50772-101
REBOOT DOCUMENTATION
*" ' i PAGE
REPORT NO.
S. Recipient** Accm*lon No.
4. TNI* and SuMKIe
TRIBUTYLTIN - POSITION DOCUMENT 4
5. Report Oat*
10/4/88
7. AutttorU)
EPA, OPP, REGISTRATION DIVISION
. Performing Organization Rapt. No:
540/09- 90-110
9. Performing Organization N*m« and Address
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
10. ProJect/Task/Work Unit No.
11. Corrtrect(C) or Grent(G) No.
(0
(G)
12. Sponioring Organization Name and Addratt
SAME AS #9
13. Type of Report & Period Covered
U.
IS. Supplernentary Notes
16. Atxtract (Limit: 200 words)
This Position Document addresses the risks and benefits of pesticide products
containing the subject active ingredient. The Agency has determined that the use
of products containing the subject active ingredient may meet or exceed a risk
criterion described in 40 CFR Part 154. Potential hazards will be examined
further to determine the nature and extent of the risk, and considering the
benefits of the subject active ingredient, whether such risks cause unreasonable
adverse effects on the environment.
17. Document Analysis a. Descriptors
PESTICIDES, STANDARDS, REGULATIONS, MANUFACTURING, CHEMISTRY, TOXICOIOGY,
RESIDUES, ECOLOGY, PATH OF POLLUTANTS
b. Id«ntin*rs/Open-Cnded Terms
c. COSATI Held/Group
. Availability SUtenxnt
PUBLICLY AVAILABLE
(See ANSI-Z39.18)
EJBD
ARCHIVE
EPA
540-
09-
90-
110
19. Security Oast (This Report)
UNCLASSIFIED
20. Security Class (This Page)
UNCLASSIFIED
21. No. of Paces
21
22. Price
S«* ln*trucfiomi on ft«v*r»e
OPTIONAL FORM 272 (4-77)
(Formerly NT1S-35)
Department of Commerce
-------
b4U/U9-9U-llU
Tuesday
October 4, 1988
Part III
Environmental
Protection Agency
Trlbutyltln Antlfoulants; Notice of Intent
to Cancel; Denial of Applications for
Registration; Partial Conclusion of
Special Review
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89022
Federal Register / Vol. S3. No. 192 / Tuesday. October 4. 1986 / Notices
ENVIRONMENTAL PROTECTION
AGENCY
|OPP-MOn/4*8; FRL *45*-7J
TribtftyMn Antffoulanta; Notice of
Intent to Cancel; Denial of Applications
lor RegtefcaHon; Partial Conduaton of
Special Review
AGENCY: Eufkunmental ProtecUon
Agency (EPA).
ACTION: Notice of partial conclusion of
the special review; noUce of intent to
cancel: notice of intent to deny
applications tor registration.
UMMAirr On October 7,1987 (52 FR
17510). EPA proposed to cancel the
registrations of certain tributylUn (TBT)
products and deny the applications of
others anless the registrants modified -
certain terms and conditions of
registration. This Notice partly "
concludes the Special Review end
announces EPA's final decision to
cancel registrations and deny
applications of all pesticide products
containing tributyltln (TBT1 compounds
as active Ingredients (aJ.) for use as
antifoulants unless the registrations/
applications comply with the specific
terms and conditions of registration as
provided herein. This action is based on
the Agency's determination that the use
of TBT products without such modified
terms and conditions of registration will
result in unreasonable adverse effects
on the environment.
The Agency is keeping the Special
Review open on the issue of release
rate. The Organotin Antifouling Paint
Control Act (OAPCA) which was signed
Into law on June 16,1988, established an
Interim release rate restriction and
certification program for TBT
antifoulant paints. These Interim
provisions will expire when the
Agency's final determination regarding
the release of organotln Into the aquatic
environment by antifouling paints
becomes effective. As noted herein, such
acUon has not been taken in this Notice,
and thus the interim provisions of
OAPCA remain in effect
DATE: A request for a hearing by a
registrant or applicant must be received
by November 3.1988, or 30 days from
receipt by mail of this Notice, whichever
b the later applicable deadline. A
request for a hearing from any other
adversely affected person must be
received by November 3.1988.
ADORE**: Requests for a hearing must
be submitted to: Hearing Clerk (A-110),
Environmental Protection Agency, 401 M
St., SW. Washington. DC 20460.
FOR FURTHER INFORMATION CONTACT:
By mail:
Rebecca 8. Cool Special Review and
Reregistration Division (TS-7B7C).
Office of Pesticide Programs, .
Environmental Protection Agency, 401
M SU SWH Washington. DC 20460.
Office location and telephone number
Rm. 1006, CM #2. 1921 Jefferson Davis
Highway, Arlington. VA 22202. (703-r
657-7453).
Notice is organized into 11 units. Unit I
is an Introduction providing background
information concerning this cancellation
action and the provisions and
Implications of the Organotin
Antifouling Paint Control Act of 1988
(OAPCA). Unit D summarizes the risks
associated with the use of trlbntyltin
(TBT) antifouling paints. Unit III
provides a discussion of TBT release
rate testing and results. Unit IV
summarizes the benefits associated with
the use of TBT antifouling paints.
Comments received from interested.
parties on specific risk, release rate, or
benefits Issues are also discussed la
these units. Unit V discusses the
comments of the Scientific Advisory
Panel, the Secretary of Agriculture, and
other public comments on the regulatory '
actions previously proposed by EPA in
Its Notice of Preliminary Determination
of October 7, 1987. Unit VI describes the
Agency's risk and benefit conclusions.
Unit VII describes future Agency
activities regarding tributylUn
antifouling paints. Unit VIII describes
the Agency's regulatory decision as well
as existing stocks and disposal
provisions. Unit IX describes the
-procedures which *vill be followed in
implementing the regulatory actions
EPA is announcing in this Notice,
Including the procedures for amending
registrations of applications, for
requesting a hearing, and the
consequences of requesting or failing to
request a hearing. Unit X describes the
public docket established for the
Tributyltln Antifouling Paint Special
Review. Unit XI lists references used in
this Notice.
L Introduction
A. The Notice of Special Review and the
Preliminary Notice of Intent To Cancel
there are nine TBT compounds
registered for use as antifoulants. These
are: bis(tributyltin) adipate.
bis(tributyltin) dodecenyl sucdnate,
bis(tributyltin) oxide, bis(tributyltin)
sulfide. tributylUn acetate, tributyltln
acrylate, tributyltln fluoride, tributylUn
methacrylate. and tributylUn resinate.
TBT compounds are registered for use
In paint formulations as antifoulants on
vessel hulls and other marine structures
to inhibit the growth of certain aquatic
organisms such as barnacles and algae
which cause fouling. The major use of
TBT paints is on ship and boat hulls
with less than four percent of the use on
docks, buoys, crab pots, fish nets. etc.
Approximately 624.000 gallons of TBT
antifouling paint, using approximately 1
million pounds of TBT compounds, are
fold annually. When the TBT Special
Review was initiated in 1986. there were
a total of 61 registrants with 364
registered TBT antifouling paints and 20
formulating Intermediate or
manufacturing use products.
- On January 8,1986, EPA Issued a
Notice of Special Review on certain
pesticide products containing any of the
nine tributyltln (TBT) compounds which
were registered as anUfouiants (51 FR '
778), following a finding that TBT met or .
exceeded the risk criteria In 40 CFR
162.11(a)(3)(i)(B) and (I1)(C). which were
in effect at that time. Subsequently, the
risk criteria in 40 CFR 182.11 were
superseded by new criteria set forth In
40 CFR 154.7(a)(3). EPA has determined
that TBT compounds used in antifouling
paints exceed both the old and the new
risk criteria for exposure of nontarget
aquatic organisms to concentrations
which are acutely or chronically toxic to
such organisms.
The TBT Special Review was Initiated
on the basis of bioassay and laboratory
toxiciry studies which indicated that
TBT compounds are highly toxic,
frequently at the parts per trillion (ppt)
level, to nontarget marine and fresh
water aquatic organisms. The Agency
noted that TBT residue concentrations
reported at sites in U.S. coastal waters
exceeded the levels reported to have
caused adverse effects in the laboratory
studies.
At the Initiation of the TBT Special
Review, the Agency determined that it
needed certain additional data for use in
characterizing the toxlclty, exposure,
and benefits of TBT antifouling paints.
EPA, using Its authority under section
3(c)(2)(B) of F1FRA, Issued a Data Call-
in Notice (DCI) on July 29.1986, to all
registrants of TBT antifouling paints end
the producer* of the TBT active
ingredients. The DCI required product
chemistry data, ecological effects data.
environmental fate data. TBT paint
release rate data, worker exposure data.
quantitative usage and application data.
and efficacy data. Additional ecological
effects and worker exposure data are
due into the Agency in 1 to 4 years and
environmental fate data are due in 1 to 2
years. The other data have already been
submitted to the Agency. Registrants
failing to submit required data have had
their registrations suspended.
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Federal Register / Vol. S3. No; 192 / Tuesday. October 4. 1988 / Notices
39023
based on public comments received in
response to the Federal Register Notice, 4
the data submitted to the Agency in ; <.<:.
response to the DQ, and on additional «
analyses performed since the initiation
of the TBT Special Review, the Agency -r
on October 7.1987, made a preliminary o
determination to propose (1) , ...-..>
cucellatioB of TBT antifouling paint \:.\>\\
products with short term cumulative .~'.>YI
release (first 14 days of release rate test) i.
exceeding 168 microgramsjMg) of . < - .
erganotin (calculated as TBT cation) per I.
square centimeter (cm*) or average daily»:
release rates (avenged over weeks 3 to -u
5 of release rate test) exceeding 4 ug of 4
organotin (calculated as TBT cation)/^»ji
an*/day, (2) prohibition of use of TBT i ''
antifouling paints on non-aluminum ..-r t,I
hulled vessels less than 65 feet in length:'.
