulting effects on ozone Economic Assessment Panel prepare a 2004a, EPA 1992). Therefore, we
depletion would be too small to report on the assessment referred to in conclude further testing for
measure.'' The same commenter said paragraph 1 in time for the twenty- bioaccumulation of this chemical is not
that the effects on ozone would only be seventh meeting of the Open-ended needed before rendering a decision for

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use of nPB in the solvent cleaning Pensky-Martens closed cup. Based on risks associated with other substitutes
sector. these data, we find that nPB is not that are currently or potentially
Currently, the estimated amount of flammable under standard test available.
nPB used in the U.S. in SNAP sectors conditions. EPA concludes that nPB Our long-standing interpretation is
is on the order of 10 to 12 million should not be considered unacceptable that worker safety is a factor we
pounds per year, which corresponds to on the basis of flammability risks. consider in determining whether a
roughly 1% of the organic solvent substitute poses significantly greater
F. Legal Authority to Set Exposure
cleaning market, a relatively small risk than other available substitutes. In
amount. It is unlikely that very large the original SNAP rule, we promulgated
Comment: Two commenters stated
amounts of nPB will enter and remain the criteria we would review for
that EPA has no jurisdiction to develop
in the nation's water supply, because: purposes of determining whether a
?nPB tends to evaporate quickly, any AEL designed to be applicable to a substitute posed more risk than other
workplace environment, and that this
with a calculated half-life of 3.4 hours available substitutes. Specifically, 40
right belongs to OSHA.
in a river or 4.4 days in a lake due to CFR 82.178(a) specifies the information
Response: As an initial matter, EPA
volatilization. we require as part of a SNAP
?nPB hydrolyzes readily, with a notes that it has not established an AEL
application and 40 CFR 82.180(a)(7)
applicable to the workplace in this rule.
measured hydrolysis half-life of 26 days
identifies the criteria for review.
Rather, EPA reviewed the available
at 25?C and pH 7.
Notably, we require submitters to
?If released to the atmosphere, nPB information to determine what a safe
provide information regarding the
will exist solely in the vapor phase workplace exposure might be in order to
exposure data (40 CFR 82.178(a)(10))
based on its vapor pressure of 110.8 mm determine whether use of nPB in the
and we identify ``occupational risks'' as
Hg. Thus, it is unlikely to be solvent cleaning sector poses
one of the criteria for review (40 CFR
redeposited in rainwater in significant substantially more risk than use of other
82.180(a)(7)(iv)). In the preamble of the
amounts. (PBT Profiler, 2007; ICF, available substitutes. The analysis
original SNAP rule, we said that we
2004a) performed by EPA imposes no binding
would use any available OSHA PELs,
obligation on anyone, particularly in
Further, because nPB is short-lived
EPA inhalation reference
this case where EPA determined that
compared to ODS and many ODS
concentrations, or EPA cancer slope
nPB is acceptable for use in the solvent
substitutes, it is unlikely that nPB will
factor data for a substitute together with
cleaning sector.
create a substantially greater impact
exposure data to explore possible
Although the Occupational Safety and
than other acceptable cleaning solvents
concerns with toxicity (March 18, 1994;
Health Act (OSH Act) gives the
and than the ODS it replaces. EPA is
59 FR 13066). We have reviewed
Occupational Safety and Health
required by the Clean Air Act to
substitutes based on existing OSHA
Administration (OSHA) authority to
consider whether a replacement for an
PELs, where available, and, where not
issue a rule setting or revising an
ODS is more harmful, overall, to human
available, based on our own assessment
occupational safety or health standard
health and the environment than other
of what level is safe for workers. (See
(29 U.S.C. 655(b)), it does not prohibit
available or potentially available
e.g., March 18, 1994, 59 FR 13044; Sept.
other Federal agencies from reviewing
substitutes. The available information
5, 1996, 61 FR 47012; June 8, 1999, 64
the safe level of exposure under other
shows that nPB will not be more
FR 30410; June 19, 2000, 65 FR 37900;
statutes that require consideration of the
hazardous than other available,
December 18, 2000, 65 FR 78977; March
human health and environmental effects
acceptable solvents if it pollutes water
22, 2002, 67 FR 13272; August 21, 2003,
of a substance. Conversely, although
or soil.
68 FR 50533). In making our own
section 4(b)(1) of the OSH Act prohibits
E. Flammability assessment, we review any existing
OSHA from regulating a working
recommended exposure guidelines and
condition addressed by another federal
In the June 2003 NPRM, we proposed
available scientific studies and use
agency's regulations affecting
that nPB should not be restricted or
EPA's risk assessment guidelines (e.g.,
occupational safety or health, this
found unacceptable because of
U.S. EPA, 1994b).
provision is overridden with respect to
flammability (68 FR 33303). EPA
In the case of EPA's evaluation of
EPA's exercise of authority under the
specifically requested data concerning
nPB, there is no final OSHA PEL for
Clean Air Act by 42 U.S.C. 7610. That
the flashpoint of pure nPB, including
EPA to use in evaluating workplace
provision states: ``(a) Except as provided
the test method used to provide the
exposure risks. There is a wide
in subsection (b) of this section, this
variability in the workplace exposure
Comment: Several manufacturers of chapter shall not be construed as
guidelines recommended by
nPB and nPB-based solvents and an superseding or limiting the authorities
manufacturers of nPB-based products,
independent contractor stated that nPB and responsibilities, under any other
ranging from 5 ppm to 100 ppm, thus
has no flash point under a number of provision of law, of the Administrator or
providing no definitive value for
accepted consensus standards for flash any other Federal officer, department, or
evaluating the human health risks of
point. In support of these statements, agency.''
Section 612 of the Clean Air Act workplace exposure. The ACGIH has
the manufacturers of nPB and nPB-
expressly recognizes that some recently established a TLV for nPB of 10
based solvents provided flash point test
substitutes for ODS may pose more risk ppm; however, as discussed above in
data from a number of different test
to human health and the environment section IV.E, EPA has concerns about
methods (ASTM D 92 open cup, ASTM
than others and expressly requires EPA the scientific basis for this TLV. As
D56 Tag closed cup, and ASTM D93
to prohibit use of substitutes that pose provided in the original SNAP rule, in
Pensky-Martens closed cup).
more risk than other substitutes that are the absence of a definitive workplace
Response: EPA agrees. The test results
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exposure limit set by OSHA, we
provided by the commenters indicates currently or potentially available. Thus,
evaluated the available information to
that nPB has no flash point using a in evaluating whether a substitute
establish our own health-based criteria
number of standard test methods, should be found acceptable, we must
including ASTM D 92 open cup, ASTM compare the risks to human health and for evaluating nPB's human health risks
to workers.
D56 Tag closed cup, and ASTM D93 the environment of that substitute to the

