February 17, 2010

SUBJECT:  Minutes from Meeting with the Society of Chemical Manufactures
and a Number of Their Member Companies Regarding the Definition of Solid
Waste Final Rule and the Current CERCLA 108(b) Rulemaking Effort

FROM:  Matt Straus, Advisor to Assistant Administrator of OSWER

TO:  DSW and CERCLA 108(b) Dockets

On February 12, staff from the Society of Chemical Manufacturers (SOCMA)
and representatives of a number of their member companies had a
conference call with Mathy Stanislaus, Assistant Administrator for the
Office of Solid Waste and Emergency Response (OSWER) and Barry Breen and
Lisa Feldt, Deputy Assistant Administrators to OSWER to discuss the
definition of solid waste (DSW) final rule (which was promulgated on
October 30, 2008) and the current rulemaking effort for determining
financial responsibility requirements under the section 108(b) of the
Comprehensive Emergency Response, Compensation, and Liability Act
(CERCLA).  Also on the call were representatives for the Office of
Resource Conservation and Recovery (ORCR) within OSWER, the Office of
General Counsel, and the Office of Enforcement and Compliance Assurance.
  This note briefly describes what was discussed during the conference
call.

	Initially, SOCMA described who they are and represent, and generally
how their member companies operate.  They noted that they have
approximately 300 member companies, of which about 70 percent are small
businesses, and thus, one of the themes of their discussions reflected
upon the impact of these rulemaking efforts on small businesses.

Definition of Solid Waste

SOCMA indicated that they have worked closely with staff in ORCR,
previously known as the Office of Solid Waste, since the early 1990s in
order that the DSW final rule would produce environmental benefits from
increased recycling, while at the same time save costs to small
businesses.  As part of those discussions, SOCMA stated that it was
their suggestion, in part, that tolling arrangements be considered
differently from third party transactions.

SOCMA stated that environmental justice was a major focus at the public
hearing that was held on June 30, 2009 on the definition of solid waste,
and indicated that while environmental justice “deserves it due,”
they also said that holding up this reform effort is a significant issue
for industry.

At that point, Mathy Stanislaus indicated that while he is a strong
supporter of recycling and reuse, he also noted that the Agency needs to
take a hard look at environmental justice in this rule, to ensure that
no unintended consequences will occur.  He also asked SOCMA staff and
their member companies whether they had any comments on the U.S.
Environmental Protection Agency’s (EPA’s) recently released “Draft
Environmental Justice Methodology for the Definition of Solid Waste
Rule,” which is EPA’s draft plan for conducting a more robust
analysis on the environmental justice impacts to the final rule.

SOCMA and their members did not have any immediate reaction to the draft
environmental justice methodology, but did indicate that they would like
this analysis to be conducted/completed as quickly as possible, and that
the Agency reach resolution of Sierra Club’s administrative petition
to the DSW final rule in a relatively quick timeframe.  Specifically,
they indicated their view that as long as EPA was conducting this
analysis and considering Sierra Club’s administrative petition, the
states will likely not adopt the rule because of its uncertainty, and
instead will wait to see if EPA will be making any changes to the DSW
final rule.  (Note:  SOCMA stated that it recognizes that the DSW final
rule is in effect and that the states can adopt the rule now, but
expressed concern that as long as this additional analysis is underway,
that the States will be reluctant to adopt the rule.)

One suggestion that SOCMA did make was for EPA to signal to the states
that the part of the rule that deals with “under the control of the
generator,” that the states could go ahead with authorization with
this portion of the final rule since there is less uncertainty with this
aspect of the final rule.  Specifically, it was noted in EPA’s May 27,
2009 Federal Register notice in which EPA announced the June 30, 2009
public meeting, that EPA is not likely to repeal the exclusion for
hazardous secondary materials reclaimed under the control of the
generator—see 74 FR 25202 where it states, “Because the final
revisions to the definition of solid waste are closely tied to EPA’s
interpretation of the concept of “discard,” EPA does not plan to
repeal the rule in whole or stay its implementation.  Such an action
could result in hazardous secondary materials that are not discarded
from being regulated as hazardous waste.  In particular, EPA does not
expect to repeal either the exclusion for hazardous secondary materials
reclaimed under the control of the generator or the non-waste
determination petition process.”

SOCMA stated that they believe this could be done without going through
any rulemaking process, but could be done through outreach to the states
to remind them that this portion of the final rule is unlikely to
change.

Finally, it was noted to SOCMA and its member companies that the
environmental justice analysis will be conducted for the entire rule,
including those hazardous secondary materials that are reclaimed under
the control of the generator.  Thus, it was suggested that SOCMA may
want to submit comments on the draft methodology, particularly if they
thought that the analysis should be different for those hazardous
secondary materials reclaimed under the control of the generator. SOCMA
indicated that they will look at this, and will get comments to the
Agency before the end of the comment deadline of March 15, 2010.

CERCLA 108(b)

SOCMA first discussed the letter they co-signed with the American
Chemistry Council and other organizations, which was sent to EPA in the
fall of 2009 and before EPA published its Advance Notice of Proposed
Rulemaking regarding additional classes of facilities that the Agency
will evaluate regarding the development of financial responsibility
requirements under CERCLA 108(b).

 Among other things, SOCMA stated that the letter indicated that CERCLA
108(b) looks at prospective risks and that past practices is not a
reliable indicator of what will happen in the future—they stated that
the world in the 1980’s and before is much different from the world in
the 1990’s and later and that needs to be considered in determining
whether financial responsibility requirements are appropriate.  SOCMA
also stated that since many of their members are small businesses, such
a rule could have a significant impact on SOCMA’s members.  (See
attached letter for additional arguments made in the letter.)

Then one of SOCMA’s member companies—Rhodia, discussed their
experience with their facilities, many of which they said they acquired
through acquisition, in the State of New Jersey, that already has a rule
requiring financial responsibility.  They also stated that they used to
have five facilities in the State of New Jersey, but no longer have any
facilities.

One of the primary arguments Rhodia made was that to be competitive in
the world today, they need to make quality products, and that
environmental costs come off the bottom line.  Thus, Rhodia said that if
all their facilities needed financial responsibility, it could make them
less competitive, particularly if in addition to putting aside funds for
financial responsibility, they also needed to pay fees that the states
may impose.

In response to an EPA question on the types of financial responsibility
mechanisms they used, Rhodia indicated that if corporate guarantee was
allowed, they thought that would be helpful, but they did indicate that
with the one facility in New Jersey that they discussed, the facility
did not qualify for a corporate guarantee, and thus, they needed to get
a letter of credit.   They also indicated that if the facility already
had financial responsibility requirements in place, that it would be
helpful if that could be used and not have the CERCLA 108(b) requirement
be in addition to those requirements already in place.

At the end, Mathy Stanislaus indicated that he would like to set up a
face-to face discussion on CERCLA 108(b), at the appropriate
time—probably, after the close of the comment period to the ANPRM, so
that he can better understand the points raised by SOCMA and their
member companies, such as why they view past history as not being a good
indicator of future actions, and their views on the impact such a
requirement would have on small businesses.

 EPA notes that while the FR notice cited by SOCMA says that EPA does
not expect to repeal the “generator-controlled exclusion,” this
should not be interpreted as saying that EPA will not make changes that
may impact this exclusion.  On the contrary, a number of the possible
changes discussed in the FR notice (e.g., definition of “contained,”
notification as a possible condition, and definition of “legitimacy”
would affect the “generator-controlled exclusion.”  See 74 FR
25202-25204.