(3) classification of TBT antifouling -,-*
paints as restricted use pesticides and ;-\
restriclion of their sale to certified . . J .
commercial applicators and their use by ;
persons under the direct supervision of .1
an on-site certified commercial, ,. ;.i: jj
applicator, and (4) compliance with > ?;.
certain requirements pertaining to .-'.'.-. :/-
removal and disposal of old paint prior "
to application of new paints, and/or.. ' >
application of new TBT paints. Also, at A
this time, the Agency issued the ^ ..., :\I
Tributyltln Technical Support Document ,
dated September 30,1987, which, along ..;
with accompanying scientific reviews, vr
comprise the technical documents in,. ..i;
(upport of the Agency's preliminary '.: \\*
determination.. . _ i.. ': . .. '.<-. .
Subsequently, the Congress passed ' >
the Organotin Antifouling Paint Control. >
Act of 1988 rOAPCA") which was . . ;>'
signed into law on June 16,1988, by the ..i
President It con tains both interim and n,
permanent TBT use restrictions which -'u
TO further described in Unit l.C. of this A
document The Act established an. -.. .. »i
interim release rate restriction and ..', .<.*:
certification program for TBT . .«M. t-ri
antifoulant paints which will expire!;; AJ-'
when the Agency's final determination i 'n
regarding the release of ore .&
Unit 1 .A. of this document in light of the >;>
newly enacted legislation and comments '
and additional data received during the -v
Special Review process. In summary, *>'.
EPA is announcing that It will cancel all}'
TBT antifouling paint registrations , L .
which (a) do not comply with OAPCA's ^
average daily release rate of 4.0 ug
organotin/cm2/day; (b) do not comply.
with OAPCA's prohibition of the use of
TBT antifouling paints on all non- >. .'.
aluminum vessels under 82 feet (or 25
meters) in length (on deck); (c) are not
classified as restricted use pesticides,
restricting their sale to certified
commercial applicators and their use to
persons under the direct supervision of
an on-site certified commercial
applicator (except for products which
are packaged in 16 ounce or less spray-
can containers and are labeled for use
only on outboard motors, propellers, and
other non-hull underwater aluminum
components), (d) do not have required
labeling which requires compliance with
applicable OSHA regulations and with
the directions for work practices for
application, removal, and disposal of
TfTT paints to reduce the Introduction of
TBT paint wastes into the aquatic . .'
environment, and (e) do not limit certain
uses for some types of products.
This Notice announces the Agency's
intention to cancel registrations and
deny application for registration of all
antifouling paint products containing
TBT compounds, unless the terms and
conditions of registration are amended
as described in Unit VTILB of this
document This action is based on the
Agency's determination that the use of
TBT antifouling paints will result in
unreasonable adverse effects to '
nontarget aquatic organisms unless the
required measures are adopted. A
detailed discussion of the basis of this
action is contained in the Notice of
Preliminary Determination and the .
Tributyl tin Technical Support
Document ..-.....'
B. Legal Background ? v < " - : * ';
In order to obtain a registration for a
pesticide under the Federal Insecticide.
Fungicide, and Rodenticide Act (FIFRA).
as amended, an applicant for .
registration must demonstrate that the '
pesticide satisfies the statutory standard
for registration, section 3(c)(5) of FIFRA.
That standard requires, among other
things, that the pesticide perform Its
intended function without causing .
"unreasonable adverse effects on the ":
environment" The term "unreasonable
adverse effects on Ihe environment" is
defined under FIFRA section 2(bb) as
"any unreasonable risk to man or the
environment taking into account the
economic, social, and environmental
costs and benefits of the use of any .'
pesticide." This standard requires a
finding that the benefits of the use of the
pesticide exceed the risks of use, when
. the pesticide is used in compliance with
the terms and conditions of registration
or In accordance with widespread and
commonly recognized practice. ,
The burden of proving that a pesticide
atisfies the standard for registration
rests on the proponents of registration
and continues as long as the registration
remains in effect. Under section 6 of
FIFRA, the Administrator may cancel
the registration of a pesticide or require
modification of the terms and conditions
of registration whenever it is determined
that the pesticide causes unreasonable
adverse effects on the environment
. The Special Review process, formerly*
called the Rebuttable Presumption
. Against Registration (RPAR), is a
mechanism by which EPA collects
information on the risks and benefits
associated with the uses of pesticides to
determine whether any use causes
unreasonable adverse effects to human
health or the environment The Special
Review Process is currently governed by
40 CFR Part 154 and was further
described in the Notice of Preliminary
Determination. . '
In determining whether the use of a
pesticide poses risk which are greater
than the benefits of use. EPA consldero
both possible changes to the terms and
conditions of registration which can .-,
reduce risks, as well as the impacts of
such modifications on the benefits of
use. If EPA determines that such
changes reduce risks to the level where
. the benefits outweigh the risks, it may
require such changes be made in the ;
terms and conditions of registration. -: :
Alternatively, EPA may determine ' t';
that no changes in the terms and
conditions of a registration will ',
. adequately ensure that use of the '
pesticide will not pose any ,»
unreasonable adverse effects. In that'-'.
event the Administrator may issue a '
Notice of Intent to Cancel the u ;-.:\, .>.
registration or may hold a hearing to ...i:>
determine whether it should be . .-.
cancelled under FIFRA section 6(b). In
determining whether to Issue such a '
Notice, the Administrator must take into
account the impact of the action on ,
production and prices of agricultural '
commodities, retail food prices, and v .
otherwise on the agricultural economy.
In the case of TBT. the impact of the .,
action on the marine paint and..-(' *.
shipbuilding industry and theuser-'V-.
community was considered. At least 60
days before formally issuing such a. .
Notice, the Administrator must inform
the Secretary of Agriculture in writing of
the substance of the proposed actions . .
and supply the Secretary with an - :
analysis of the expected impact oh'thev
agricultural economy. At the same time',
under FIFRA section 25(d), the .
Administrator Is required to submit the
proposal to the Scientific Advisory '
Panel for comment as to the impact on '
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39024
Federal Register / Vol. 53. No. 192 / Tuesday. October 4. 1988 / Notices
health and the environment of the action
proposed to the cancellation notice. EPA
li also required by law, when
appropriate, to consult with the VS.
Department of the Interior to we if the
proposed action may affect an
endangered species.
Unless expedited proceduics are
employed. EPA informs the public of its
proposals to issue cancellation notices
so that registrants and other interested
persons can also comment or provide
relevant information before a final
Notice of blent to Cancel is issued.
Registrants and other interested persons
are invited to review the data upon
which the proposal is based and to
submit data and information to address
whether EPA's initial determination of
risk was in error. In addition to evidence
relating to risks, comments may include
evidence as to whether any economic.
social, and environmental benefits of
use of the pesticide outweigh the risk* of
me.
If, after reviewing the comments
received. EPA decides to issue a Notice
of Intent to Cancel, any adversely
affected person may request a hearing to
challenge the action. In the hearing, any
party opposing cancellation would have
en opportunity to present evidence.
Other interested parlies could intervene
to present evidence. At the end of the
hearing EPA woold decide on the basis
of the evidence presented whether or
not to cancel or restrict the registration
of pesticide products. If no hearing Is
requested, each registration would be
cancelled by operation of law 30 days
- a Her receipt by -the-registrant w
publication in the Federal Register of the
Final Notice, whichever occurs later.
C. The Orgaaotin Antifouling Paint
Control Act of 1988
The Organotin Antlfouling Paint
Control Act of 1988 ("OAPCA") (Pub. L
100-333) was signed by the President on
June 16,19B& It is free-standing
iegislBtlcr.that is Independent of FIFRA.
It has-interim and permanent TUT use .
restrictions at well as provisions
regarding sale and use of existing
stocks, environmental monitoring,
:research on alternatives, reports to
Congress, and penalties for non-
compliance. All of the provisions were
effective open the date of enactment
The interim provisions pertaining to the
release rate restriction and certification
of TBT entifoulent paints will expire
when the Agency's final regulatory
decision regarding the release of
organotin into the aquatic environment
by anlifouling paints becomes effective.
As noted herein, such action has not
been taken in this Notice, and thus the
interim provisions of OAPCA remain In
effect
OAPCA establishes a certification
program under which only products
which do not exceed a release rate of 4
fig of organotin/an2/day can be sold
and used. OAPCA requires EPA to
review all release rate data submitted to
the Agency before the new law was.
enacted and to determine which
products meet this release rate standard
by September 14,1988. For any release '
rate data submitted after June 16,1988,
EPA is required to make a decision
regarding product certification within 80
days of receipt of such data.
OAPCA also establishes maximum
existing stocks provisions, starting from
the date of enactment, of 160 days for
sale, and 1 year for use, for all organotin
antifoullng paints and organotin
additives in existence on the date of
enactment OAPCA provides that the
Administrator shall no later than 90
days from enactment provide
reasonable times for sale and use of
existing stocks which do not exceed the
above noted limits. Any organotin
antifouling paints certified as meeting
the 4 ug release rate restriction will not
be subject to these sales or use limits
after notice of certification.
OAPCA also contains the following
permanent provisions.
1. Vessel site. Subject to the existing
stocks provision, all TBT products are
prohibited from use on vessels that are
less than 25 meters (82 feet), unless the
vessels are aluminum. Outboard motors
-end-lower drive units are-also^xempt
from the prohibition.
2. Paint additive products. Subject to
the existing stocks provision, all retail
sale, distribution^ purchase, and receipt
is prohibited for TBT additives used to
create antifouling paints. No such
products are currently registered
3. Estuarine monitoring. EPA. in
consultation with the Department of
Commerce, for the next 10 years, must
conduct monitoring studies of TBT
concentrations in water, sediment and
aquatic organisms from representative
areas in the United Slates. The Agency
must submit annual reports of the
results of the monitoring studies to
Congress (House of Representatives and
Senate).
