[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Rules and Regulations]
[Pages 38862-38864]
[FR Doc No: 2019-16811]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0578; Product Identifier 2019-NM-111-AD; Amendment
39-19697; AD 2019-15-04]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bombardier, Inc., Model BD-100-1A10 airplanes. This AD was
prompted by a report of a mis-installed no-back pawl discovered on a
horizontal stabilizer trim actuator (HSTA). This AD requires an
inspection to verify the horizontal stabilizer trim electronic control
unit (HSTECU) part number, a software upgrade for certain HSTECUs, and
installation of HSTECUs with upgraded software. The FAA is issuing this
AD to address the unsafe condition on these products.

DATES: This AD becomes effective August 23, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 23,
2019.
    The FAA must receive comments on this AD by September 23, 2019.

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 final rule, contact
Bombardier, Inc., 200 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 2A3, Canada; North America toll-free telephone 1-866-538-1247 or
direct-dial telephone 1-514-855-2999; email<EMAIL_ADDRESS>
internet http://www.bombardier.com. You may view this referenced
service information at the FAA, Transport Standards Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2019-0578.

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-2019-
0578; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations office
is listed above. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Darren Gassetto, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2019-23, dated June 18,
2019 (referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for
certain Bombardier, Inc., Model BD-100-1A10 airplanes. The MCAI states:

    During an unscheduled inspection, a mis-installed no-back pawl
was discovered on a Horizontal Stabilizer Trim Actuator (HSTA). The
no-back mechanism is a primary means to prevent back driving of the
HSTA, and the Motor Brake Assemblies (MBA) are the secondary means.
If not corrected, unavailability of the no-back mechanism in
combination with loss of, or degraded HSTA MBA braking capability,
could lead to a loss of the aeroplane.
    This [TCCA] AD mandates a software upgrade for the HSTECU to
verify the MBA for braking capability during the power up test.

    You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0578.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 100-27-15, Revision 01,
dated June 11, 2019. This service information describes procedures for
an inspection to verify the HSTECU part number, a software upgrade for
certain HSTECUs, and installation of HSTECUs with upgraded software.
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.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the agency has been notified of the unsafe condition described in the
MCAI and service information referenced above. The FAA is issuing this
AD because it has evaluated all pertinent information and determined
the unsafe condition exists and is likely to exist or develop on other
products of the same type design.

Requirements of This AD

    This AD requires accomplishing the actions specified in the service
information described previously.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C.) authorizes agencies to dispense with notice and comment
procedures for rules when the agency, for ``good cause,'' finds that
those procedures are ``impracticable, unnecessary, or contrary to the
public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without seeking comment prior to the
rulemaking. Similarly, Section 553(d) of the APA authorizes agencies to
make rules effective in less than thirty days, upon a finding of good
cause.
    The FAA has received a report that a mis-installed no-back pawl was
discovered on a HSTA. The no-back pawl is a primary means to prevent
back driving of the HSTA, and the MBA are the secondary means. If not
corrected, unavailability of the no-back pawl, in combination with loss
of or degraded HSTA MBA braking capability, could lead to a loss of the
airplane.
    The FAA therefore considers the prompt identification and
prevention of this unsafe condition to be an urgent safety issue.
Accordingly, notice and opportunity for prior public comment are
impracticable and contrary to the public interest pursuant to 5 U.S.C.
553(b)(3)(B). In addition, the FAA finds that good cause exists
pursuant to 5 U.S.C. 553(d) for making this amendment effective in less
than 30 days.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and was not preceded by notice and opportunity for public
comment. The FAA invites you to send any written relevant data, views,
or arguments about this AD. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0578;
Product Identifier 2019-NM-111-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this AD. The agency will
consider all comments received by the closing date and may amend this
AD based on those comments.
    The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide.
The agency will also post a report summarizing each substantive verbal
contact received about this AD.

Costs of Compliance

    The FAA estimates that this AD affects 9 airplanes of U.S.
registry. The agency estimates the following costs to comply with this
AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
          Labor cost                    Parts cost               Cost per product        Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 4 work-hours x $85 per    Up to $27,138.............  Up to $27,478............  Up to $247,302.
 hour = Up to $340.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the agency has included all known
costs in its cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of

power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2019-15-04 Bombardier, Inc.: Amendment 39-19697; Docket No. FAA-
2019-0578; Product Identifier 2019-NM-111-AD.

(a) Effective Date

    This AD becomes effective August 23, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model BD-100-1A10
airplanes, certificated in any category, serial numbers 20001
through 20337 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Reason

    This AD was prompted by a report of a mis-installed no-back pawl
discovered on a horizontal stabilizer trim actuator (HSTA). The FAA
is issuing this AD to address the possible unavailability of the no-
back pawl which, in combination with loss of or degraded HSTA motor
brake assembly (MBA) braking capability, could lead to a loss of the
airplane.

(f) Compliance

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

(g) Inspection

    Within 100 flight hours or 60 days, whichever occurs first,
after the effective date of this AD: Perform an inspection to verify
the part number (P/N) of the horizontal stabilizer trim electronic
control unit (HSTECU) installed on the airplane, in accordance with
paragraph 2.B.(1) of the Accomplishment Instructions of Bombardier
Service Bulletin 100-27-15, Revision 01, dated June 11, 2019. If the
installed HSTECU has P/N C47329-007 or subsequent configurations, no
further action is required by this paragraph.

(h) Installation of HSTECUs With Upgraded Software

    (1) If, during the inspection specified in paragraph (g) of this
AD, the installed HSTECU has P/N C47329-003: Within 100 flight hours
or 60 days, whichever occurs first, after the effective date of this
AD, remove the HSTECU and install an upgraded HSTECU having P/N
C47329-010, C47329-011 or C47329-012, in accordance with paragraphs
2.B.(2) through 2.B.(4) of the Accomplishment Instructions of
Bombardier Service Bulletin 100-27-15, Revision 01, dated June 11,
2019.
    (2) If, during the inspection specified in paragraph (g) of this
AD, the installed HSTECU has P/N C47329-004, C47329-005 or C47329-
006: Within 100 flight hours or 60 days, whichever occurs first,
after the effective date of this AD, remove the HSTECU, upgrade the
HSTECU software, and reinstall the upgraded HSTECU, in accordance
with paragraphs 2.B.(2) through 2.B.(4) of the Accomplishment
Instructions of Bombardier Service Bulletin 100-27-15, Revision 01,
dated June 11, 2019.

(i) Parts Installation Limitation

    As of the effective date of this AD, no person may install, on
any airplane, an HSTECU having P/N C47329-003, C47329-004, C47329-
005 or C47329-006.

(j) No Reporting Requirement

    Although Bombardier Service Bulletin 100-27-15, Revision 01,
dated June 11, 2019, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. 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.
    (2) Contacting the Manufacturer: 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, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2019-23, dated June 18, 2019, 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-2019-0578.
    (2) For more information about this AD, contact Darren Gassetto,
Aerospace Engineer, Mechanical Systems and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 100-27-15, Revision 01, dated
June 11, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Bombardier, Inc., 200 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 2A3, Canada; North America toll-free telephone 1-
866-538-1247 or direct-dial telephone 1-514-855-2999; email
<EMAIL_ADDRESS>internet http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on July 23, 2019.
Dionne Palermo,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-16811 Filed 8-7-19; 8:45 am]
 BILLING CODE 4910-13-P


Problem Formulation for the Reassessment of Ecological Risks from the Use of Atrazine Errata Sheet for Appendix C of the White Paper - Open Literature Review of Amphibian Data

While preparing the SAP presentation on evaluation of amphibian toxicity data, discrepancies were observed for some of the endpoint classifications as well as some clarifications needed for others.  The following table represents the classification changes made to endpoints in a study.  In all but three cases, the endpoints reported no effects at the highest concentration tested.  In all but four cases, the reason for the classification change was due to lack of summary data; in the other four cases, endpoints were downgraded as there was uncertainty in whether statistical results were analyzed using pseudoreplication which may have changed the outcome of the results or in the number of replicates used in the study.  Also, all the classification changes were from Qualitative lower level of confidence to Invalid or the endpoint was already classified as Invalid.  As such, these changes do not change the overall understanding of the effects for these endpoints when considering the entire available dataset.

