methods for minimizing respondent burden, including through the use of
automated collection techniques. Send comments to EPA as part of your
overall comments on this proposed rule in the manner specified under
ADDRESSES. In developing the final rule, the Agency will address any
comments received regarding the information collection requirements
contained in this proposed rule.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of this proposed rule on small entities, the Agency hereby certifies
that this proposed rule would not have a significant adverse economic
impact on a substantial number of small entities. The factual basis for
the Agency's determination is presented in the small entity impact
analysis prepared as part of the economic analysis for this proposed
rule (Ref. 14), which is summarized in Unit VI., and a copy of which is
available in the docket for this proposed rule. The following is a
brief summary of the factual basis for this certification.
    Under RFA, small entities include small businesses, small
organizations, and small governmental jurisdictions. For purposes of
assessing the impacts of this proposed rule on small entities, small
entity is defined in accordance with RFA as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201.
    2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
Based on the industry profile that EPA prepared as part of the economic
analysis for this proposed rule (Ref. 14), EPA has determined that this
proposed rule is not expected to impact any small not-for-profit
organizations or small governmental jurisdictions. As such, the
Agency's analysis presents only the estimated potential impacts on
small business.
    Two factors are examined in EPA's small entity impact analysis
(Ref. 14) in order to characterize the potential small entity impacts
of this proposed rule on small business:
     The size of the adverse economic impact (measured as the
ratio of the cost to sales or revenue).
     The total number of small entities that experience the
adverse economic impact.
    Section 601(3) of RFA establishes as the default definition of
``small business'' the definition used in section 3 of the Small
Business Act, 15 U.S.C. 632, under which SBA establishes small business
size standards (13 CFR 121.201). For this proposed rule, EPA has
analyzed the potential small business impacts using the size standards
established under this default definition. The SBA size standards,
which are primarily intended to determine whether a business entity is
eligible for government programs and preferences reserved for small
businesses (13 CFR 121.101), ``seek to ensure that a concern that meets
a specific size standard is not dominant in its field of operation.''
(13 CFR 121.102(b)). See section 632(a)(1) of the Small Business Act.
In analyzing potential impacts, RFA recognizes that it may be
appropriate at times to use an alternate definition of small business.
As such, section 601(3) of RFA provides that an agency may establish a
different definition of small business after consultation with the SBA
Office of Advocacy and after notice and an opportunity for public
comment. Even though the Agency has used the default SBA definition of
small business to conduct its analysis of potential small business
impacts for this proposed rule, EPA does not believe that the SBA size
standards are generally the best size standards to use in assessing
potential small entity impacts with regard to TSCA section 4(a) test
rules.
    The SBA size standard is generally based on the number of employees
an entity in a particular industrial sector may have. For example, in
the chemical manufacturing industrial sector (i.e., NAICS code 325 and
NAICS code 324110), approximately 98% of the firms would be classified
as small businesses under the default SBA definition. The SBA size
standard for 75% of this industry sector is 500 employees, and the size
standard for 23% of this industry sector is either 750, 1,000, or 1,500
employees. When assessing the potential impacts of test rules on
chemical manufacturers, EPA believes that a standard based on total
annual sales may provide a more appropriate means to judge the ability
of a chemical manufacturing firm to support chemical testing without
significant costs or burdens.
    EPA is currently determining what level of annual sales would
provide the most appropriate size cutoff with regard to various
segments of the chemical industry usually impacted by TSCA section 4(a)
test rules, but has not yet reached a determination. As stated in this
unit, therefore, the factual basis for the RFA determination for this
proposed rule is based on an analysis using the default SBA size
standards. Although EPA is not currently proposing to establish an
alternate definition for use in the analysis conducted for this
proposed rule, the analysis for this proposed rule also presents the
results of calculations using a standard based on total annual sales
(40 CFR 704.3). EPA is interested in receiving comments on whether the
Agency should consider establishing an alternate definition for small
business to use in the small entity impact analyses for future TSCA
section 4(a) test rules, and what size cutoff may be appropriate.
    SBA has developed 6-digit NAICS code-specific size standards based
on employment thresholds. These size standards range from 500 to 1,500
employees for the various 6-digit NAICS codes that are potentially
affected (Ref. 14). For a conservative estimate of the number of small
businesses affected by the HPV rules, the Agency uses an employment
threshold of less than 1,500 employees for all businesses regardless of
the NAIC-specific threshold to determine small business status.
    For each manufacturer of the 29 chemical substances covered by this

proposed rule, the parent company (ultimate corporate entity or UCE)
was identified and sales and employment data were obtained for
companies where data was publicly available. The search determined that
there were 54 affected UCEs. Sales and employment data could be found
for 52 of these UCEs (96%). Two companies could not be classified as
small or large because there were no employment data available, but
were still included in the small business impact analysis.
    Parent company sales data were collected to identify companies that
qualified as a ``small business'' for purposes of RFA analysis. Based
on the SBA size standard applied (1,500 employees or less), 21
companies (39%) were identified as small.
    The potential significance of this proposed rule's impact on small
businesses was analyzed by examining the number of small entities that
experienced different levels of costs as a percentage of their sales.
Small businesses were placed in the following categories on the basis
of cost-to sales ratios: Less than 1%, greater than 1%, and greater
than 3%. This analysis was conducted under both a least and average
cost scenario.
    Of the 21 businesses designated as small business, none had cost-
to-sales ratios of greater than 1% and 3% under both the least and
average cost scenarios. For the chemical substances where sales data
were unavailable, EPA used the median sales value sales of all other
small businesses equal to $24.7 million. The costs for the two
companies were estimated to be well below 1% of this sales level. Given
these results, the Agency has determined that there is not a
significant economic impact on a substantial number of small entities
as a result of this proposed rule, if finalized.
    The estimated cost of the TSCA section 12(b)(1) export
notification, which, as a result of the final rule, would be required
for the first export to a particular country of a chemical substance
subject to the final rule, is estimated to be $85.70 for the first time
that an exporter must comply with TSCA section 12(b)(1) export
notification requirements, and $26.86 for each subsequent export
notification submitted by that exporter (Refs. 14, 42, and 43). EPA has
concluded that the costs of TSCA section 12(b)(1) export notification
would have a negligible impact on exporters of the chemical substances
in the final rule, regardless of the size of the exporter.
    Any comments regarding the impacts that this action may impose on
small entities, or regarding whether the Agency should consider
establishing an alternate definition of small business to be used for
analytical purposes for future test rules and what size cutoff may be
appropriate, should be submitted to the Agency in the manner specified
under ADDRESSES.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), Public Law 104-4, EPA has determined that this proposed rule
does not contain a Federal mandate that may result in expenditures of
$100 million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. It is estimated that
the total aggregate costs of this proposed rule to the private sector,
which are summarized in Unit VI., would be $10.21 million. The total
annualized costs of this proposed rule to the private sector are
estimated to be $3.61 and 3.89 million using a 3% and 7% discount rate
over 3 years (average cost scenario). In addition, since EPA does not
have any information to indicate that any State, local, or tribal
government manufactures or processes the chemical substances covered by
this action such that the final rule would apply directly to State,
local, or tribal governments, EPA has determined that this proposed
rule would not significantly or uniquely affect small governments.
Accordingly, this proposed rule is not subject to the requirements of
sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