4. Navy monitoring and testing. The
Navy must conduct similar
environmental monitoring studies in
naval ports serving TBT-treated vessels,
continue laboratory toxicity and
environmental risk studies, and report
annually to each state with a naval port
and to EPA for inclusion in the Agency's
annual report to Congress.
5. State assistance. EPA must assist
states, to the extent practicable, in
monitoring and analyzing for TBT in*.
waters in the states. .
6. Effectiveness report EPA. in S
years, must report to Congress on the
effectiveness of the TBT restrictions,
compliance with the organotin water
quality criteria document and
recommendations for additional
protective measures.
7. Antifoulant alternatives research.
EPA and the Navy must conduct
research on chemical and nonchemlcal
alternatives to organotin paints and, In 4
years, must report to Congress the
results of such research.
& Water quality criteria. EPA must
issue a final water quality criteria
document for organotin, pursuant to
section 304(a) of the Clean Water Act
by March 30,1989.
9. Penalties. Civil (not to exceed
$5,000) and criminal (not to exceed
$25,000) penalties will be imposed for
violating the above use, sale,
distribution, purchase and receipt
provisions.
TBT registrants were notified of
OAPCA and its provisions by en
Agency letter dated August 1Z1988.
Data necessary to make the OAPCA
certification of release rates were
required to be. submitted by a July 29,
1988, Data Call-in Notice forTributyltins
Used in Paint Antlfoulants and a follow-
up Notice of August 13,1987, both of
which were issued under the authority
of section 3(c)(2)(B) of FIFRA. All
submissions of data required by these
notices were determined to be
Inadequate because of the use of
Inappropriate testing procedures or the
absence of critical data. The letter dated
August 12,1988, specified additional
raw data and/or information that were
necessary for the Agency to validate the
release rate studies and required
submission of such data/Information
within 30 days of the registrant's receipt
of the letter. Registrants were Informed
that failure to submit adequate data
might result in their receipt of a Notice
of Intent to Suspend and would prevent
the Agency from reaching a decision on
their product's release rate and
certification under OAPCA.
In a letter dated September 14,1988.
the Agency notified registrants by letter
that none of their release rate data were
certified under OAPCA and that the
following existing stocks provisions
were in effect until they were able to
satisfy OAPCA's certification
requirements:
1. December 16,1988. for sale,
delivery, purchase, and receipt;
2. June 16,1989 for use.
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Federal Register / Vol S3. No. 192 / Tuesday. October 4. 1088 / Notices
39025
0. Determinations on Riik > ..
Laboratory letting and field trial*
have established that TOT ii toxic to :.
fish (at Departs per billion (ppb)),
bivalve* (at OJB to 045 ppb). gastropod*
(at OOS ppb). crustaceans (at 0.14 to ai9
ppb). and algae (at 0.1 to O35 ppb). TUT
concentrations at or above 0.02 ppb '
have been reported for at least 80 cite*
la the United State*, predominantly in '
areas with heavy boating and chipping :
activity.
Harbor* and boating activity an ''.
niually concentrated in relatively ' '
hallow (<30 ft) coatUl water*. These
areas also coincide with many estuariea'.
or ecologically dynamic environment*
that »upport large fisherle* and are
important nunery area*. Although TOT
distribution in the environment 1* not .
completely understood, a biologically
significant amount ha* been observed to
be accumulated by aquatic organism* at
all taxonomk level*. Documented
effect* of TUT have been found in *hell
deformities of the commercially
important oyster, Crassostrea gigas (in
France, England, and the United States).
and in sexual deformities and possible
population declines of the marine snail.
Nucella lapillua (in the United State*
and England). . .
A. Toxicity to Nontarget Aquatic "
Organ/sou - . '. .-. . .
The full extent of the risk* of TOT to '.
nontarget aquatic organisms is unknown
at this time. While observable effect*
under field condition* have not been
determined for many aquatic species.
TOT toxicity studies have been
conducted on algae, fish, crustaceans.
and molluscs (both bivalves and . '':
gastropods). Although short-term studies
nuvo domonslrulcd that TOT Is highly
toxic to certain aquatic organisms
(LCu=0.1 to 24 ppb), long-term studies
have revealed toxic effects from TOT
concentrations that are one to two :' '
orders of magnitude lower (> 0.02 ppb). "
Most aquatic organisms appear to be ';
extremely sensitive to TOT toxicity : .<
during the time of development from ' '
fertilized eggs through various larval 1
tages. In addition to developmental v.'
effects, the sublethal toxic effects of '
TOT may be sufficient to gradually alter.
aquatic populations by changing their
size or composition (individual year -
class strength), metabolism (TOT is a ' "
membrane effector), behavior
(competition abilities, defense . f .
mechanisms, feeding strategies), and/or
by deteriorating the environmental
conditions through physical, chemical
or biotic factors.
The Agency's Office of Water is '
required to issue its Ambient Water
Quality Criteria for Tributyltin by March
80,1988 under OAPCA. The document
will be a guideline to EPA Regional
Office* suggesting the maximum TOT
residue concentration* which the
Agency believes will protect fresh and
talt water organisms. The value* in the
Criteria Document may be changed
subsequently depending upon new
scientific data made available to the
Agency. Additional aquatic toxicity data
have been required of TOT registrants;
these data are due to be cubmlUed to
the Agency over the next few year*.
However, there are sufficient laboratory
and field data to indicate that certain
harbor and estuarine area* have TOT
residues above levels which may be safe
to certain aquatic organism*.
1. Fith. Acute toxidty to both fresh
and marine fish spedes have been
reported with values ranging from 1.5
ppb to 24 ppb. TOT compound* have
been widely used in the *almon
aquaculture industry to retard fouling of
net pen*. However, researchers at the
Alaskan National Marine Fisheries
Service have observed, on several
occasions, high mortalities in groups of
Chinook salmon (Oncortiynchug
tshawytscha) after, transfer to marine
net pens newly treated with TOT.
Chronic exposure of fish to TOT has
resulted in physiological alteration* in
growth rate and in histological damage
to rainbow trout [Salmo gairdneri) at
. concentrations as low as 0£ ppb TOT.
Chronic TOT exposure may affect fish
fecundity or progeny survival Exposure
-of parental cheepsheed minnows
(Cyprinodon variegafus) to TOT has
been found to result in significant
mortality of progeny that were not
directly exposed to the toxicant
Bioaccumulation (accumulation in the
body of an organism at concentrations
higher than in surrounding water) of
TOT has been reported for sheepshead
minnow where an equilibrium was not
reached during « 4ay test period.
With exposures B to 2.07 ppb.
residues were as ugb as 4.19 ppb in the ,
whole body. When transferred to clean
water, depuration (loss of the toxicant >
from the organism) was rapid for the
first 7 days, but slowed over the next 21
days. Chinook salmon were also
reported to bloaccumulate TOT by a
factor 200 to 4300 time* greater than the
TOT concentration In the water column.
2. Bivalves, l-arval stages are more
sensitive to TOT than adults. Acute
toxicity to bivalve larvae (48-hour LCw)
has been reported to be 0.9 ppb for
Pacific oyster larvae (Crassostrea gigas)
and 2.3 ppb for mussel larvae [Mytilus
edulis).
Chronic effects of TOT exposurr are
reported to cause growth retardation at .
OJJ2 to 0.05 ppb in European oysters
(Ostrea edulis) and clams [Venerupis
decussate), shell deformities at 0.02 ppb
in the Pacific oyster (C. gigas). and
reproductive aberration* (predominance
of male* in the hermaphroditic European
oyster) at 0.24 ppb. ___
Bivalve* rapidly accumulate TOT in
lipid-rich tissue, especially gonadal
tissue. Bioaccumulation factor* of two
thousand to twenty thousandfold for
Pacific oyster and a thousandfold to
fifteen hundredfold for European oyster
have been recorded. Unlike fish.
bivalves do not readily metabolize this
toxicant and the resulting effect is slow
depuration of TOT.
S. Gastropods. Marine snails
(specifically Nassarius obsoletut and
Nucella lapillus) are reported to develop
a condition termed "imposex" as a
result of TOT exposure. Imposex is the
superimposltion of male characteristics
(penis and vas deferens) on female
organisms. In the extreme, imposex
impacts gastropod reproduction. A
direct relationship between TOT
exposure and the development of
imposex has been demonstrated in the
laboratory at exposure levels of 0.05 ppb
TOT for 120 days and corroborated in :
the field A high frequency of imposex .
has been observed in areas with heavy
boating and shipping activities and high
levels of TOT in the water column. .
Imposex is Infrequent in more pristine
areas.
4. Crustaceans. Acute toxicity of TOT
to tested crustacean species ranges from
0.42 ppb for a 90-hour Ldo for juvenile
mysid shrimp (Acanthomysis tculpta) to
41 ppb for a 96-hour LU* for adult
shrimp [Crangon crangon).
The sublelhal chronic effects of TOT
to crustaceans have involved growth
retardation in mysld shrimp (0.25 ppb).
delayed metamorphosis in mysid shrimp
(10 to 20 ppb), delayed limb regeneration
in fiddler crabs (Uca pugilator) (0.5 ppb),
reproductive effects in adult female
mysid shrimp (0.14 to 0.19 ppb), and
behavioral changes in daphnids
(Daphn/a magna) (0.5 ppb).
5. Algae. A limited number of marine
diatoms and fresh water algae have
been examined for toxic effects from
TOT compounds. In laboratory studies,
an ECtc (the environmental
concentration at which 50 percent of the
population is effected) for growth
inhibition of the marine diatoms
Skeletonema costatum and
Thalassiosira pseudonana was
observed after 75 hours exposure at 0.33
ppb and 1.33 ppb, respectively. Growth
reduction was reported for 5. costatum,
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Federal Register / Vol. S3. No. 192 / Tuesday. October 4. 1988 / Notices
Pavlova latheri, and Dunoliello
tertiolecto at 04 ppb and death at 5 ppb
after 2 days.