Table 1.  Clarifications of Endpoints  Citation Endpoint Endpoint Result Reason for Change Classification Change Changes in Endpoint Classification Allran and Karasov 2000 Growth; Bio/Mol  No effect on mass or hematocrit @ 192 ppb  Summary data not reported (SVL results reported) Qualitative lower to Invalid Allran and Karasov 2001 Growth;  Behavior;  Bio/Mol No effect on mass, swimming, hemoglobin @ 20000ppb

Summary data not reported Qualitative lower to Invalid Clements et al. 1997 Bio/Mol ↑ DNA damage (erythrocyctes) @ 4800 ppb Lack of test design (# reps)/possible pseudoreplication Qualitative lower to Invalid Coady et al. 2005 Growth; Metamorphosis No effect on mass, SVL or age at metamorphosis @ 25 ppb Summary data not reported Stayed  Invalid Forson and Storfer 2006b Growth; Metamorphosis No effect on time to metamorphosis, mass or SVL @ 160 ppb Summary data not reported Qualitative lower to Invalid Gibble et al. 2011 Bio/Mol No effect on peptide activity @ 986 ppb Limited data on test design (# reps and animals Qualitative lower to Invalid Haridon  et al. 1993 Bio/Mol No effect on micronucleated RBCs (genotox) at 300 ppb Uncertain if only one replicate used (pseudoreplication) Qualitative lower to Invalid Kerby and Stofer 2009 Imm/Inf No effects on infection rate @ 200 ppb Summary data not reported Qualitative lower to Invalid Orton et al. 2006 Growth; Metamorphosis No effect on SVL or time for forelimb emergence @ 15 ppb Summary data not reported Stayed  Invalid Rohr et al. 2003 Growth No effect on mass @ 400 ppb  Summary data not reported (SVL results reported) Qualitative lower to Invalid Tavera-Mendoza et al. 2002a Sexual Development Effects on male gonadal development @ 18 ppb Uncertain if statistical analysis used pseudoreplication Qualitative lower to Invalid Tavera-Mendoza et al. 2002b Sexual Development Effects on female gonadal development @ 18 ppb Uncertain if statistical analysis used pseudoreplication Qualitative lower to Invalid Williams and Semlitsch 2010 Growth No effect on mass @ 1.25 ppb Summary data not reported Qualitative lower to Invalid Other Endpoint Clarifications Allran and Karasov 2001 Behavioral Feeding LOAEC = 20000 ppb; NOAEC = 12000 ppb  Need to add endpoint to study summary in Table in Appendix C Qualitative lower Coady et al. 2005 Metamorphosis Age at metamorphosis NOAEC = 25 ppb; LOAEC > 25 ppb Need to add endpoint to study summary in Table in Appendix C Invalid (see above) Forson and Storfer 2006a Imm/Inf Infection rate NOAEC = 184 ppb; LOAEC > 184 ppb Need to add endpoint to study summary in Table in Appendix C Qualitative lower Hecker et al. 2005 a Bio/Mol Aromatase, estradiol, CYP19 NOAEC = 258; LOAEC > 258 Need to add endpoint to study summary in Table in Appendix C Qualitative lower Morgan et al. 1996 Survival Need to remove results reported as a.i. Results already adjusted for percent active ingredient Qualitative medium Villeneuve et  al. 2003 Bio/Mol No effect on gonad and brain aromatase @ 25 ppb

Typographical error in classification Qualitative higher to lower

                          Citation / ECOTOX(E)/ MRID         Species / Source / Exposure Period (stages & test duration)                                    TS / % ai              Solvent  (%) / NC/SC (Y/N);       MA in CNT (Y/N/NS)                              Test vessel material                             Loading; Renewal Period Reported Results             Indentified Uncertainties / Concerns and Classification

                                                                                Endpoint NOEC (ug/L) LOEC (ug/L) Effect

Allran & Karasov 2000 / E56572

Rana pipiens / Nasco(unknown if Lab/field / TP (G25) to M (138 d total)                                     T / 99                                 NA / (Y/NA); NS                                       NS                                    20 TP/7L;                                      48 hr Metam Gro Bio/Mol Surv 192 (M) 192 192 192 >192 >192 >192 >192 % & time to metamorphosis Mass; SVL Hematocrit % mortality Metamorphosis and growth endpoints based on subset (50%) of organisms and uncertainty in ability to get a true randomization based on information presented; summary data for each treatment group for mass, mortality and hematocrit not reported (only reported mean & SE for all replicates combined); ammonia levels not reported

Qualitative-Lower level of confidence  for growth and metamorphosis endpoints based on sub sampling as cannot discount potential confounding factors and also for mortality and hematocrit as no treatment summary information present; Invalid for mass and hematocrit as summary data not presented Allran & Karasov 2001 / E59251 R. pipiens & R. sylvatica & Bufo americanus / Field / A (R. pipiens)for 14 d and E for 96 hr ph                                     T / 99                                 NA / (Y/NA); NS                               Glass (E) / NS (A)                          50 or 30 E/0.075L (E); 24 hr Meta Gro Behav (E) Behav (A) Behav (A) Gro (A) Bio/Mol (A) Surv 2590 20000 20000 2590 12000 20000 20000

20000

4320 >20000 >20000 4320 20000 >20000 >20000

>20000

Deformities (tail, facial edema)(E) Mass (E) Swimming (E) Buccal ventilation ↓ Feeding Mass (A) Hemoglobin   Hatch and mortality Atrazine measured at organism collection site; water quality parameters not specified-authors state conducted according to ASTM; Summary data growth,, swimming, hemoglobin not presented

Qualitative-Lower level of confidence  as low levels of atrazine measured at organism collection site; Invalid for growth, swimming and hemoglobin due to lack of summary data Birge et al. 1980 / E6187 R. catesbeiana, R. pipiens, R. palustris, B. americanus / NS (purchased) / E for 4 dph                                     F / 80                         NS / (Y unsure if NC or SC); NS                                      glass                             50 -103 E / 0.5L; 2.5 h Surv 4 dph LC50 -- -- R. catesbeiana = 410 R. pipiens = 7680 R. palustris = 17960 B. americanus >48000 LC50s were not based on mortality per se, but on abnormalities that would reportedly preclude survival under natural conditions; solvent (if used) was not identified; formulation used so uncertainty in source of toxicity

Qualitative  -  Higher level of confidence; however LC50 values are combination of both lethality and abnormal effects and formulation used Brodeur  et al. 2009 / E112588  R. arernarum / LP/ TP (G38/39)-M                                      T/ 98                                 NA / (Y/NA); N                                      glass                               10 TP /0.04L; 48 hr Metam Surv (LC50)

NDR (N) NA

100 NA

↓ & ↑Time metamorphic stage and/or duration between stages LC50 (stage 4) = 7150-25370 LC50 (stage 25) = 2320-27160 LC50 (stage 38-39) = 12630-18270 (LC50s range from 4 d to 28 d) No water quality parameters reported; metamorphosis results not dose responsive (not sign. at 1000 or 5000 ug/L depending on metam endpoint (100 lowest conc tested); hypothesis testing for effects on metamorphosis conducted using EC50 values

Qualitative-Lower level of confidence based on higher loading with no water quality parameters reported Brodkin et al 2007 / E103351 R. pipiens / Field (ANA) / A for 8 d                                      T/ NS                             NA / (N & N/NA); NS                                     plastic                                    NA; 24 hr Imm/inf Surv

<0.01(N) 10

0.01 >10

↓ White Blood Cells Study indicated atrazine did not cause mortality; not explicitly reported in terms of NOEC/LOEC

Adult frogs cultured using Styrofoam rafts; uncertainty in how organisms were given what treatments; effects are not clearly and quantitatively linked to the assessment endpoints of growth, reproduction, and survival

Invalid based on lack dilution water only control (dilution water but subject to immune treatments used) Choung et al. 2011a / E153858  Litoria raniformis / Lab / TP (G26) for 10 wks                                    T/ >98                                 NA / (Y/NA); NS                                      glass                                10 TP /10L; 2X/wk Metam Gro Surv