    Under Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined that this proposed rule does not
have ``federalism implications'' because it will not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in the Executive Order. This proposed rule would establish testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemical substances. Because EPA
has no information to indicate that any State or local government
manufactures or processes the chemical substances covered by this
action, this proposed rule does not apply directly to States and
localities and will not affect State and local governments. Thus,
Executive Order 13132 does not apply to this proposed rule.

F. Executive Order 13175

    Under Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has
determined that this proposed rule does not have tribal implications
because it will not have any affect on tribal governments, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in the Executive Order. As
indicated previously, EPA has no information to indicate that any
tribal government manufactures or processes the chemical substances
covered by this action. Thus, Executive Order 13175 does not apply to
this proposed rule.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997), because it does not
establish an environmental standard intended to mitigate health or
safety risks, will not have an annual effect on the economy of $100
million or more, nor does it otherwise have a disproportionate effect
on children. This proposed rule would establish testing and
recordkeeping requirements that apply to manufacturers (including
importers) and processors of certain chemical substances, and would
result in the development of data about those chemical substances that
can subsequently be used to assist the Agency and others in determining
whether the chemical substances in this proposed rule present potential
risks, allowing the Agency and others to take appropriate action to
investigate and mitigate those risks.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations that Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because it is unlikely to have any significant adverse effect on the
supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent

with applicable law or otherwise impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, and business practices) that are
developed or adopted by voluntary consensus standards bodies. The NTTAA
directs EPA to provide Congress, through OMB, explanations when the
Agency decides not to use available and applicable voluntary consensus
standards.
    This proposed rule involves technical standards because it proposes
to require the use of particular test methods. If the Agency makes
findings under TSCA section 4(a), EPA is required by TSCA section 4(b)
to include specific standards or test methods that are to be used for
the development of the data required in the test rules issued under
TSCA section 4. For some of the testing that would be required by the
final rule, EPA is proposing the use of voluntary consensus standards
issued by ASTM International and ISO which evaluate the same type of
toxicity as the TSCA 799 test guidelines and OECD test guidelines,
where applicable. Copies of the 17 ASTM International and ISO standards
referenced in the proposed regulatory text at Sec.  799.5089(h) have
been placed in the docket for this proposed rule. You may obtain copies
of the ASTM International standards from the American Society for
Testing and Materials International, 100 Bar Harbor Dr., West
Conshohocken, PA 19428-2959, and copies of the ISO standards from the
International Organization for Standardization, Case Postale, 56 CH-
1211 Gen[egrave]ve 20 Switzerland. In the final rule, EPA intends to
seek approval from the Director of the Federal Register for the
incorporation by reference of the ASTM International and ISO standards
used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.
    EPA is not aware of any potentially applicable voluntary consensus
standards which evaluate partition coefficient (n-octanol/water)
generator column, water solubility (column elution and generator
column), acute inhalation toxicity, bacterial reverse mutations, in
vivo mammalian bone marrow chromosomal aberrations, combined repeated
dose with reproductive/developmental toxicity screen, repeated dose 28-
day oral toxicity screen, or the reproductive developmental toxicity
screen which could be considered in lieu of the TSCA 799 test
guidelines, 40 CFR 799.6756, 799.6784, 799.6786, 799.9130, 799.9510,
799.9538, 799.9365, 799.9305, and 799.9355, respectively, upon which
the test standards in this proposed rule are based. The Agency invites
comment on the potential use of voluntary consensus standards in this
proposed rule, and, specifically, invites the public to identify
potentially applicable consensus standard(s) and to explain why such
standard(s) should be used here.

J. Executive Order 12898

    This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities that require special consideration by the Agency under
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). The Agency believes that
the information collected under this proposed rule, if finalized, will
assist EPA and others in determining the potential hazards and risks
associated with the chemical substances covered by this proposed rule.
Although not directly impacting environmental justice-related concerns,
this information will enable the Agency to better protect human health
and the environment, including in low-income and minority communities.

List of Subjects in 40 CFR Part 799

    Environmental protection, Chemicals, Hazardous substances,
Laboratories, Reporting and recordkeeping requirements.

    Dated: February 17, 2010.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 799-- IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND
MIXTURE TESTING REQUIREMENTS

    1. The authority citation for part 799 continues to read as
follows:

    Authority:  15 U.S.C. 2603, 2611, 2625.

    2. Add Sec.  799.5089 to subpart D of part 799 to read as follows:

Sec.  799.5089  Chemical testing requirements for certain high
production volume chemicals; third group of chemicals.