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Comment: A commenter said that Report, S璓rt 103?8 at 1337. The under the CAA only when the
legislative history cited by the complaint concerned substances
EPA's authority for the SNAP program
commenter is not pertinent. The emitted to the ambient air. Claims
is under section 615 of the Clean Air
legislative history for Part B of Title I of regarding air quality within the
Act and that the SNAP program only
the Act is not relevant because that workplace are brought under the
has authority to take action based on
section was repealed in 1990. Public whistleblower provisions of the OSH
effects on the stratosphere. Specifically,
Law 101?49, section 601. Nor is the Act.
the commenter claims section 615 of the
Response: The commenter overstates
legislative history for other statutes,
CAA limits EPA's authority under title
the import of the decisions issued by the
such as TSCA, relevant for determining
VI to regulating for purposes of
Administrative Review Board. In each of
what authority Congress granted to EPA
protecting the stratospheric ozone layer.
the cited decisions, the Board examined
under the CAA.
Citing section 618, the commenter also
The commenter incorrectly states that the specific circumstances before it to
contends that section 618 identified
sections 615 and 618 of the CAA place determine which statutory
SNAP requirements as ``requirements
limits on EPA's authority under section whistleblower provision provided the
for the control and abatement of air
612 of the Act. These provisions basis for the claimed action. While
pollution'' and cites the CAA and EPA
expand, rather than restrict, the making general pronouncements that
policy documents as identifying
Administrator's authority. Section 615 the CAA regulates ambient air and
ambient air as air external to buildings.
is a separate provision of the statute and OSHA regulates air within the
The commenter also notes that title VI
provides general authority for the workplace, none of these opinions
was intended to implement the
Administrator to regulate for purposes specifically addressed the scope of
Montreal Protocol and that it replaced
of addressing adverse effects to the EPA's authority under section 612, the
former Part B. The commenter cites
stratosphere. This provision does not SNAP provisions of the Act.
legislative history from the enactment of
Comment: A commenter stated that
explicitly or implicitly purport to limit
Part B that indicated EPA's authority
even if ventilation or other measures
the Administrator's authority under
under Part B was not intended to pre-
could reduce exposures to below 25
other provisions of the Act. Rather, it is
empt authority of other agencies to take
ppm, there is nothing to ensure that
a general provision authorizing the
action with respect to hazards in their
companies will take such measures.
Administrator to regulate for protecting
areas of jurisdiction and that EPA's
This commenter also stated that he is
against adverse effects to the
authority under Part B was only to fill
aware of nPB formulators that have
stratospheric ozone layer.
regulatory gaps and not to supersede
With respect to section 618, we first already announced they will not adhere
existing authority of other agencies.
note that the commenter appears to to this voluntary standard. Three
With respect to the legislative history of
equate the stratospheric ozone layer commenters, all representing local
the 1990 Amendments, the commenter
with ``ambient air.'' In fact, they are two environmental regulators, stated that a
argues that there is no suggestion that
different things. Ambient air is defined recommendation that worker exposure
``EPA has authority to set workplace
as ``that portion of the atmosphere, be limited to 25 ppm will not carry the
worker-exposure standards.'' The
external to buildings, to which the enforcement powers of an OSHA
commenter also cites legislative history
general public has access.'' 40 CFR standard, and that this lack of control
from the Toxic Substances Control Act
50.1(e). The stratospheric level generally will encourage the use of nPB in
in which Congress indicated EPA's
extends from 10 to 50 kilometers above applications beyond those envisioned
authority under that statute does not
the earth and is not considered air to by EPA. Another commenter asserted
extend to setting workplace standards.
which the public has access. [See that the proposed exposure limits (both
Response: While many provisions in]. the AEL and the STEL) should be
title VI address the regulation of The definition of ``air pollutant'' under established as use conditions, citing
substances that deplete the stratospheric the CAA is defined in terms of Section 612 as the basis for EPA's
ozone layer, section 612 which governs substances emitted to the ``ambient air.'' authority to do so. This commenter
the SNAP program is broader. The The purpose of section 618 is to make stated that a precedent has already been
purpose of Section 612 is to review clear that for purposes of sections 116 set for EPA to accept an alternative
substitutes for ODS and Section 612 of (retention of state authority) and 118 chemical subject to use conditions--
the Clean Air Act clearly requires EPA (control of pollution from federal including that observance of workplace
to consider both the environmental facilities), the provisions in Title VI concentration limits--in the adhesives,
effects as well as human health, which governing protection of the stratospheric aerosols, and solvent cleaning sectors
includes both the health of the general ozone layer shall be treated the same as (e.g., HCFC?25 ca/cb, HFC?310mee,
population and workers. EPA believes if they were for the purpose of monochlorotoluenes, benzotrifluorides;
there is no doubt that the statutory controlling and abating ``air pollution'' 40 CFR part 82, subpart G, appendices
language requires EPA to consider (i.e., pollution to the ambient air). A, B, and D).
effects beyond those on the Response: EPA agrees that a
Again, this is not for the purpose of
stratospheric ozone layer. In addition, recommended AEL from EPA does not
restricting the Administrator's authority
the legislative history makes clear that provide the same level of protection as
under any provision of the Act. Rather,
this language is to be interpreted an enforceable standard from OSHA. We
it is for the purpose of extending the
broadly. Specifically, the report of also agree that EPA has the authority
protections of Title VI to programs that
House Debate on the Clean Air Act under section 612 to require use
otherwise only address air pollution
Amendments provides ``the conditions in those circumstances
(i.e., ambient air, which does not
Administrator shall base risk estimates where use of a potentially promising
include the stratospheric ozone layer).
on the total environmental risk (toxicity, Comment: A commenter stated that substitute would otherwise be
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flammability, atmospheric, etc.) that is EPA's claim to authority conflicts with unacceptable unless those use
perceived to exist, not just the risk as it the Department of Labor's conditions are met and there are
relates to ozone depletion.'' House administrative ``whistleblower'' case significant concerns about the ability of
Debate on the Clean Air Act law. These cases hold that a industry to meet a safe level for use. In
Amendments of 1990 Conference whistleblower action may proceed the preamble to the original SNAP rule,

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VI. How can I use nPB as safely as
we recognized that there may be cases nPB will pose significantly greater risk
where OSHA has not regulated worker possible?
than other substitutes that are available
exposure to a substitute. We went on to in the same end use. The range of levels Below are actions that will help nPB
say that ``EPA anticipates applying use EPA used for its analysis is not binding. users minimize exposure levels:
conditions only in the rare instances Moreover, as explained above in section
All End Uses
where clear regulatory gaps exist, and V.B.2, EPA has concluded that for
where an unreasonable risk would exist ?All users of nPB should wear
purposes of finding nPB acceptable in
in the absence of any conditions.'' For the solvent cleaning end use, it is not appropriate personal protective
the solvent cleaning end use, we do not necessary to provide a non-binding equipment, including chemical goggles,
believe that there is an unreasonable flexible laminate protective gloves (e.g.,
recommended workplace exposure limit
risk in the absence of a use condition. Viton, Silvershield) and chemical-
because these users in the solvent
Available exposure data show that resistant clothing. Special care should
cleaning sector are regularly able to
roughly 88% of samples from nPB users be taken to avoid contact with the skin
comply with even the lowest level EPA
in solvent cleaning met an exposure since nPB, like many halogenated
considered in performing its evaluation.
level of 25 ppm, 81% met an exposure solvents, can be absorbed through the
For standards covering hazardous
level of 18 ppm, and 70% met an skin. Refer to OSHA's standard for the
chemicals in the workplace, the OSH
exposure level of 10 ppm (U.S. EPA, selection and use of Personal Protective
Act requires OSHA to set standards that,
2003). One nPB supplier provided Equipment, 29 CFR 1910.132.
to the extent feasible, ensure that
evidence that on the few occasions ?Limit worker exposure to solvents
when nPB concentrations from vapor workers do not suffer material to minimize any potential adverse
degreasers were higher than the impairments of health. Standards health effects. Workers should avoid
company's recommended AEL of 25 established by OSHA under their statute staying for long periods of time in areas
ppm, users were able to reduce have not typically prohibited the use of near where they have been using the
exposure easily and inexpensively by the chemical in any particular solvent. Where possible, shorten the
changing work practices, such as application, but instead establish period during each day when a worker
reducing drafts near the cleaning performance goals for the use and is exposed. Where respiratory protection
equipment (Kassem, 2003). Therefore, handling of hazardous chemicals that is necessary to limit worker exposures,
we expect that users of nPB in the reduce such risks to the extent feasible. respirators must be selected and used in
solvent cleaning sector following typical The available information on health accordance with OSHA's Respiratory
industry practices and using typical effects of nPB on workers is not Protection standard, 29 CFR 1910.134.
equipment for vapor degreasing will
?Use less solvent, or use a different
sufficiently well-characterized to
continue to use nPB at levels considered
develop a standard based on avoiding solvent, either alone or in a mixture
safe for workers. As noted above, this is
material impairments of health in with nPB.
the approach we indicated we would
?Follow all recommended safety
workers. Most manufacturers and
follow at the time of the original SNAP
precautions specified in the
organizations that set workplace
rule and we have taken this same
manufacturer's MSDS.
exposure limits such as ACGIH and the
approach for many other solvents where
?Workers should receive safety
American Industrial Hygiene
users are readily able to meet a
training and education that includes
Association use an approach similar to
workplace exposure limit that will
potential health effects of exposure to
EPA's and do not base exposure limits
protect human health and there is no
nPB, covering information included on
on avoiding material impairments of
enforceable OSHA PEL (e.g., HFC?br> the appropriate MSDSs, as required by
health in workers. Because of the need
365mfc and heptafluorocyclopentane at
OSHA's Hazard Communication
for large amounts of well-characterized
65 FR 78977, ketones, alcohols, esters,
Standard (29 CFR 1910.1200).
data from the workplace on exposures
and hydrocarbons at 59 FR 13044).
?Request a confidential consultation
Comment: One commenter claims that and associated health effects to prepare
from your State government on all
section 6 of the Occupational Safety and an AEL to prevent material impairment,
aspects of occupational safety and
Health Act requires OSHA to make if EPA were to develop AELs for nPB
health. You can contact the appropriate
certain legal findings before and other chemicals based on the
state agency that participates in OSHA's
promulgating a standard and that approach required by section 6 of the
consultation program. These contacts
therefore EPA has no authority to OSH Act, EPA would effectively be
are on OSHA's Web site at http://
develop any AEL applicable to a unable to assess the human health For
workplace environment. Furthermore, effects of ODS alternatives in time to
further information on OSHA's
since OSHA is the only agency that can assist industry in transitioning away confidential consultancy program, visit
make standards applicable in the from ODS. In order to provide for a OSHA's web page at http://
workplace, any level developed by EPA
more timely assessment of human
is misleading. The same commenter said
health effects, as well as one that is ?Use the employee exposure
that EPA offers no reasoning as to why
consistent with federal guidelines of the monitoring programs and product
a different methodology for setting an
National Academies of Science (NAS, stewardship programs where offered by
AEL (from that of OSHA) is necessary or
1983), we have considered exposure manufacturers and formulators of nPB-
advisable. Therefore, this commenter
levels following EPA guidance (U.S. based products.
believes that the Agency's process
?If the manufacturer or formulator of
EPA, 1994b). Different substances have
violates equal protection unless EPA is
different toxicological effects and those your nPB-based product does not have
publishing a new standard for chemical
effects must be considered based on the an exposure monitoring program, we
review under SNAP.
rwilkins on PROD1PC63 with RULES_2