25 (N) 25 --

>25 >25 --

Time to metamorphosis Mass; SVL Study indicated survival >97.5% for study; not explicitly reported in terms of NOEC/LOEC  Limited reporting of potential contaminants in food and water; number of egg masses used not specified; measured ammonium (not NH3)

Qualitative-Higher level of confidence; however there is a  lack of reported measurements in food water and number of egg masses Clements et al. 1997 / E20274 R. catesbeiana /  CBSC /  TP for 24 hr                                    F / 88.2                                 NA / (Y/NA); NS                                      glass                                     NS; NA Bio/Mol

Surv

<4800 (4200 ai) --

4800 (4200 ai) --

↑ DNA damage in erythrocyctes

NS; reported testing the maximum survival concentration and dilutions from that conc.  Limited reporting on water quality parameters and test design (# of replicates); conducted above water solubility

Invalid based on lack of test design parameters Coady et al 2004 / 46965605 R. clamitans/ Field / TP (G25)-G42 (273 d)                                     T/ 97.1                             EtOH (0.005) / (Y/Y); Y                                       NS                            30 TP/4L then 16L; 72 hr  Metam

Gro Surv

NDR(M)

28 28

11

>28 >28

↑ Time to metamorphosis at 11 but not 28 Mass; SVL % mortality

Poor water quality; high control mortality; lack of responsiveness to positive control (estradiol)

Invalid based on control contamination; high control mortality Coady et al 2005 / 46965602 Xenopus laevis/Lab/ TP (72 h ph)- M                                     T/ 97.1                                 NA / (Y/NA); Y                                      glass                            30 TP/4L; 50% every 72 hr Gro Sexdev

Bio/Mol Surv Metam 25 25

0.1 25 25 >25 >25

1 >25 >25 Mass; SVL Gonad development; laryngeal muscle ↓ estradiol males % mortality Age at metamorphosis Higher loading  with 50% renewal of solution at 72 hr may have promoted  poor water quality; delayed metamorphosis in controls; statistical difference between controls (possible confounding factor); lack of responsiveness to positive control (estradiol); no summary data for growth, metamorphosis

Invalid based on control contamination and for growth and metamorphosis for lack of summary data Forson & Storfer 2006a / E82033 A. macrodactylum / Field / LV (ca. 6 wks) for 30 d                                    T / 86.5                                 NA / (Y/NA); NS                                       PE                                1 LV/ 0.5L; 3X/wk Metam Gro Surv Imm/Inf

18.4 (M) 18.4 184 184

184 184 >184 >184

↑ larval period ↓ mass & SVL % mortality Infection Rate

Limited reported water quality;

Qualitative-Lower level of confidence due to lack of reported measurements in control with slightly higher than recommended loading with limited water quality and  a renewal rate of 72hr periodically Forson & Storfer 2006b / E103072 A. tigrinum / Lab / LV (12wks)-M (111 d total)                                     T / NS                                 NA / (Y/NA); NS                                       PE                            1 LV /0.5L; every 3 days Metam Gro Imm/inf

Surv

160 (N) 160 1.6 (NDR); 16 --

>160 >160 16;160

--

Time to metamorphosis Mass, SVL ↑ infection rate; ↓leukocytes

Reported 31 mortalities (384 exposed, 8% mortality); results not presented in terms of NOEC/LOEC Limited reported water quality; infection rate not dose responsive (not sign at 160 ug/L) ; potential stress from repetitive mass measurements; summary data for metamorphosis and growth not presented

Qualitative-Lower level of confidence due to  slightly higher than recommended loading with limited water quality and  a renewal rate of 72hr; Invalid for metamorphosis and growth as summary data not presented  Fort et al. 2004 / E81751 X. tropicalis  & X. laevis /  Xenopus I (adults) / E  - NF 46                                       T/ NS                             DMSO (1%) / (Y/NS); NS                                       NS                                20 E/0.01L; 24 hr Metam Surv (FETAX) -- -- X. laevis-  LC50 = 24500 or 25600 EC50 = 4100 or 4400 X. tropicalis LC50 = 19400  -  31800 EC50 = 2100 - 9300  Limited water quality reported; use of not recommended solvent and high conc (although allowed under ASTM FETAX assay guideline)

Invalid based on solvent choice and concentration Freeman & Rayburn 2004 / E78644 B. americanus & X. laevis / Field (parents)(Bufo) & Nasco  / TP (NF NS) for 3-5 wks

                                    T / NS                         NS / (C used NS if NC, SC); NS                                       NS                            NS (2 TP/3L tank); weekly Bio/Mol Surv

800 NS

>800 NS

Nuclei (represent genotox) Not specified; based on reported `N' in tables appears 100% survival

Stats for nuclei conducted on CVs; uncertainty in sample sizes; no reported water quality; loading unknown (fill volume not reported)

Qualitative-Lower level of confidence due to uncertainty in sample sizes and loading unknown with no reported water quality and relatively long renewal period Freeman & Rayburn 2005 / E81459 X. laevis / Nasco/Xenopus Express  / TP (varied NF40 to 54) for 3-5 wks

                                    T / 98                                 NA / (Y/NA); NS                                       NS                            NS (1 TP/3L tank); weekly Metam Gro Bio/Mol

Surv

<100 (N) 800 Varied

--

100 >800 800

--

↓ metamorphic stage Mass ↑ flow cytometric analysis meant to illustrate metemorphosis and development); results varied based on test  % Mortality (0-16.7%) for different assays, reported as occurring randomly in treatments; mortality in terms of NOEC/LOEC not reported

Stats for flow cytometric conducted on CVs; uncertainty in weight analysis with regards to accounting for  different stages of organisms; fill volume of test vessel (3L) not reported however water quality appears to be acceptable

Qualitative- Medium level of confidence for molecular endpoint due to analysis using CV and other reasons described for metamorphosis; Invalid for weight due to potential confounding factor; Qualitative  - Higher  - for metamorphosis stage;  however, lack of analysis of atrazine in control Freeman et al. 2005 / E81460 Bufo americanus / Field (Adults) / TP (G20 or 25) for 3 or 4 wks                                      T/ 98                                 NA/ (Y/NA); NS                                       NS                            NS (2 TP/3L tank); weekly Metam Gro Bio/Mol Surv NDR (N) NDR 10000 --

250 800 >10000 -- ↑ Stage at test completion  ↓ Mass at test termination Mean total #  of nuclei  Reports no acute toxicity observed; mortality in terms of NOEC/LOEC not reported Water quality parameters in study not reported; fill volume of test vessel (3L) not reported-unable to verify loading; metamorphosis and mass not dose responsive (metam-not sign at 800 ug/L in other test different age at initiation; mass- not sign at 800 in other test or 250-10000 in another test)

Qualitative- Lower level of confidence for Metamorphosis and Bio/Mol- due to loading not defined and no water quality parameters with weekly renewal; Invalid for weight due to potential confounding factor Gibble & Baer 2011 / E153856 X. laevis / Nasco / TP (NF49/50)-M (90 d total)                                T/ 98 or F/ 40.8                   DMSO (0.0173) / (Y/Y); N (Tech), NS (Form)                                       NS      1g/L [per day  -  reviewer assume] for T / NS for F; 7X/day or 3X/wk Metam Gro Surv Imm

-- -- -- 986 (N)

-- -- -- >986

Specific parameters within these endpoints not reported for metamorphosis, growth, survival Peptide activity (expressed as total protein)

Atrazine measured in solvent control (exposed for potentially 48 hours) in atrazine technical study; survival not reported; study design (replicates, # organisms) not reported for the formulation; appears frogs used as experimental unit, not tanks, for peptide assay for tech atrazine (unknown for formulation)

Invalid for growth, survival and metamorphosis based on lack of reporting results and control contamination; Invalid- for peptide bioactivity analyses for atrazine formulation based on lack of test design  Goleman & Carr 2003 / 45867707 X. laevis / Xenopus Express (Adults)  / TP (48 hph)-NF66 (78 d total)                                     T/ 98.6                    ethanol (0.0025)- E2 group only / (Y/Y);N                                      glass                 Varied 60-65 TP /0.250  -  4L; 50% every 72 hr Metam Gro Behav Sexdev Surv 19.5 (M) 19.5 10.3 10.3 19.5 >19.5 >19.5 19.5 19.5 >19.5 Forelimb emergence, tail resorption Mass; SVL ↑abnormal swimming ↑ ovotestes % mortality Water quality concerns; lack of response to positive control and potential delayed development

Invalid based on appeared lack of response to positive control and potential overall delayed development in the study Gunderson  et al 2011 / E153613 R.catesbeiana / Field / TP (NS) for 2 d                                      T/ NS                             IPA (0.001) / (N/Y); NS                                      glass                        0.63 g/L; static (48hr exposure) Bio/Mol Surv 10 -- >10 -- Relative fold difference for CYP19 and SF-1 Reported no mortalities in study not reported in terms of LOEC/NOEC Limited water quality reported; while no sign diff in CYP19 and SF-1 for each treatment, correlation of CYP19 and SF-1 m RNA in the brain when combining 1 & 10 ppb resulted in sign diff.