    (a) What substances will be tested under this section? Table 2 in
paragraph (j) of this section identifies the chemical substances that
must be tested under this section. For the chemical substances
identified as ``Class 1'' chemical substances in Table 2 in paragraph
(j) of this section, the purity of each chemical substance must be 99%
or greater, unless otherwise specified in this section. For the
chemical substances identified as ``Class 2'' chemical substances in
Table 2 in paragraph (j), a representative form of each chemical
substance must be tested. The representative form selected for a given
Class 2 chemical substance should meet industry or consensus standards
where they exist.
    (b) Am I subject to this section? (1) If you manufacture (including
import) or intend to manufacture, or process or intend to process, any
chemical substance listed in Table 2 in paragraph (j) of this section
at any time from the effective date of the final rule to the end of the
test data reimbursement period as defined in 40 CFR 791.3(h), you are
subject to this section with respect to that chemical substance.
    (2) If you do not know or cannot reasonably ascertain that you
manufacture or process a chemical substance listed in Table 2 in
paragraph (j) of this section during the time period described in
paragraph (b)(1) of this section (based on all information in your
possession or control, as well as all information that a reasonable
person similarly situated might be expected to possess, control, or
know, or could obtain without unreasonable burden), you are not subject
to this section with respect to that chemical substance.
    (c) If I am subject to this section, when must I comply with it?
(1) (i) Persons subject to this section are divided into two groups, as
set forth in Table 1 of this paragraph: Tier 1 (persons initially
required to comply) and Tier 2 (persons not initially required to
comply). If you are subject to this section, you must determine if you
fall within Tier 1 or Tier 2, based on Table 1 of this paragraph.

   Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
                                          Tier 2 (Persons not initially
 Tier 1 (Persons initially required to     required to comply with this
       comply with this section)                     section)
------------------------------------------------------------------------
Persons not otherwise specified in       Tier 2A. Persons who
 column 2 of this table that              manufacture (as defined at
 manufacture (as defined at TSCA          TSCA section 3(7)) or intend
 section 3(7)) or intend to manufacture   to manufacture a chemical
 a chemical substance included in this    substance included in this
 section.                                 section solely as one or more
                                          of the following:
                                         --As a byproduct (as defined at
                                          40 CFR 791.3(c));
                                         --As an impurity (as defined at
                                          40 CFR 790.3);
                                         --As a naturally occurring
                                          substance (as defined at 40
                                          CFR 710.4(b));
                                         --As a non-isolated
                                          intermediate (as defined at 40
                                          CFR 704.3);
                                         --As a component of a Class 2
                                          substance (as described at 40
                                          CFR 720.45(a)(1)(i));
                                         --In amounts of less than 500
                                          kilogram (kg) (1,100 lbs.)
                                          annually (as described at 40
                                          CFR 790.42(a)(4)); or
                                         --For research and development
                                          (as described at 40 CFR
                                          790.42(a)(5)).
                                         B. Persons who process (as
                                          defined at TSCA section 3(10))
                                          or intend to process a
                                          chemical substance included in
                                          this section (see 40 CFR
                                          790.42(a)(2)).
------------------------------------------------------------------------

    (ii) Table 1 of paragraph (c)(1)(i) of this section expands the
list of persons in Tier 2, that is those persons specified in Sec.
790.42(a)(2), (a)(4) and (a)(5) of this chapter, who, while legally
subject to this section, must comply with the requirements of this
section only if directed to do so by EPA under the circumstances set
forth in paragraphs (c)(4), (c)(5), (c)(6), (c)(7), and (c)(10) of this
section.
    (2) If you are in Tier 1 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you must, for each
test required under this section for that chemical substance, either
submit to EPA a letter of intent to test or apply to EPA for an
exemption from testing. The letter of intent to test or the exemption
application must be received by EPA no later than 30 days after the
effective date of the final rule.
    (3) If you are in Tier 2 with respect to a chemical substance
listed in Table 2 in paragraph (j) of this section, you are considered
to have an automatic conditional exemption and you will be required to
comply with this section with regard to that chemical substance only if
directed to do so by EPA under paragraphs (c)(5), (c)(7), or (c)(10) of
this section.
    (4) If no person in Tier 1 has notified EPA of its intent to
conduct one or more of the tests required by this section on any
chemical substance listed in Table 2 in paragraph (j) of this section
within 30 days after the effective date of the final rule, EPA will
publish a Federal Register document that would specify the test(s) and
the chemical substance(s) for which no letter of intent has been
submitted and notify manufacturers in Tier 2A of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
    (5) If you are in Tier 2A (as specified in Table 1 in paragraph (c)
of this section) with respect to a chemical substance listed in Table 2
in paragraph (j) of this section, and if you manufacture, or intend to
manufacture, this chemical substance as of [30 days after date of
publication of the final rule in the Federal Register], or within 30
days after publication of the Federal Register document described in
paragraph (c)(4) of this section, you must, for each test specified for
that chemical substance in the document described in paragraph (c)(4)
of this section, either submit to EPA a letter of intent to test or
apply to EPA for an exemption from testing. The letter of intent to
test or the exemption application must be received by EPA no later than
30 days after publication of the Federal Register document described in
paragraph (c)(4) of this section.
    (6) If no manufacturer in Tier 1 or Tier 2A has notified EPA of its
intent to conduct one or more of the tests required by this section on
any chemical substance listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(4) of this section, EPA will
publish another Federal Register document that would specify the
test(s) and the chemical substance(s) for which no letter of intent has
been submitted, and notify processors in Tier 2B of their obligation to
submit a letter of intent to test or to apply for an exemption from
testing.
    (7) If you are in Tier 2B (as specified in Table 1 in paragraph (c)
of this section) with respect to a chemical substance listed in Table 2
in paragraph (j) of this section, and if you process, or intend to
process, this chemical substance as of [30 days after date of
publication of the final rule in the Federal Register], or within 30
days after publication of the Federal Register document described in
paragraph (c)(6) of this section, you must, for each test specified for
that chemical substance in the Federal Register document described in
paragraph (c)(6) of this section, either submit to EPA a letter of
intent to test or apply to EPA for an exemption from testing. The
letter of intent to test or the exemption application must be received
by EPA no later than 30 days after publication of the Federal Register
document described in paragraph (c)(6) of this section.
    (8) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after the publication of the Federal Register
document described in paragraph (c)(6) of this section, EPA will notify
all manufacturers and processors of those chemical substances of this
fact by certified letter or by publishing a Federal Register document
specifying the test(s) for which no letter of intent has been
submitted. This letter or Federal Register document will additionally
notify all manufacturers and processors that all exemption applications
concerning the test(s) have been denied, and will give the
manufacturers and processors of the chemical substance(s) an
opportunity to take corrective action.
    (9) If no manufacturer or processor has notified EPA of its intent
to conduct one or more of the tests required by this section for any of
the chemical substances listed in Table 2 in paragraph (j) of this
section within 30 days after receipt of the certified letter or
publication of the Federal Register document described in paragraph
(c)(8) of this section, all manufacturers and processors subject to
this section with respect to that chemical substance who are not
already in violation of this

