[Federal Register: July 16, 2009 (Volume 74, Number 135)]
[Notices]
[Page 34602]
[DOCID:fr16jy09-82]

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 SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold Closed Meetings on Monday, July 20,
2009 at 3 p.m. and on Tuesday, July 21, 2009 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meetings.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(10) and 17 CFR 200.402(a)(10), permit consideration
of the scheduled matters at the Closed Meetings.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the Closed Meetings in a closed session.
    The subject matter of the Closed Meetings scheduled for Monday,
July 20, 2009 and Tuesday, July 21, 2009 will be: Post-argument
discussions.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: July 13, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-17001 Filed 7-15-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Proposed Rules]
[Pages 64416-64419]
[FR Doc No: 2021-25072]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1006; Project Identifier MCAI-2021-00700-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2019-26-01, which applies to certain Airbus SAS Model A350-941 and -
1041 airplanes. AD 2019-26-01 requires repetitive detailed inspections,
and applicable corrective actions, and provides an optional
modification that would terminate the inspections. Since the FAA issued
AD 2019-26-01, a determination was made that a related production
modification was not properly installed on certain airplanes. This
proposed AD would retain the requirements of AD 2019-26-01, and, for
certain airplanes, would add a one-time detailed inspection of the
modification for proper installation, and applicable corrective actions
if necessary, as specified in a European Union Aviation Safety Agency
(EASA) AD, which is proposed for incorporation by reference. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by January 3,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For the material that will be incorporated by reference (IBR) in
this AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne,
Germany; telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may view this IBR material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2021-1006.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
1006; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-1006; Project Identifier
MCAI-2021-00700-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

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

Background

    The FAA issued AD 2019-26-01, Amendment 39-21023 (85 FR 4199,
January 24, 2020) (AD 2019-26-01), which applies to certain Airbus SAS
Model A350-941 and -1041 airplanes. AD 2019-26-01 requires repetitive
detailed inspections, and applicable corrective actions, and provides
an optional modification that would terminate the inspections. The FAA
issued AD 2019-26-01 to address possible water ingress due to sealant
bead damage, which could result in

corrosion damage in the aluminum corner fitting. This condition, if not
addressed, could lead to detachment and loss of the trimmable
horizontal stabilizer (THS), possibly resulting in loss of control of
the airplane and injury to persons on the ground.

Actions Since AD 2019-26-01 Was Issued

    Since the FAA issued AD 2019-26-01, it has been determined that
Airbus production modification 113102 was not properly installed on
certain Airbus SAS Model A350-941 and -1041 airplanes.
    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0141, dated June 15, 2021 (EASA
AD 2021-0141) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for certain Airbus SAS Model A350-941 and -1041 airplanes. EASA AD
2021-0141 supersedes EASA AD 2019-0206 (which corresponds to FAA AD
2019-26-01).
    This proposed AD was prompted by a determination that a related
production modification was not properly installed on certain
airplanes. The FAA is proposing this AD to address possible water
ingress due to sealant bead damage, which could result in corrosion
damage in the aluminum corner fitting. This condition, if not
addressed, could lead to detachment and loss of the THS, possibly
resulting in loss of control of the airplane and injury to persons on
the ground. See the MCAI for additional background information.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2019-26-01, this proposed AD would retain all of the
requirements of AD 2019-26-01. Those requirements are referenced in
EASA AD 2021-0141, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0141 describes procedures for repetitive detailed
inspections for damage of the fillet sealant and corrosion on aluminum
in the lower and upper corner fittings and bearing assembly attachment
interface at frame (FR) 102, left-hand and right-hand sides, and an
optional modification (application of new corrosion protection in the
THS upper and lower attachment fitting bearing assembly) that would
eliminate the need for the repetitive inspections. EASA AD 2021-0141
also describes procedures for a one-time detailed inspection of the
modification of the lower and upper corner fittings and bearing
assembly attachment interface at FR 102, left-hand and right-hand sides
(Airbus production modification 113102) for discrepancies (including
missing sealant bead, cracks in the sealant bead, and corrosion on the
affected bearing zone) and corrective actions (including, but not
limited to, a check for grease, a check for cracks in the sealant bead,
applying sealant, torqueing the bearing nut, inspecting for corrosion
on the affected bearing zone, applying corrosion preventative compound
and actions to address missing grease and corrosion). This material is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
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.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0141 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0141 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0141 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0141 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0141. Service information required by EASA AD 2021-0141 for compliance
will be available at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-1006 after the FAA final rule is
published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 15 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2019-          30 work-hours x $85 per               $0          $2,550         $38,250
 26[dash]01.                             hour = $2,550.
New proposed actions..................  32 work-hours x $85 per                0           2,720          40,800
                                         hour = $2,720.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the corrective actions (including
repair) specified in this proposed AD.