Invalid based on use on solvent choice (not recommended solvent) and no negative control used in study Haridon et al. 1993 / E4324 Pleurodeles waltl / LV for 12 d                                     T / NS                            DMSO (0.05) / (NS/NS); NS                                      glass                               15 LV / 1.5L; 24 hr Bio/Mol Surv

300 NS

>300 NS

Micronuceated RBCs (genotox) Reported that maximum concentration was dose not to induce detectable physiological disturbances for 12 days of treatment Limited water quality reported; Used DMSO at higher than recommended conc.; uncertain in what the control was comprised of; uncertain if used pseudoreplication in results

Invalid due to uncertain if only one replicate used (pseudoreplication Hayes 2002 / E70207 X.laevis / Lab / TP(NF46)-M (NF66); A for 46 d                                      T/ NS                              EtOH (0.004) (N/Y);NS                                     plastic                                30 TP /4L; 72 hr Metam Gro Sexdel Bio/Mol Surv 200 (N) 200 0.01;0.8 <25 200 >200 >200 0.1;1 25 >200 Time to metamorphosis Mass; SVL ↑Ovotestes; ↓Laryngeal dilator ↓Plasm testosterone Mortality Limited water quality reporting; use of plastic test vessels; indirect measured of effect (laryngeal); in report results on metamorphosis, growth and survival not reported in study

Qualitative  -  Lower level of confidence based on higher loading with limited water quality reporting and a renewal period of every 3 days Hayes et al. 2003  R. pipiens / Field / (48hr post hatch)-M                                     T / 98                            EtOH (0.0036) / (N/Y) NS                                       NS                                30 TP / 4L; 72 hr Metam Growth Surv Sexdev NS NS NS <0.1 NS NS NS 0.1 Results not presented in report for metamorphosis, growth, survival ↑ male gonadal dysgenesis (underdeveloped); Sex reversal No statistical results associated with sexual development endpoints ; study reported at metamorphosis growth measurements taken but results not presented in study

Qualitative  -  Lower level of confidence based on higher loading with limited water quality reporting and a renewal period of every 3 days  Hayes et al 2006a X.laevis / Lab / TP (4d post hatch)-M (NF66)                                      T/ NS                            MeOH (0.004) / (Y/Y); NS                                     plastic                                 30 TP/4L; 72 hr Sexdev Uncertainty if animals exposed to atrazine in this study or if from another study.   May have used different clutches to make comparisons

Sex ratio of controls skewed;  lack of a consistent and clear dose response; limited water quality parameters reported.

Invalid due to uncertainty if animals were exposed to atrazine in this study or were from another study Hayes et al. 2006b / E85815 R..pipiens / Field (Adult)/ TP (48hr post hatch)-G46; X. laevis /Lab /A for 27 d                                      T/ 98                            EtOH (0.0036) / (N/Y); N                                     plastic                                30 TP /4L; 72 hr Metam Gro Imm/inf Surv 0.19 (M) <0.19 <0.19 0.19 >0.19 0.19 0.19 >0.19 Time to metamorphosis  ↓ Mass; SVL ↑ Thymic plaques (X. laevis) Mortality Water quality parameters not reported; reported results are inconsistent with the data presented in report; authors rely on the lack of statistical significance to draw conclusions.

Qualitative  - Lower level of confidence based on higher loading with limited water quality reporting and a renewal period of every 3 days as well as inconsistent reporting adding to level of uncertainty Hayes et al 2010 / E153853 X.laevis / Lab / H-A (up to 3 yrs post M)                                      T/ NS                            EtOH (0.003) / (N/Y); NS                                     plastic                                 30 TP/4L; 72 hr Sexdev

Bio/Mol Behav Surv Metam Gro <2.5(N)

<2.5 <2.5 NS NS NS 2.5

2.5 2.5 NS NS NS ↓ Breeding gland, laryngeal development ↓ Testosterone ↓Mating behavior Results on survival, metamorphosis and growth of animal not reported

In general, the study does not describe and/or account for all of the animals used in each treatment/replicate; uncertainty in reported results (e.g., # of phenotypic female/genotypic male compared to total exposed); Results for survival, metamorphosis and growth not reported

Qualitative  -  Lower level of confidence based on higher loading with limited water quality reporting and a renewal period of every 3 days and uncertainty in reported results add to level of uncertainty; Invalid for survival, growth and metamorphosis Hecker et al 2005a / E79287 X.laevis / Xenopus Express / A for 36 d                                     T/ 97.1                                  NA (Y/NA); N                                       NS                               1 frog/10L; 3 days Sexdev Bio/Mol Bio/Mol Surv

258(M) 24.6 258 --

>258 258 >258 --

Gondal abnormalities ↓ Plasma testosterone Aromatase, estradiol, CYP19 4 total mortalities (65 exposed) reported; mortality nor presented in terms of  NOAEC/LOAEC  Uncertainty in methods for weights (and it cascading effect) and gonad evaluation; LOD/LOQ not reported for steroid analyses; unclear about sample size for steroid analyses

Qualitative-Lower level of confidence due to uncertainty in methodology for weights, gonad evaluation and biochemical analyses Hecker et al 2005b / E79288 X.laevis / Xenopus Express / A for 49 d                                     T/ 97.1                                  NA (Y/NA); N                                   fiberglass                                 4.9 g/L;3 days Sexdev Bio/Mol Surv

<11.6 M 107 --

11.6 >107 --

GSI Plasma testosterone; estradiol 1 total mortality reported; mortality not presented in terms of NOAEC/LOAEC No solvent control for positive control; Some water quality reported but no reporting of nitrates, nitrites, and ammonia; limited sensitivity for aromatase assay

Qualitative  -  Lower level of confidence based on higher loading with limited water quality reporting and a renewal period of every 3 days Howe et al 1998 / MRID 45202910 R. pipiens, B. americanus / F / TP (G29 & 40) for 96 h                                    F / 40.8                                  NA (Y/NA); N                                      glass                                  20 TP / 15L  Surv 96 hr LC50 -- -- LC50 values R. pipiens (early stage) = 47600 R. pipiens (late stage) = 14500 B. americanus (early) = 26500 B. americanus (late) = 10700 Control survival not reported; no raw data; tested above water solubility

Qualitative  -  Medium level of confidence based on lack of control data and only LC50 values reported and testing above water solubility Houck  & Sessions 2006 / E117318 R. pipiens / NS / A for 4 or 8 wks                                       NS                                NS / (NS/NS); NS                                      glass                                   NA; 3 days Imm/inf

Imm/inf Surv

<1(N)

10 --

>10

>10 --

↓ plaques representing antibody-secreting cells (4 wks) Number of Lymphocytes 1 mortality (believed 24 exposed) reported; mortality not presented in terms of NOAEC/LOAEC No information provided on culturing conditions and limited information on experimental parameters; uncertainty in whether used a solvent or not as test solution preparation not reported; uncertainty in source of frogs;  frogs were reported to not be feeding in trial 2; analytical measurements of treatment groups not reported; uncertainty in how animals in Trial 1 were used in study