section will be in violation of this section.
    (10) If a problem occurs with the initiation, conduct, or
completion of the required testing or the submission of the required
data with respect to a chemical substance listed in Table 2 in
paragraph (j) of this section, under the procedures in Sec. Sec.
790.93 and 790.97 of this chapter, EPA may initiate termination
proceedings for all testing exemptions with respect to that chemical
substance and may notify persons in Tier 1 and Tier 2 that they are
required to submit letters of intent to test or exemption applications
within a specified period of time.
    (11) If you are required to comply with this section, but your
manufacture or processing of, or intent to manufacture or process, a
chemical substance listed in Table 2 in paragraph (j) of this section
begins after the applicable compliance date referred to in paragraphs
(c)(2), (c)(5), or (c)(6) of this section, you must either submit a
letter of intent to test or apply to EPA for an exemption. The letter
of intent to test or the exemption application must be received by EPA
no later than the day you begin manufacture or processing.
    (d)  What must I do comply with this section? (1) To comply with
this section you must either submit to EPA a letter of intent to test,
or apply to and obtain from EPA an exemption from testing.
    (2) For each test with respect to which you submit to EPA a letter
of intent to test, you must conduct the testing specified in paragraph
(h) of this section and submit the test data to EPA.
    (3) You must also comply with the procedures governing test rule
requirements in part 790 of this chapter, as modified by this section,
including the submission of letters of intent to test or exemption
applications, the submission of study plans prior to testing, the
conduct of testing, and the submission of data; Part 792--Good
Laboratory Practice Standards of this chapter; and this section. The
following provisions of 40 CFR part 790 do not apply to this section:
Paragraphs (a), (d), (e), and (f) of Sec.  790.45; Sec.  790.48;
paragraph (a)(2) and paragraph (b) of Sec.  790.80; paragraph (e)(1) of
Sec.  790.82; and Sec.  790.85.
    (e)  If I do not comply with this section, when will I be
considered in violation of it? You will be considered in violation of
this section as of 1 day after the date by which you are required to
comply with this section.
    (f)  How are EPA's data reimbursement procedures affected for
purposes of this section? If persons subject to this section are unable
to agree on the amount or method of reimbursement for test data
development for one or more chemical substances included in this
section, any person may request a hearing as described in 40 CFR part
791. In the determination of fair reimbursement shares under this
section, if the hearing officer chooses to use a formula based on
production volume, the total production volume amount will include
amounts of a chemical substance produced as an impurity.
    (g)  Who must comply with the export notification requirements? Any
person who exports, or intends to export, a chemical substance listed
in Table 2 in paragraph (j) of this section is subject to part 707,
subpart D, of this chapter.
    (h)  How must I conduct my testing? The tests that are required for
each chemical substance are indicated in Table 2 in paragraph (j) of
this section. The test methods that must be followed are provided in
Table 3 in paragraph (j) of this section. You must proceed in
accordance with these test methods as required according to Table 3 in
paragraph (j) of this section, or as appropriate if more than one
alternative is allowed according to Table 3 in paragraph (j) of this
section.
    (i)  Reporting requirements. A final report for each specific test
for each subject chemical substance must be received by EPA by [13
months after the effective date of the final rule] unless an extension
is granted in writing pursuant to 40 CFR 790.55. A robust summary of
the final report for each specific test shall be submitted
electronically in addition to and at the same time as the final report.
The term ``robust summary'' is used to describe the technical
information necessary to adequately describe an experiment or study and
includes the objectives, methods, results, and conclusions of the full
study report which can be either an experiment or in some cases an
estimation or prediction method. Guidance for the compilation of robust
summaries is described in a document entitled ``Draft Guidance on
Developing Robust Summaries'' which is available on-line at: http://
www.epa.gov/chemrtk/pubs/general/robsumgd.htm.
    (j)  Designation of specific chemical substances and testing
requirements. The chemical substances identified by chemical name,
Chemical Abstract Service Registry number (CAS No.), and class in Table
2 of this paragraph must be tested in accordance with the requirements
designated in Tables 2 and 3 of this paragraph, and the requirements
described in 40 CFR Part 792-Good Laboratory Practice Standards:

                             Table 2.--Chemical Substances and Testing Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                Required Tests  (See
               CAS No.                      Chemical Name                Class               Table 3 of this
                                                                                section)
----------------------------------------------------------------------------------------------------------------
83-41-0                                Benzene, 1,2-dimethyl-3- 1                         A1, A2, A3, A4, A5, D,
                                        nitro-                                            E2, F1
----------------------------------------------------------------------------------------------------------------
96-22-0                                3-Pentanone              1                         E1, F2
----------------------------------------------------------------------------------------------------------------
98-09-9                                Benzenesulfonyl          1                         C2, E1, E2, F1
                                        chloride
----------------------------------------------------------------------------------------------------------------
98-56-6                                Benzene, 1-chloro-4-     1                         A4, B, C1, F2
                                        (trifluoromethyl)-
----------------------------------------------------------------------------------------------------------------
111-44-4                               'Ethane, 1,1'-oxybis[2-  1                         C6, F1
                                        chloro-
----------------------------------------------------------------------------------------------------------------
127-68-4                               Benzenesulfonic acid, 3- 1                        A3, F2
                                        nitro-, sodium salt
                                        (1:1)
----------------------------------------------------------------------------------------------------------------
506-51-4                               1-Tetracosanol           1                         A2, A3, A4, A5, B, C1,
                                                                                D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
506-52-5                               1-Hexacosanol            1                         A2, A3, A4, A5, C1, D,
                                                                                E1, E2, F1
----------------------------------------------------------------------------------------------------------------
515-40-2                               Benzene, (2-chloro-1,1-  1                         A1, A3, A4, A5, B, C1,
                                        dimethylethyl)-                                   D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------

2494-89-5                              Ethanol, 2-[(4-          1                         A1, A2, A3, A4, A5, B,
                                        aminophenyl)sulfonyl]-                            C1, D, E1, E2, F1
                                        , 1-(hydrogen sulfate)
----------------------------------------------------------------------------------------------------------------
5026-74-4                              2-Oxiranemethanamine, N- 1                        A1, A2, A3, A4, A5, B,
                                        [4-(2-                                            C2, F1
                                        oxiranylmethoxy)phenyl
                                        ]-N-(2-oxiranylmethyl)-