[Federal Register Volume 81, Number 176 (Monday, September 12, 2016)]
[Proposed Rules]
[Pages 62668-62672]
[FR Doc No: 2016-21145]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0059; Directorate Identifier 2013-NM-075-AD]
RIN 2120-AA64

Airworthiness Directives; Embraer S.A. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for certain Embraer S.A. Model ERJ 170 airplanes. The NPRM
proposed to supersede AD 2012-07-08, which requires revising the
maintenance or inspection program to incorporate structural inspection
requirements. The NPRM was prompted by a determination that more
restrictive maintenance requirements and airworthiness limitations are
necessary. Since the NPRM was issued, a new revision of the
airworthiness limitations section (ALS) of the EMBRAER S.A. ERJ 170/175
Maintenance Review Board Report (MRBR) was issued, which contains more
restrictive airworthiness limitations. This action revises the NPRM by
proposing to require revising the maintenance or inspection program, as
applicable, to incorporate the new ALS of the MRBR. This supplemental
NPRM (SNPRM) would also remove certain airplanes from the
applicability. In addition, we propose to supersede AD 2006-06-09, AD
2012-05-08, and AD 2012-07-08, which require tasks that are now
included in the new revision of the MRBR. We are proposing

this SNPRM to detect and correct fatigue cracking of various principal
structural elements; such cracking could result in reduced structural
integrity of the airplane. We are also proposing this SNPRM to prevent
safety-significant latent failures; such failures, in combination with
one or more other specified failures or events, could result in a
hazardous or catastrophic failure condition of avionics, hydraulic
systems, fire detection systems, fuel systems, or other critical
systems. In addition, we are also proposing this SNPRM to prevent the
potential for ignition sources inside fuel tanks caused by latent
failures, alterations, repairs, or maintenance actions; such failures,
in combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane. Since these actions
impose an additional burden over those proposed in the NPRM, we are
reopening the comment period to allow the public the chance to comment
on these proposed changes.

DATES: We must receive comments on this SNPRM by October 27, 2016.

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 http://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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Embraer S.A., Technical Publications Section (PC 060), Av. Brigadeiro
Faria Lima, 2170--Putim--12227-901 S[atilde]o Jose dos Campos--SP--
BRASIL; telephone +55 12 3927-5852 or +55 12 3309-0732; fax +55 12
3927-7546; email<EMAIL_ADDRESS>Internet http://www.flyembraer.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0059; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Ana Martinez Hueto, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0059;
Directorate Identifier 2013-NM-075-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued a NPRM to amend 14 CFR part 39 by adding an AD that would
apply to all Embraer S.A. Model ERJ 170 airplanes. The NPRM published
in the Federal Register on February 27, 2014 (79 FR 11013) (``the
NPRM''). The NPRM was prompted by a determination that more restrictive
maintenance requirements and airworthiness limitations were necessary.
The NPRM proposed to require a revision to the maintenance or
inspection program to incorporate new inspections.

Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, a new revision to the ALS of the EMBRAER
S.A. ERJ 170/175 MRBR was issued, which contains more restrictive
airworthiness limitations. The Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC), which is the aviation authority for
Brazil, has issued Brazilian Airworthiness Directive 2015-06-01,
effective June 2, 2015 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition on certain Embraer S.A. Model ERJ 170 airplanes. The
MCAI states:

    This [Brazilian] AD was prompted by a new revision to the
airworthiness limitations of the Maintenance Review Board Report.
This [Brazilian] AD is being issued to ensure that fatigue cracking
of various principal structural elements is detected and corrected;
such fatigue cracking, could adversely affect the structural
integrity of these airplanes.

The required action is revising the maintenance or inspection program,
as applicable, to incorporate the airworthiness limitations in Appendix
A--``Airworthiness Limitations;'' to the EMBRAER 170/175 Maintenance
Review Board Report, MRB-1621, Revision 10, dated February 23, 2015,
which is divided into four parts: Part 1--Certification Maintenance
Requirements, Part 2--Airworthiness Limitation Inspections, Part 3--
Fuel System Limitation Items, and Part 4--Life Limited Parts. You may
examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0059.
    This SNPRM also proposes to supersede AD 2006-06-09, Amendment 39-
14518 (71 FR 14365, March 22, 2006); AD 2012-05-08, Amendment 39-16980
(77 FR 16155, March 20, 2012); and AD 2012-07-08, Amendment 39-17014
(77 FR 24342, April 24, 2012); which require tasks that are now
included in the new revision of the MRBR.
    This SNPRM also proposes to remove airplanes with an original
airworthiness certificate or original export certificate of
airworthiness issued on or after February 23, 2015, from the
applicability.

Related Service Information Under 1 CFR Part 51

    Embraer S.A. has issued Part 1--``Certification Maintenance
Requirements;'' Part 2--``Airworthiness Limitation Inspections (ALI)--
Structures;'' Part 3--``Fuel System Limitation Items;'' and Part 4--
``Life Limited Items;'' of Appendix A--``Airworthiness Limitations;''
to the EMBRAER 170/175 Maintenance Review Board Report, MRB-1621,
Revision 10, dated February 23, 2015. This service information
describes airworthiness limitations (Part 1, Part 2, Part 3, and Part 4
of the MRBR make up

the airworthiness limitations). This service information 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.

Comments

    We gave the public the opportunity to participate in developing
this proposed AD. We considered the comment received.

Request To Refer to Revised Service Information

    An anonymous commenter noted that paragraph (i) of the proposed AD
(in the NPRM) included terminating action(s) for the requirements of
paragraph (g) of the proposed AD (in the NPRM) if a revision to the
maintenance or inspection program was accomplished by the incorporation
of the tasks in Part 2--``Airworthiness Limitation Inspections (ALI)--
Structures,'' of the EMBRAER 170 Maintenance Review Board Report, MRB-
1621, Revision 8, dated August 20, 2012. The commenter stated that
since August 20, 2012, five additional temporary revisions to Part 2
had been issued and the NPRM did not include the incorporation of these
temporary revisions as being acceptable for compliance with the
requirements of paragraph (g) of the proposed AD (in the NPRM). We
infer that the commenter is requesting that the NPRM be revised to
allow incorporation of the tasks in the current service information
into an operator's maintenance or inspection program and that this
should be acceptable for compliance with the requirements of paragraph
(g) of the proposed AD (in the NPRM).
    We agree with the commenter's request to refer to the current
revision of the EMBRAER 170/175 MRBR, which includes the temporary
revisions mentioned by the commenter. Paragraph (i) of this proposed AD
has been revised to refer to the EMBRAER 170/175 Maintenance Review
Board Report, MRB-1621, Revision 10, dated February 23, 2015.

FAA's Determination and Requirements of This SNPRM

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections) and
Critical Design Configuration Control Limitations (CDCCLs). Compliance
with these actions and CDCCLs is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance according to paragraph
(k)(1) of this proposed AD. The request should include a description of
changes to the required inspections that will ensure the continued
damage tolerance of the affected structure.
    Notwithstanding any other maintenance or operational requirements,
components that have been identified as airworthy or installed on the
affected airplanes before accomplishing the revision of the airplane
maintenance or inspection program specified in this proposed AD, do not
need to be reworked in accordance with the CDCCLs. However, once the
airplane maintenance or inspection program has been revised as required
by this proposed AD, future maintenance actions on these components
must be done in accordance with the CDCCLs.
    Certain changes described above expand the scope of the NPRM. As a
result, we have determined that it is necessary to reopen the comment
period to provide additional opportunity for the public to comment on
this SNPRM.

Airworthiness Limitations Based on Type Design

    The FAA recently became aware of an issue related to the
applicability of ADs that require incorporation of an ALS revision into
an operator's maintenance or inspection program.
    Typically, when these types of ADs are issued by civil aviation
authorities of other countries, they apply to all airplanes covered
under an identified type certificate (TC). The corresponding FAA AD
typically retains applicability to all of those airplanes.
    In addition, U.S. operators must operate their airplanes in an
airworthy condition, in accordance with 14 CFR 91.7(a). Included in
this obligation is the requirement to perform any maintenance or
inspections specified in the ALS, and in accordance with the ALS as
specified in 14 CFR 43.16 and 91.403(c), unless an alternative has been
approved by the FAA.
    When a type certificate is issued for a type design, the specific
ALS, including revisions, is a part of that type design, as specified
in 14 CFR 21.31(c).
    The sum effect of these operational and maintenance requirements is
an obligation to comply with the ALS defined in the type design
referenced in the manufacturer's conformity statement. This obligation
may introduce a conflict with an AD that requires a specific ALS
revision if new airplanes are delivered with a later revision as part
of their type design.
    To address this conflict, the FAA has approved alternative methods
of compliance (AMOCs) that allow operators to incorporate the most
recent ALS revision into their maintenance/inspection programs, in lieu
of the ALS revision required by the AD. This eliminates the conflict
and enables the operator to comply with both the AD and the type
design.
    However, compliance with AMOCs is normally optional, and we
recently became aware that some operators choose to retain the AD-
mandated ALS revision in their fleet-wide maintenance/inspection
programs, including those for new airplanes delivered with later ALS
revisions, to help standardize the maintenance of the fleet. To ensure
that operators comply with the applicable ALS revision for newly
delivered airplanes containing a later revision than that specified in
an AD, we plan to limit the applicability of ADs that mandate ALS
revisions to those airplanes that are subject to an earlier revision of
the ALS, either as part of the type design or as mandated by an earlier
AD.
    This proposed AD, therefore, would apply to Model ERJ 170 airplanes
with an original certificate of airworthiness or original export
certificate of airworthiness that was issued before the date of
approval of the ALS revision identified in this proposed AD (airplanes
having serial numbers 17000002, 17000004 through 17000013 inclusive,
and 17000015 through 17000453 inclusive). Operators of airplanes with
an original certificate of airworthiness or original export certificate
of airworthiness issued on or after that date must comply with the
airworthiness limitations specified as part of the approved type design
and referenced on the type certificate data sheet.