best scientific information and recommend that you start your own
Response: In this rulemaking, EPA
methodologies available. It is incorrect exposure monitoring program, and/or
has not developed an AEL that is
to claim that such reviews, which focus request a confidential consultation from
applicable in any workplace. Rather,
on the effects of different substances, your State government. A medical
EPA looked at a range of possible AELs
resulted in disparate treatment of nPB. monitoring program should be
for purposes of determining whether

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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

established for the early detection and emissions controls (e.g., secondary Ave., NW., Washington, DC 20460 or by
cooling coils, automated lifts or hoists) calling (202) 566?672.
prevention of acute and chronic effects
Burden means the total time, effort, or
within a year of installation. Based on
of exposure to nPB. The workers'
financial resources expended by persons
evidence from solvent suppliers, EPA
physician(s) should be given
to generate, maintain, retain, or disclose
believes that some of those users would
information about the adverse health
or provide information to or for a
have chosen to use nPB in order to
effects of exposure to nPB and the
Federal agency. This includes the time
avoid meeting requirements of the
workers' potential for exposure.
?For non-aerosol solvent cleaning, needed to review instructions; develop,
national emission standard for
acquire, install, and utilize technology
halogenated solvents cleaning and that
follow guidelines in the National
and systems for the purposes of
they would only become aware of the
Emissions Standards for Hazardous Air
collecting, validating, and verifying
potential savings due to reduced solvent
Pollutant (NESHAP) for halogenated
information, processing and
usage as a result of this proposal
solvents cleaning if you are using nPB.
maintaining information, and disclosing
(Ultronix, 2001; Kassem, 2003;
The equipment and procedural changes
and providing information; adjust the
Tattersall, 2004). Based on available
described in the halogenated solvents
existing ways to comply with any
exposure data for each sector, we
NESHAP can reduce emissions, reduce
previously applicable instructions and
assumed that 81% of nPB users in the
solvent losses and lower the cost of
requirements; train personnel to be able
non-aerosol solvent cleaning sector
cleaning with organic solvents. For
to respond to a collection of
already achieve exposure levels at the
more information on the halogenated
information; search data sources;
lowest level that we considered, i.e., 18
solvents NESHAP, visit http://
complete and review the collection of
ppm (U.S. EPA, 2003). Of those nPB and
information; and transmit or otherwise
solvent users with exposure levels
disclose the information.
above that, we examined the cost
halopg.html. We note that these steps
An agency may not conduct or
associated with reducing emissions on
are useful for reducing exposure to any
sponsor, and a person is not required to
average by 60%.
industrial solvent, and not just nPB.
respond to a collection of information
If all nPB users in solvent cleaning
VII. Statutory and Executive Order unless it displays a currently valid OMB
reduced exposures to 18 ppm, EPA
Reviews control number. The OMB control
estimates that users would save up to $2
numbers for EPA's regulations in 40
million dollars per year, overall (U.S.
A. Executive Order 12866: Regulatory
CFR are listed in 40 CFR part 9.
EPA, 2007). The value will depend on
Planning and Review
the number of users that attempt to meet C. Regulatory Flexibility Act
Under Executive Order (EO) 12866 an acceptable exposure level which is
(58 FR 51735, October 4, 1993), this The Regulatory Flexibility Act (RFA)
already being achieved with existing
action is a ``significant regulatory generally requires an agency to prepare
equipment, the initial exposure level of
action.'' It raises novel legal or policy a regulatory flexibility analysis of any
cleaning solvent users, the price of nPB,
issues arising out of legal mandates, the rule subject to notice and comment
and the amount of emission control
President's priorities, or the principles rulemaking requirements under the
equipment installed.
set forth in the Executive Order. Administrative Procedure Act or any
B. Paperwork Reduction Act
Accordingly, EPA submitted this action other statute unless the agency certifies
that the rule will not have a significant
to the Office of Management and Budget There are no new requirements for
economic impact on a substantial
(OMB) for review under EO 12866 and reporting or recordkeeping or
number of small entities. Small entities
any changes made in response to OMB information collection associated with
include small businesses, small
recommendations have been this final rule. The final rule merely
organizations, and small governmental
documented in the docket for this allows the use of substitutes for ozone-
jurisdictions. The RFA provides default
action. depleting substances, without requiring
In addition, EPA prepared an analysis definitions for each type of small entity.
the collection, keeping, or reporting of
of the potential costs and benefits Small entities are defined as: (1) A small
information. OMB has previously
associated with this action. This business as defined by the Small
approved the information collection
analysis is contained in the document Business Administration's (SBA)
requirements contained in the existing
``Analysis of Economic Impacts of nPB regulations in subpart G of 40 CFR part regulations at 13 CFR 121.201; (2) a
82 under the provisions of the
Rulemaking.'' A copy of the analysis is small governmental jurisdiction that is a
Paperwork Reduction Act, 44 U.S.C.
available in the docket for this action government of a city, county, town,
3501 et seq. and has assigned OMB
(Ref. EPA璈Q璒AR?002?064) and school district or special district with a
control number 2060?226 (EPA ICR
the analysis is briefly summarized here. population of less than 50,000; and (3)
No. 1596.06). This ICR included five
In our analysis, we assumed that a small organization that is any not-for-
types of respondent reporting and
capital costs are annualized over 15 profit enterprise which is independently
record-keeping activities pursuant to
years or less using a discount rate for owned and operated and is not
SNAP regulations: submission of a
determining net present value of 7.0%. dominant in its field. However, the RFA
SNAP petition, filing a SNAP//Toxic
The acceptability determination for also authorizes an agency to use
Substance Control Act (TSCA)
solvents cleaning imposes no alternate definitions for each category of
Addendum, notification for test
requirements and thus creates no small entity, ``which are appropriate to
marketing activity, record-keeping for
additional cost to users. the activities of the agency'' after
EPA also considered potential costs substitutes acceptable subject to use proposing the alternate definition(s) in
end users could incur to meet restrictions, and record-keeping for the Federal Register and taking
acceptable exposure levels if they are small volume uses. A copy of the OMB comment. 5 U.S.C. 601(3)--(5). In
rwilkins on PROD1PC63 with RULES_2

not already achieving it. EPA found that approved Information Collection addition, to establish an alternate small
those users using nPB-based solvents in Request (ICR) may be obtained from business definition, agencies must
a vapor degreaser would save money by Susan Auby, Collection Strategies consult with SBA's Office of Advocacy.
reducing solvent losses, and that the Division; U.S. Environmental Protection For purposes of assessing the impacts
savings would recover the costs of Agency (2822T); 1200 Pennsylvania of EPA's June 2003 proposed rule on