6. Registrants'comments on aquatic
toxidty tones, b response to the
Agency's Ptefioinary Determination and
the TBT Tetanfcal Support Document
registrants and other parties submitted
specific »MHiifiiU concerning the
Agency's interpretation of data It used
to assessing the toxidty of TBT to non-
target aquatic organisms. These
comments and EPA'a detailed
evaluations are indnded in the public
docket (OPP-aoooo/4BAL and are
available for Inspection as noted at the
beginning of this Notice under
"ADDRESS". Below Is a summary of the
prmdpal Issoe regarding aquatic
toxidty from TBT raised by the
commenters.
The Agency based a portion of its
hazard assessment on chronic effects of
TBT to non-target aquatic organisms.
One registrant argued Ihnt the nhrll
thickening effed noted in the Pacific
oyster (C gigos) may be caused by other
environmental fadors. induding other
chemical contaminants and high
turbidity, rather than TBT. The Agency
has reviewed the published literature
regarding this Issue and maintains Its
conclusion that data from both field and
laboratory studies appear to support a
finding that TBT is the causative factor.
Other environmental pollutants have
been determined to be unlikely causes.
Over 200 xenotrioticB, Induding diesel
fuel aromatic hydrocarbons, copper,
and zinc, were not found to cause the
-shell thickening effect (Kefs. 1,2,-S, and
4). Likewise, particnlate matter, once
believed to be assodaled with the
effect, was subsequently discounted as
a likely cause because further studies
demonstrated that the paniculate matter
was contaminated with TBT fRef. 1).
TBT levels of 0.15 and 1.6 fig/L. which
were similar to those measured in areas
of England where affected spedes were
observed, had a propensity to cause
shell deformities in C gigas with or
without particnlate matter present while
particnlate matter alone did not cause
the shell thickening effect (Ref. 2). These
findings have been further confirmed in
field studies (Ref. 5).
B. Compantm TmiciUesof
Tributyltin. Triphenyhin, end Copper
Copper baaed antifoullng paints are
the major alternative to TBT paints.
Although copper can be highly toxic to
aquatic organisms, it appears to be less
toxic than TBT by one to three orders of
magnitude. Copper toxidty and
bioavailability are reduced in the
marine environment because the toxic
unit the free cupric ion, is adsorbed by
and forms complexes with organic and
inorganic Uganda.
Abo. triphenyltin (TFT) could be used
s a substitute antifonling compound in
paints. The Agency has a United aet of
data on TFT (based on nominal
concentrations} which Indicates that
TPT causes chronic effects in fish at 2.0
ppb and effects in crustacean* at >0i27
-ppb. TBT effed levels for these
organisms are >OJ ppb and 0.09 ppb,
respectively. The Agency issued a DCI
on TPT anttfoulant uses on August 28,
1887 which required ecological effects
data along with other data. Protocols for
some of the required studies have been
submitted and an be*lng reviewed by
the Agency. The information obtained
from this DCI will be useful to the
Agency in assessing the risks of TPT to
nontarget aquatic organisms.
C. International Reports of TBT
Contamination and Population Effects
1. France. In France, a corrclnllon hits
been found between TBT residue levels
in certain estuaries and gross
malformations in Pacific oysters (C
gigas) grown In commercial oyster beds
in and adjacent to areas of heavy
boating activity. These deformities are
characterized by the perturbation of the
calcification mechanism. Abnormal
shells are thickened and have numerous
chambers filled with a Jelly-like
substance consisting of high levels of
the amino add threonlne, and a smaller
amount of the amino acids serine,
glycine. and aspartic add as compared
to normal oysters.
Environmental concentrations-of
organotin in the water column were
measured (as Sn) at 0.2 to 0.3 ppb in
Arcachon Bay during 1982 and appeared
to have caused shell deformities in 70 to
100 percent of the 2-year old oysters.
Following a ban on TBT antlfoulihg
paints on vessels less than 25 meters (82
feet) in length, the degree of shell
deformities has decreased and the
' regeneration rate of juvenile oysters
(spat) has improved
. - 2. England. A recent study found that
environmental concentrations of 0.02
ppb TBT in the Crouch estuary resulted
in oyster shell deformities similar to
those found in France. This finding was
corroborated in the laboratory. A
reproductive abnormality (imposex) has
been observed in the dogwelk snail
[Nucella lapillus) and may be
responsible for the possible decline of
this once abundant population.
Researchers established that this > .
reproductive anomaly can occur in
certain species of marine snails when
TBT tissue concentrations exceed 0.1
ppb. Laboratory testing demonstrated
that tissue levels of 1.65 ppb have been
found to induce Imposex after snails'
were exposed to 0.05 ppb TBTifor four
months.
8. Canada. In Canada, organotin
residues have been found in several
freshwater locations induding lakes,
rivers, and harbors. Several sample
stations had TBT levels (0.22 to 5.0 ppb)
that were comparable to the chronic
level (>0-2 ppb) assodated with growth
retardation in rainbow trout larvae.
High levels of TBT residues at these
sample stations were assodated with
heavy boating or shipping activity.
4. United States. Reports on the
effects of TBT on aquatic populations in
the United States have been limited -
because the environmental impact of
tin-based antifoulant paints has only
been studied for a few yean. However, '
from the information that Is available, It
appears that adverse effects to
nontarget aquatic organisms may have
occurred. Immfficlnnt dnln are available
to define the full extent of the problem.
The Department of Fish and Wildlife
of Oregon recently found shell
deformities in oysters from Coos Bay,
and have attributed these abnormalities
to TBT residues from paint chips coming
from a nearby shipyard. Researchers at
California Department of Fish and Came
demonstrated that oysters (C. gigos) and
mussels (M. edulis and M.
califomianus) transplanted along a
known gradient of TBT concentrations
in San Diego Bay exhibited shell
thickening and growth effects similar to
laboratory and field findings
documented in France and England. A
recent monitoring program indicates
that TBT levels are sufficiently elevated
and persistent in several major bays and
harbors in California to cause the shell
deformities observed in C. gigas (Ref. 6).
Imposex in female mud snails has been
reported in the United States along the
East Coast and in California in dose
proximity to yacht harbors and marinas.
Li marinas and areas of high boating
activity of the southern Chesapeake
Bay, TBT concentrations are reported to
be at 0.014 to 0.1 ppb, levels that
laboratory tests indicate cause
reproductive effects in molluscs.
D. Endangered Species
There are approximately 90
endangered species in fresh water lakes
and streams and in marine estuaries of
the United States There are no available
organotin toxidty data for these spedes;
however, EPA has asked the Fish and
Wildlife Service. Department of Interior
and the Marine and Estuaries Fisheries
Service in the Department of Commerce
to determine if organotin compounds
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Federal Register / Vol. S3. No. 192 / Tuesday. October 4. 1988 / Notices
39027
would (eopardize any endangered ;
species.
B. Exposure ' .
I. Environmental fate. The
environmental fate of tributyltin in
estuaries la complex and not completely
understood Studies indicate that
photolysis and microbial action an
potential mechanisms of degradation
from tri- to di- to monobutyltin and
finally to inorganic tin. Studies indicate
the half-life of TBT may be 116 days in
aerobic soils. 815 days in anaerobic
Mils. 6 to 12 days in sea water, and up to
238 days in fresh water. TBT is readily
aorbed to soils and sediments.
Sedimentwater partition coefficients of
3000 and 700 ug/kg/ug/L have been . '.
reported for suspended participate
loadings of 10 and 100,000 mg/L.
respectively. Thus, newly deposited
'sediments might be expected to have
TBT residue concentrations 3000 times
greater than the ambient water column
concentration when the suspended
partlculate concentration was 10 mg/L
in the water column. As the
concentration of suspended particulates
in the water column increased, the
difference between the ambient water '
column TBT concentration and the
sediment TBT concentration would
decrease. Data from monitoring studies
have consistently indicated that TBT
and its di- and monobutyltin degradates
concentrate in bottom sediments.
Sediment-bound residues contain a
higher ratio of the degradates than that
found in the wa ler column. The means
of-TBT-deposilion-in-sedimentsend the
relulive strength of TBT migorption
versus desorption of the degradates are
not known. The overall partitioning of
TBT among water, biota, sediment,
surface microlayer, and atmosphere has
not been fully investigated.
2. Bioavailability. TBT residues
accumulate in sediment at levels that
are one to four orders of magnitude
greater than the total concentration of
TBT residues measured in the water
column. This amassing of toxicant may
have serious consequences for
organisms living and feeding in the
benthos (bottom of the body of water).
For example. It has been found in
laboratory experiments and field trials .
that TBT contaminated sediment can
affect growth in Pacific oyster (C gigas)
at 0.15 ppb. In addition, the results of a ,
laboratory study suggest that mud crabs
(RhiUirQ-panopeuB ham'ssi] accumulate
TBT from food as well as water .
exposure. . . . , .-.. .-
. In estuarine environments, 85 percent.
of the particulatebound TBT may be .:
associated with bacterial cell walls ,, . .
(dead and alive cells). The adsorption of
TBT to bacteria is a significant exposure
component that may affect aquatic
organisms that feed on detritus (organic
matter) and suspended partlculate.
These organisms include species of
polychaetes, snails, amphipods.
sponges, bivalve molluscs, and
arthropods.
.. I. Environmental monitoring.