                   Estimated Costs of Optional Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
34 work-hours x $85 per hour = $2,890.              $0           $2,890
------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2019-26-01, Amendment 39-21023
(85 FR 4199, January 24, 2020); and
0
b. Adding the following new AD:

Airbus SAS: Docket No. FAA-2021-1006; Project Identifier MCAI-2021-
00700-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 3, 2022.

(b) Affected ADs

    This AD replaces AD 2019-26-01, Amendment 39-21023 (85 FR 4199,
January 24, 2020) (AD 2019-26-01).

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 and -1041
airplanes, certificated in any category, as identified in European
Union Aviation Safety Agency (EASA) AD 2021-0141, dated June 15,
2021 (EASA AD 2021-0141).

(d) Subject

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

(e) Reason

    This AD was prompted by reports of sealant bead damage caused by
rotation of the attachment fitting bearing assembly of a trimmable
horizontal stabilizer (THS) and a determination that a related
production modification was not properly installed on certain
airplanes. The FAA is issuing this AD to address possible water
ingress due to sealant bead damage, which could result in corrosion
damage in the aluminum corner fitting. This condition, if not
addressed, could lead to detachment and loss of the THS, possibly
resulting in loss of control of the airplane and injury to persons
on the ground.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2021-0141.

(h) Exceptions to EASA AD 2021-0141

    (1) Where EASA AD 2021-0141 refers to February 21, 2018 (the
effective date of EASA AD 2018-0037), this AD requires using
February 28, 2020 (the effective date of FAA AD 2019-26-01).
    (2) Where EASA AD 2021-0141 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) The ``Remarks'' section of EASA AD 2021-0141 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j)(2) of
this AD. Information may be emailed to: [email protected].
    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (ii) AMOCs approved previously for AD 2019-26-01 are approved as
AMOCs for the corresponding provisions of EASA AD 2021-0141 that are
required by paragraph (g) of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2021-0141 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) For information about EASA AD 2021-0141, contact EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-1006.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email [email protected].

    Issued on November 12, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-25072 Filed 11-17-21; 8:45 am]
BILLING CODE 4910-13-P


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      UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
       	     WASHINGTON, D.C. 20460

                         				OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
                             OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

   MEMORANDUM                                                                   February 10, 2012

SUBJECT:	Summary of Ecotoxicity Data for Methyl Nonyl Ketone  Registration Review Scoping Document

            Registration Review
            Case #:
            PC Code:	              44102
            CAS Numbers:	       112-12-9
            Chemical Class:		Aliphatic ketone

   FROM:	Miachel Rexrode, Ph.D., Senior Biologist          /s/             02/10/2012
               Biochemical Pesticides Branch
               Biopesticide & Pollution Prevention Division (7511P)

   TO:		Leonard Cole, Regulatory Action Leader   /s/                      02/10/2012
               Biochemical Pesticides Branch
               Biopesticide & Pollution Prevention Division (7511P)

ACTION REQUESTED

The following is the final ecotoxicity assessment for methyl nonyl ketone  in support of the Registration Review Decision Document.