Costs of Compliance

    We estimate that this SNPRM affects 286 airplanes of U.S. registry.

    The actions that are required by AD 2012-07-08, Amendment 39-17014
(77 FR 24342, April 24, 2012), and retained in this SNPRM take about 1
work-hour per product, at an average labor rate of $85 per work-hour.
Required parts cost about $0 per product. Based on these figures, the
estimated cost of the actions that were required by AD 2012-07-08 is
$85 per product.
    We also estimate that it would take about 1 work-hour per product
to comply with the new basic requirements of this SNPRM. The average
labor rate is $85 per work-hour. Required parts would cost about $0 per
product. Based on these figures, we estimate the cost of this SNPRM on
U.S. operators to be $24,310, or $85 per product.

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.
    We are 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

    We 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The 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 directives AD 2006-06-09, Amendment 39-14518
(71 FR 14365, March 22, 2006); AD 2012-0508, Amendment 39-16980 (77 FR
16155, March 20, 2012); and AD 2012-07-08, Amendment 39-17014 (77 FR
24342, April 24, 2012); and
0
b. Adding the following new AD:

Embraer S.A: Docket No. FAA-2014-0059; Directorate Identifier 2013-
NM-075-AD.

(a) Comments Due Date

    We must receive comments by October 27, 2016.

(b) Affected ADs

    This AD replaces the ADs specified in paragraphs (b)(1), (b)(2),
and (b)(3) of this AD:
    (1) AD 2006-06-09, Amendment 39-14518 (71 FR 14365, March 22,
2006) (``AD 2006-06-06'').
    (2) AD 2012-05-08, Amendment 39-16980 (77 FR 16155, March 20,
2012) (``AD 2012-05-08'').
    (3) AD 2012-07-08, Amendment 39--17014 (77 FR 24342, April 24,
2012) (``AD 2012-07-08'').

(c) Applicability

    This AD applies to Embraer S.A. Model ERJ 170-100 LR, -100 STD,
-100 SE, and -100 SU airplanes; and Model ERJ 170-200 LR, -200 SU,
and -200 STD airplanes; certificated in any category; manufacturer
serial numbers 17000002, 17000004 through 17000013 inclusive, and
17000015 through 17000453 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Codes 27, Flight
controls; 28, Fuel; 52, Doors; 53, Fuselage; 54, Nacelles/pylons;
55, Stabilizers; 57, Wings; 71, Powerplant; and 78, Exhaust.

(e) Reason

    This AD was prompted by a determination that more restrictive
airworthiness limitations are necessary. We are issuing this AD to
detect and correct fatigue cracking of various principal structural
elements; such cracking could result in reduced structural integrity
of the airplane. We are also issuing this AD to prevent safety-
significant latent failures; such failures, in combination with one
or more other specified failures or events, could result in a
hazardous or catastrophic failure condition of avionics, hydraulic
systems, fire detection systems, fuel systems, or other critical
systems. We are also issuing this AD to prevent the potential for
ignition sources inside fuel tanks caused by latent failures,
alterations, repairs, or maintenance actions; such failures, in
combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane.

(f) Compliance

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

(g) Retained Maintenance Program Revision, With No Changes

    This paragraph restates the action required by paragraph (i) of
AD 2012-07-08, with no changes.
    (1) Within 60 days after May 29, 2012 (the effective date of AD
2012-07-08): Revise the maintenance program to incorporate the new
or revised tasks specified in Part 2--``Airworthiness Limitation
Inspection (ALI)--Structures,'' of Appendix A, ``Airworthiness
Limitations,'' to the EMBRAER 170 MRBR, MRB-1621, Revision 7, dated
November 11, 2010; and EMBRAER Temporary Revision (TR) 7-1, dated
February 11, 2011, to Part 2--``Airworthiness Limitation Inspection
(ALI)--Structures,'' of Appendix A, ``Airworthiness Limitations,''
to the EMBRAER 170 MRBR, MRB-1621, Revision 7, dated November 11,
2010; with the initial compliance times and intervals specified in
these documents.
    (2) The initial compliance times for the tasks start from the
date of issuance of the original Brazilian airworthiness certificate
or the date of issuance of the original Brazilian export certificate
of airworthiness of the applicable airplane at the applicable time
specified in the tasks, or within 600 flight cycles after revising
the maintenance program, whichever occurs later. For certain tasks,
the compliance times depend on the pre-modification and post-
modification status of the actions specified in the associated
service bulletin, as specified in the ``Applicability'' column of
Part 2--``Airworthiness Limitation Inspection (ALI)--Structures,''
of Appendix A, ``Airworthiness Limitations,'' to the EMBRAER 170
MRBR, MRB-1621, Revision 7, dated November 11, 2010; and Embraer
Temporary Revision 7-1, dated February 11, 2011, to Part 2--
``Airworthiness Limitation Inspection (ALI)--Structures,'' of
Appendix A, ``Airworthiness Limitations,'' to the EMBRAER 170 MRBR,
MRB-1621, Revision 7, dated November 11, 2010.

(h) Retained No Alternative Actions Intervals, and/or Critical Design
Configuration Control Limitations (CDCCLs), With New Exception

    This paragraph restates the action required by paragraph (j) of
AD 2012-07-08, with a new exception. Except as required by

paragraph (i) of this AD, after accomplishing the revisions required
by paragraph (g) of this AD, no alternative actions (e.g.,
inspections), intervals, and/or CDCCLs may be used other than those
specified in Part 2--Airworthiness Limitation Inspection (ALI)--
Structures, of Appendix A, Airworthiness Limitations, of the EMBRAER
170 MRBR MRB-1621, Revision 7, dated November 11, 2010; and EMBRAER
Temporary Revision 7-1, dated February 11, 2011, to Part 2--
Airworthiness Limitation Inspection (ALI)--Structures, of Appendix
A, Airworthiness Limitations, of the EMBRAER 170 MRBR MRB-1621,
Revision 7, unless the actions, intervals, and/or CDCCLs are
approved as an AMOC in accordance with the procedures specified in
paragraph (k)(1) of this AD.

(i) New Revision of Maintenance or Inspection Program

    Within 12 months after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate the
airworthiness limitations specified in Part 1--``Certification
Maintenance Requirements;'' Part 2--``Airworthiness Limitation
Inspections (ALI)--Structures;'' Part 3--``Fuel System Limitation
Items;'' and Part 4--``Life Limited Items;'' of Appendix A--
``Airworthiness Limitations;'' of the EMBRAER 170/175 MRBR, MRB-
1621, Revision 10, dated February 23, 2015. The initial compliance
times and repetitive intervals are specified in the applicable part
of the EMBRAER 170/175 MRBR, MRB-1621, Revision 10, dated February
23, 2015. Accomplishing the revision to the maintenance or
inspection program required by this paragraph terminates the
requirements of paragraph (g) of this AD.

(j) No Alternative Actions, Intervals, CDCCLs

    After accomplishing the revision required by paragraph (i) of
this AD, no alternative actions (e.g., inspections), intervals, or
CDCCLs may be used unless the actions, intervals, and CDCCLs are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (k)(1) of this AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Ana Martinez
Hueto, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the Ag[ecirc]ncia Nacional de
Avia[ccedil][atilde]o Civil (ANAC); or ANAC's authorized Designee.
If approved by the ANAC Designee, the approval must include the
Designee's authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
Brazilian Airworthiness Directive 2015-06-01, effective June 2,
2015, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2014-0059.
    (2) For service information identified in this AD, contact
Embraer S.A., Technical Publications Section (PC 060), Av.
Brigadeiro Faria Lima, 2170--Putim--12227-901 S[atilde]o Jose dos
Campos--SP--BRASIL; telephone +55 12 3927-5852 or +55 12 3309-0732;
fax +55 12 3927-7546; email<EMAIL_ADDRESS>Internet http://www.flyembraer.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 25, 2016.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-21145 Filed 9-9-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: January 6, 2010 (Volume 75, Number 3)]
[Notices]
[Page 876]
[DOCID:fr06ja10-45]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Anesthetic and Life Support Drugs Advisory Committee;
Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The meeting of the Anesthetic and Life Support Drugs Advisory
Committee scheduled for January 28, 2010, is cancelled. This meeting
was announced in the Federal Register of December 8, 2009 (74 FR
64702). This meeting has been cancelled to allow time for the FDA to
review new information that is relevant to the benefit risk balance for
the proposed new indication. The agency intends to continue evaluating
the application and, as needed, will announce future meeting dates in
the Federal Register.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512529. Please call the Information Line for up-to-date information
on this meeting.