----------------------------------------------------------------------------------------------------------------
22527-63-5                             Propanoic acid, 2-       1                        A1, A2, A3, A4, A5, B,
                                        methyl-, 3-                                       C1, D, E1, E2, F1
                                        (benzoyloxy)-2,2,4-
                                        trimethylpentyl ester
----------------------------------------------------------------------------------------------------------------
24615-84-7                             2-Propenoic acid, 2-     1                         A1, A2, A3, A4, A5, B,
                                        carboxyethyl ester                                C1, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
25321-41-9                             Benzenesulfonic acid,    1                        A2, A3, A4, A5, B, C1,
                                        dimethyl-                                         D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
25646-71-3                             Methanesulfonamide, N-   1                        A1, A2, A3, A4, A5, B,
                                        [2-[(4-amino-3-                                   C1, F1
                                        methylphenyl)ethylamin
                                        o]ethyl]-, sulfate
                                        (2:3)
----------------------------------------------------------------------------------------------------------------
52556-42-0                             1-Propanesulfonic acid,  1                         A1, A2, A3, A4, A5, B,
                                        2-hydroxy-3-(2-                                   C1, D, E1, E2, F1
                                        propenyloxy)-, sodium
                                        salt (1:1)
----------------------------------------------------------------------------------------------------------------
61788-76-9                             Alkanes, chloro          2                        A2, A3, A4, A5, B,
----------------------------------------------------------------------------------------------------------------
65996-79-4                             Solvent naphtha (coal)   2                        A3, A4, A5, B, C1, D,
                                                                                E1, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-82-9                             Tar oils, coal           2                        A3, A4, A5, B, C1, D,
                                                                                E1, E2, F1
----------------------------------------------------------------------------------------------------------------
65996-89-6                             Tar, coal, high-         2                        A4, A5, B, C1, D, E1,
                                        temperature                                       E2, F1
----------------------------------------------------------------------------------------------------------------
65996-92-1                             Distillates (coal tar)   2                        A3, A4, A5, B, C1, D,
                                                                                E1, E2, F2
----------------------------------------------------------------------------------------------------------------
68082-78-0                             Lard, oil, Me esters     2                        A1, A2, A3, A4, A5, B,
                                                                                C1, D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
68187-57-5                             Pitch, coal tar-         2                        A4, A5, B, C6, D, E1,
                                        petroleum                                         E2, F1
----------------------------------------------------------------------------------------------------------------
68442-60-4                             Acetaldehyde, reaction   2                        A1, A2, A3, A4, A5, B,
                                        products with                                     C1, D, E1, E2, F1
                                        formaldehyde, by-
                                        products from
----------------------------------------------------------------------------------------------------------------
68610-90-2                             2-Butenedioic acid (2E)- 2                        A1, A2, A3, A4, A5, B,
                                        , di-C8-18-alkyl                                  C1, D, E1, E2, F1
                                        esters
----------------------------------------------------------------------------------------------------------------
68988-22-7                             1,4-Benzenedicarboxylic  2                        A1, A2, A3, A4, A5, B,
                                        acid, 1,4-dimethyl                                C1, D, E1, E2, F1
                                        ester, manuf. of, by-
                                        products from
----------------------------------------------------------------------------------------------------------------
70693-50-4                             Phenol, 2,4-bis(1-       1                        A1, A2, A3, A4, A5, B,
                                        methyl-1-phenylethyl)-                            C1, D, E1, E2, F1
                                        6-[2-(2-
                                        nitrophenyl)diazenyl]-
----------------------------------------------------------------------------------------------------------------
72162-15-3                             1-Decene, sulfurized     2                         A2, A3, A4, A5, B, C1,
                                                                                D, E1, E2, F1
----------------------------------------------------------------------------------------------------------------
73665-18-6                             Extract residues         2                         A2, A3, A4, A5, B, C1,
                                        (coal), tar oil alk.,                             D, E1, E2, F1
                                        naphthalene distn.
                                        residues
----------------------------------------------------------------------------------------------------------------