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30162 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

small entities, EPA proposed to define believes businesses using nPB-based rule on the private sector is less than
cleaning solvents for metals cleaning, $100 million per year. Thus, this rule is
``small business'' as a small business
electronics cleaning, or precision not subject to the requirements of
with less than 500 employees, rather
cleaning would experience significant sections 202 and 205 of the UMRA. EPA
than use the individual SBA size
cost benefits by reducing spending on has determined that this rule contains
standards for the numerous NAICS
solvent. no regulatory requirements that might
subsectors and codes to simplify the
significantly or uniquely affect small
economic analysis. We solicited D. Unfunded Mandates Reform Act
governments. This regulation applies
comments on the use of this alternate
Title II of the Unfunded Mandates directly to facilities that use these
definition for this analysis in the June
Reform Act of 1995 (UMRA), Public substances and not to governmental
2003 NPRM and received no public
Law 104?, establishes requirements for entities.
comments. EPA also consulted with the
Federal agencies to assess the effects of
SBA's Office of Advocacy on the use of E. Executive Order 13132: Federalism
their regulatory actions on State, local,
an alternate small business definition of
and tribal governments and the private Executive Order 13132, entitled
500 employees. The Office of Advocacy
sector. Under section 202 of the UMRA, ``Federalism'' (64 FR 43255, August 10,
concurred with EPA's use of this
EPA generally must prepare a written 1999), requires EPA to develop an
alternate definition to analysis the
statement, including a cost-benefit accountable process to ensure
economic impacts on small businesses
analysis, for proposed and final rules ``meaningful and timely input by State
from the use of n-propyl bromide as an
with ``Federal mandates'' that may and local officials in the development of
acceptable substitute for use in metals,
result in expenditures to State, local, regulatory policies that have federalism
precision, and electronics cleaning, and
and tribal governments, in the aggregate, implications.'' ``Policies that have
in aerosols and adhesives end-uses.
or to the private sector, of $100 million federalism implications'' is defined in
Therefore, EPA used this alternate
or more in any one year. Before the Executive Order to include
definition for this final rule. We believe
promulgating an EPA rule for which a regulations that have ``substantial direct
that no small governments or small
written statement is needed, section 205 effects on the States, on the relationship
organizations are affected by this rule.
of the UMRA generally requires EPA to between the national government and
This approach slightly reduced the
identify and consider a reasonable the States, or on the distribution of
number of small businesses included in
number of regulatory alternatives and power and responsibilities among the
our analysis and slightly increased the
adopt the least costly, most cost- various levels of government.''
percentage of small businesses for
This final rule does not have
effective or least burdensome alternative
whom the analysis indicated the use of
federalism implications. It will not have
that achieves the objectives of the rule.
nPB in metals, precision, and
substantial direct effects on the States,
The provisions of section 205 do not
electronics cleaning may have an
on the relationship between the national
apply when they are inconsistent with
economically significant impact. The
government and the States, or on the
applicable law. Moreover, section 205
number and types of small businesses
distribution of power and
allows EPA to adopt an alternative other
that are subject to this rule have not
than the least costly, most cost-effective responsibilities among the various
changed significantly since the June
or least burdensome alternative if the levels of government, as specified in
2003 proposal. EPA intends to use this
Administrator publishes with the final Executive Order 13132. This regulation
alternate definition of ``small business'' rule an explanation why that alternative applies directly to facilities that use
for regulatory flexibility analyses under was not adopted. Before EPA establishes these substances and not to
the RFA for any other rule related to the any regulatory requirements that may governmental entities. Thus, Executive
use of nPB as a chemical alternative to significantly or uniquely affect small Order 13132 does not apply to this rule.
ozone-depleting substances (ODS) for governments, including tribal
F. Executive Order 13175: Consultation
the same end uses in the June 2003 governments, it must have developed
and Coordination With Indian Tribal
NPRM (e.g., adhesives and aerosol under section 203 of the UMRA a small
solvents). government agency plan. The plan must
After considering the economic Executive Order 13175, entitled
provide for notifying potentially
impacts of this rule on small entities, I ``Consultation and Coordination with
affected small governments, enabling
certify that this action will not have a Indian Tribal Governments'' (65 FR
officials of affected small governments
significant economic impact on a 67249, November 6, 2000), requires EPA
to have meaningful and timely input in
substantial number of small entities. to develop an accountable process to
the development of EPA regulatory
EPA estimates that approximately 1470 ensure ``meaningful and timely input by
proposals with significant Federal
users of nPB industrial cleaning tribal officials in the development of
intergovernmental mandates, and
solvents (e.g., cleaning with vapor regulatory policies that have tribal
informing, educating, and advising
degreasers) would be subject to this implications.'' ``Policies that have tribal
small governments on compliance with
rule. This rule lists nPB as an acceptable the regulatory requirements. EPA has implications'' is defined in the
substitute for ODS. This rule itself does determined that this rule does not Executive Order to include regulations
not impose any binding requirements on contain a Federal mandate that may that have ``substantial direct effects on
users of nPB, and therefore will not result in expenditures of $100 million or one or more Indian tribes, on the
have a significant economic impact on more for State, local, and tribal relationship between the Federal
a substantial number of small entities. governments, in the aggregate, or the government and the Indian tribes, or on
EPA did however analyze the potential private sector in any one year. This final the distribution of power and
economic impacts on small businesses rule does not affect State, local, or tribal responsibilities between the Federal
that use nPB for cleaning solvents for governments. This rule contains no government and Indian tribes.''
rwilkins on PROD1PC63 with RULES_2

metals cleaning, electronics cleaning, or enforceable requirements. The impact of This final rule does not have tribal
precision cleaning. The details of EPA's users meeting the AEL range discussed implications. It will not have substantial
analysis are described in the supporting in the preamble is from a savings of $2 direct effects on tribal governments, on
materials for this rulemaking (U.S. EPA, million per year to a cost of $0 million the relationship between the Federal
2007). Based on its analysis, EPA per year. Therefore, the impact of this government and Indian tribes, or on the

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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