    Dated: December 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-31306 Filed 1-5-10; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 128 (Monday, July 6, 2015)]
[Proposed Rules]
[Pages 38419-38423]
[FR Doc No: 2015-16389]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2008-0633; FRL-9929-06-Region 6]

Approval and Promulgation of Implementation Plans; Arkansas;
Interstate Transport State Implementation Plan To Address Pollution
Affecting Visibility

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
disapprove a revision to the Arkansas State Implementation Plan (SIP)
submitted by the State of Arkansas on September 16, 2009, for the
purpose of addressing the requirements of the Clean Air Act (CAA)
regarding interference with other states' programs for visibility
protection for the 2006

revised 24-hour fine particulate matter (PM2.5) National
Ambient Air Quality Standard (NAAQS). The EPA is proposing that the
Federal Implementation Plan (FIP) we proposed on April 8, 2015, to
address certain regional haze and visibility transport requirements for
the State of Arkansas also remedies the deficiency created by our
proposed disapproval of Arkansas' SIP submittal to address the
requirement regarding interference with other states' programs for
visibility protection for the 2006 PM2.5 NAAQS.

DATES: Comments must be received on or before August 5, 2015.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2008-0633, by one of the following methods:
     Federal e-Rulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
     Mail or delivery: Mr. Guy Donaldson, Chief, Air Planning
Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202-2733.
    Instructions: Direct your comments to Docket No. EPA-R06-OAR-2008-
0633. Our policy is that all comments received will be included in the
public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means we will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to us without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, we recommend that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If we cannot read your
comment due to technical difficulties and cannot contact you for
clarification, we may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas. While all documents in the
docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available at either location (e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Ms. Dayana Medina,<PHONE_NUMBER>;
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Ms. Medina or Mr. Bill Deese at 214-665-
7253.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

A. Interstate Transport and the 2006 PM2.5 NAAQS

    In 2006, we revised the 24-hour PM2.5 NAAQS to 35 [mu]g/
m\3\ (October 17, 2006, 71 FR 6114). SIPs addressing the interstate
transport requirements of section 110(a)(2)(D)(i) of the CAA are due to
us within three years after the promulgation of a new or revised NAAQS
(or within such shorter period as we may prescribe).\1\ Section
110(a)(2)(D)(i) of the CAA identifies four distinct elements, sometimes
referred to as prongs, related to the evaluation of impacts of
interstate transport of air pollutants with respect to a new or revised
NAAQS. In this action for the State of Arkansas, we are addressing the
second element of section 110(a)(2)(D)(i)(II) with respect to the 2006
24-hour PM2.5 NAAQS. The second element of section
110(a)(2)(D)(i)(II) of the CAA (hereafter referred to as Prong 4)
requires that states have a SIP, or submit a SIP revision, containing
provisions prohibiting emissions from within a state from interfering
with measures required to be included in the implementation plan for
any other state under the provisions of Part C of the CAA protecting
visibility. Because of the impacts on visibility from the interstate
transport of pollutants, we interpret this ``good neighbor'' provision
in section 110 of the CAA as requiring states to include in their SIPs
measures to prohibit emissions that would interfere with the reasonable
progress goals set to protect Class I areas in other states. This is
consistent with the requirements in the regional haze program which
explicitly require each state to address its share of the emission
reductions needed to meet the reasonable progress goals for surrounding
Class I areas.\2\
---------------------------------------------------------------------------

    \1\ CAA Section 110(a)(1).
    \2\ 64 FR 35714, 35735 (July 1, 1999).
---------------------------------------------------------------------------

B. Arkansas' Interstate Visibility Transport Submittal for the 2006
PM2.5 NAAQS

    On September 16, 2009, Arkansas submitted a SIP revision intended
to address the requirements of Prong 4 with respect to visibility
transport for the 2006 PM2.5 NAAQS. This submittal also
addressed other ``infrastructure'' elements specified in CAA section
110(a)(2), necessary to implement, maintain, and enforce the 2006
PM2.5 NAAQS. We previously acted on the portions of the
September 16, 2009 submittal that addressed these other infrastructure
elements specified in CAA Section 110(a)(2).\3\ Arkansas' September 16,
2009 SIP submittal that addresses transport for the 2006
PM2.5 NAAQS may be accessed through the www.regulations.gov
Web site (Docket No. EPA-R06-OAR-2008-0633). Arkansas indicated in the
submittal that it meets the required protection of visibility
provisions of CAA section 110(a)(2)(D)(i)(II) for the 2006
PM2.5 NAAQS.
---------------------------------------------------------------------------

    \3\ 77 FR 50033 (August 20, 2012) and 78 FR 53269 (August 29,
2013).
---------------------------------------------------------------------------

II. EPA's Evaluation

A. EPA's Approach for Evaluating Interstate Visibility Transport

    In three memos released in 2006, 2009, and 2013, we provided
guidance to the states regarding their obligations with respect to
Prong 4. In the 2006 memo, we informed states that they could satisfy
prong 4 for the 1997 8-hour ozone and PM2.5 NAAQS by making
a simple SIP submission confirming that it was not possible at the time
to assess whether there was any interference with measures in the SIPs
of other states designed to protect visibility until the states'
regional haze SIPs were submitted and approved.\4\ In the 2009 memo, we
recommended that a state could meet prong 4 requirements

through its Regional Haze SIP.\5\ EPA's rationale supporting this
recommendation was that the development of the regional haze SIPs was
intended to occur in a collaborative environment among the states, and
that through this process states would coordinate on emissions controls
to protect visibility on an interstate basis. The common understanding
was that, as a result of this collaborative environment, each state
would take action to achieve the emissions reductions relied upon by
other states in their reasonable progress demonstrations under the
regional haze rule. This interpretation is consistent with the
requirement in the regional haze rule that a state participating in a
regional planning process must include ``all measures needed to achieve
its apportionment of emission reduction obligations agreed upon through
that process.'' See 40 CFR 51.308(d)(3)(ii). Most recently, in the 2013
memo, we suggest ways prong 4 obligations can be satisfied with respect
to the 2008 ozone NAAQS, 2010 nitrogen dioxide (NO2) NAAQS,
2010 sulfur dioxide (SO2) NAAQS, and 2012 PM2.5
NAAQS infrastructure SIPs.\6\ There, we reiterated that states could
satisfy prong 4 by confirming that they had fully approved regional
haze SIPs.\7\ We reasoned that a fully approved regional haze SIP
necessarily would ensure that emissions from a state's sources were not
interfering with measures required to be included in other states' SIPs
to protect visibility.\8\ Alternatively, we explained that a state
could satisfy its prong 4 obligations by including in its
infrastructure SIP a demonstration that emissions within its
jurisdiction do not interfere with other states' plans to protect
visibility.\9\ We clarified that such a submission would need to
include measures to limit visibility-impairing pollutants and ensure
that the reductions were sufficient to comply with any mutually agreed
upon RPGs for downwind Class I areas.\10\
---------------------------------------------------------------------------

    \4\ Office of Air Quality Planning & Standards, U.S. Envtl.
Protection Agency, Guidance for State Implementation Plan (SIP)
Submissions to Meet Current Outstanding Obligations Under Section
110(a)(2)(D)(i) for the 8-Hour Ozone and PM2.5 National
Ambient Air Quality Standards, at 9-10 (Aug. 15, 2006).
    \5\ Office of Air Quality Planning & Standards, U.S. Envtl.
Protection Agency, Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2006 24-Hour Fine Particle
(PM2.5) National Ambient Air Quality Standards (NAAQS),
at 5 (Sept. 25, 2009).
    \6\ Office of Air Quality Planning & Standards, U.S. Envtl.
Protection Agency, Guidance on Infrastructure State Implementation
Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and
110(a)(2) (Sept. 13, 2013).
    \7\ Id. at 33.
    \8\ Id.
    \9\ Id. at 34.
    \10\ Id.
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B. Evaluation of Arkansas' Submittal