       Table 3.--Key to the Test Requirements Denoted by Alphanumeric Symbols in Table 2 of This Paragraph
----------------------------------------------------------------------------------------------------------------
                                                                Test Requirements and
          Testing Category                      Test                  References           Special Conditions
----------------------------------------------------------------------------------------------------------------
Physical/Chemical Properties          A                        1. Melting Point: ASTM   n-Octanol/Water
                                                                E 324-99 (capillary      Partition Coefficient
                                                                tube)                    or log Kow:
                                                               2. Boiling Point: ASTM   Which method is
                                                                E 1719-05                required, if any, is
                                                                (ebulliometry).          determined by the test
                                                               3. Vapor Pressure: ASTM   substance's estimated
                                                                E 1782-03 (thermal       \i\ log Kow as follows:
                                                                analysis).              log Kow < 0: no testing
                                                               4. n-Octanol/Water        required.
                                                                Partition Coefficient   log Kow range 0-1:
                                                                (log 10 basis) or log    Method A or B.
                                                                Kow: (See Special       log Kow range > 1-4:
                                                                Conditions for the log   Method A or B or C.
                                                                Kow test requirement    log Kow range > 4-6:
                                                                and select the           Method B or C.
                                                                appropriate method to   log Kow > 6: Method C.
                                                                use, if any, from       Test sponsors must
                                                                those listed in this     provide in the final
                                                                column.).                study report the
                                                                Method A: 40 CFR         underlying rationale
                                                                799.6755 (shake flask).  for the method and pH
                                                                Method B: ASTM E 1147-   selected. In order to
                                                                92(2005) (liquid         ensure environmental
                                                                chromatography).         relevance, EPA highly
                                                                Method C: 40 CFR         recommends that the
                                                                799.6756 (generator      selected study be
                                                                column).                 conducted at pH 7.
                                                               5. Water Solubility:     Water Solubility:
                                                                (See Special            Which method is
                                                                Conditions for the       required, if any, is
                                                                water solubility test    determined by the test
                                                                requirement and select   substance's estimated
                                                                the appropriate method   \ii\ water solubility.
                                                                to use, if any, from     Test sponsors must
                                                                those listed in this     provide in the final
                                                                column.).                study report the
                                                                Method A: ASTM E 1148-   underlying rationale
                                                                02 (shake flask).        for the method and pH
                                                                Method B: 40 CFR         selected. In order to
                                                                799.6784 (shake flask).  ensure environmental
                                                                Method C: 40 CFR         relevance, EPA highly
                                                                799.6784 (column         recommends that the
                                                                elution).                selected study be
                                                                Method D: 40 CFR         conducted starting at
                                                                799.6786 (generator      pH 7.
                                                                column).                > 5,000 mg/L: Method A
                                                                                or B.
                                                                                > 10 mg/L--5,000 mg/L:
                                                                                Method A, B, C, or D.
                                                                                > 0.001 mg/L--10 mg/L:
                                                                                Method C or D.
                                                                                <= 0.001 mg/L: no
                                                                                testing required.
----------------------------------------------------------------------------------------------------------------
Environmental Fate and Pathways--     B                        For B, consult ISO       Which method is
 Ready Biodegradation                                           10634 for guidance,      required, if any, is
                                                                and choose one of the    determined by the test
                                                                methods listed in this   substance's physical
                                                                column:                  and chemical
                                                               1. ASTM 1720-01 (sealed   properties, including
                                                                vessel CO2 production    its water solubility.
                                                                test).                   ISO 10634 provides
                                                                OR....................   guidance for selection
                                                               2. ISO 14593 (CO2         of an appropriate test
                                                                headspace test).         method for a given test
                                                                OR....................   substance. Test
                                                               3. ISO 7827 (analysis     sponsors must provide
                                                                of DOC).                 in the final study
                                                                OR....................   report the underlying
                                                               4. ISO 9408               rationale for the
                                                                (determination of        method selected.
                                                                oxygen demand in a
                                                                closed respirometer).
                                                                OR....................
                                                               5. ISO 9439 (CO2
                                                                evolution test).
                                                                OR....................
                                                               6. ISO 10707 (closed
                                                                bottle test).
                                                                OR....................
                                                               7. ISO 10708 (two-phase
                                                                closed bottle test).
----------------------------------------------------------------------------------------------------------------
Aquatic Toxicity                      C1                       For C1, Test Group 1 or  The following are the
                                                                Test Group 2 listed in   Special Conditions for
                                                                this column must be      C1, C2, C3, C4, C5, and
                                                                used to fulfill the      C7 testing; there are
                                                                testing requirements--   no Special Conditions
                                                                see Special              for C6. Which test
                                                                Conditions.              group is required is
                                                               Test Group 1 for C1:...   determined by the test
                                                               1. Acute Toxicity To      substance's measured
                                                                Fish: ASTM E 729-        log KOW as obtained
                                                                96(2002).                under Test Category A,
                                                               2. Acute Toxicity To      or using an existing
                                                                Daphnia: ASTM E 729-     measured log KOW. \iii\
                                                                96(2002).               If log Kow < 4.2: Test
                                                               3. Toxicity To Plants     Group 1 is required.
                                                                (Algae): ASTM E 1218-   If log Kow >= 4.2: Test
                                                                04e1.                    Group 2 is required.
                                                               Test Group 2 for C1:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------

                                      C2                       For C2, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions..
                                                               Test Group 1 for C2:...
                                                               1. Acute Toxicity To
                                                                Daphnia: ASTM E 729-
                                                                96(2002).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                                               Test Group 2 for C2:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------
                                      C3                       For C3, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C3:...
                                                               1. Acute Toxicity To
                                                                Fish: ASTM E 729-
                                                                96(2002).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                                               Test Group 2 for C3:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. Toxicity To Plants
                                                                (Algae): ASTM E 1218-
                                                                04e1.
                                     --------------------------------------------------
                                      C4                       For C4, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C4:...
                                                               1. Acute Toxicity To
                                                                Fish: ASTM E 729-
                                                                96(2002).
                                                               2. Acute Toxicity To
                                                                Daphnia: ASTM E 729-
                                                                96(2002).
                                                               Test Group 2 for C4:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. [Reserved]..........
                                     --------------------------------------------------
                                      C5                       For C5, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C5:...
                                                               1. Acute Toxicity To
                                                                Daphnia: ASTM E 729-
                                                                96(2002).
                                                               2. [Reserved]..........
                                                               Test Group 2 for C5:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. [Reserved]..........
                                     --------------------------------------------------
                                      C6                       Toxicity To Plants       ........................
                                                                (Algae): ASTM E 1218-
                                                                04e1
                                     --------------------------------------------------