RECOMMENDATIONS AND CONCLUSIONS

Executive Summary

Based on the available information for methyl nonyl ketone  the Agency does not foresee the need for additional ecotoxicity data for a new risk assessment and has waived all hazard and exposure data on these chemicals. The unique characteristics of these products, there non-toxic mode of action, biodegradability (low to no persistence), and use patterns (non agricultural use, residential uses) should minimize the risks to all non-targets, including threatened and endangered species. Methyl nonyl ketone risk in the environment should be low because of a lack of potential exposure (residential and indoor use) suggesting minimal risk to terrestrial and aquatic organisms and a no effect (NE) to endangered/threatened species for registered uses.

Background

Methyl nonyl ketone, also known as 2-Undecanone and IBI-246, is an oily organic liquid manufactured synthetically, but which can also be extracted from oil of rue. It is found naturally in bananas, cloves, ginger, guava, strawberries, wild-grown tomatoes, and the perennial Houttuynia cordata. Methyl nonyl ketone is used in the perfumery and flavoring industries, but because of its strong odor it is primarily used as an insect repellent or dog and cat repellent/ training aid and iris borer deterrent. Typically, 1 - 2% concentrations of 2-undecanone are found in dog and cat repellents in the form of a liquid, aerosol spray, or gel. This pesticide is used in and around households, paths, patios, solid waste containers and ornamental plants. Methyl nonyl ketone is formulated as a pressurized liquid, granular, liquid ready-to-use (pump/sprayer), solid (crystalline), and liquid for reformulating use only. EPA assumes that the volume of use of this pesticide is relatively low. Methyl nonyl ketone was first registered in the United States in 1966 for use as a dog and cat repellant. Currently, there are 18 active products registered. The Agency does not foresee the need for additional ecotoxicity data for a new risk assessment.  Ecological effects data requirements were fulfilled.

Toxicity to Terrestrial Animals

Birds: Acute and Subacute Toxicity

In order to establish the acute and subacute toxicity of methyl nonyl ketone to birds, the following tests were required using the technical grade of the active ingredient (a.i.): one avian single-dose oral (LD50) study on one species (preferably mallard or Bobwhite quail) and subacute dietary studies (LC50) on one species of waterfowl (preferably the mallard duck) and one species of upland game bird (preferably Bobwhite quail). The results of the studies summarized in Tables 1.0 and 2.0 show that methyl nonyl ketone is practically nontoxic to avian species on an acute oral and subacute dietary basis. The guideline requirements for both the avian acute oral LD50 and the avian subacute dietary LD50 studies have been met.

Table 1.0  Avian Acute Oral Toxicity
Species Tested
% AI
LD50 (mg/kg)
MRID
Conclusions
Northern  Bobwhite Quail
100
100 > 2,250
41986501
Practically nontoxic
Mallard
100
100 > 2,250
41986502
Practically
nontoxic

Table 2.0 Avian Subacute Dietary Toxicity
Species Tested
% AI
LD50 (mg/kg)
MRID
Conclusions
Northern  Bobwhite Quail
100
100 > 5,620
41947901
Practically
nontoxic
Mallard
100
100 > 5,620
41947902
Practically
nontoxic

 Mammals

Wild mammal testing is required on a case-by-case basis, depending on the results of the lower tier studies such as acute and subacute testing, intended use pattern, and pertinent environmental fate characteristics. Under the conditions of a range-finding and developmental toxicity study done for the Agency, as summarized in the Human Health Assessment, doses up to 1,000 mg/kg/day produced no apparent related maternal or developmental effects on rats. Based on these conclusions, wild animal testing was not required for methyl nonyl ketone. The rat oral LD50 > 5,000 mg/kg suggesting a practically non-toxic compound to mammals (MRID 41904101).

Toxicity to Aquatic Animals

Freshwater Fish

In order to establish the toxicity of methyl nonyl ketone to freshwater fish, the minimum data required on the technical grade of the active ingredient are two freshwater fish toxicity studies. One study should use a coldwater species (preferably the rainbow trout), and the other should
use a warmwater species (preferably the bluegill sunfish). The results of the acute toxicity studies summarized in Table 3.0 indicate that methyl nonyl ketone is moderately toxic to both cold and warmwater fish. The guideline requirements for the freshwater fish toxicity
studies have been met.