Invalid based on frogs not eating in trial 2 and overall lack of culturing and experimental parameters and uncertainty in reported results in Trial 1 Kerby and Storfer 2009a / E117314 A. tigrinum / Lab / LV (4wks) for 14 d                                      T/ NS                             MeOH (0.02); (N/Y); NS                                     plastic                              1 LV /0.5L; 1X/week  Imm/inf Surv

200 (N) 200

>200 >200

Infection rate % Survival basedon atrazine alone, reported interactive effect (p=0.03) atrazine-virus with atrazine slightly increasing survival w/o virus and slightly decrease survival w/virus  Uncertainty in affect of dead larvae on measured viral load that was used in analyses; limited water quality reported

Qualitative-Lower level of confidence given higher than recommended loading rate with limited water quality reported and a weekly renewal period; Invalid for infection rate as summary data not presented Kiesecker 2002 / E68326 R. sylvatica /Field /TP (G25) for  4 wk                                     T / NS                         ACNT & DMSO (NS); (Y,Y); NS                                       PE                                1 TP/3.5L; 48 hr Imm/inf Surv

<3 NS

3 NS

↓ eosinophils ↑ trematode infections Mortality not reported; based on sample size in Figure 2 in report survival appears to be 100% Uncertain if cercariae used for infection trial were exposed to atrazine, therefore there is some uncertainty in the environmental relevance of this scenario; dilution water only group (no exposure to cercariae not used; limited water quality reported; uncertainty in statistical analysis

Invalid based on lack of dilution water only control, also due to environmental relevance with different exposure scenarios between tadpole and parasite, unsure of statistical analyses adds to uncertainty Kloas 2009a / E112914 X. laevis / Xenopus I / TP (8 dpf) for 83 d                                      T / NS                                 NA / (Y/NA); Y                                      glass                              <1 g/L/day; 7X/day Metam Gro Sexdev Surv 100 (N) 100 100 100 >100 >100 >100 >100 Time to metamorphosis Mass; SVL>100 Sex ratio; gonadal development % Survival Atrazine contamination of controls; marked fluctuations in water quality parameters; histological endpoint comparisons not made relative to amphibian reference

Quantitative based on fact that although deficiencies, study design and reporting were robust enough to properly evaluate results Kloas 2009b / 153612 X. laevis / Lab / TP (NF 48 and 58) for 4 d                                     T / NS                                 NS / (NS,NS); NS                                      glass                           NS (25TP / 10L tank); 24 hr Bio/Mol

Surv

25

NS

>25

NS

Aromatase, LH, FSH, 5-alpha reductase Mortality not reported

Analysis based on  n=8, however only two independent tanks tested (removed 4 from each tank that contained 25 tadpoles at initiation); limited water quality parameters reported during test, test solution preparation and what constitutes the control was not reported

Qualitative  -  Low level of confidence based on lack test design reporting  Koprivnikar et al 2007 / E103348 R. sylvatica / Field / TP (G28/29) for ca. 31 d                                    F / 40.8                                 NA / (N/NA); NS                                     plastic                               1 TP /1.8L; 72 hrs Imm/inf

Surv 3 (N)

30 30

>30 ↑ intensity of infection (frogs exposed but cercariae not) Mortality Control survival was 61.9%; Dilution water only treatment (no cercariae) was not used; replicate variability not reported; effects only observed when tadpoles, not cercariae were exposed to atrazine  - uncertainty in environmental relevance; limited water quality reported

Invalid based on lack of dilution water only control, lack of reported replicate variability and adverse effects observed only when tadpoles, not cercariae, were exposed (unknown environmental relevance) adds to the level of uncertainty Koprivnikar et al 2010 / E153870 R. pipiens / E from CBSC / TP (<G27)- ~ G43                                     T/ 99.2                           EtOH (100ug/L) / (Y/Y); NS                                     plastic                                 1 TP/L; weekly Metam Gro Surv <3 (N) <3 <3 3 3 3 Developmental stage Mass Mortality Variability in mortality across 3 ppb treatment groups; uncertain if developmental stage was accounted for in mass endpoint; uncertainty in reported results in figures; uncertainty if organisms were field collected or laboratory reared

Invalid based on uncertainty in reported results based on Figures in report and limited reported water quality with relatively long renewal period and variability in mortality across treatment groups add to uncertainty La Fiandra et al. 2008 / E103336 H. versicolor / Lab / TP (G25) -30 d past M                                     F/ 88.2                                 NA; (Y/NA); NS                                      glass                               3 TP/7L; 50% 1X/wk Metam Gro Sexdev Surv 195 (M) 195 195 195 >195 >195 >195 >195 Larval period Mass; SUL Sex ratio; gonad development % Survival Limited water quality reported; uncertainty if adults used to obtain eggs for culturing were from the field or laboratory

Qualitative-Lower level of confidence, while  loading was within recommended limit,  limited reported water quality with relatively long renewal period(50% renewal every week) may have potential environmental condition issues Langerveld 2009 / E121497 X. laevis / Lab / TP (NF43) to NF46                                     T/ 99.4                                 NA / (Y/NA); NS                                      Pyrex                            4 TP/1L;  every 2-3 days Gro Bio/Mol Surv <400 (N) <400 <400 400 400 400 ↓ Mass; SVL Expression of multiple genes % Survival Limited water quality reported;  Uncertainty regarding overall mortality in control and 400 ppb however, substantial mortality observed at 400 ppb when approaching stage 63, therefore  may not be unexpected to observe significant sublethal changes

Invalid  for growth and bio/mol due to significant mortality compared to control in the only atrazine concentration tested also high loading rate with limited water quality and renewal rate periodically >48 hours; Qualitative Low level of confidence for survival  based on limited water quality, loading and renewal rate. Larson et al. 1998 / E60632 A. tigrinum / Field / LV (SVL= 30mm) for 86 d                                     T / NS                              ACTN  (NS)/  (N/Y); Y                                       PE                              1 TP/4L; 50% at 48hr Metam Gro Bio/Mol Surv <81.8(M 81.8 <81.8 -- 81.8 >81.8 81.8 -- ↓metamorphosis Mass; SVL ↑plasma thyroxine;↓ corticosterone Reported no exposure related mortalities; mortality not reported in terms of NOAEC/LOAEC Atrazine measured in controls; lower dissolved oxygen reported

Invalid due to control contamination and solvent concentration not reported and no negative control tested add to uncertainty Lenkowski  & McLaughlin 2010 / E153851 X. laevis / Lab / TP (NF41) for 6-48 hr                                      T/ NS                           DMSO (0.1-0.35) / (Y/Y); NS                                       NS                     13-18 TP /0.01L; 24 hr (48 hr exposure) Bio/Mol Surv 350(N) NS 3500 NS ↑ MMP18 expression

Limited reporting on test elements (replicates, solution preparation, test vessels, analysis of test solutions, water quality parameters, loading, control survival)

Invalid due to solvent concentration and solvent choice and lack of reporting on test design and experimental parameters contributing to higher level of uncertainty Lenkowski 2010 / E153876 X. laevis / Lab / TP (NF41) for 48 hr                                      T/ NS                           DMSO (0.1-0.35) / (Y/Y); NS                                       NS                    13-18 TP /0.010L; 24 hr (48-hr exposure) Metam Surv

350 (N) --

3500 --

↑ Malformations in intestines and cranial cartilage Reported no mortality in atrazine exposures, control mortality not explicitly reported

Limited reporting on test elements (solution preparation, test vessels, analysis of test solutions, water quality parameters)

Invalid due to solvent concentration and choice and lack of reporting on test design and experimental parameters contributing to higher level of uncertainty Lenkowski et al 2008 / E103268 X. laevis / Lab /TP (NF41-46) for 48 hr                                     T / 98                           DMSO (0.1-0.35) / (Y/Y); NS                                       NS                      15 TP /0.01L; 24 hr (48 hr exposure) Metam

Surv <10,000 (N) --

10000

-- ↑ visceral bleeding & organ malformations Mortality reported as <5%

Limited reporting on test elements (test vessels, analysis of test solutions, water quality parameters)