                                      C7                       For C7, Test Group 1 or  ........................
                                                                Test Group 2 listed in
                                                                this column must be
                                                                used to fulfill the
                                                                testing requirements--
                                                                see Special
                                                                Conditions.
                                                               Test Group 1 for C7:...
                                                               1. Acute Toxicity To
                                                                Fish: ASTM E 729-
                                                                96(2002).
                                                               2. [Reserved]..........
                                                               Test Group 2 for C7:...
                                                               1. Chronic Toxicity To
                                                                Daphnia: ASTM E 1193-
                                                                97(2004).
                                                               2. [Reserved]..........
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Acute             D                        See Special Conditions   Which testing method is
                                                                for this test            required is determined
                                                                requirement and select   by the test substance's
                                                                the method that must     physical state at room
                                                                be used from those       temperature (25[deg]C).
                                                                listed in this column.   For those test
                                                               Method A: Acute           substances that are
                                                                Inhalation Toxicity      gases at room
                                                                (rat): 40 CFR 799.9130.  temperature, Method A
                                                               Method B: EITHER:......   is required; otherwise,
                                                               1. Acute (Up/Down) Oral   use either of the two
                                                                Toxicity (rat): ASTM E   methods listed under
                                                                1163-98(2002).           Method B.
                                                                OR....................  In Method B, 40 CFR
                                                               2. Acute (Up/Down) Oral   799.9110(d)(1)(i)(A)
                                                                Toxicity (rat): 40 CFR   refers to the OECD 425
                                                                799.9110(d)(1)(i)(A).    Up/Down Procedure. \iv\
                                                                                Estimating starting dose
                                                                                for Method B: Data from
                                                                                the neutral red uptake
                                                                                basal cytotoxicity
                                                                                assay \v\ using normal
                                                                                human keratinocytes or
                                                                                mouse BALB/c 3T3 cells
                                                                                may be used to estimate
                                                                                the starting dose.
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Genotoxicity      E1                       Bacterial Reverse        None
                                                                Mutation Test (in
                                                                vitro): 40 CFR
                                                                799.9510
                                     ---------------------------------------------------------------------------
                                      E2                       Conduct any one of the   Persons required to
                                                                following three tests    conduct testing for
                                                                for chromosomal          chromosomal damage are
                                                                damage:                  encouraged to use the
                                                               In vitro Mammalian        in vitro Mammalian
                                                                Chromosome Aberration    Chromosome Aberration
                                                                Test: 40 CFR 799.9537.   Test (40 CFR 799.9537)
                                                                OR....................   to generate the needed
                                                               Mammalian Bone Marrow     data unless known
                                                                Chromosomal Aberration   chemical properties
                                                                Test (in vivo in         (e.g., physical/
                                                                rodents: mouse           chemical properties,
                                                                (preferred species),     chemical class
                                                                rat, or Chinese          characteristics)
                                                                hamster): 40 CFR         preclude its use. A
                                                                799.9538.                subject person who uses
                                                                OR....................   one of the in vivo
                                                               Mammalian Erythrocyte     methods instead of the
                                                                Micronucleus Test        in vitro method to
                                                                [sampled in bone         address a chromosomal
                                                                marrow] (in vivo in      damage test requirement
                                                                rodents: mouse           must submit to EPA a
                                                                (preferred species),     rationale for
                                                                rat, or Chinese          conducting that
                                                                hamster): 40 CFR         alternate test in the
                                                                799.9539.                final study report.
----------------------------------------------------------------------------------------------------------------
Mammalian Toxicity--Repeated Dose/    F1                       Combined Repeated Dose   Where F1 is required,
 Reproduction/Developmental                                     Toxicity Study with      EPA recommends use of
                                                                the Reproduction/        the Combined Repeated
                                                                Developmental Toxicity   Dose Toxicity Study
                                                                Screening Test: 40 CFR   with the Reproduction/
                                                                799.9365                 Developmental Toxicity
                                                                OR....................   Screening Test (40 CFR
                                                               Reproduction/             799.9365). However,
                                                                Developmental Toxicity   there may be valid
                                                                Screening Test: 40 CFR   reasons to test a
                                                                799.9355.                particular chemical
                                                                AND...................   using both 40 CFR
                                                               Repeated Dose 28-Day      799.9355 and 40 CFR
                                                                Oral Toxicity Study in   799.9305 to fill
                                                                rodents: 40 CFR          Mammalian Toxicity--
                                                                799.9305.                Repeated Dose/
                                                                                Reproduction/
                                                                                Developmental data
                                                                                needs. A subject person
                                                                                who uses the
                                                                                combination of 40 CFR
                                                                                799.9355 and 40 CFR
                                                                                799.9305 in place of 40
                                                                                CFR 799.9365 must
                                                                                submit to EPA a
                                                                                rationale for
                                                                                conducting these
                                                                                alternate tests in the
                                                                                final study reports.
                                                                                Where F2 or F3 is
                                                                                required, no rationale
                                                                                for conducting the
                                                                                required test need be
                                                                                provided in the final
                                                                                study report.
                                     --------------------------------------------------
                                      F2                       Reproduction/            ........................
                                                                Developmental Toxicity
                                                                Screening Test: 40 CFR
                                                                799.9355
                                     --------------------------------------------------
                                      F3                       Repeated Dose 28-Day     ........................
                                                                Oral Toxicity Study in
                                                                rodents: 40 CFR
                                                                799.9305
----------------------------------------------------------------------------------------------------------------
i. EPA recommends, but does not require, that log KOW be quantitatively estimated prior to initiating this
  study. One method, among many similar methods, for estimating log KOW is described in the article entitled
  ``Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients'' by W.M. Meylan and
  P.H. Howard in the Journal of Pharmaceutical Sciences. 84(1):83-92. January 1992. This reference is available
  under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located
  at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
  legal holidays.

ii. EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating
  this study. One method, among many similar methods, for estimating water solubility is described in the
  article entitled ``Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient''
  by W.M. Meylan, P.H. Howard, and R.S. Boethling in Environmental Toxicology and Chemistry. 15(2):100-106.
  1996. This reference is available under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm.
  3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30
  p.m., Monday through Friday, excluding legal holidays.
iii. Chemical substances that are dispersible in water may have log Kow values greater than 4.2 and may still be
  acutely toxic to aquatic organisms. Test sponsors who wish to conduct Test Group 1 studies on such chemical
  substances may request a modification to the test standard as described in 40 CFR 790.55. Based upon the
  supporting rationale provided by the test sponsor, EPA may allow an alternative threshold or method be used
  for determining whether acute or chronic aquatic toxicity testing be performed for a specific substance.
iv. The OECD 425 Up/Down Procedure, revised by OECD test guidelines in December 2001, is available under docket
  ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket Center, Rm. 3334 in the EPA West Bldg. located at 1301
  Constitution Ave., NW., Washington, DC, from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
  holidays.
v. The neutral red uptake basal cytotoxicity assay, which may be used to estimate the starting dose for the
  mammalian toxicity-acute endpoint, is available under docket ID number EPA-HQ-OPPT-2007-0531 at the EPA Docket
  Center, Rm. 3334 in the EPA West Bldg. located at 1301 Constitution Ave., NW., Washington, DC, from 8:30 a.m.
  to 4:30 p.m., Monday through Friday, excluding legal holidays.

    (k) Effective date. This section is effective on [30 days after
date of publication of the final rule in the Federal Register].

[FR Doc. 2010-3734 Filed 2-24-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Proposed Rules]
[Pages 47144-47146]
[FR Doc No: 2022-16451]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0986; Project Identifier MCAI-2021-01440-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2000-20-15, which applies to certain Airbus SAS Model A300 and A300-600
series airplanes. AD 2000-20-15 requires a high frequency eddy current
(HFEC) inspection to detect cracking of the rear fittings of fuselage
frame FR40 at stringer 27, and repetitive inspections or repair, as
applicable. In lieu of accomplishing the repetitive inspections, AD
2000-20-15 provides a modification that would allow the inspection to
be deferred for a certain period of time. This AD was prompted by
cracking of the rear fittings of fuselage frame FR40 at stringer 27,
and a determination that reduced compliance times are necessary. This
proposed AD would continue to require the actions in AD 2000-20-15, but
at reduced compliance times, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is proposed for incorporation by
reference. This proposed AD would also remove airplanes from the
applicability. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by September
16, 2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov.
Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket at www.regulations.gov by searching for and locating Docket No.
FAA-2022-0986.