distribution of power and likely to have any adverse energy Availability
responsibilities between the Federal IBSA, 2002. Record of September 5, 2002
government and Indian tribes, as Meeting with the International
I. National Technology Transfer and
specified in Executive Order 13175. Brominated Solvents Association Inc.
Advancement Act
This final rule would not significantly (A?001?7, II璂?0)
Section 12(d) of the National
or uniquely affect the communities of
Ozone-Depletion Potential and Other
Technology Transfer and Advancement
Indian tribal governments, because this Environmental Impacts
Act of 1995 (``NTTAA''), Public Law
regulation applies directly to facilities
ATSDR, 1994. Toxicological Profile For
104?13, section 12(d) (15 U.S.C. 272
that use these substances and not to
Acetone. Agency for Toxic Substances
note) directs EPA to use voluntary
governmental entities. Thus, Executive and Disease Registry. May, 1994.
consensus standards in its regulatory
Order 13175 does not apply to this final Available at
activities unless to do so would be
rule. toxprofiles/tp21-c5.pdf (EPA璈Q璒AR?br> inconsistent with applicable law or
G. Executive Order 13045: Protection of otherwise impractical. Voluntary ATSDR, 1996. Toxicological Profile For 1,2-
Children From Environmental Health consensus standards are technical Dichloroethene. Agency for Toxic
and Safety Risks standards (e.g., materials specifications, Substances and Disease Registry. August,
test methods, sampling procedures, and 1996. Available at http://
Executive Order 13045: ``Protection of
business practices) that are developed or
Children from Environmental Health
adopted by voluntary consensus c5.pdf (EPA璈Q璒AR?002?064?br> Risks and Safety Risks'' (62 FR 19885,
standards bodies. The NTTAA directs
April 23, 1997) applies to any rule that: ATSDR, 1997. Toxicological Profile For
EPA to provide Congress, through OMB,
(1) Is determined to be ``economically Trichloroethylene. Agency for Toxic
explanations when the Agency decides
significant'' as defined under Executive Substances and Disease Registry.
not to use available and applicable
Order 12866, and (2) concerns an September, 1997. Available at http://
voluntary consensus standards.
environmental health or safety risk that
This action does not involve technical c5.pdf (EPA璈Q璒AR?002?064?br> EPA has reason to believe may have a
standards. Therefore, EPA did not 0123)
disproportionate effect on children. If
consider the use of any voluntary ATSDR, 2004. Draft Toxicological Profile For
the regulatory action meets both criteria,
consensus standards. 1,1,1-Trichloroethane. Agency for Toxic
the Agency must evaluate the
Substances and Disease Registry.
J. Congressional Review Act
environmental health or safety effects of September, 2004. Updated draft for
the planned rule on children, and The Congressional Review Act, 5 comment. Available at http://
explain why the planned regulation is
U.S.C. 801 et seq., as added by the Small
preferable to other potentially effective c6.pdf (EPA璈Q璒AR?002?064?br> Business Regulatory Enforcement
and reasonably feasible alternatives 0132)
Fairness Act of 1996, generally provides
EDSTAC, 1998. Final Report of the Endocrine
considered by the Agency. that before a rule may take effect, the
Disruptor Screening and Testing
This final rule is not subject to the agency promulgating the rule must Advisory Committee. August, 1998.
Executive Order because it is not submit a rule report, which includes a (EPA璈Q璒AR?002?064?136)
economically significant as defined in copy of the rule, to each House of the Geiger et al., 1998. Geiger, D.L., Call, D.J.,
Executive Order 12866, and because the Congress and to the Comptroller General and Brooke, L.T. 1988. Acute Toxicities
Agency does not have reason to believe of the United States. EPA will submit a of Organic Chemicals to Fathead
the environmental health or safety risks Minnows (Pimephales promelas), Vol. 4.
report containing this rule and other
addressed by this action present a In: Center for Lake Superior
required information to the U.S. Senate,
Environmental Stud., Univ. of
disproportionate risk to children. The the U.S. House of Representatives, and
Wisconsin-Superior, Superior, WI I:355.
exposure limits and acceptability the Comptroller General of the United
(Summarized in ICF, 2004a)
listings in this final rule apply to the States prior to publication of the rule in HSDB, 2004. Hazardous Substances Databank
workplace. These are areas where we the Federal Register. A major rule File for 1-Bromopropane. Accessed 1/
expect adults are more likely to be cannot take effect until 60 days after it 2004 from the World Wide Web at http://
present than children, and thus, the is published in the Federal Register.
agents do not put children at risk This action is not a ``major rule'' as temp/dLwM9e:1 (Summarized in ICF,
disproportionately. 2004a)
defined by 5 U.S.C. 804(2). This rule
ICF, 2004a. ICF Consulting. Memo to E.
will be effective July 30, 2007.
H. Executive Order 13211: Actions That Birgfeld, EPA, re: nPB Aquatic Toxicity.
Significantly Affect Energy Supply, VIII. References January 19, 2004. (EPA璈Q璒AR?002?br> Distribution, or Use 0064?193)
The documents below are referenced
LaGrega, M., Buckingham, P., Evans, J., and
This rule is not a ``significant energy in the preamble. All documents are
Environmental Resources Management,
action'' as defined in Executive Order located in the Air Docket at the address 2001. Hazardous Waste Management.
13211, ``Actions Concerning Regulations listed in section I.B.1 at the beginning Second Edition. McGraw-Hill, New
That Significantly Affect Energy Supply, of this document. Unless specified York, NY. 2001. (EPA璈Q璒AR?002?br> Distribution, or Use'' (66 FR 28355 (May otherwise, all documents are available 0064?112)
22, 2001)) because it is not likely to electronically through the Federal Linnell, 2003. Comments from the
Electronics Industry Alliance. (EPA璈Q?br> have a significant adverse effect on the Docket Management System, Docket #
OAR?002?064 items ?043, ?044,
supply, distribution, or use of energy. EPA璈Q璒AR?002?064. Some
and ?045)
This action would impact specific items are available only in hard
NPS, 1997. Irwin, R.J., M. VanMouwerik, L.
manufacturing of various metal, copy in dockets A?001?7 or A?2?2
rwilkins on PROD1PC63 with RULES_2

Stevens, M.S. Seese, and W. Basham.
electronic, medical, and optical (legacy docket numbers for SNAP nPB 1997. Environmental Contaminants
products cleaned with solvents rule and for SNAP program and Encyclopedia. National Park Service,
containing nPB and products made with submissions). Numbers listed after the Water Resources Division, Fort Collins,
adhesives containing nPB. Further, we reference indicate the docket and item Colorado. (EPA璈Q璒AR?002?064?br> have concluded that this rule is not numbers. 0086)

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30164 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