Monitoring studies have been carried
out to determine the extent of TBT
contamination in the water column of
marine and fresh waters. Sampling was
designed to compare levels of
contamination in areas of varying
boating activity (recreational and
commercial). The seasonal, tidal, and
spatial flux of TBT and Its degradates
were examined in some cases. Limited
analyses of sediment and aquatic biota
also have been performed
TBT levels in tested areas of the
Chesapeake Bay and San Diego Bay
ranged from ND (nondetecteble. .
meaning below the level of detection for
the analytical method used) to 0.8 ppb
and ND to 1 ppb. respectively. Other
reported water column concentrations
were: San Francisco Bay ND to 0.16 ppb,
Honolulu Harbor 0.045 to 0.27 ppb. Los
Angeles/Long Beach Harbor ND to 0.12
ppb, Narragansett Bay, Rhode Island,
ND to 0.13 ppb, Thames River,
Connecticut, ND to 0.009 ppb, and
Mayport, Florida ND to 0.016 ppb. Fresh
water samples from 265 locations across
Canada were analyzed for TBT. fa 10
percent of the water samples, TBT was
found at levels >0.2 ppb. Consistently,
TBT concentrations were bigbestJn
areas of heavy boating activity. A
monitoring study in the Chesapeake Bay
during the summer of 1986 showed a
strong correlation between boat density
and observed TBT concentrations in
four harbors.
TBT concentrations have been shown
to vary seasonally. In areas of moderate
to high TBT loading, the water column
levels of TBT appear to correlate to
seasonal boating activity and boat
maintenance activities. Seasonal
variation in temperature may also
influence the leaching of TBT from
paints and/or the mobility and
persistence of TBT in the marine
.environment
Tidal exchange, dispersion, and
convection are the most important
. factors affecting short-term changes in
TBT concentre (ion. Sites with fresh
water Influx areas or recirculating
currents generally have very low .
concentrations of TBT. In areas where
water residence times are relatively
long. TBT levels increase in proportion
to the loading. Accumulation of TBT
degradates has been observed in
locations where water movement is very
slow (e.g.. southern end of San Diego
Bay).
4. Environmental modeling. The.
Agency Is engaged in an effort to model
Norfolk Harbor in Virginia. Norfolk
Harbor is a major fishery with large
populations of hard clams and Eastern
oyster and is a nursery for spot. Atlantic
Crocker. Atlantic menhaden, stripped
bass, black sea bass, and summer
flounder. The area is also an active
boating and shipping area with
recreational commercial, and military
use and contains large and small boat/
shipyards. The Agency model will
examine environmental concentrations
under several loading levels and attempt
to estimate the impact of possible
regulatory approaches on TBT
concentrations. The information may be
useful to the Agency in making future
regulatory decisions.
5. Registrants' comments on exposure '
Issues. Registrants and other interested
parties submitted many specific
comments concerning the Agency's
interpretation of data used in evaluating
the exposure of non-target aquatic
organisms to TBT. These comments and
EPA's detailed evaluation are available
for inspection In the public docket.
There were five major exposure issues
raised by the registrants. They were
degradation, bioavailability,
bio-accumulation, environmental
concentrations, and environmental
loading. The Agency's responses are
summarized below.
a. Degradation. A registrant
commented that factors such as
hydrolysis, photolysis, dissipation, end
other degradation pathways were not
factored into the Agency's calculations
regarding exposure. The registrant
stated that calculation of exposure
should be based on recently generated
data such as that reported by Dr.
Richard Lee (Ref. 7) which indicated
tiv half-life of TBT In water may be
let .1 one week, depending on the
concentration of algae.
Response: The Agency has evaluated
and considered all of the available
information regarding physical and
biological degradation of TBT. including
the study by Dr. Lee which was not
available to the Agency at the time of
the Preliminary Determination.
TBT can be degraded through
photolysis. However, because of the
limited penetration of sunlight into an
aquatic environment this pathway is
not expected to significantly affect TBT
concentrations. .
Hydrolysis is not a viable degradation
consideration since TBT is relatively
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Federal Register / Vol. 53. No. 192 / Tuesday. October 4. 1988 / Notices
table hi water with a degradation half-
life of 1 to J years (Ref. B).
The OTcnll partitioning of TUT among
water, biota, sediment ratface
microlaya. and atmosphere hai not
been experimentally Investigated
although Inferences may be drawn
boot relative partitioning from analysis
of available monitoring data discussed
n Unit OB4. of this document
Biodegndation of TFT by algae was
first suggested by the work done by
Magulre et oL (Ref. 9). They concluded
that the freshwater green algae
An&JBtmdemuB faloatus could degrade
TBT to dibntyltin resulting in a half-life
of 25 days. However, the authors note
mat these estimates should be viewed
with caution, since the reaction was not
followed to completion.
LnetaL (Ref. 7) found that at a TBT
concentration of 1.5 ppb under
laboratory conditions with a very high
phytoplankton population (Skeletonema
eostatum], TBT was degraded with a
half-life of 4 to 9 days. This information
was Interesting; however, insufficient
data were given in the study to confirm
the results. The results of this study
al. (Ref. 10) who used the same species
of algae and calculated an EC» for
growth inhibition of 0.33 ppb TBT. Lee et
ol. (Ref. 7). as well as Walsh et al. (Ref.
10), found low or no degradation of TBT
by cultures of dinoflagellates, green
algae and chrysophytes. Although the
diatom used by \jne et al. (Ref. 7) may
degrade TBT under certain optimal
conditions, their presence hi the water
column Is cyclic and appears to be
dominant in temperate -water during the
Spring.
The effectiveness of algae degradation
of TBT to a function of temperature,
species, population density, and the
nutritional state of TBT tolerant algae.
Therefore, it is difficult to assess
whether algal degradation of TBT would
be a significant pathway in the
environment. However, bacterial
blodegradation is a strong possibility.
Several researchers have concluded that
certain bacteria have this capability
(Refs. 6. 7,11.12, and 13).
b. Bioavailability. A registrant
commented that EPA incorrectly
assumes that particulate and sediment-
bound TBT is potentially 100 percent
bioavailable. The registrant contends
that the bfoaveilability of sediment-
bound TBT to limited
Response: The Agency has never
assumed that particulate end sediment-
bound TBT were potentially 100 percent
bioavailable. The Agency has concluded
that the available data indicate that the
level of TBT bloavailabillty Is affected
by suspended particulate, bottom
sediments, and dissolved organics. :
However, the Agency believes that the
available data are Insufficient to f>
completely assess the impact of
sediment-bound TBT to aquatic
organisms. Organotin bioassaya
required by the Agency's Data Call-In
Notice of July 38,1986 are designed to
address this.
The registrant dies data published by
Salaxar and Salaxar (Ref. 14) to support
their contention that no adverse effects
occur in bottom organisms exposed to
TBT bound sediments. The Agency
evaluated this study and found it to be
limited and incomplete. The 10- to 20-
day solid phase (sediment) test used
nysid shrimp, clams, and polychaete
worms. Supplemental feeding of the
mysld shrimp and polychaete worms
limited the usefulness of the test which
was to determine whether organisms
that ingest TBT-laden sediment are
affected The authors do acknowledge
that the clams (filter feeders) did
accumulate significantly more tin (2.82
ppm) than controls (028 ppb). In fact
they conclude that "these values . . .
demonstrate that the organotins
associated with sediment are bio-
available." The static test of the
suspended particulate phase showed no
significant mortality because: (1) The
test organisms (shrimp and sandcrabs)
are not filter-feeding organisms that
would normally ingest the particulate-
bound TBT, and (2) the test organisms
(except fish) were given a supplemental
nncontamlnated diet.
c. Bioaccumulation. A registrant
commented that he does not believe that
lethal levels of-TBT will bioaccumuiate
in an organism exposed to low
environmental concentrations because
ail organisms will depurate their TBT
body burden, and environmental levels
of TBT are not maintained for long
periods.
Response: The Agency Is not only
concerned with lethal concentrations
from bloaccumulation; sublethal levels
of bloaccumulation which may lead) to
effects short of death also are of concern
to the Agency. The risk from 1ET
bioaccumulation cannot be dismissed
Body burdens In various aquatic
organisms (i.e. fish, bivalves, algae, and
bacteria) are not totally depurated. The
Agency has relied upon the work of
several researchers In establishing that
TBT accumulation occurs In fish.
bivalves, gastropods, algae, bacteria,
and crustaceans (Refs. 4,15,18). An
interpretation of the toxicity data
suggests that two poisoning mechanisms
may be occurring. At high TBT
concentrations, gill-breathing organisms
may be affected by rapid suffocation
resulting from destruction of gill
epithelium. However, at low
concentrations, organisms that do not
efficiently depurate or metabolite TBT
may accumulate levels that will inhibit
main metabolic pathways. Either one of
these mechanisms could result in lethal
or sublethal effects. In regard to
environmental levels, several
researchers have found that while
peaks in TBT environmental
concentrations occur in some areas (e.g.,
areas where there Is a Spring launching
of recreational boats), a relatively
significant level of TBT is maintained
for 8 to 7 months In temperate areas and
may be even more extensive in warmer
climates where boating activity Is less
affected by seasonal changes. Waldock
and Miller (Ref. 4) found that TBT
residues were still found in C. gigas
tissue during the winter months when
boating activity had ceased and most
pleasure craft had been removed from
the Crouch estuary. This suggests that C.
gigas was either still being exposed to
environmental residues of TBT or
depuration was very slow.
d. Environmental concentrations. A
registrant stated that he does not
believe that residues of TBT in the
environment will equal or exceed levels
which produce adverse effects in
nontarget organisms.