    An approved regional haze SIP that fully meets the regional haze
requirements in 40 CFR 51.308 satisfies the requirement for visibility
protection as it ensures that emissions from the state will not
interfere with measures required to be included in other state SIPs to
protect visibility. Regional haze is visibility impairment that is
produced by a multitude of sources and activities which are located
across a broad geographic area and emit fine particles
(PM2.5) (e.g., sulfates, nitrates, organic carbon, elemental
carbon, and soil dust), and their precursors (e.g., SO2,
nitrogen oxides (NOX), and in some cases, ammonia
(NH3) and volatile organic compounds (VOC)). Fine particle
precursors react in the atmosphere to form fine particulate matter that
impairs visibility by scattering and absorbing light. Visibility
impairment reduces the clarity, color, and visible distance that one
can see. PM2.5 can also cause serious health effects and
mortality in humans and contributes to environmental effects such as
acid deposition and eutrophication.
    In the September 16, 2009 infrastructure SIP submittal for the 2006
PM2.5 NAAQS, Arkansas indicated that it meets the required
protection of visibility provisions of section 110(a)(2)(D)(i) of the
CAA but did not explain how it meets this requirement. We are proposing
to find that Arkansas' SIP does not fully ensure that emissions from
sources in Arkansas do not interfere with other states' visibility
programs as required under the Prong 4 provision because the SIP does
not demonstrate how the requirement is satisfied. Furthermore, we
previously found the Arkansas Regional Haze SIP to be deficient and
partially disapproved it. In our final rule published on March 12,
2012, we partially approved and partially disapproved the SIP revision
submitted by Arkansas in 2008 to address the regional haze requirements
(Arkansas Regional Haze SIP).\11\ This action included a disapproval of
a large portion of Arkansas' best available retrofit technology (BART)
determinations for its subject to BART sources, as we concluded these
BART determinations did not meet the requirements of the CAA and our
regional haze regulations. As a result, the corresponding emissions
reductions from Arkansas sources that other states had relied upon in
their regional haze SIPs would not take place. Therefore, we are
proposing to disapprove the portion of Arkansas' September 16, 2009 SIP
submittal that addresses the requirements of section
110(a)(2)(D)(i)(II) with respect to visibility transport for the 2006
PM2.5 NAAQS.
---------------------------------------------------------------------------

    \11\ 77 FR 14604.
---------------------------------------------------------------------------

    Under section 110(c) of the Act, whenever we disapprove a mandatory
SIP submission in whole or in part, we are required to promulgate a FIP
within 2 years unless we approve a SIP revision correcting the
deficiencies before promulgating a FIP. Specifically, CAA section
110(c) provides that the Administrator shall promulgate a FIP within 2
years after the Administrator disapproves a state implementation plan
submission ``unless the State corrects the deficiency, and the
Administrator approves the plan or plan revision, before the
Administrator promulgates such Federal implementation plan.'' The term
``Federal implementation plan'' is defined in section 302(y) of the CAA
in pertinent part as a plan promulgated by the Administrator to correct
an inadequacy in a SIP. Thus, upon finalizing our proposed disapproval
of Arkansas' SIP submittal addressing the requirements of section
110(a)(2)(D)(i)(II) with respect to visibility transport for the 2006
PM2.5 NAAQS, we would have an obligation to promulgate a FIP
for Arkansas, unless we first approve a SIP revision that corrects the
deficiencies in the disapproved SIP submittal.
    Our April 8, 2015 proposed FIP corrects the disapproved portions of
the Arkansas Regional Haze SIP. The disapproved portions included a
majority of the State's BART determinations, the State's reasonable
progress analysis and reasonable progress goals, and a portion of the
State's long term strategies for its Class I areas.\12\ Our proposed
FIP addresses BART requirements for nine units at six facilities,
proposes a reasonable progress analysis and controls for two units at
one power plant under the reasonable progress requirements, and
proposes revised reasonable progress goals and long-term strategies for
Arkansas' two Class I areas. Our proposed Regional Haze FIP together
with the already approved portions of the Arkansas Regional Haze SIP
address all regional haze requirements for Arkansas and would ensure
that the emissions reductions from Arkansas sources that other states
relied upon in their regional haze SIPs are achieved. As such, there
would be adequate provisions prohibiting any source or other type of
emissions activity within Arkansas from emitting any air pollutant in
amounts

which would interfere with measures required to be included in the
applicable implementation plan for any other state to protect
visibility.
---------------------------------------------------------------------------

    \12\ 77 FR 14604.
---------------------------------------------------------------------------

III. Proposed Action

    We are proposing to disapprove a portion of a SIP submittal that
was submitted by Arkansas on September 16, 2009. The portion of the SIP
submittal we are proposing to disapprove addresses the CAA provisions
for prohibiting air pollutant emissions from interfering with measures
required to protect visibility in any other state for the 2006 24-hour
PM2.5 NAAQS. We are proposing to find that the requirements
of CAA section 110(a)(2)(D)(i)(II) with respect to visibility transport
for the 2006 PM2.5 NAAQS will be satisfied by the
combination of the emission control measures in the Regional Haze FIP
we proposed on April 8, 2015, and the already approved portions of the
Arkansas Regional Haze SIP. We are proposing to determine that the
Regional Haze FIP we proposed for Arkansas on April 8, 2015, will
satisfy our FIP obligation for interstate transport of air pollution
and visibility protection for the 2006 24-hour PM2.5 NAAQS.
We will not finalize our proposal that the Regional Haze FIP addresses
our FIP obligation unless and until, we finalize our action on the
Regional Haze FIP.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to act on state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This proposed action is not a ``significant regulatory action''
under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under Executive Orders 12866 and
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This proposed action does not impose an information collection
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq., because this proposed SIP disapproval under section 110
and subchapter I, part D of the CAA will not in-and-of itself create
any new information collection burdens but simply disapproves certain
State requirements for inclusion into the SIP. Burden is defined at 5
CFR 1320.3(b).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions. For purposes of assessing the impacts of today's rule on
small entities, small entity is defined 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; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
impact on a substantial number of small entities. This rule does not
impose any requirements or create impacts on small entities. This
proposed SIP disapproval under section 110 and subchapter I, part D of
the CAA will not in-and-of itself create any new requirements but
simply disapproves certain State requirements for inclusion into the
SIP. Accordingly, it affords no opportunity for EPA to fashion for
small entities less burdensome compliance or reporting requirements or
timetables or exemptions from all or part of the rule. The fact that
the CAA prescribes that various consequences (e.g., higher offset
requirements) may or will flow from this disapproval does not mean that
EPA either can or must conduct a regulatory flexibility analysis for
this action. Therefore, this action will not have a significant
economic impact on a substantial number of small entities.
    We continue to be interested in the potential impacts of this
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. EPA has determined that the proposed disapproval action does
not include a Federal mandate that may result in estimated costs of
$100 million or more to either State, local, or tribal governments in
the aggregate, or to the private sector. This action proposes to
disapprove pre-existing requirements under State or local law, and
imposes no new requirements. Accordingly, no additional costs to State,
local, or tribal governments, or to the private sector, result from
this action.

E. Executive Order 13132, Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that 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.''
    This proposed action does not have federalism implications. 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 Executive Order 13132, because it merely disapproves
certain State requirements for inclusion into the SIP and does not
alter the relationship or the distribution of power and
responsibilities established in the CAA. Thus, Executive Order 13132
does not apply to this action.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, this proposed
action does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
proposed action is not subject to Executive Order 13045 because it is
not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997). This proposed SIP disapproval under section 110 and subchapter
I, part D of the CAA will not in-and-of itself create any new
regulations but simply disapproves certain State requirements for
inclusion into the SIP.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution or Use

    This proposed action is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001) because it is not a significant regulatory action
under Executive Order 12866.