Invalid due to solvent concentration and lack of reporting on test design and experimental parameters contributing to higher level of uncertainty Oka 2008 / E103345 X. laevis / Lab / TP (NF49)-M (56 d total)                                      T/ 97.4                            EtOH  (0.01) / (N/Y); NS                                      glass                                30 TP /10L; 3X/wk Metam Bio/Mol Sexdev Surv

100 (N) 100 1 --

>100 >100 10 --

Time to metamorphosis Aromatase ↑ female ratio Reported >= survival in controls and some treatment groups with low survival in one of two tanks for two concentrations Estrogenic activity measured in parental food; variable replicate mortality which resulted in only one replicate for analysis for two treatment groups for sex ratio endpoint; no statistical results reported for metamorphosis; limited water quality reported

Qualitative- Lower level of  confidence based on higher loading with limited water quality reporting and an occasional renewal period of every 3 days  coupled with variable mortality in tanks for two treatment groups (not dose responsive); Invalid for metamorphosis as statistical results not reported. Olivier & Moon 2010 / E153629 A.maculatum / Field / E for ~ 76 d                                     F/ 42.6                                 NA / (Y/NA); NS                                     plastic                            1 egg mass /0.750L; 3 wks Metam

Surv 50 (N)

50 100

100 Developmental stage before death or hatch % Hatch; mortality reported as egg mass mortality specific stats not reported Temperature regulator malfunction in which pathologies were observed in treatment groups (not control) shortly thereafter and mortality in atrazine treatments occurred shortly after solution renewal; Uncertainty in number of embryos per treatment and evaluation of oxygen depletion; limited water quality

Qualitative-Lower level of confidence as it appears that additional potential stressors of temperature change and solution renewal may have contributed to observed pathologies as well as limited water quality reported with long renewal period (21 d) Orton et al 2006 / E82034 R.pipiens / Carolina Biological /  Taylor-Kollros Stage 2/3  -  23.24

                                    T/ 98.2                                 NA / (Y/NA); N                                       NS                             20 TP /8L; 75% at 48 hr Metam Gro Sexdev Surv 15 (M) 15 <15 <15 >15 >15 15 15 Time for forlimb emergence SVL Sex ratio; gonad develop % mortality; lower in treatment groups High control mortality (ca. 50%); higher incidence of intersex (12.5%) in controls; sex ratio of controls appears skewed; summary data for metamorphosis and growth not presented

Invalid based on higher incidence of reported gonadal  intersex in control and higher control mortality also no summary data for metamorphosis and growth Morgan 1996 / E63246 X. laevis / Xenopus I (adults) / E for 96 hr                                    F / 40.8                                 NA / (Y/NA); NS                                     plastic                          NS (20 E/petri dish) ; 24 hr Metam Surv  -- 11000 or 1100 LC50 = 100000 or 126000  EC50 (abnormalities) = 33000 or <8000  Limited water quality reported, test solution fill volume not reported; conducted above water solubility; formulation used so source of toxicity unknown

Qualitative  -  Medium level of confidence based on limited water quality reported  Rohr et al., 2003/ E71723   A. barbouri / Field / E for 37 d (53 d total test)                                     T / 80                            DMSO  (0.03) / (Y/Y); NS                                      Glass                             10 LV/2L; 50% at 48 hr Gro Behav Surv 400 (N) 40 400 >400 400 >400 Mass; SVL; limb deformaties ↑Locomotor activity Total Survival  Solvent control contained both acetone and DMSO whereas atrazine concentrations only contained DMSO (which is not a recommended solvent); author states organisms likely exposed to atrazine prior to test due to agricultural activities around collection site;  limited water quality reported; uncertain if potentially different stages at test termination (stages not reported) influenced growth analysis; mass summary data not presented

Qualtiative- Lower level of confidence based on higher than recommended solvent concentration using a non-recommended solvent in addition the limited reported water quality with the higher loading rate add to the level of uncertainty; Invalid for mass as summary data not presented Rohr et al., 2004 / E81748 A. barbouri / Field / E-M (mean 64 d)                                     T / 80                    DMSO (0.03) & ACTN (0.03) / (N/Y); N                                       NS                             31 or 40 E/9.5L; weekly Metam Gro Behav Surv 4(N) 40 40 40 40 400 400 400 ↑ time to metamorph ↓ mass ↑ locomotion activity; ↓refuge use ↓ Survival White film on dead embryo unknown if fungus caused or followed mortality; larval survival differences between years; although pH, temp, and DO ok, nitrates and ammonia not reported;

Qualitative-Lower level of confidence based on higher than recommended solvent concentration using a non-recommended solvent in addition to uncertainty in the source of mortality in the dead embryos Rohr and Palmer, 2005 / E81664 A. barbouri / Field / Metamorphs  for 5 hrs                                     T / 80                              DMSO (NS) / (N/Y); NS                                       NS                                NA; 5 hr exposure Behav Surv

4(N) --

40 --

↓ water conserving behavior; ↑ activity Reported no mortality; results not presented in NOAEC/LOAEC terms

This study used metamorphs from previous study (Rohr et al 2004, E81748) in which organisms were exposed to different atrazine concentrations and test subjects in this study were not exposed to any additional atrazine during the behavioral study (water conserving behaviors).  See Rohr et al 2004 (E81748) for comments

Qualitative-Lower level of confidence based on identified uncertainties in the other study from which the organisms in this study were obtained   Rohr 2008b / E112912 R. clamitans / Field / TP (G24-26) for 14 d                                    T/ >98                                      ACTN                                (NS) / (Y/Y); NS                                      glass                                 4 TP /0.3L; NS Imm/inf Surv

<201 (M) 201

201 >201

↑ % of encyted cercariae Mortality

Tadpoles exposed to atrazine before and after cercariae exposure but cercariae not-uncertainty in environmental relevance; for cercariae-tadpole results, the treatments are compared to the solvent control suggesting a significant difference between the controls; limited water quality reported; control mortality not clearly indicated

Qualtiative- Lower level of confidence as control mortality not clearly reported limited water quality reported with a non-specified renewal period (tadpoles exposed for 7 days at a time) and higher than  recommended loading and environmental relevancy that adds to the uncertainty Rohr  et al. 2009 / E117315  B. americanus / Field / LV (G25-27) for 4 d                                      T/ 99                           ACTN  (0.0002) / (N/Y); NS                                       NS                      6 TP/0.5L (96hr) then 1/3.5L; static Behav Surv 196 (M) -- >196 -- Fear queues  (predator and parasite); activity Reported no effect on mortality with nearly 100% survival No negative control (authors report no effect from solvent based on previous data); limited water quality reported

Qualitative-Higher level of confidence, however  no negative control and limited water quality Rohr et al., 2006 / E82038 A. barbouri / Field / A                                     T / 80                    DMSO (0.03) & ACTN (0.03) / (N/Y); N                                       NS                              31 or 40 E/9.5L; NA  Surv <4 4 ↓ Long term survival (carryover effects) This study used metamorphs from previous study (Rohr et al 2004, E81748) in which organisms were exposed to different atrazine concentrations and test subjects in this study were not exposed to any additional atrazine to observe survival due to carryover effects.  See Rohr et al 2004 (E81748) for comments

Qualitative-Lower level of confidence based on identified uncertainties in the other study from which the organisms in this study were obtained   Rohr et al. 2011 / E153803 A.barbouri / Field / E-H (49d) or LV (NS)-M or 19 d                                      T/ 99                             ACTN (8.25) / (N/Y); NS                                      glass                                 12 E/2L; weekly Gro(E) Metam (L) Gro (L) Surv 40 (N) NS

NS <4 400 NS

NS 4 Mass Authors indicate effect on metam and growth but conc. not reported

Embryos  -  ↑ Mortality; larval experiment- no significant for atrazine treatment group Larval survival lower across all treatments and control for study at 19°C; larval mass from embryo study conducted using preserved organisms; limited water quality reported

Invalid based on higher than recommended solvent concentration using a non-recommended solvent in addition to not using a negative control group; also limited water quality reporting with higher than recommended loading and weekly renewal period add to the level of uncertainty Spolyarich  et al. 2010 / E153638 L.tasmaniensis   / Field / TP (G28) to G42 (4wks)                                      T/ 98                                 NA / (Y/NA); N                                      glass                                10 TP/10L; 2X/wk Metam Gro Sexdev Surv