Response: The Agency has cited
incidents from Europe where TBT has
been implicated In causing adverse
effects to aquatic organisms. In fact It is
because of these occurrences that
regulatory actions have been initiated in
France and England. Concern was first
expressed urErance where.severe
deformities were found in the
commercially cultivated Pacific oyster '
(C. gigas) in areas where there was
intense boating activity and relatively
poor water exchange. The affected
oysters were found to contain high
concentrations of tin although scientists
at the time could not distinguish
between the inorganic and organic
forms. These high levels of tin coincided
with the increasing use of organotln
compounds (especially TBT) as biocidal
agents in antifouling paint The French
government responded by banning the
use of organotln paints on boats under
25 meters In 1382. Similar problems were
subsequently noted In the United
Kingdom and resulted in legislation to
control the total concentration of tin in
antifouling paints. U.S. researchers
noted several incidents of shell
deformities In oysters transplanted to
various California harbors and bays,
that were known to contain elevated
levels of TBT. These findings in
California were consistent with those
observed in the UK and France.
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89029
e. Environmental loading. A registrant
maintained that TBT environmental
concentration* are correlated with
marina maintenance activities and not _
with leaching from boat hulls.
Response: Although some data on
TBT environmental levels can be
attributed to paint chip contamination
from improper disposal there are
examples of high levels that can be
attributed exclusively to boat paint .
leaching. Seligman et al. (Ref. 17).
sampling at Shelter bland Yacht Basin,
San Diego, found near surf ice
concentrations of TBT (0.027 to O23S ug/
1) that were significantly higher than
sear bottom concentrations. The large
difference in vertical distribution was '..
accredited to the TBT leaching from ..
hulls in the upper 1 to 2 meters of the .
water column with relatively little
mixing below that level. According to
Stephenson (Ref. 16). marina ;
maintenance activities are not occurring
at the Shelter Island Yacht Basin.
However, if paint chip contamination
was occurring, it is expected that high
levels of TBT would be found much
further down the water column, due to
the density of the paint chips.
The Agency has developed a model
for examining environmental ; :
concentrations of TBT in the Norfolk.
Virginia, area with regard to various
TBT loading levels. One set of studies
simulated the continuous long-term
release of TBT paints by boat hulls. At a
release rate of 1 ug/cmf/day. It was
projected that TBT leaching from boat
bulls would be comparable to levels .
found in the" Norfolk area. These results
lend support to the Agency's position
that TBT leaching from boat hulls is a
primary source of TBT contamination.
P. Risk Assessment Summary
The risk assessment contained herein
Is a summary of the risk assessment
contained in the the Technical Support .
Document of the Preliminary
Determination. Laboratory and field .
studies have demonstrated that low
concentre lions of TBT can cause
irreversible chronic effects to a broad
spectrum of nontarget aquatic
organisms. At laboratory and field
concentrations of approximately 0-02 to
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89030 Federal Renter / Vol. 83. No. 192 / Tuesday. October 4.1988 / Notices
submissions are currently deficient.
Many nbmissions did not include raw
data (Instrument readings), adequate
Information on instrument calibration,
or tuffidrai data on blanks and <:' :
controls. Toe descriptions of leaching '
and analytical methodologies wera;
Incomplete. Information needed to
demonstrate that proper environmental
controls (pH. temperature, and salinity)
were maintained were not included In
most submissions. In some cases,
samples were stored beyond the period
specified by the ASTM/EPA method;
however, storage stability data wera not
submitted.
At this time no release rate studies
have been validated. Registrants were
mfonned to an Agency letter dated
August 12,1988, that additional data/
information were required to be
submitted before any decisions
regarding specific release rates can be
made.
In addition to the above deficiencies,
many of the submitted studies did not .
adhere to the ASTM/EPA method
specification that the TBT concentration
hi the measuring tank not exceed 60 .
pnb. This restriction was Imposed to
eliminate the possibility of
autoinhibition of TBT release from the
paint film. EPA and the ASTM
committee suspect that the 60 ppb
restriction may be too conservative.
Testing is being initiated at EPA'a
Environmental Chemistry Laboratory
(ECL) in Bay SL Louis, Mississippi, to
determine the true autoinhibitory
threshold.
After (he ECL test results are
available and (he registrants respond to"
the above Notice, the Agency wUl
reevaluate each study. If it is ' '
determined that the measuring tank
concentration did not exceed the true
autoinhibitory threshold and if the '
Agency finds that the registrant has
supplied the additional data/
Information necessary to validate his
submission, the Agency will use the
study for regulatory purposes. . .
B. Release Rate Restriction
The proposed restrictions fa the
Preliminary Determination specified that
no TBT antifouling paint could be sold
or distributed which exceeds the short-
term cumulative release (cumulative
release over the first 14 days of the
ASTM/EPA test) of 168 fig TBT
(includes tribatyltin and trlphenyllin)/ -
cm* or an average daily release rate
(average over weeks 9 through 6) of 4.0
pg TBT/cm'/day. The proposed short-
term cumulative release restriction was
indexed to the average release rate
restriction (3 x the average release rate
.over 14 days).
The short-term cumulative release '
was intended to reflect the initial surge
of TBT release when a freshly painted
vessel is first placed in the water.^t was
calculated by summing the time '" :>
weighted release for each sampling over
the first 14 days of the test The time
weighted release was calculated by
multiplying the rate of TBT release for a
given sampling time by the preceding .!'
length of time between sampling times.
The average release rate reflects the'.,
long-term TBT release pattern that is' '.
established after the initial surge. It Is.
defined as a simple average of the .
release rates measured over a certain
number of weeks. .-..,
In the Preliminary Determination, ' <
release rate values were normalized to
adjust for variation between testing <
facilities and the average dally release
rate was defined as the mean of
Individual release rates over weeks 3 /
through 6. The Agency received .;.'!
numerous comments from TBT
registrants and the FIFRA Scientific 4"
Advisory Panel regarding this analysis
of the release rate data. Most
commentera felt that the proposed ':'
release rate restrictions should be '
adjusted to account for the variability of
the test method but that normalization
was not an appropriate means of :
accounting for variability.
The standard test paint data were the
only data common to all registrants and
as such were used to evaluate the *
variability of the ASTM/EPA release '
rate method. Additional standard test '-
paint data and information on testing
procedures from-individual testing
facilities submitted after the Preliminary
Determination was Issued, were
included in the Agency's analysis of the
method's variability. It was not possible
to establish that variation among testing
faculties was attributable to systematic
error, as was previously assumed.
Variation associated with testing
facilities is now assumed to represent a
component of method variance.
Normalization is not appropriate tinder
these circumstances, tnd the Agency
agrees that release rate data should not
be normalized. The available data could
not be analyzed by standard statistical
procedures because sampling was
unbalanced (a wide variation in the
number of samples per laboratory). The
Agency could only perform a qualitative
analysis of the method's variability. It ;
was determined that most of the
variability was associated with testing
among different laboratories and
sampling over time within a given test
Variation between replicate cylinders
and between replicate runs was low by
comparison,, .
'The Agency has determined that, due
to the Incomplete nature of the release^
rale data submissions and the ~
uncertainty over autoinhibition, it would
. be inappropriate at this time to try to
quantify the variability associated with
the EPA/ASTM method. The Agency is
unable to determine whether the high
variance of the results Is attributable
solely to the inherent variaWlty of the
method or to possible improper conduct
of the release rate studies. It would also
' be inappropriate to determine a release
* rate restriction which attempts to
account for this variability based solely
on the current data base. ..- -
For the present the Agency Is keeping
the Special Review open on the Issue of
release rates and is deferring to the
interim release rate restriction (4 fig/
cm'/day) and certification program
established by OAPCA. Products will be
certified on the basis of the average
daily release rate calculated from :
validated release rate studies conducted
according to the current draft ASTM/
EPA method. Any new release rate data
submission or resubmlssion (such as ';
. those required by the Agency's August
12,1988 letter) will be reviewed and a
determination regarding certification
reached within 90 days of the Agency's
receipt of such data. . '
The average dally release rate will
.now be calculated as the non-
normalized mean of all release rate
measurements during weeks 3 through
10. In the Preliminary Determination the
average dally release rate was defined
as the average of release rates measured
over weeks 3 through ~B. However,
examination of the standard paint
release rate date indicated that
Individual release rate measurements
made during week 8 and beyond were
equivalent to those made during weeks 3
through B. Release rate measurements
beyond 10 weeks may be requlredfor '
paints with atypical patterns of TBT '[
release over time. The additional >''*'
measurements inclu-fed Li the - >
calculation of the aver age release rats
are expected to increase accuracy.
The Agency will consider release rate
levels again when additional ,M
environmental monitoring data are
available and the release rate method is
1 improved. The Agency has already
identified certain procedures within the
method as potential sources of ". "':
variability and has initiated
experimentation to determine how the ;
release rate method can be improved.
ThlB testing Is further discussed In Unit
VD. When the research is completed, the
. Agency may decide to replace the
current OAPCA release rate restriction
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Federal Register /Vol. 53. No. 192 / Tuesday. October 4. 1988 / Notlcei
39031
with a rettridion derived from die
improved method
C. Retain
Release rate data for 109 currently
registered TBT antifoulant paint
product* have been submitted to the
Agoncy. Additkmul data have boon
required for M of these products. Data
submissions cove lug 15 paints have
been invalidated because the testing
facility used inappropriate testing
procedures. One specification in the
protocol is temporarily deferred pending
the results of EPA laboratory testing.
This exception is the acceptance of data
where the concentration of TBT to the
. measuring tank sea water exceeds 50
ppb. This concentration was exceeded
for 42 of the 94 paint products.
Of the 94 paints for which release rate
data were submitted, 68 have estimated
release rates which tentatively meet
OAPCA's average dally release rate .
restriction of 4.0 ug/an*/day. These
products may be certified under OAPCA
provided the registrants of these
products submit adequate data as
required by the Agency's letter of
August 12,1988, which will allow the
Agency to validate the registrant's
study. Table I characterizes the number
of paints that would meet OAPCA's
release rate restriction.