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. NTTAA directs EPA to
provide Congress, through OMB, explanations when the Agency decides not
to use available and applicable voluntary consensus standards.
    The EPA believes that this proposed action is not subject to
requirements of Section 12(d) of NTTAA because application of those
requirements would be inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA lacks the discretionary authority to address environmental
justice in this proposed action. In reviewing SIP submissions, EPA's
role is to approve or disapprove state choices, based on the criteria
of the CAA. Accordingly, this action merely proposes to disapprove
certain State requirements for inclusion into the SIP under section 110
and subchapter I, part D of the CAA and will not in-and-of itself
create any new requirements. Accordingly, it does not provide EPA with
the discretionary authority to address, as appropriate,
disproportionate human health or environmental effects, using
practicable and legally permissible methods, under Executive Order
12898.

K. Statutory Authority

    The statutory authority for this action is provided by section 110
of the CAA, as amended (42 U.S.C. 7410).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
matter, Reporting and recordkeeping requirements, Sulfur dioxides,
Visibility, Interstate transport of pollution, Regional haze, Best
available control technology.

    Dated: June 18, 2015.
Ron Curry,
Regional Administrator, Region 6.

    Title 40, chapter I, of the Code of Federal Regulations is proposed
to be amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. Amend Sec.  52.173 by adding paragraphs (c) and (d) to read as
follows:

Subpart E--Arkansas

Sec.  52.173  Visibility Protection

* * * * *
    (c) The portion of the SIP addressing noninterference with measures
required to protect visibility in any other state are disapproved for
the 2006 24-hour PM2.5 NAAQS.
    (d) The deficiencies in the portion of the SIP pertaining to
adequate provisions to prohibit emissions in Arkansas from interfering
with measures required to protect visibility in any other state for the
2006 24-hour PM2.5 NAAQS, submitted on September 16, 2009,
are remedied by Section 52.173(c).
[FR Doc. 2015-16389 Filed 7-2-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 189 (Tuesday, September 30, 2014)]
[Notices]
[Pages 58763-58764]
[FR Doc No: 2014-23197]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC14-147-000.
    Applicants: Portland General Electric Company.
    Description: Application for Authorization under Section 203 of the
Federal Power Act and Request for Expedited Consideration of Portland
General Electric Company.
    Filed Date: 9/19/14.
    Accession Number: 20140919-5166.
    Comments Due: 5 p.m. ET 10/10/14.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG14-107-000.
    Applicants: Rattlesnake Wind I LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Rattlesnake Wind I LLC.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5037.
    Comments Due: 5 p.m. ET 10/14/14.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-1040-002.
    Applicants: Wisconsin Public Service Corporation.
    Description: eTariff filing per 35.19a(b): WPSC Compliance Filing
in Docket Nos. ER13-1040, et al. and AC13-179 to be effective N/A.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5054.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-1172-000.
    Applicants: Wisconsin Public Service Corporation.
    Description: eTariff filing per 35.19a(b): WPSC Compliance Filing
in Docket Nos. ER13-1040, et al. and AC13-179 to be effective N/A.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5043.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-1243-004.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: eTariff filing per 35.19a(b): 2014-09-
22Presque Isle SSR Refund Report to be effective N/A.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5071.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-1725-001.
    Applicants: Midcontinent Independent System Operator, Inc.

    Description: eTariff filing per 35.19a(b): 2014-09-22White
Pine SSR Refund Report to be effective N/A.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5072.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2180-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: eTariff filing per 35.19a(b): 2014-09-
22Escanaba Refund Report to be effective N/A.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5073.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2399-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment per 35.17(b): Attachment AE--
Integrated Marketplace Deferral of Action in ER14-2399 to be effective
12/31/9998.
    Filed Date: 9/19/14.
    Accession Number: 20140919-5144.
    Comments Due: 5 p.m. ET 10/10/14.

    Docket Numbers: ER14-2584-001.
    Applicants: San Diego Gas & Electric Company.
    Description: Tariff Amendment per 35.17(b): SDGE Amendment to WDAT
Appendix H SGIA and GIP to be effective 10/3/2014.
    Filed Date: 9/19/14.
    Accession Number: 20140919-5143.
    Comments Due: 5 p.m. ET 10/10/14.

    Docket Numbers: ER14-2918-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Regulation Market Dispatch Changes to be effective 3/31/2015.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5034.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2919-000.
    Applicants: Wisconsin Public Service Corporation.
    Description: Tariff Withdrawal per 35.15: Notice of Cancellation of
WPSC and Marshfield Letter Agreement to be effective 8/27/2014.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5044.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2920-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2014-
09-22SA 2421 METC-Beebe Renewable Energy GIA (J132/J246) to be
effective 9/23/2014.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5084.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2921-000.
    Applicants: Southwestern Public Service Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 9-22-
14RS135 FCA-SPP IM Anc Srvc to be effective 3/1/2014.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5086.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2922-000.
    Applicants: Southwestern Public Service Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 9-22-
14RS136 FCA-SPP IM Anc Srvc to be effective 3/1/2014 .
    Filed Date: 9/22/14.
    Accession Number: 20140922-5087.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2923-000.
    Applicants: Southwestern Public Service Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 9-22-
14RS114-117, 137 FCA-SPP IM Anc Srvc to be effective 3/1/2014.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5088.
    Comments Due: 5 p.m. ET 10/14/14.

    Docket Numbers: ER14-2924-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2014-
09-22SA 2694 ITC Transmission-Oregon Clean Energy FCA (Y1-069)
to be effective 9/23/2014.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5104.
    Comments Due: 5 p.m. ET 10/14/14.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES14-47-000.
    Applicants: Wheeling Power Company.
    Description: Amendment to July 31, 2014 Application to issue
securities pursuant to Section 204 of the Federal Power Act of Wheeling
Power Company.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5067.
    Comments Due: 5 p.m. ET 10/2/14.

    Docket Numbers: ES14-49-000.
    Applicants: MDU Resources Group, Inc.
    Description: Supplement to August 22, 2014 Application for
authorization to issue securities of MDU Resources Group, Inc.
    Filed Date: 9/22/14.
    Accession Number: 20140922-5141.
    Comments Due: 5 p.m. ET 10/2/14

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 22, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-23197 Filed 9-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 13, 2006 (Volume 71, Number 71)]
[Notices]
[Page 19175-19176]
[DOCID:fr13ap06-57]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-200-150]

CenterPoint Energy Gas Transmission Company; Notice of Negotiated
Rate Filing

April 6, 2006.
    Take notice that on March 31, 2006, CenterPoint Energy Gas
Transmission Company (CEGT) tendered for filing and approval a
negotiated rate agreement between CEGT and Constellation Energy
Commodities Group, Inc. CEGT has entered into an agreement to provide
firm transportation service to this shipper under Rate Schedule FT to
be effective April 1, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and

385.214). Protests will be considered by the Commission in determining
the appropriate action to be taken, but will not serve to make
protestants parties to the proceeding. Any person wishing to become a
party must file a notice of intervention or motion to intervene, as
appropriate. Such notices, motions, or protests must be filed in
accordance with the provisions of Section 154.210 of the Commission's
regulations (18 CFR 154.210). Anyone filing an intervention or protest
must serve a copy of that document on the Applicant. Anyone filing an
intervention or protest on or before the intervention or protest date
need not serve motions to intervene or protests on persons other than
the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-5450 Filed 4-12-06; 8:45 am]

BILLING CODE 6717-01-P


ECOLOGICAL HAZARD AND ENVIRONMENTAL RISK ASSESSMENT

Iodine and Iodine Complexes

CASE 3080

PC CODES 046905 (iodine), 075701 (potassium iodide), 046901 (butoxypolypropoxypolyethoxyethanol -iodine complex), 046904 (polypropoxypolyethoxyethanol-iodine complex), 046921 (alpha-alkyl-omega-hydroxypoly(oxyethylene)-iodine complex), 046918 (alkly(C12-15)poly(oxypropylene)poly(oxyethylene)-iodine complex), 046903 (nonylphenoxypolyethodyethanol-iodine complex), 046915 (octylphenoxypolyethodxyethanol-iodine complex), 046914 (polyvinylpyrrolidone-iodine complex),  046923 (amino acid-iodine complex), and 046905 (iodinated resins)

Kathryn V. Montague, M.S.