Steminiski, 2003. July 27, 2003 Comment Morford, 2003a, b. Enviro Tech International mitogen-activated protein kinase in the
from J. Steminiski, PhD. (EPA璈Q? Comment re Section IV D Flammability hippocampus of rats exposed to 1-
OAR?002?064?035 and ?043) with Exhibits (7/25/03) (EPA璈Q璒AR? bromopropane. 2002. Life Sciences 72
U.S. Economic Census, 2002a. General 2002?064?030 and EPA璈Q璒AR? (2002) 521?29. (EPA璈Q璒AR?002?br> Summary: 2002. Subject Series. Report 2002?064?031) 0064?115)
No. EC02?1SG?, October, 2005. U.S. Morford, 2003c. Enviro Tech Int. Fueta et al., 2004. Y. Fueta, T. Fukuda, T.
Census Bureau. (EPA璈Q璒AR?002? Flammability of nPB & Comparison With Ishidao, H. Hori. Electrophysiology and
0064?133) Methylene Chloride-Additional immunohistochemistry in the
U.S. Economic Census, 2002b. U.S. Economic Comments on Flammability (7/29/03) hippocampal CA1 and the Dentate Gyrus
Census for Island Areas, 2002. Report for (EPA璈Q璒AR?002?064?036) of Rats Chronically exposed to 1?br> Northern Marianas Islands, Rpt. No. Shubkin, 2003. R. Shubkin, Poly Systems, Bromopropane, a Substitute for Specific
IA02?0A璑MI, May, 2004. U.S. Census EPA received 7/23/03 Re: Comment on Chlorofluorocarbons. Neuroscience 124
Bureau. (EPA璈Q璒AR?002?064? Flammability of n-Propyl Bromide as (2004) 593?03. (EPA璈Q璒AR?002?br> 0091) Discussed in Proposed Rule Published in 0064?142)
U.S. Economic Census, 2002c. U.S. Economic Federal Register (EPA璈Q璒AR?002? Honma et al., 2003. Honma, T, Suda M,
Census for Island Areas, 2002. Report for 0064?025) Miyagawa M. ``Inhalation of 1-
Guam, Rpt. No. IA02?0A璆UAM, Weiss Cohen, 2003. T. Weiss Cohen, Dead bromopropane causes excitation in the
March, 2005. U.S. Census Bureau. (EPA? Sea Bromine Group, 7/31/2003 Comment central nervous system of male F344
HQ璒AR?002?064?102) to Federal Register Proposed Rules of rats.'' Neurotoxicology. 2003 Aug; 24 (4?br> U.S. Economic Census, 2002d. U.S. June 3, 2003, on Protection of 5):563?5. (EPA璈Q璒AR?002?064?br> Economic Census for Island Areas, 2002. Stratospheric Ozone: Listing of 0138)
Report for Virgin Islands, Rpt. No. IA02? Substitutes for Ozone-Depleting ICF, 2002. Risk Screen for Use of N-Propyl
00A璙I , April, 2005. U.S. Census Substances--n-Propyl Bromide (EPA? Bromide. ICF Consulting. Prepared for
Bureau. (EPA璈Q璒AR?002?064? HQ璒AR?002?064?053) U.S. EPA, May, 2002. (EPA璈Q璒AR?br> 0131) 2002?064?006 through ?012)
Human Health
U.S. Economic Census, 2002e. U.S. Economic ICF, 2004b. ICF Consulting. ICF Consulting
Census for Island Areas, 2002. Report for Review of the TERA Report. December
ACGIH, 1991. Skin Notation Documentation
American Samoa, Rpt. No. IA02?0A? 13, 2004
for Methyl Chloride. Available online at
AS, April, 2005. U.S. Census Bureau. ICF, 2004c. ICF Consulting. External Expert
(EPA璈Q璒AR?002?064?103) Review Panel on n-Propyl Bromide.
ACGIH, 2005. Documentation for Threshold
U.S. Economic Census, 2002f. U.S. Economic
December 13, 2004
Limit Value for 1-Bromopropane. 2005.
Census for Island Areas, 2002. Report for
ICF, 2004d. ICF Consulting. Review of
Available online at
Puerto Rico: Manufacturing, Rpt. No.
ACGIH's Proposed Threshold Limit
Albemarle, 2003. Product Description for
IA02?0I璓RM, October, 2005. U.S.
Abzol() Cleaners. 2003. (EPA璈Q? Value for 1-Bromopropane. April 26,
Census Bureau. (EPA璈Q璒AR?002?br> 2004
ICF, 2006a. ICF Consulting. Risk Screen on
Beck and Caravati, 2003. Neurotoxicity
U.S. EPA, 1980. Ambient Water Quality
Substitutes for Ozone-Depleting
associated with 1-bromopropane
Criteria for Dichloroethylenes. EPA 440/
Substances for Adhesive, Aerosol
exposure. Utah Poison Control Center,
5?0?41 October, 1980. Available at
Solvent, and Solvent Cleaning
University of Utah, Salt Lake City, UT.
Applications. Proposed Substitute: n-
J Toxicology Clinical Toxicology
Propyl Bromide. April 18, 2006.
41(5):729. (Abstract from conference).
U.S. EPA, 1992. Hazard Assessment
2003. (EPA璈Q璒AR?002?064?111) Attachments: A, Determination of an
Guidelines for Listing Chemicals on the
CERHR, 2002a. NTP-Center for the AEL; B, Derivation of an RfC; C,
Toxic Release Inventory, Revised Draft.
Evaluation of Risks to Human Evaluation of the Global Warming
Washington, DC: Office of Pollution,
Reproduction Expert Panel Report on the Potential; D, Occupational Exposure
Prevention and Toxics. As referenced in
Reproductive and Developmental Analysis for Adhesive Applications; E,
ICF, 2004a.
Toxicity of 1瑽romopropane [nPB]. Occupational Exposure Analysis for
U.S. EPA, 1994a. Chemical Summary for
March 2002. (EPA璈Q璒AR?002? Aerosol Solvent Applications; F, General
Methyl Chloroform, prepared by Office
0064?096) Population Exposure Assessment for n-
of Pollution Prevention and Toxics,
ClinTrials, 1997a. A 28-Day Inhalation Study Propyl Bromide
August, 1994. (EPA璈Q璒AR?002?br> of a VaporFormulation of ALBTA1 in the ICF, 2006b. ICF Consulting. Revised
Albino Rat. Report No. 91189. Prepared Memorandum regarding RTI Metabolism
WMO, 2002: Scientific Assessment of Ozone
by ClinTrials BioResearch Laboratories, Study on nPB. April, 2006. (EPA璈Q?br> Depletion: 2002, Global Ozone Research
Ltd., Senneville, Quebec, Canada. May OAR?002?064?179)
and Monitoring Project--Report No. 47,
Geneva, 2003 Full report available online 15, 1997. Sponsored by Albemarle Ichihara G., Jong X., Onizuka J., et al., 1999.
at Corporation, Baton Rouge, LA. (A?1? Histopathological changes of nervous
(A?001?7, II瑼?0) 42, X瑼?) system and reproductive organ and
Wuebbles, Donald J. 2002. ``The Effect of ClinTrials, 1997b. ALBTA1: A 13璚eek blood biochemical findings in rats
Short Atmospheric Lifetimes on Inhalation Study of a Vapor Formulation exposed to 1-bromopropane. (Abstract
Stratospheric Ozone.'' Written for Enviro of ALBTA1 in the Albino Rat. Report No. only) Abstracts of the 72nd Annual
Tech International, Inc. Department of 91190. Prepared by ClinTrials Meeting of Japan Society for
Atmospheric Sciences, University of BioResearch Laboratories, Ltd., Occupational Health. May 1999. Tokyo.
Illinois-Urbana. (EPA璈Q璒AR?002? Senneville, Quebec, Canada. February (A?001?7, II瑼?5)
0064?114) 28, 1997. Sponsored by Albemarle Ichihara G., Kitoh J., Yu, X., et al., 2000a. 1-
Corporation, Baton Rouge, LA. (A?1? Bromopropane, an alternative to ozone
Flammability and Fire Safety 42, X瑼?) layer depleting solvents, is dose-
Dunson et al, 2002. Dunson, D., Colombo, dependently neurotoxic to rats in long-
BSOC, 2000. February 1, 2000 Tabulation of
and B., Baird, D. Changes with age in the term inhalation exposure. Toxicol
Flammability Studies on n-Propyl
level and duration of fertility in the Sciences 55:116?23. (A?001?7, II瑼?br> Bromide from the Brominated Solvents
menstrual cycle. Human Reproduction, 8)
Committee, and other information on
rwilkins on PROD1PC63 with RULES_2

Vol. 17, No. 5, pp. 1399?403, 2002. Ichihara G., Yu X., Kitoh J., et al. 2000b.
flammability of n-propyl bromide. (A?br> (EPA璈Q璒AR?002?064?120) Reproductive toxicity of 1-
2001?7, II璂?5)
Fueta et al., 2002. Y. Fueta, K. Fukunaga, T. bromopropane, a newly introduced
Miller, 2003. Albemarle Corporation
Ishidao, H. Hori. Hyperexcitability and alternative to ozone layer depleting
comments-Flash Point Data for n-Propyl
changes in activities of Ca2+/ solvents, in male rats. Toxicol Sciences
Bromide. (EPA璈Q璒AR?002?064?br> 0040) calmodulin-dependent kinase II and 54:416?23. (A?001?7, II瑼?)