Table 3.0 Freshwater Fish Acute Toxicity to Methyl  Nonyl Ketone
Species Tested
% AI
LC50 (ppm)
MRID
Conclusions
Rainbow Trout
100
3.0
41909603
Moderately toxic
Bluegill sunfish
100
2.1
41909602
Moderately toxic

Aquatic Invertebrates

The minimum testing required to assess the hazard of methyl nonyl ketone to freshwater invertebrates is a freshwater aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early instar amphipods, stoneflies, mayflies, or midges. The results of the freshwater aquatic invertebrate toxicity study summarized in Table 4.0 indicate that there is sufficient information to characterize methyl nonyl ketone as highly toxic to aquatic invertebrates. The guideline requirement for the freshwater aquatic invertebrate toxicity study has been met.

Table 4.0 Freshwater Aquatic Invertebrates Acute Toxicity to Methyl  Nonyl Ketone
Species Tested
% AI
EC50 (ppm)
MRID
Conclusions
Daphnia magna
97.9
0.54
41909604
Highly toxic

Ecological Effects and Endangered Species Risk Assessment

Terrestrial Species

The unique characteristics of this product, methyl nonyl ketone, the non-toxic mode of action, biodegradability (0.5 days aerobic and anaerobic degradation) and low potential for exposure will result in no risk to non-target organisms, including threatened and endangered species. Due to the non-toxic mode of action and/or lack of exposure to non-targets by this product, a Risk Quotient (RQ) is not typically calculated since the point estimates of either toxicity and/or exposure will be at or near zero. The product is not applied to plants or foliage. Label instructions specify that application is to the ground around bushes and plants (emulsifiable concentrate and granular product). The exposure is limited to residential areas and not to crops. However, the Agency has estimated potential acute toxicity end points for avian and mammalian species (LD50 > 2,250 mg/kg) and calculated potential risk using the Terrestrial Residue Exposure Model (T-REX) Version 1.4.1 for granular formulations (Appendix A). The Agency estimated that if the granular formulation were used on one acre (1 lb product/250 sq ft) the number of granular that would be required to achieve LC50 for terrestrial organisms (0.02 kg birds) would be about 274,884, a large amount of product. In addition, the product is a repellent, which lessens the likihood for non-target exposure. The low toxic risk of methyl nonyl ketone to terrestrial organisms through granular or aerosol application, the short environmental half life (0.5 days), the low potential for exposure to non-target avian and mammalian species (residential application), the direct application to the ground (no contact with foliage), and an understanding of the repellent mode of action of this compound show that there is a very low potential for toxic risk to terrestrial species. In addition to this low risk to non-target terrestrial species, the potential for exposure to endangered/threatened species is also very low because the formulated products are used indoors and/or in enclosed areas outdoors (residential). Based on this information on the active ingredients, there will not be toxic risk to endangered/ threatened species from exposure to the end use products. Methyl nonyl ketone presents a No Effect (NE) to threatened or endangered terrestrial species, if used in accordance with approved labeling.

Aquatic Species

It is difficult to assess the risks posed to aquatic species from the use of methyl nonyl ketone since uses are contained or indoors and the compound is non persistent (0.5 days) and relatively insoluble in water (18 ppm). The potential for methyl nonyl ketone leaching into ground water or to moving offsite to surface water is unlikely. In a Leaching-Adsorption/Desorption study (MRID 42208301) methyl nonyl ketone was observed to be relatively immobile in soil (sodium azide-sterilized sandy loam, clay loam, sand, and silt loam soils). The Kads =18 and the Koc = 2,480. This lack of potential exposure shows that methyl nonyl ketone risk to aquatic organisms is very low and that there is a no effect (NE) to aquatic endangered/threatened species.