Antimicrobials Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Table of Contents

1.  Ecological Toxicity Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

a.  Toxicity to Terrestrial Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

1.  Birds, Acute and Subacute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. Mammals, Acute and Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

b.  Toxicity to Aquatic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.  Freshwater Fish, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

2.  Freshwater Invertebrates, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

3.  Estuarine and Marine Organisms, Acute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

4.  Aquatic Organisms, Chronic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

c.  Toxicity to Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2.  Risk Assessment and Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

a.  Environmental Fate Assessment Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

b.  Environmental Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

c.  Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

d.  Endangered Species Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

	Ecological Effects Hazard and Environmental Risk Assessment

	Iodine and Iodine Complexes

Iodine and various iodine complexes are used for a variety of indoor antimicrobial uses.  They all function as microbiocides by releasing iodine.  The complexes are grouped into several categories for the purposes of this RED:

1.  Iodine [PC Codes 046905 (iodine) and 075701 (potassium iodide)]

2.  Surfactant-iodine complexes, which includes several subgroups:

a.  Polypropoxypolyethoxyethanol-iodine complexes (PC codes 046901, 046904, 046921, and 046918)

b.  Phenoxypolyethoxyethanol-iodine complexes (PC codes 046903 and 046915)

c.  Polyvinylpyrrolidone-iodine complexes (PC Code 046914)

3.  Amino acid-Iodine Complex (PC Code 046923)

4.  Iodinated Resins (PC Code 046905)

Currently registered uses include emergency drinking water purification, fresh food sanitization, food-contact surface sanitization, hospital surface disinfection, materials preservation, and recirculating industrial water system treatment.  Registered antimicrobial products account for approximately 2 million pounds of iodine annually.

I.	Ecological Toxicity Data

  The toxicity endpoints presented below are based on the results of ecotoxicity studies submitted to EPA to meet the Agency’s data requirements for the uses of iodine and iodine complexes (iodophores). Since the iodine complexes function by releasing elemental iodine, iodine is the chemical of concern for this assessment.  Iodine was registered at one time for once-through cooling system treatment, but that use was subsequently dropped, and the associated ecotoxicity data requirements (e.g., marine/estuarine organism testing) were no longer applicable.

A.	Toxicity to Terrestrial Animals

(1)	Birds, Acute and Subacute

In order to establish the toxicity of iodine and iodophores to avian species for indoor uses, the Agency required an acute oral toxicity study using the TGAI.  The preferred test species is either mallard duck (a waterfowl) or bobwhite quail (an upland game bird).  The results of one toxicity study are provided in the following table (Table 1).

Table 1.  Acute Oral Toxicity of Iodine and Iodophores to Birds

Species

chemical, % Active Ingredient (ai)

Endpoint

(mg/kg)

Toxicity Category (TGAI)

Satisfies Guidelines/

Comments

Reference

Northern bobwhite

(Colinus virginianus)

Iodine, 99.8%

LD50 > 2000 mg ai/kg

NOEL = 500 mg ai /kg

Practically non-toxic

Yes

(  core study

(  14-day test duration

(  NOEL based on reduced body weight gain in males

431384-01

Northern bobwhite

(Colinus virginianus)

Tetraglycerine hydroperiodide, 100%

LD50 >250 mg/kg

NOEL = 250 mg/kg

Moderately toxic

Supplemental information

- did not test at high enough levels and did not achieve and LD50

- actual toxicity may be less than (moderately toxic(

423283-01

Northern bobwhite

(Colinus virginianus)

Nonylphenoxypolyethodyethanol-iodine complex, 100%

LD50 = 1700 mg/kg, NOEL = 631 mg/kg

Slightly toxic

Yes

- core study

- NOEL based on mortality, weight loss, and signs of toxicity

ACC238200

The results indicate that iodine is moderately toxic to practically non-toxic to avian species on an acute oral basis. The iodine study fulfills guideline requirements (71-1/OPPTS 850.2100).

A subacute dietary study using the TGAI may be required on a case-by-case basis depending on the results of lower-tier ecological studies and pertinent environmental fate characteristics in order to establish the toxicity of a chemical to avian species.  This testing was not required for the indoor uses of iodine.  However, several studies were available in the OPP database. Results of these studies are provided in Table 2.

Table 2.  Subacute Dietary Toxicity of Iodine and Iodophores to Birds

Species

% Active Ingredient (ai)

Endpoint

(ppm)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

Bobwhite quail

(Colinus virginianus)

Iodine, 99.8%

LC50 > 5620 ppm ai

NOEC =562 ppm ai

Practically non-toxic (TGAI)

Yes

- Core study

- NOEC based on signs of toxicity

431917-01

Bobwhite quail

(Colinus virginianus)

Tetraglycine hydroperiodide, 100%

LC50 > 5000 ppm ai

NOEC= 2500 ppm ai

Practically non-toxic

Supplemental study

- analytical data for diet not provided

- NOEC based on reduction in body weight

423291-01

Bobwhite quail

(Colinus virginianus)

Nonylphenoxypolyethodyethanol-iodine complex, 100%

LC50 > 5620 ppm

NOEC = 5620 ppm

Practically non-toxic

Yes

- core study

ACC238200

Mallard (Anas platyrhynchos)

Nonylphenoxypolyethodyethanol-iodine complex, 100%

LC50 > 5620 ppm

NOEC = 3160 ppm

Practically non-toxic

Yes

- core study

- NOEC based on signs of toxicity

ACC238200

The results indicate that iodine is practically non-toxic to avian species on a subacute dietary basis. Several studies are acceptable and fulfill guideline requirements (71-2/OPPTS 850.2200).

(2)	Mammals, Acute and Chronic Toxicity

Wild mammal testing was not required by the Agency.  In most cases, rat toxicity values obtained from studies conducted to support data requirements for human health risk assessments substitute for wild mammal testing.  These toxicity values are reported below (Table 3). Further information on the mammalian toxicology of iodine and iodophores may be found in the Toxicology Disciplinary Chapter of this RED document.

Table 3.  Acute Toxicity of Iodine and Iodophores to Mammals (excerpted from Toxicology Chapter)

Species

Test Type

LD50

(mg/kg)

Toxicity Category

Reference

(MRID)

Rat

Acute oral

315 mg/kg

II

42326704

Rat

Acute dermal

3,333 mg/kg

III

42326705

Rat

Acute inhalation

0.363 mg/L

II

42961002

Rabbit

Primary skin irritation

corrosive, severe erythema, edema

I

42326706

Guinea pig

Dermal sensitization

no sensitization observed (Buehler method)

N/A

42326707

Acute toxicity of iodine is low for dermal toxicity, but is somewhat higher for acute oral and inhalation toxicity and dermal irritation.

B.	Toxicity to Aquatic Animals

(1)	Freshwater Fish, Acute

In order to establish the acute toxicity of pesticides to freshwater fish, the Agency requires freshwater fish toxicity studies using the TGAI.  The preferred test species are rainbow trout (a coldwater fish) or bluegill sunfish (a warmwater fish).  Results of freshwater fish acute testing for iodine and iodophores are presented in Table 4.

Table 4.  Acute Toxicity of Iodine and Iodophores to Freshwater Fish

Species

% Active Ingredient (ai)

Endpoints

(ppm)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

Bluegill sunfish

(Lepomis macrochirus)

Igepal CO-630 (technical(

96hr LC50 = 7.9 mg/L

Moderately toxic

No

- supplemental study

- test substance did not include iodine complex

ACC238200

Bluegill sunfish

(Lepomis macrochirus)

	Iobio

99.8% iodine	96-hour LC50 = 0.61 mg/L

NOEC= 0.16 mg/L	Highly toxic	Yes	MRID #430445-01

(2)	Freshwater Invertebrates, Acute

The Agency requires a freshwater aquatic invertebrate toxicity study using the TGAI to establish the acute toxicity of pesticides to freshwater invertebrates.  The preferred test species is Daphnia magna.  Results of the submitted studies for iodine and iodophores are provided in the following table (Table 5).

Table 5.  Acute Toxicity of Iodine and Iodophores to Freshwater Invertebrates

Species

% Active Ingredient (ai)

Endpoints

(ppm)

Toxicity Category

Satisfies Guidelines/

Comments

Reference

Waterflea

(Daphnia magna)

Iodine, 99.8%

48-hr. EC50 = 0.33 (95% conf. limits 0.20 - 0.37) mg ai/L

NOEC = 0.09 mg ai/L

Very highly toxic

Yes

(	Core study

- NOEC based on signs of toxicity

429610-01

The results of this study indicate that iodine is very highly toxic to freshwater invertebrates.  The guideline requirement has been fulfilled (850.1010/72-2).

(3)	Estuarine and Marine Organisms, Acute

Acute toxicity testing with estuarine and marine organisms using the TGAI is required when the end-use product is intended for direct application to the marine/estuarine environment or effluent containing the active ingredient is expected to reach this environment. This testing is not required for iodine or iodophores, as all the currently registered uses are indoor applications.