TABLE INUMBER OF PAINTS THAT TEN-
TATIVELY MEET OAPCA's RELEASE
RATE RESTRICTION OF 4.0 JIG/CM*/DAY
Typ«tOlp«ints
Fr*e mudito ptlnu
etti
MWl
copper
' 12
8
Without
copper
IV. Detennhution of Benefits . ;
. The following discussion of benefits -
Includes consideration of the impacts of
both OAPCA's requirements and the
additional requirements imposed by this
Notice. The OAPCA requirements, for
which benefits Impacts have been .
reviewed, include the vessel length and
release rate restrictions. This Notice
adds the restricted use classification .
requirement and requires labeling
relating to OAPCA's requirements and
those of this Notice. Under F1FRA the
Agency const weigh the impacts on :
benefits of the risk-related requirements
imposed pursuant to FIFRA. The Agency
is not required to consider, other than as
part of the already existing benefits
situation, the impacts of requirements
imposed pursuant to other legislative .
authority, such as OAPCA or OSHA. to
FIFRA-mandated rUk/bem.3t
weighing.
The benefits of TBT antifouling paints
were analyzed for the boat and shipyard
Industry and three user groups:
recreational, commercial and military.
Aa explained in the Technical Support
Docuimmt of tlto Prulliulnury
Determination, analysis was performed
for three possible regulatory options: (1)
Total ban of TBT antifouling paints, (2)
restriction of TBT paints by release rate,
and (3) restriction by release rate, sice
of vessel, and classification as a
restricted use pesticide. The benefits of
other regulatory options discussed in the
Technical Support Document were not
analyzed because it was determined
that they were not feasible options to
reduce the risks from TBT exposure to
nontarget aquatic organisms.
Comparisons were made for TBT
copolymer/ablatlve. TBT free
association, copper conventional and
copper ablative paint systems. For each
user group and each paint system, the
impact of regulation was determined by
subtracting the cost of hull maintenance
using a particular paint system from the
operational benefits gained from that
system (i.e., fuel efficiency, increased
time between dry dockings). The
different paint systems were then
compared for each user group. Hull :
preparation costs are lower when
ablative paints are used because vessel
operators can achieve extended dry
docking intervals. The longer a vessel
can stay in service between dry
dockings or hull cleanings, the less
. expensive a vessel is to operate. Oil-
ship trials conducted by the U.8. Navy
indicate that organotin co-polymer/
ablative paints would enable vessels to
operate on a 5- to 7- year dry docking
schedule. .
The major, currently available
alternatives to TBT antifouling paints
are copper compounds, chiefly cuprous
oxide. There are copper ablatives which,
like TBT copolymer/abletives, do not
require hull cleaning or frequent dry
docking. There are currently only three
registered copper ablative paints. More
testing is needed to determine if they
can give the 6 to 7 years of service noted
for certain TBT copolymer/ablative
paints. Testing now being conducted
indicates copper ablatives give
acceptable control of fouling for 3 to 4
years. The conventional copper paints
require frequent hull cleanings (every 9
to 18 months) to remove fouling
organisms and the layer of insoluble
. copper compounds that precipitate near
the paint surface and block the release
of the toxicant However, there is .
published research indicating that .
conventional copper paints may last
over 3 years with several hull cleanings.
The major disadvantage of copper is
that it may cause galvanic corrosion to
aluminum vessel hulls. Even with high
quality anticorrosive primers, there may
be small flaws in the primer coat that
could ullow oop|M>r corrosion to an
Aluminum hull, especially on vessels
with long dry docking intervals.
Commercial vessels use ^^
approximately 60 percent of the TBT
antifouling paints. For ocean going
vessels, long periods between dry
dockings and reduced fuel consumption
are important considerations. Although
many commercial vessels are dry
docked and Inspected every 2 years,
TBT copolymer/ablative paints provide
an estimated $318 million per year
savings to U.S. commercial vessels over
copper conventional paints and an
estimated $143 million savings over
copper ablative paints.
There are approximately 5 million'
recreational vessels in the U.S. Most
recreational vessels are removed from
the water after every use and do not use
antifouling paint However, 14 percent of
recreational vessels (700.000 vessels)
use some type of antifouling paint
containing either copper compounds,
tributyltin compounds, or a combination
of the two biocides. It is estimated that
approximately 80,000 recreational
vessels are painted with TBT
copolymer/ablative paints, but of these
only some 21 percent take advantage of
the extended dry docking intervals that
can be achieved through use of these
paints: the other users tend 1o paint
more frequently than may be necessary.
The loss of TBT paints would cost
recreational boaters currently using TBT
copolymer/ablative paints $0.85 million
per year. Recreational vessel owners
who currently use free association TBT
paints would incur an estimated
additional cost of $078 million per year
over using less expensive copper based
paints which will give one to two
seasons of protection. Therefore, to
terms of antifouling use, there appears
to be an economic benefit only to those
recreational boat owners who use TBT
copolymer/ebletive paints and take full
advantage of the extended dry docking
Intervals by not repainting too
frequently. Another consideration Is that
TBT compounds are colorless and offer
recreational boat owners more choice of
paint colors than copper based paints.
The impact of a total ban of TBT
antifouling paints was calculated for the
U.S. Coast Guard. Navy Sealift
Command, and U.S. Navy, assuming
implementation of the proposed Navy
fleetwide conversion to organotin
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Federal Register / Vol. B3. No. 182 / TucBday. Octpbet «. 1986 / Notices
antifonllng paints. The estimated
average annual net benefit of using TBT
copolymer/ablative points versus
copper ablative paints ia $35.3 million
and $142 million over using conventional
copper paints. Estimates for loss of fleet
readiness (ag. time spent ia drydock)
were not quantified.
The total annual benefits (including
commercial and recreational vessels
and assuming fleetwide conversion by
the Navy) of en estimated $179 million
would be lost if all users of TBT paints
witched to copper based paints (copper
ablatives substituted for TBT
CDpolymer/ablatives and conventional
coppers substituted for TBT free
association paints). If all users
substituted conventional copper paints
for all TBT paint use. due to the proven
product performance of conventional
copper paints over the recently
developed copper ablative paints, the
loss would be an estimated $4604
million annually.
The foregone benefit (i.e., additional
expense) of using copper ablatives may
be reduced If copper ablatives cnn be
shown to hare service lives comparable
to TBT copolymer/ablative paints. Since
It has been shown that existing copper
ablative paint formulations have in-
service lives of at least 3 years, dry
docking on a 3-year schedule was used
as an assumption for all copper ablative
paint calculations.
There are approximately 6000 boat
and shipyards in the United States, 44
percent of which use antlfouling paint
Approximately 48 percent of the
anUfouling paints used by these firms
are TBT products; this accounts" (or
about 70 percent of the TBT antifouling
paints used in boat/shipyards. VS.
shipyards compete with foreign
countries as well as domestically for
business. Many U.S. flag (ocean going)
vessels are currently docked end
painted abroad because foreign labor
and materials in this sector are
generally less expensive despite a
substantial ad valorem tax (imposed by
the U.S. government) on these services.
The regulatory restrictions are likely to
have little impact on this practice. The
expected cost of the TBT regulation is
small in comparison to the od valorem
tax currently paid and does not appear.
to be so excessive that it would cause
shipping compnnles to have more work
done abroad. Boat and shipyard serving
vessels too small to go abroad may have
more business If conventional copper
paint systems are used that require
frequent hull cleaning and more frequent
painting than TBT copolymer/ablative
paints.
Under the Agency option to restrict
release rates, which is now mandated
by OAPCA. then would be TBT paints <
(both copolymer/ablatives and free
association) available for all user groups
and for aluminum hulled vessels as well
An initial short supply of acceptable
paints is likely and prices may be
elevated in the short term until new
additional paints with acceptable
release rates are registered
The last option included the following
elements: (1) Release rate restrictions,
(2) limiting the stie of vessel treated;
and (3) classifying TBT antifouling
paints as restricted use pesticides. The
effects on benefits from release rate
restrictions and the Impact on TBT paint
availability was discussed above. In the
Preliminary Determination, die Agency
argued that restricting the size of vessel
to be treated with TBT should have a
minor economic impact on users
because most non-aluminum hulled
vessels under 65 feet In length do not
gain an economic benefit from the use of
TBT antifouling paints because vessels
are painted frequently and there are
effective alternatives. The Agency
believes this conclusion is still accurate
now that the OAPCA 82-foot restriction
is in effect The benefits for vessels
between 65 and 82 feet in length are
similar because generally they are
hauled and repainted every year or two
and therefore do not receive the
economic benefits from extended
drydocking intervals available with TBT
copolymer/ablative paints.
Classifying TBT antifouling paints as
restricted use pesticides builds upon
OAPCA's release rate and vessel length
restrictions and provides even further
protection. This requirement Is expected
to cost users an estimated $600,000 the
first year and $150,000 in subsequent .
year* to lost revenues while they are
undergoing certified applicator training.
In addition, there would be an estimated
cost of $25,000 to $30.000 incurred by
affected states each year to establish
and maintain the required training
programs. The state of California has
already classified TBT antifouling paints
as restricted use pesticides, which
lessens the cost of design and
implementation of a certification and
training program incurred by that State
as a result of the classification in this
Notice. The same would be true for any
other states that may on their own
classify TBT as a restricted use
pesticide. Furthermore, the existence of
one or more state certification and
training programs may aid the design of
additional programs.
The estimated cost of required
compliance with the application,
removal, and/or disposal directions
would vary depending upon vessel size
and shipyard capabilities. Qualitatively,
based on Information submitted by the
U.S. Navy (Ref. 19). it appears that a 90
to 95 percent clean-up of drydock
surfaces can be attained at minimal cost
while an increase to 99% clean-up would
add substantially higher costs.