VerDate Aug<31>2005 18:10 May 29, 2007 Jkt 211001 PO 00000 Frm 00024 Fmt 4701 Sfmt 4700 E:\FR\FM\30MYR2.SGM 30MYR2
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Ichihara G. et al., 2002. Neurological Industrial Hygienists. Comments on the Limit Derivations--Preliminary
Disorders in Three Workers Exposed to draft Documentation for proposed TLV Thoughts and Areas for Further
1瑽romopropane. J Occu. Health 44:1?. for 1-bropmopropane (1-BP). July 30, Analysis. 2004. (EPA璈Q璒AR?002?br> (A?001?7, II璂?4) 2004. (EPA璈Q璒AR?002?064?128) 0064?189)
Ichihara et al., 2004a. G. Ichihara, W. Li, X. Raymond and Ford, 2005. ``Clinical Case Toraason, M., Lynch, D.W., DeBorda, D.G.,
Ding, S. Peng, X. Yu, E. Shibata, T. Presentations from a Foam Furniture Singh, N., Krieg, E., Butler,
Yamada, H. Wang, S. Itohara, S. Kanno, Fabrication Plant in North Carolina,'' M.A.,Toennis, C.A., Nemhauser, J.B.,
K. Sakai, H. Ito, K. Kanefusa, and Y. Presentation by Drs. Larry Raymond and 2006. DNA damage in leukocytes of
Takeuchi. A Survey on Exposure Level, Marsha Ford at the North American workers occupationally exposed to 1-
Health Status, and Biomarkers in Congress of Clinical Toxicologists. bromopropane. Mutation Research 603
Workers Exposed to 1-Bromopropane. September 14, 2005. (EPA璈Q璒AR? (2006) 1?4 (EPA璈Q璒AR?002?064?br> Am Jrnl of Ind Med 45:63?5 (2004) 2002?064?170) 0130)
(EPA璈Q璒AR?002?064?093) Risotto, 2003. Comments of the Halogenated U.S. EPA, 1991. Guidelines for
Ichihara et al., 2004b. Gaku Ichihara, Weihua Solvents Industry Alliance on nPB Developmental Toxicity Risk
Li, Eiji Shibata, Xuncheng Ding, Hailan proposed rule. June, 2003. (EPA璈Q? Assessment. U.S. Environmental
Wang, Yideng Liang, Simeng Peng, OAR?002?064?050) Protection Agency. (A?001?7, II瑼?br> Seiichiro Itohara, Michihiro Kamijima, Rodricks, 2002. October 21, 2002 remarks 51)
Qiyuan Fan, Yunhui Zhang, Enhong from Dr. J. Rodricks, Environ, to R. U.S. EPA, 1994b. U.S. Environmental
Zhong, Xiaoyun Wu, William M. Morford, Enviro Tech International Protection Agency (U.S. EPA). 1994.
Valentine, and Yasuhiro Takeuchi. concerning derivation of an OEL for n- Methods for derivation of inhalation
Neurological Abnormalities in Workers propyl bromide with cover letter to EPA reference concentrations and application
of inhalation dosimetry. EPA/600/8?0/
of 1-Bromopropane Factory. Env'l Health from Enviro Tech International (A?001?br> 066F. Office of Health and
Perspectives, 30 June 2004. (EPA璈Q? 07, II璂?5)
Environmental Assessment, Washington,
OAR?002?064?139) Rozman and Doull, 2002. ``Derivation of an
DC. 1994. (A?001?7, II瑼?6)
Ishidao et al., 2002. Ishidao T, Kunugita N, Occupational Exposure Limit for n-
Available online at
Fueta Y, Arashidani K, Hori H. Effects of Propyl Bromide Using an Improved
inhaled 1-bromopropane vapor on rat Methodology'' App Occu. Env. Hyg. 17:
U.S. EPA, 1995b. The Use of the Benchmark
metabolism. Toxicol Lett. 2002 Aug 5; 711?16 (A?001?7, II璂?3)
Dose Approach in Health Risk
134(1?):237?3 (EPA璈Q璒AR?002? Rozman and Doull, 2005. Presentation by
Assessment. EPA/630璕?4?07. Risk
0064?125) Drs. Rozman and Doull at the North
Assessment Forum, Washington, DC. (A?br> Majersik et al., 2004. Chronic Exposure to 1- American Congress of Clinical
2001?7, II瑼?7)
Bromopropane Associated with Spastic Toxicologists. September 14, 2005.
U.S. EPA, 1996. Guidelines for Reproductive
Paraparesis and Distal Neuropathy: A (EPA璈Q璒AR?002?064?126)
Toxicity Risk Assessment. U.S.
Report of Six Foam Cushion Gluers. RTI, 2005. Report on uptake and metabolism
Environmental Protection Agency, Risk
Poster paper from 129th Annual Meeting of 1-bromopropane in rats and mice.
Assessment Forum, Washington, DC,
of the American Neurological Research Triangle Institute report for the
630/R?6/009, 1996. (EPA璈Q璒AR?br> Association, Toronto. October, 2004. National Toxicology Program. June,
(EPA璈Q璒AR?002?064?219) 2005. (EPA璈Q璒AR?002?064?077,
U.S. EPA, 2003. Summary of Data on
Majersik et al, 2005. ``Spastic Paraparesis and ?080, ?081, ?082, ?101, ?104,
Workplace Exposure to n-Propyl
Distal Neuropathy Associated with ?137, ?137.1)
Bromide, May 21, 2003. EPA's summary
Chronic Exposure to 1BP,'' Presentation Sekiguchi, S., Suda, M., Zhai, Y.L., Honma,
of exposure data from nPB suppliers and
by Drs. J. Majersik, M. Caravati, and J. T., ``Effects of 1-bromopropane, 2-
NIOSH. (EPA璈Q璒AR?002?064?br> Steffens at the North American Congress bromopropane, and 1,2-dichloropropane
0015 and EPA璈Q璒AR?002?064?br> of Clinical Toxicologists. September 14, on the estrous cycle and ovulation in
2005. (EPA璈Q璒AR?002?064?116) F344 rats.'' Toxicol Lett 2002 Jan 5;
Wang et al., 2003. H. Wang, G. Ichihara, H.
Miller, 2005. ``1-Bromopropane: A Private 126(1):41? (A?001?7, II璂?9)
Ito, K. Kato, J. Kitoh, T. Yamada, X. Yu,
Neurological Practice Experience in SLR International, 2001. ``Inhalation
S. Tsuboi, Y. Moriyama, and Y.
2000,'' Presentation by Dr. J.M. Miller, at Occupational Exposure Limit for n-
Takeuchi. 2003. ``Dose-Dependant
the North American Congress of Clinical Propyl Bromide.'' Prepared for Enviro
Biochemical Changes in RateCentral
Toxicologists. September 14, 2005 (EPA? Tech International, Inc. 2001. (A?001?br> Nervous System after 12-Week Exposure
HQ璒AR?002?064?216) 07, II璂?5)
to 1-Bromopropane'' NeuroToxicology
Nemhauser, 2005. ``Bromopropane: A Health Sohn et al., 2002. Sohn, Y.K., Suh, J.S., Kim,
24: 199?06 (EPA璈Q璒AR?002?br> Hazard Evaluation Revisited'' J.W., Seo, H.H., Kim, J.Y., Kim, H.Y., Lee,
Presentation by Dr. J. Nemhauser, U.S. J.Y., Lee, S.B., Han, J.H., Lee, Y.M., Lee,
Werner, 2003. Comments from 3M on nPB
Public Health Service, Centers for J.Y. ``A histopathologic study of the
proposed rule. (EPA璈Q璒AR?002?br> Disease Control & Presentation at the nervous system after inhalation exposure
North American Congress of Clinical of 1-bromopropane in rat.'' Toxicol Lett.
WIL, 2001. WIL Research Laboratories. ``An
Toxicologists. September 14, 2005. 2002 May 28; 131(3):195?01. (EPA?br> inhalation two-generation reproductive
(EPA璈Q璒AR?002?064?105) HQ璒AR?002?064?127)
toxicity study of 1-bromopropane in
NIOSH, 2003a. NIOSH Health Hazard Stelljes and Wood, 2004. Stelljes, M., Wood,
rats.'' Sponsored by the Brominated
Evaluation Report #99?260?906 Marx R. Development of an occupational
Solvent Consortium. May 24, 2001.
Industries, Inc. Sawmills, NC. Available exposure limit for n-propylbromide
(A?001?7, II璂?0)
online at using benchmark dose methods.
Yamada T. et al., 2003. Exposure to
reports/pdfs/1999-0260-2906.pdf. (EPA? Regulatory Toxicology and
1-Bromopropane Causes Ovarian
HQ璒AR?002?064?094) Pharmacology 40 (2004) 136?50 (EPA?br> Dysfunction in Rats. Toxicol Sci 71:96?br> NTP, 2003. Results of 13-week Inhalation HQ璒AR?002?064?087)
103 (EPA璈Q璒AR?002?064?097)
Testing by the National Toxicology Stelljes, ME, 2005. Mechanistic Hypothesis
Program. Available at http://ntp- for n-Propylbromide and Ramifications How Is EPA Responding to Comments? for Occupational Exposure Limit in the
index.cfm?fuseaction= United States. Technical Memorandum ACGIH, 1991. Full citation above in ``Human
rwilkins on PROD1PC63 with RULES_2

ntpsearch.searchresults&searchterm= to EnviroTech International. 7 Health'' section.
106-94-5 September, 2005. (EPA璈Q璒AR?002? ACGIH, 2004. TLVs and BEIs: Threshold
O'Malley, 2004. Letter from Nancy O'Malley, 0064?144) Limit Values for Chemical Substances
Toxicology Advisor, Albemarle TERA, 2004. Toxicological Excellence for and Physical Agents, Biological
Corporation to The Science Group of the Risk Assessment. Scientific Review of 1- Exposure Indices. American Conference
American Conference of Governmental Bromopropane Occupational Exposure of Governmental Industrial Hygienists.

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30166 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