Examining the AD Docket

    You may examine the AD docket at www.regulations.gov by searching
for and locating Docket No. FAA-2022-0986; or in person at Docket
Operations between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The AD docket contains this NPRM, the mandatory
continuing airworthiness information (MCAI), any comments received, and
other information. The street address for Docket Operations is listed
above.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0986; Project Identifier
MCAI-2021-01440-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
www.regulations.gov, including any personal information you provide.
The agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Dan
Rodina, Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected]. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Background

    The FAA issued AD 2000-20-15, Amendment 39-11926 (65 FR 60349,
October 11, 2000) (AD 2000-20-15), for certain Airbus SAS Model A300
and A300-600 series airplanes. AD 2000-20-15 requires a high frequency
eddy current (HFEC) inspection to detect cracking of the rear fittings
of fuselage frame FR40 at stringer 27, and repetitive inspections or
repair, as applicable. In lieu of accomplishing the repetitive
inspections, AD 2000-20-15 specifies a modification that would allow
the inspection to be deferred for a certain period of time. The FAA
issued AD 2000-20-15 to address fatigue cracking of the rear fittings
of fuselage frame FR40 at stringer 27, which could result in reduced
structural integrity of the airplane.

Actions Since AD 2000-20-15 Was Issued

    Since the FAA issued AD 2000-20-15, the average flight time (AFT)
of Model A300-600 airplanes has changed. It was determined that the
existing inspection compliance times must be reduced.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued AD 2021-0288, dated December 21, 2021 (EASA
AD 2021-0288) (also referred to as the MCAI), to correct an unsafe
condition for all

Airbus SAS Model A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-103, B4-120, B4-
203, B4-220, C4-203, and F4-203 airplanes; and certain Airbus SAS Model
A300 B4-603, B4-622, and B4-622R airplanes; Model A300 B4-605R series
airplanes; Model C4-620 airplanes; and Model F4-605R airplanes. Model
A300 B4-120, B4-220, C4-203, C4-620, and F4-203 airplanes are not
certificated by the FAA and are not included on the U.S. type
certificate data sheet; this proposed AD therefore does not include
those airplanes in the applicability.
    This proposed AD was prompted by cracking of the rear fittings of
fuselage frame FR40 at stringer 27, and a determination that reduced
compliance times are necessary. The FAA is proposing this AD to address
fatigue cracking of the rear fittings of fuselage frame FR40 at
stringer 27, which could result in reduced structural integrity of the
airplane. See the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0288 specifies procedures for repetitive inspections
of the rear fittings of fuselage frame FR40 at stringer 27 for
cracking, and repair of any cracking. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this NPRM after determining that
the unsafe condition described previously is likely to exist or develop
in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would retain all of the requirements of AD 2000-
20-15, but would reduce the compliance times and remove airplanes from
the applicability. This proposed AD would require accomplishing the
actions specified in EASA AD 2021-0288 described previously, except for
any differences identified as exceptions in the regulatory text of this
proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0288 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0288 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0288 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0288. Service information required by EASA AD 2021-0288 for compliance
will be available at www.regulations.gov by searching for and locating
Docket No. FAA-2022-0986 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 67 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                              Cost per          Cost on U.S.
              Action                      Labor cost         Parts cost        product           operators
----------------------------------------------------------------------------------------------------------------
Inspection........................  6 work-hours x $85                 $0            $510  $34,170, per
                                     per hour = $510.                                       inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary repair
that would be required based on the results of any required inspection.
The FAA has no way of determining the number of aircraft that might
need this repair:

                                     Estimated Costs of On-Condition Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                                  Labor cost                                       Parts cost        product
----------------------------------------------------------------------------------------------------------------
31 work-hours x $85 per hour = $2,635.........................................            $132           $2,767
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2000-20-15, Amendment 39-11926
(65 FR 60349, October 11, 2000); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2022-0986; Project Identifier MCAI-2021-
01440-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by September 16, 2022.

(b) Affected ADs

    This AD replaces AD 2000-20-15, Amendment 39-11926 (65 FR 60349,
October 11, 2000) (AD 2000-20-15).

(c) Applicability

    This AD applies to Airbus SAS airplanes identified in paragraphs
(c)(1) through (4) of this AD, certificated in any category, as
specified in European Union Aviation Safety Agency (EASA) AD 2021-
0288, dated December 21, 2021 (EASA AD 2021-0288).
    (1) Model A300 B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and B4-203
airplanes.
    (2) Model A300 B4-603 and B4-622 airplanes.
    (3) Model A300 B4-605R and B4-622R airplanes.
    (4) Model A300 F4-605R airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by cracking of the rear fittings of
fuselage frame FR40 at stringer 27, and a determination that reduced
compliance times are necessary. The FAA is issuing this AD to
address fatigue cracking of the rear fittings of fuselage frame FR40
at stringer 27, which could result in reduced structural integrity
of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraphs (h) and (i) of this AD: Comply
with all required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0288.

(h) Exceptions to EASA AD 2021-0288

    (1) Where paragraph (1) of EASA AD 2021-0288 specifies, for
certain conditions, using the compliance time and repetitive
intervals ``in the applicable SB,'' and where ``the applicable SB''
specifies that the ``1st inspection will be done within [a specified
number of flight cycles] after receipt of the Service Bulletin,''
this AD requires compliance within the specified number of flight
cycles after the effective date of this AD.
    (2) Where EASA AD 2021-0288 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) The ``Remarks'' section of EASA AD 2021-0288 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-0288
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Additional FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k)(2) of
this AD. Information may be emailed to: [email protected].
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.

(k) Related Information

    (1) For EASA AD 2021-0288, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. This material may be found in the AD docket at
www.regulations.gov by searching for and locating Docket No. FAA-
2022-0986.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

    Issued on July 27, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-16451 Filed 8-1-22; 8:45 am]
BILLING CODE 4910-13-P