30 (N) 30 30 --

>30 >30 >30 --

Rate of development Length Sex ratio; gonad development Reported 2.3% mortality in test overall; mortality not reported in terms of NOAEC/LOAEC Sex determination based on gross morphology; histology on male gonads only; Metamorphosis and length data analysis appear to be based using the individual frog as the experimental unit and not the tank as data in figures appears to be on pooled results of the three trials

Qualitative-Higher level of confidence as loading seemed within recommended levels, however, ammonia and nitrate concentrations not reported with a 2X/wk renewal period and field collected organisms (Sydney Australia suburb) so prior exposure history is unknown Storrs and Kiesecker 2004 / E78290 Pseudacris crucifer, R. sylvatica, B. americanus, R. clamitans / Field / TP (early stage G25-27) & (late stage G29-36) for ca. 30 d                                     F / 85                                 NA / (Y/NA); NS                                       PE                         1 TP/ 0.1 or 0.5L; every 3 days Surv NDR 2.84 Survival- not dose responsive, for all but wood frog, report sign. effects at 2.84, but not always at 25 or 64  Survival not dose- responsive;  animals that metamorphosed during the experiment were eliminated from the data set; limited water quality reported

Qualitative-Lower level of confidence due to survival response not dose-responsive and limited water quality reported with loading and renewal rate. Storrs & Semlitsch 2008 / E103378 H. versicolor; R. sphenocphala; B. americanus / Field / TP (G25)-Metamorphs                                      T/ 99.2                            EtOH (0.0125) / (Y/Y); N                               Glass & plastic                                1 TP/ 0.8L; 72 hr Metam & Sexdev (H. vers.) Metam & Sexdev (R. sphen) Metam & Sexdev (B. amer) Surv (all) 25.1 (M)

30.4

125

NS >25.1

>30.4

>125

NS Time to metamorphosis;  Ovarian stage

Time to metamorphosis; Ovarian stage

Time to metamorphosis; Ovarian stage

Mortality not reported Limited water quality reported; very slight estrogenic activity measured in dilution water; Uncertainty in number of animals exposed

Qualitative-Lower level of confidence based on limited water quality reported with slightly higher than recommended loading and renewal period of  72hr as well as slightly higher than recommended solvent concentration Storrs Mendez et al. 2009/ E118898 B. americanus / Field / Metamorphs for 2 d                                      T/ 99.2                             ACTN (NS)/ (NS/NS); NS                                       NS                                     NA; NA Behav

Surv 1430 ug/kg(N) NS >1430

NS Soil choice preference (ATZ or no ATZ) Limited reporting on control group preparation-uncertainty regarding whether control contained solvent; uncertainty in measured conc. due to less than nominal and long storage time

Qualitative-Medium level of confidence based on limited reporting for control preparation   Storrs-Mendez & Semlitsch 2009/ E153841 H. versicolor; R. sphenocphala; B. americanus / Field / TP (G25)-Metamorphs and TP (G25)-J (4 or 6 mnths)                                     T/ 99.2                              EtOH (NS) / (N/Y); N                                       NS                          1 TP/0.8L or 20TP/20L; 72 hr Sexdev (L) B. amer R. sphen H. versi. Sexdev (J) B. amer. R. sphen H. versi  Surv All

7.55(M) 0.8 <0.92

<3 29.5 24.6

NS

124 3 0.92

3 >29.5 >24.6

NS Sex ratio for all endpoints Mortality not specified Results on larvae appear to be same as reported in Storrs & Semlitsch 2008 / E103378;  Results not dose responsive between treatments and time; Uncertainties about test design for juveniles

Qualitative-Lower level of confidence;  see comments for Storrs & Semlitsch 2008 / E103378 Sullivan & Spence 2003 X.laevis / Xenopus I(Adults) /  TP(NF46-48)-M                                      T /99                            ACTN (0.0032) / (Y/N); NS                                      glass               6 TP/0.5L starting varied over time;every 3-4 days  Metam Gro

Surv 40 <20

320 320 20

>320 ↑ Time to metamorphosis w/nitrate  ↓Mass at metamorphosis; no effect on metamorphosis for this study Reported mean mortality for entire atrazine only study (p value not reported); when atrazine w/nitrite, mortality sign. greater for nitrate with  320 ug/L atrazine than 0 ug/L nitrate Changing exposure conditions and alterations in the number of replicates;

Qualitative-Lower level of confidence based on changing exposure conditions and alterations in number of replicates Tavera-Mendoza et al 2002 / E60639 X.laevis/Xenopus I/ TP(NG56) for 48 h                                       T/ 99                                 NA / (Y/NA); N                                      glass                       16 TP/ 15L; static (48hr exposure) Sexdev

Surv

<18

--

18

-- ↓ testes size, spermatogonial nests and nurse cells  Reported no mortalities in control or treatment; mortality not reported in terms of NOAEC/LOAEC Need documentation of the measurement endpoints, elaboration on the ecological relevancy of the measurement endpoints, and clarification of the number of exposed animals; appeared to use individual animals not replicates as experimental unit

Invalid based on uncertainty if results based on pseudoreplication Tavera-Mendoza et al 2002 / E77830 X. laevis /Xenopus I / TP(NF56) for 48 h                                     T / 99                                 NA / (Y/NA); N                                      glass                       16 TP/15L; static (48 hr exposure) Sexdev

Surv <18

NS 18

NS ↓ primary oogonia ↑ secondary oogonia ↑ atresia  Survival not specified but based on sample size it appears to be 100%

Only one dose; uncertainty of the nature of the measurement endpoints, and the relevancy of the endpoint to higher order measures of organismal fitness; used individual animals not replicates as experimental unit

Invalid based on uncertainty if results based on pseudoreplication Villeneuve et  al. 2003 / 45867708 X. laevis / / A for 26, 43 or 47 d                                     T / NS                                 NA / (Y/NA); NS                                   fiberglass                          15 A /120L; 50% every 3 days Bio/Mol Surv 25 (N) -- >25 -- Gonad and brain aromatase Mortality ranged from 3-19% and was not presented in terms of  NOAEC/LOAEC Lack of replication in some studies; observed variability in endpoints; potential water quality issues

Invalid for studies (male) due to no replication; Qualitative-Lower level of confidence in remaining study (female) due to higher variability in endpoint in control Wan et al. 2006 / E89626 R. catesbeiana /Ward's Natural Science / TP (10cm) for 96 hr                              T / 98 & F / 48.5                 ACNT (NS); (Y/Y); NS (dilution water analysed)                                      glass                                 0.8 g/L; static Surv -- -- Technical 96 hr LC50 > 16000

Formulation 96 hr LC50 > 480000 (232800 ai) Solvent concentration not reported; raw data not provided, control mortality not reported

Qualitative  -  Medium level of confidence based on lack of summary data and no reported solvent concentration Williams & Semlitsch 2010 / E153825 B.americanus & P. triseriata & H. versicolor / Field / TP (G25)-M                                    F / 48.8                                  NA / (Y/N); N                               Glass &plastic                          NS (1 TP/1L container); 72 hr Metam Gro (all species) Surv 1.25(M) 1.25

1.25 >1.25 >1.25

1.25 Time to metamorphosis Mass

% Surviving Limited water quality reported; fill volume of test vessel not reported (1 TP /1L container); mass summary data not presented

Qualitative- Lower level of confidence based on limited water quality reported with a renewal period of 72 hrs and probably slightly higher than  recommended loading; Invalid for mass as summary data not presented Zaya et al. 2011a / E153847 X.laevis / NS (Nasco?) / TP (NF47)-NF 58or 62                                      T/ NS                                 NA / (Y/NA); NS                                      glass                                 4 TP/1L; 3X/wk Metam Gro Behav Sexdev Imm/inf Surv 200 (N) 25 400 400 200 400 400 200 >400 >400 400 >400 Time to metamorphosis Mass; fat bodies Feeding Sex ratio (gross morphology) ↑ Activated caspase 3 immuno(+) cells Survival Potential effects of stress during weighing and staging during study; uncertainty about protocol for feeding endpoint; variability in fat body and liver size endpoints; limited water quality reported