(4)  Aquatic Organisms, Chronic

Chronic toxicity testing (Fish early life stage, 850.1300/72-4a and aquatic invertebrate life cycle, 850.1400/72-4b) is required for pesticides when certain conditions of use and environmental fate apply.  This testing is not required for iodine and iodophores as all the currently registered uses are indoor applications.

C.  Toxicity to Plants

Phytotoxicity testing is required for pesticides when certain conditions of use and environmental fate apply.  This testing is not required for iodine and iodophores as all the currently registered uses are indoor applications.

Risk Assessment and Characterization

Risk assessment integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. One method of integrating the results of exposure and ecotoxicity data is called the quotient method.  For this method, risk quotients (RQs) are calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic:

           RQ = EXPOSURE/TOXICITY

RQs are then compared to OPP's levels of concern (LOCs).  These LOCs are criteria used by OPP to indicate potential risk to nontarget organisms and the need to consider regulatory action.  The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms.  LOCs currently address the following risk presumption categories: (1) acute high - potential for acute risk is high, and regulatory action may be warranted in addition to restricted use classification; (2) acute restricted use - the potential for acute risk is high, but this may be mitigated through restricted use classification; (3) acute endangered species - the potential for acute risk to endangered species is high, and regulatory action may be warranted; and (4) chronic risk - the potential for chronic risk is high, and regulatory action may be warranted.   Currently, AD does not perform assessments for chronic risk to plants, acute or chronic risks to nontarget insects, or chronic risk from granular/bait formulations to mammalian or avian species.

The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk quotients are derived from the results of required studies.  Examples of ecotoxicity values derived from the results of short-term laboratory studies that assess acute effects are: (1) LC50 (fish and birds) (2) LD50 (birds and mammals) (3) EC50 (aquatic plants and aquatic invertebrates) and (4) EC25 (terrestrial plants).  Examples of toxicity test effect levels derived from the results of long-term laboratory studies that assess chronic effects are: (1) LOEC (birds, fish, and aquatic invertebrates) (2) NOEC (birds, fish and aquatic invertebrates) and (3) MATC (Maximum Allowable Toxic Concentration) (fish and aquatic invertebrates).  For birds and mammals, the NOEC value is used as the ecotoxicity test value in assessing chronic effects.  Other values may be used when justified.  Generally, the MATC (defined as the geometric mean of the NOEC and LOEC) is used as the ecotoxicity test value in assessing chronic effects to fish and aquatic invertebrates.  However, the NOEC is used if the measurement endpoint is production of offspring or survival.

Risk presumptions, along with the corresponding RQs and LOCs are tabulated below.

Risk Presumptions for Terrestrial Animals

Risk Presumption

RQ

LOC

Birds and Wild Mammals

Acute High Risk

EEC1/LC50 or LD50/sqft2 or LD50/day3

0.5

Acute Restricted Use

EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50 mg/kg)

0.2

Acute Endangered Species

EEC/LC50 or LD50/sqft or LD50/day

0.1

Chronic Risk

EEC/NOEC

1

 1 abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items

 2    mg/ft2             	3 mg of toxicant consumed/day

   LD50 * wt. of bird             	LD50 * wt. of bird

Risk Presumptions for Aquatic Animals

Risk Presumption

RQ

LOC

Acute High Risk

EEC1/LC50 or EC50

0.5

Acute Restricted Use

EEC/LC50 or EC50

0.1

Acute Endangered Species

EEC/LC50 or EC50

0.05

Chronic Risk

EEC/MATC or NOEC

1

 1 EEC = (ppm or ppb) in water

Risk Presumptions for Plants

Risk Presumption

RQ

LOC

Terrestrial and Semi-Aquatic Plants

 tc \l2 "Terrestrial and Semi-Aquatic Plants

Acute High Risk

EEC1/EC25

1

Acute Endangered Species

EEC/EC05 or NOEC

1

Aquatic Plants

 tc \l2 "Aquatic Plants

Acute High Risk

EEC2/EC50

1

Acute Endangered Species

EEC/EC05 or NOEC

1

 1 EEC = lbs ai/A

 2 EEC = (ppb/ppm) in water

A.  Environmental Fate Assessment Summary (excerpted from the Environmental Fate Science Chapter of this RED document)

Iodine is an element ubiquoutously present in water, air, and soils. It is a part of human diet. Iodine is not likely to volatilize from iodophors due to lower vapor pressure.   Iodine is likely mobile in soils; iodine as iodide and iodate exist in water and the iodophor use is not likely to contaminate the surface waters. The estimated log Kow is about 2.5, which makes it less likely to bioaccumulate in aquatic organisms like fish.

Iodine is not hydrolyzed in water as are other halogens proceeding it in the halogen family. It is photolytically unstable in the atmosphere as it can form iodine radicals.

The transfer of iodine from air, water, and land is due to the volatility of iodine.  The wet deposition of iodine is  predominantly into soil.  Iodine in water exists as iodide and iodate, at a 55:45 ratio.  Mobility of iodine in soil depends on the soil porosity, saturation and the amount of organic matter and iron/ aluminum oxides in the soil.  In most soils it is immobile to moderately immobile.

OPP’s Lower Risk Pesticide Chemical Group (LRPCG), in its Science Assessment for iodine chemicals as active and inerts, did not observe any real or potential environmental concerns for these pesticides (Chemicals assessed were: Iodine, Potassium Iodide, Sodium Iodide, Hydroiodic Acid, Potassium Iodate)3

B.  Environmental Exposure Assessment

Environmental exposure modeling was not conducted for iodine and iodophores as all the currently registered uses are indoor applications. Industrial water treatment requires a NPDES permit in order to discharge effluents.  Little or no environmental exposure is expected from these uses.

C.  Environmental Risk Assessment

The uses of iodine and iodophores considered in this RED make it unlikely that any appreciable exposure to terrestrial or aquatic organisms would occur.

Endangered Species Considerations

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated habitat.  Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.  To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 C.F.R. ( 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection (a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004).  After the Agency’s screening-level risk assessment is performed, if any of the Agency’s Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co-occur in the area of the proposed pesticide use.  If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is undertaken.  The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, pg.81).  Chemicals in these categories therefore do not undergo a full screening-level risk assessment, and are considered to fall under a “No Effect” determination.  The registered uses of iodine and iodophores fall into this category.

REFERENCES

ACC238200.

1.  Fink, R.  1978. Acute Oral LD50 - Bobwhite Quail Biopal NR-20.

2.  Fink, R.  1978. Eight-day Dietary LC50 - Bobwhite Quail Biopal NR-20.

3.  Fink, R.  1978. Eight-day Dietary LC50 - Mallard Duck Biopal NR-20.

Unpublished data.  Conducted by Wildlife International for GAF Corporation.

4.  Macek, K.J. and S.F. Krzeminski.  1975.  Susceptibility of Bluegill sunfish (Lepomis macrochirus) to Nonionic Surfactants.  Bul. Env. Contam. Toxicol. 13(3):377-384.

MRID 42328301. Pedersen, C.A. 1991.  Tetraglycine Hydroperiodide: 21-day Acute Oral LD50 Studt in Bobwhite Quail. Unpublished data.  Conducted by Bio-Life Associates for the U.S. Army Natick Research Development and Engineering Center.

MRID 42329101.  Pedersen, C.A.  1991.  Tetraglycine Hydroperiodide: 8-day Acute Dietary LC50 Study in Bobwhite Quail.  Conducted by Bio-Life Associates for the U.S. Army Natick Research Development and Engineering Center.

MRID 42961001.  Zelinka, E.A., C.M. Holmes, K.H. Martin, and J.P. Swigert.  1993.  A 48-hour Flow-through Acute Toxicity Test with the Cladoceran (Daphnia magna).  Unpublished data.  Conducted by Wildlife International for the Baltimore Aircoil Company.

MRID 43138401. Campbell, S.M. and J.B. Beavers.  1994.  IOBIO: An Acute Oral Toxicity Study with the Northern Bobwhite.  Unpublished data.  Conducted by Wildlife International for the Baltimore Aircoil Company.

MRID 43191701. Campbell, S.M., and J. B. Beavers.  1994.  IOBIO: A Dietary LC50 Study with the Northern Bobwhite.  Unpublished data.  Conducted by Wildlife International for the Baltimore Aircoil Company.

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