References

Beavers, J.; Grimes, J.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): A Dietary LC50 Study with the Northern Bobwhite: Lab Project
Number: 163-114. Unpublished study prepared by Wildlife International Ltd.
24 p. (MRID 41947901)

Beavers, J.; Grimes, J.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): A Dietary LC50 Study with the Mallard: Lab Project Number:
163-115. Unpublished study prepared by Wildlife International Ltd. 24 p. (MRID 41947902)

Campbell, S.; Lynn, S.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): An Acute Oral Toxicity Study with the Northern Bobwhite: Lab
Project Number: 163-116. Unpublished study prepared by Wildlife International
Ltd. 29 p. (MRID 41986501)

Campbell, S.; Lynn, S.; Smith, G. (1991) Methyl Nonyl Ketone (MGK Dog and
Cat Repellent): An Acute Oral Toxicity Study with the Mallard: Lab Project
Number: 163-117. Unpublished study prepared by Wildlife International Ltd.
28 p. (MRID 41986502).

EPA (1993) Reregistration Eligibility Decision (RED) Methyl Nonyl Ketone. Washington, DC, US Environmental Protection Agency, EPA 738-R-95-038, 63 pp.

Gabriel, D. (1991) MGK Dog and Cat Repellent (Methyl Nonyl Ketone)-Code
#(...): Acute Oral Toxicity, Single Level-Rats: Lab Project Number: 91-7236A.
Unpublished study prepared by Biosearch Inc. 10 p. (MRID 41904101)

Pesselman, R. (1991) Water Solubility Determination of Methyl Nonyl Ketone:
Final Report: Lab Project Number: HWI 6001-709. Unpublished study prepared
by Hazleton Wisc. Inc. 33 p. (MRID 41986503)

Williams, M. (1992) Soil/Sediment Adsorption-Desorption of Methyl Nonyl
Ketone: Lab Project Number: 39436. Unpublished study prepared by ABC
Labs., Inc. 51 p. (MRID 42208301)

Appendix A  T-REX Output for Methyl Nonyl Ketone Granular Formulation

Estimation of the number of granules needed to achieve toxicity thresholds
Step 1.  Estimate mass of a.i. consumed for the assessed species weight to achieve the desired toxicity threshold
Weight of assessed bird (kg)
                                     0.02
INPUT (0.02 kg is typically used for general assessments)
Adjusted LD50, mg/kg-bw
                                    1168.26
Calculated from the body weight entered in B13 and the LD50 entered in the "Inputs" sheet.
Mg a.i. needed to achieve the adjusted LD50 for bird of assessed weight
                                     23.37
mg a.i./kg-bw * kg-bw = mg a.i.
Mg a.i. needed to achieve acute LOC exceedance (1/2 adjusted LD50) for bird of assessed weight
                                     11.68

Mg a.i. needed to achieve endangered species LOC exceedance (1/10th adjusted LD50) for bird of assessed weight
                                     2.34

Step 2.  Determine the mass of a.i. per granule
Percent of a.i. in formulated product
                                     2.00%
Must enter percent a.i. specified on the label
Weight of 1 granule (mg, obtained from registrant)
                                     0.43%
INPUT (Note: Be sure to enter units in mg!)
mg a.i./granule
                                    0.0001
weight of granule (mg) x fraction of a.i. = mg a.i./granule
Step 3.  Calculate number of granules with mass of a.i. equivalent to adjusted LD50 for bird of assessed weight
No. of granules needed to achieve adjusted LD50
                                   274884.04
mg a.i. needed to achieve adjusted LD50 (B14) / mg a.i. per granule (B20)
No. of granules needed to achieve acute LOC exceedance (1/2 adjusted LD50)
                                   137442.02
mg a.i. needed to achieve 1/2 adjusted LD50 (B15) / mg a.i. per granule (B20)
No. of granules needed to achieve endangered species LOC exceedance (1/10 adjusted LD50)
                                   27488.40
mg a.i. needed to achieve 1/10 adjusted LD50 (B16) / mg a.i. per granule (B20)