Qualitative-Lower level of confidence based on limited water quality reported with a higher than recommended loading and a renewal period of 72 hours  Zaya  et al 2011b / E153848 X.laevis / NS (Nasco?) / TP (NF47)-NF 58or 62                                      T/ NS                                 NA / (Y/NA); NS                                      glass                                 4 TP/1L; 3X/wk Bio/Mol

Surv <400 (N)

400 400

>400 Changes in gene expression (actyl-CoA ehydrogenase and glucocorticoid receptor) Used organisms from Zaya et al 2011a (E153847)

etiology of the effects on gene expression reported in this article are uncertain; potential bias in sampling; limited water quality reported

Qualitative-Lower level of confidence based on potential biasing and limited water quality reported with a higher than recommended loading and a renewal period of 72 hours  Cosms

Boone & Bridges-Britton 2006 / E88290 Hyla. versicolor / Field / T (G25)-  M (35 d)                                    F / 40.8                                 NA / (Y/NA); NS                                       PE                                  30 TP /1000L Metam Gro Surv 20 (N) 20 20 >20 >20 >20 Days to metamorphosis Mass Survival Low  power to detect differences;

Qualitative Boone & James  2003 / E81455 R. Sphenocephala B. americanus A. maculatum & A. texanum / Field / LV for 39-41 or 80 d                                     F/ 40.8                                 NA / (Y/NA); NS                                       PE                                20 or 60 TP/1000L Metam

Gro Surv 197 & <197 <197 197 >197 & 197 197 >197 ↑ time to metamorphosis for A. texanum; no effect other species ↓Mass (all species) Survival Limited data to interpret atrazine only effects for some endpoints/scenarios; lack of analytical measurements in dilution water

Qualitative DeNoyelles 1989 /  47543608 R. catesbiana / NS/ Stage NS for 805 d                               F / 41 & T/ 97                                 NA / (Y/NA); NS                                       NS                                       NS Gro Surv <20 (N)

20 ↓ overall biomass Bullfrogs immigrated to ponds-uneven distribution likely; potential chemicals in ponds prior to testing unknown

Qualitative Detenbeck et al. 1996 / E16839 R. pipiens / Field / TP (NS) for 41 d                                      F/ 85                                 NA / (Y/NA); Y                              Wooden cage w/plastic                          20 TP /cage/ flowering stream Metam Surv 25 (N) NS >25 NS % adult appearance; hind limb length  Not specified Control contamination; short acclimation periods; higher variability (lower power)

Qualitative based on review for plants Diana et al 2000 / E59818 H.  versicolor/ Field / TP to metamorphs                                      T/ NS                             ACTN (0.04% )/ (N/Y); Y                                     plastic                                   40 LV /90L Metam Gro Surv 2000 20 2000 >2000 200 >2000 Time to metamorphosis ↓Mass; SVL % Survival Control contamination;  pre-metamorphosis weight and length were not determined

Qualitative based on review for plants Du Preez et al 2008 (lab and cosm) / E103271 X laevis / Field / TPto A (2 yrs post metam)                                      T / NS                             MeOH (0.025) / (N/Y); N                                       NS                                 75 frogs/2,500L Metam Sexdev Surv 24.8 24.8 24.8 >24.8 >24.8 >24.8 Time to metamorphosis Gonadal development; sex ratio % Survival Continuation of Jooste 2005 (46965603); Temp concerns; uncertainty about adding tadpoles at different times effect on metamorphosis endpoint; higher occurance in testicular oocytes in controls

Invalid based on control oocytes Jooste et al 2005 / MRID 46965603 X.laevis / Field (Adults) / TP -M                                       T/                           MeOH (0.025%) / (N/Y); NS                                        PE                                 800 TP / 1100L  Metam Sexdev Surv 30.8 (M) 30.8 NS >30.8 >30.8 NS Time to metamorphosis Testicular oocytes

Preliminary to DuPreez 2008 (E103271); Unusually long development times; feeding and temperatures may have limited development. Higher incidence of testicular oocytes in controls

Invalid based on control oocytes Langlois 2010 / E120046 R.pipiens / Field / TP(G27)-M(G42)                                    F / (NS)                                 NA / (Y/NA); Y                                      HDPE                                     0.1 g/L Metam Sexdev Bio/Mol Surv <0.1 0.1 0.1 0.1 0.1 1.8 1.8 1.8 ↓ Metamorphic success ↑ Sex ratio (female) ↑ and ↓Brain eralph and tail doi3 Total survival Control contamination and atrazine detected in area where organisms collected; uncertainty in biochemical responses on gross endpoints; metamorphic success and sex ratio based on total exposed, no replicate variability reported

Qualitative  Relyea 2009 / E114296 H.versicolor & R. pipiens / NS (collected as eggs) / TP-M                                      T/ 99                            EtOH (0.003) / (Y/Y); NS                              cattle watering tanks                                     9 TP/m2 H. vers Metam Gro Surv R. pipiens Metam Gro Surv

6.4 <6.4  6.4

6.4 6.4  6.4

>6.4 6.4 >6.4

>6.4 >6.4 >6.4

Time to metamorphosis ↑Mass Survival

Time to metamorphosis Mass Survival Atrazine concentrations were not monitored throughout the experiment, although an initial measured value was reported.  Control tanks were not analyzed for atrazine and the other nine pesticides tested.  Additionally, it is unclear how much ethanol was added to atrazine-only treatment tanks.

Qualitative      Rohr and Crumine 2005 / E117319 R.sylvatica/ Field / TP-M                                       F /                           ACTN (0.00246) / (Y/Y); NS                                       PE                                   20 TP /10L Metam Gro Behav Surv 50 50 <50 --

>50 >50 50 --

Stage at test termination Mass ↓% of hiding Reported no dead tadpoles found during study; mortality not presented in terms of NOAEC/LOAEC Atrazine concentrations not monitored; unclear acclimation periods; prior exposure for tadpoles

Qualitative Rohr et al. 2008a / E112910 R.pipiens & R. clamitans / Field/ TP for 4 wks                                      T/ 98                                  NS (Y/Y); NS                                     plastic                                 65 amphibs/800L Imm/Inf

Surv <117

117 &<117 117

117 &>117 ↓ eosinophils ↑ trematode cycts (R. clam); ↓Melanomacrophage ↓ % survival for R. pipiens and no effect for R. clamitans Unknown solvent and concentration.  Atrazine concentrations were not monitored during test.  Unknown if in algal communities similar at test initiation .

Qualitative


[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Notices]
[Page 56242]
[FR Doc No: 2012-22440]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9358; 34-67801, File No. 265-28]

Dodd-Frank Investor Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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

SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting on Friday, September 28, 2012, in
Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F
Street NE., Washington, DC 20549. The meeting will begin at 10:00 a.m.
(EDT) and end at 4:00 p.m. and will be open to the public, except
during portions of the meeting reserved for meetings of the Committee's
subcommittees. The meeting will be webcast on the Commission's Web site
at www.sec.gov. Persons needing special accommodations to take part
because of a disability should notify the contact person listed below.
The public is invited to submit written statements to the Committee.
The agenda for the meeting includes: introductory remarks from
Commissioners; introductory remarks from Committee officers; and
reports from the four Investor Advisory Committee subcommittees (the
Investor as Owner subcommittee, the Investor as Purchaser subcommittee,
the Investor Education subcommittee, and the Market Structure
subcommittee).

DATES: Written statements should be received on or before September 28,
2012.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Statements

    [squf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [squf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

    [squf] Send paper statements in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Stop 1090, 100 F Street
NE., Washington, DC 20549--1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.

    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1580,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: M. Owen Donley, Chief Counsel, at
(202) 551-6322, Office of Investor Education and Advocacy, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549.

    Dated: September 7, 2012.
Elizabeth M. Murphy,
Committee Management Officer.
[FR Doc. 2012-22440 Filed 9-11-12; 8:45 am]
BILLING CODE 8011-01-P