Cincinnati, OH. Available online at Linnell, 2003. Full citation above in ``Ozone- Clinical Toxicologists. September 14,
Depletion Potential and Other 2005. (EPA璈Q璒AR?002?064?126)
Environmental Impacts'' section. RTI, 2005. Full citation above in ``Human
ACGIH, 2005. Full citation above in ``Human
Majersik, 2004. Full citation above in Health'' section.
Health'' section.
``Human Health'' section. Ruckriegel, 2003. Comment on n-Propyl
Beck and Caravati, 2003. Full citation above
Majersik, 2005. Full citation above in Bromide Recommended Workplace
in ``Human Health'' section.
``Human Health'' section. Exposure Level in Proposed Rule
Chemtura, 2006. Material Safety Data Sheet
MOP 18, 2006. Report of the Eighteenth Published in Federal Register Vol. 68,
for n-propyl bromide. April, 2006. (EPA?br> Meeting of the Parties to the Montreal No. 106, June 3, 2003. August 2, 2003
Protocol on Substances that Deplete the (EPA璈Q璒AR?002?064?055)
ClinTrials, 1997a. Full citation above in
Ozone Layer. November 16, 2006. (EPA- Rusch and Bernhard, 2003. Comments on
``Human Health'' section.
HQ璒AR?002?064?163) proposed regulation of n-propyl bromide
ClinTrials, 1997b. Full citation above in
Morford, 2003a. Full citation above in from Steven Bernhardt and George
``Human Health'' section.
``Flammability'' section. Rusch, Honeywell. August 1, 2003.
Doull and Rozman, 2001. Doull and Rozman,
Morford, 2003b. Full citation above in (EPA璈Q璒AR?002?064?059)
2001. Derivation of an Occupational
``Flammability'' section. Rusch, 2003. Late comments on proposed
Exposure Limit for n-Propyl Bromide,
Morford, 2003c. Full citation above in regulation of n-propyl bromide from
prepared by John Doull, Ph.D., M.D., and
``Flammability'' section. George Rusch, Honeywell. (EPA璈Q?br> Karl K. Rozman, Ph.D., D.A.B.T.
Morford, 2003d. Support for EPA Proposal to OAR?002?064?068)
submitted by Envirotech International,
Approve n propyl bromide and Sekiguchi, 2002. Full citation above in
Inc. (A?001?7, II璂?4)
Comments Pursuant to Section D. ``Human Health'' section.
Dunson et al., 2002. Full citation above in
SLR International, 2001. Full citation above
Flammability of Protection of
``Human Health'' section.
in ``Human Health'' section.
Stratospheric Ozone: Listing of
Elf Atochem, 1995. Elf Atochem, 1995.
Smith, 2003. Comments on Protection of
Substitutes for Ozone Depleting
Micronucleus Test by Intraperitoneal
Stratospheric Ozone: Listing of
Substances--n-Propyl Bromide:
Route in Mice. n-Propyl Bromide. Study
Substitutes for Ozone-Depleting
Proposed Rule Federal Register Vol. 68
No. 12122 MAS. Study Director, Brigitte Substances--n-Propyl Bromide, FR Vol.
No. 106, June 3, 2003. Enviro Tech
Molinier. Study performed by Centre 68, No. 106, June 3, 2003. R.L. Smith,
International, Inc. Comments Regarding
International de Toxoicologie, Misery, Albemarle Corporation. July 23, 2003.
Proposed Rule & Exhibit A Richard
France, September 6, 1995. (A?1?2, (EPA璈Q璒AR?002?064?067)
Morford, Enviro Tech International.
X瑼?) Stelljes, 2003. Comments from Dr. Marc
August 3, 2003. (EPA璈Q璒AR?002?br> ERG, 2004. Analysis of Health and Stelljes, SLR International, on proposed
Environmental Impacts of ODS rule on n-propyl bromide. (HQ璄PA?br> Morford, 2003e. Enviro Tech International,
Substitutes--Evaluating the need to set a OAR?002?064?022)
Inc. Combined Exhibits to Comment
short-term exposure or ceiling limit for Stelljes and Wood, 2004. Full citation above
0047/Morford, 2003e on Proposed Rule
n-propyl bromide. ERG. June 8, 2004. in ``Human Health'' section.
Richard Morford, Enviro Tech
Farr, 2003. Comment on proposed rule on n- Stelljes, 2005. Full citation above in ``Human
International. August 3, 2003. (EPA璈Q?br> propyl bromide from Craig Farr, Atofina. Health'' section.
July 31, 2003. (EPA璈Q璒AR?002? TERA, 2004. Full citation above in ``Human
Morford, 2003f. Initial Comments to
0064?060) Health'' section.
Protection of Stratospheric Ozone:
HDSB, 2004. Full citation above in ``Ozone- U.S. EPA, 1994b. Full citation above in
Listing of Substitutes for Ozone
Depletion Potential and Other ``Human Health'' section.
Depleting Substances--n-Propyl
Environmental Impacts'' section. U.S. EPA, 1996. Full citation above in
bromide: Proposed Rule Federal Register
HESIS, 2003. California Department of Health ``Human Health'' section.
Vol. 68 No. 106, June 3, 2003. Richard
Services--HESIS 1-Bromopropane U.S. EPA, 2003. Summary of Data on
Morford, Enviro Tech International. June
(n-Propyl Bromide) Health Hazard Alert. Workplace Exposure to n-Propyl
26, 2003. (EPA璈Q璒AR?002?064?br> (EPA璈Q璒AR?002?064?039) Bromide, May 21, 2003. EPA's summary
Honma, 2003. Full citation above in ``Human of exposure data from nPB suppliers and
Morford, 2003g. Comment regarding
Health'' section. NIOSH. (EPA璈Q璒AR?002?064?br> proposed restriction on isopropyl
ICF, 2002a. Full citation above in ``Human 0015 and ?016)
bromide Richard Morford, Enviro Tech
Health'' section. Weiss Cohen, 2003. Comments from Tammi
International. August 3, 2003. (EPA璈Q?br> ICF, 2004a. Full citation above in ``Ozone- Weiss Cohen, Dead Sea Bromine Group.
Comments To Federal Register Proposed
Depletion Potential and Other Morford, 2003h. Enviro Tech International
Rules Of June 3, 2003, On Protection Of
Environmental Impacts'' section. Inc Comment Regarding iPB Content
Stratospheric Ozone: Listing Of
ICF, 2006a. Full citation above in ``Human Restriction Exhibit A 04瑼ug?003
Substitutes For Ozone-Depleting
Health'' section. (EPA璈Q璒AR?002?064?046)
Substances--N Propyl Bromide. (EPA?br> ICF, 2006b. Full citation above in ``Human Morford, 2003i. White Paper: ``EPA Is
Health'' section. Unlawfully Regulating Occupational
Werner, 2003. Full citation above in ``Human
ICF, 2006c. ICF Consulting. Evaluation of Exposures'' Attachment to public
Health'' section.
Memorandum from Dr. M. Stelljes. May, comments. (EPA璈Q璒AR?003?064?br> WIL, 2001. Full citation above in ``Human
2006. 0049)
Health'' section.
Ichihara, 1999. Full citation above in NTP, 2003. Full citation above in ``Human
Yamada et al., 2003. Full citation above in
``Human Health'' section. Health'' section.
``Human Health'' section.
Ichihara, 2000a. Full citation above in PBT Profiler, 2007. Results from the PBT
``Human Health'' section. Profiler Tool for 1-bromopropane, CAS Executive Orders and Statutes
Ichihara, 2002. Full citation above in No. 106?4?. Downloaded on February
``Human Health'' section. 9, 2007 from Kassem, 2003. Full citation above for
Ichihara, 2004a. Full citation above in default.asp. (EPA璈Q璒AR?002? ``Decisions for Each Sector and End Use''
``Human Health'' section. 0064?168) section.
Ichihara, 2004b. Full citation above in Risotto, 2003. Full citation above in ``Human Ultronix, 2001. Response to questionnaire
rwilkins on PROD1PC63 with RULES_2

``Human Health'' section. Health'' section. from EPA by C. Wolf, Ultronix, 2001.
Kassem, 2003. January 10, 2003 Letter from Rodricks, 2002. Full citation above in (A?001?7, II璂?6)
O.M. Kassem, Albemarle Corporation to ``Human Health'' section. Tattersall, 2004. Conversation between M.
K. Bromberg, Small Business Rozman and Doull, 2005. Rozman and Doull, Sheppard, EPA, and Tom Tattersall,
Administration Re: n propyl bromide 2005. Presentation by Drs. Rozman and MicroCare Corporation. (EPA璈Q璒AR?br> SNAP. (A?001?7, II璂?8) Doull at the North American Congress of 2002?064?171)

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U.S. EPA, 2003. Full citation above for Dated: May 15, 2007.
List of Subjects in 40 CFR Part 82
``Human Health'' section. Stephen L. Johnson,
Environmental protection,
U.S. EPA, 2007. Analysis of Economic
Administrative practice and procedure, Administrator.
Impacts of Final nPB Rulemaking for
Air pollution control, Reporting and
Appendix A: Summary of Decision
Cleaning Solvent Sector. 2007.
recordkeeping requirements.
End uses Substitute Decision Further information

Metals cleaning, electronics n-propyl bromide (nPB) as Acceptable ......................... EPA recommends the use of personal protective
cleaning, and precision a substitute for CFC?13 equipment, including chemical goggles, flexible lami-
cleaning. and methyl chloroform. nate protective gloves and chemical-resistant cloth-
EPA expects that all users of nPB would comply with
any final Permissible Exposure Limit that the Occu-
pational Safety and Health Administration issues in
the future under 42 U.S.C. 7610(a).
nPB, also known as 1-bromopropane, is Number 106?br> 94? in the Chemical Abstracts Service (CAS) Reg-

[FR Doc. E7?707 Filed 5?9?7; 8:45 am]
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1424712873.asp N/A
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98-82.asp 98-82-8


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