Under section 4(b)(l) of the
Occupational Safety and Health Act
(OSHA), OSHA may be determined to,
be preempted if another agency
exercises statutory authority to
prescribe or enforce standards or
regulations affecting occupational safety
or health pertaining to working
conditions of employees. EPA does not.
Intend, by making TBT antifoulant
paints restricted use pesticides or by
specifying certain required work
practices through this Notice, to preempt
or interfere in any way with OSHA
requirements pertaining to any activities
or facilities where TBT use. removal or
disposal is occurring. This Notice
requires label language referring to
OSHA requirements; which is designed
to avoid any confusion on the matter of
preemption. Facilities subject to OSI1A
requirements, including, but not limited
to. regulations on the safety and health
of shipyard employees engaged in
surface preparation and preservation,
must already comply with such
standards. The cost impact of label
requirements in this Notice requiring
general reference to the applicability of
OSHA standards, relates only to the
cost of Including such reference on the
label The cost impact of this Notice
does not include the actual costs of
compliance with requirements imposed
by OSHA.
New technologies for controlling
antifouling may be implemented that
could reduce the impact of TBT
restrictions. For example, the U.S. Navy
is testing fluorocarbon coatings that
contain no toxicant The coating surface
must be cleaned regularly (once a month
in the summer and once every 3 months
in the winter). A tug boat painted with
the fluorocarbon coating has performed
well since 1977 without repainting. Also,
the antibiotic terramycin has recently
been registered as an additive to
antlfouling paints; it must be
Incorporated with paints containing
other toxicants and cannot be
considered a direct substitute. Control of
fouling organisms is an active area of
research, especially in the VJ&. Navy
. which conducts testing of promising new
compounds for their overall
performance. The U.S. Navy along with
the Agency will continue to conduct
research on chemical and non-chemical
alternatives to organotln antifouling
paints as required by OAPCA.
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Federal Register / Vol. S3. No. 192 / Tuesday. October 4. 1988 / Notices
39033
In conclusion. It appears that the
major benefits from the use of TBT
antifoullng painU are gained by those
vessel owners, mainly commercial, that
take advantage of the extended dry
costs of TBT paints versus copper
paints, most recreational boa tars appear'
to lose money by nsing TBT paints
because they do not take advantage of
the extended dry docking intervals. The
US. Navy claims that the use of TBT
paints will provide improved fleet
readiness in addition to economic ;'
benefits. Copper based paints are the :
major alternatives to TBT paints and,.
for some users, the copper ablative ' :
paints may prove to be equally.
effective. Further research is being .
conducted on other alternatives.
Comments: Registrants, '; :
environmental groups, and government
agencies made the following comments
on the Agency's benefit assessment in
the Preliminary Determination and
Technical Support Document
L A respondent commented that the
Agency should have utilized the same
dry docking maintenance schedule for '
the TBT copolymer and copper ablative
antifouling paints (5 years) and the
respondent questioned whether there
was sufficient data on currently
marketed TBT copolymers to predict a
6-year service life.
Response: The Agency utilized dry
docking maintenance cycles that are
representative of the reported longevity
of currently available paint products.
The Agency recognizes that the data on
copper-ablative-paints are-conservative
and that data developed over the next
few years may indicate that the dry
docking cycles are bnger than 3 years;
however, currently available efficacy
data indicate that a service life of three
is reasonable. For TBT copolymer
paints, the Agency used data supplied
by users and paint companies which :
suggest a service life of at least 6 years '
for certain currently marketed TBT
copolymer paints.
2. A second respondent stated that :
conventional copper paint lasting over 3
years with underwater hull cleaning is
not a viable alternative because the
coating is removed with the p-Wiiing
operation.
Response: Cologer and Prelser (Ref. >
20) have stated that conventional copper
paints combined with periodic
underwater hull cleaning may provide :
up to 5 years of service. According to
their data, which used in-service U.8.
Navy vessels, conventional copper
paints could be cleaned without '
destroying the paint surface although
hull cleaning was needed sooner once .
the vesnel had been cleaned for the first
time.
3. A respondent questioned the
validity of the assumptions regarding
the marginal fuel cget avoidance derived
through the use of TBT versus copper
ablatives.
Response: The assumptions used were
based upon empirical information
gathered directly from the user groups.
The Agency appreciates that numerous
externalities may be Involved in fuel
consumption: however, it has tried to
estimate the fuel cost avoidance directly
attributable to the use of TBT
antifouling paints. '
4. A respondent stated that few
facilities actually have adequate TBT
controls to prevent contamination of the
surrounding environment
Response: Data available to the
Agency, as discussed earlier, indicate
that broom sweeping or vacuum
sweeping of flat open dry dock surfaces
achieves a 90 to 95 percent cleanup of
TBT at minimal cost The Agency is
confident that most facilities will be
able to secure equipment that will
provide 80 to 85 percent cleanup.
V. Comments of the Scientific Advisory
Panel, Secretary of Agriculture and
Other Parties
As required under sections 6 and 25 of
FIFRA, the Agency provided its
Preliminary Notice of Determination and
Technical Support Document to the
Scientific Advisory Panel and the
Secretary of Agriculture, respectively.
for their comments, which are presented
below. This section also includes
general comments from other parties
which relate to the regulatory measures
. proposed in the Preliminary Notice of
Determination, as opposed to comments
on specific risk or benefit issues.
A. Comments of the Scientific Advisory
Panel
EPA presented Its proposed decision
on tributyltin antifoulant paints at a
public meeting of the Scientific Advisory
Panel held in Arlington. Virginia, on
December 15,1887. The panel issued its
response in a written report of
December 23,1987. The Panel's report is
reproduced below in its entirety.
Federal bwectidde, Fuagbid* and
Rodentidde Act (FIFRA) Scientific Atfvtsofy
Pant!
A Set of Scientific Issues Being Considered
by the Agency in Connection With the
Special Review of Tributyltin
The Federal Insectiddt. Fungicide, and
Rodentidde Act (FIFRA) Scientific Advisory
Panel (SAP) baa completed review of the
data bate lupporting the Environmental
Protection Agency's (EPA) determination that
adverse acute and chronic effect! to
nontarget aquatic organisms may result from
the use of Tributyltin (TBT) compound! at
antifoulants unless certain modification! to
the term* and condition! of registration are
made by the registrant^). The review was
conducted in an open meeting held in
Arlington. Virginia, on December 15. 1067. All
Panel member*, except Drs. Edward Bresnick
and Thomas W. Clariaon. werj present for
the review. In addition. Dr. Robert Huggelt.
Virginia Institute of Marine Science snd Dr.
Roy Laughlin. Oceanographlc Institution.
Incorporated served as ad hoc members of
the Panel. Public notice of the meeting was
published in the Federal Register on Monday.
November SO. 1887. Oral statements were
received from staff of the Environmental .
Protection Agency and from Dr. David B.
Russell. M ft T Chemicals; Dr. Alexis I.
Kaznofl. Naval Sea Systems Command. US.
Navy; Mr. Arthur Tracton, Hempel Coatings,
Inc. and Mr. David S. Bailey. Environmental
Defense Fund. In consideration of all matters
brought out during the meeting and careful
review of all documents presented by the
Agency, the Panel unanimously submits the
following report
Report of Panel ^^^
Tributyltin (TBT)
The Agency requested the Panel to focus
Its attention upon a scientific issue relating to
the Spedal Review of Tributyllln.
There follows some comments to the Issue
and the Panel's response to the issue.
General Comments
The Panel commends the Agency on its
conclusion and recommendations relative to
the use of tributyltin (TBT) In antifouling
paints for hulled vessels. The substance is
deary toxic which U, of course, why it Is
used as a blocide. Concentrations of TBT In
waters which have high boating activity are
sometimes high enough to adversely affect
non-target organisms.
For Instance, laboratory bloassays have
demonstrated acute and chronic effects at
levels less than O.2 ppb TBT. Monitoring of
'whole water, both fresh and salt, from
numerous locations around this country has
shown that TBT concentrations often exceed
LCto values.
Field investigations In Europe and North
America have detected several morphological
and physiological effects on aquatic
organisms which can be induced In the '
laboratory using TBT as the toxicant. The
locations at which the field observations
were made demonstrate that organisms living
in doser proximity to vessels painted with
TBT have a higher probability of being
affected.
Tributyltin concentrates in organisms and
sediments, snd bioaccumulation factors of
200 to 30X100 have been reported depending
on the species investigated.
The concentrations of TBT found in
sediments may be 10* to 10* times higher
than In the overlying water. TBT may
degrade in water and sediments, but
relatively high concentrations of TBT In
water, sediment and the biota can be
expected for tome time to come even If the
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89034
Fedem Register / Vol. 53. No. 192 / Tuesday. October 4. 1988 / Notices
fcfrt of the biodfcfom vessels wire ..
eJtminaled.
Tha above information leads the Panel to
endorse the Agency's conclusions reletive to
Ibe potential bkrioglcal impact of TUT on
;.' '._,'!
/requests the Panel's
BAfjeacVsaisetsmentof the
I efiecto eflBT bend on the
Migration of evaflabie monitoring data with
laboratory tndcfrt data end the a*e of field
Jfals data froB Europe and the United
Bute*.
Pontl RapoutK I. The Penel agrees that
available data rapport die EPA'i aneument
of hazard to aon-taiget oiganlimi from TBT
1 The Pane) b concerned mat the
Bomahxanon of data on Inching rates from
various registrants may have introduced a
degree of uncertainty to the Agency's
acceptable release rate.
It Is not dear to the panel how the
analytical variability has been considered to
the establishment of the acceptable leaching
rate. The Panel suggests that the Agency
carefully reevaluate test methodology for
leaching rates.
I. Finally, fat view of the potential hasard
TUT. its projected use on commercial and
military vessels, and Its subsequent release
from sediments; the Panel suggests that
monitoring of TOT ta the environment and
basic lexicological effects on organisms be
continued. In addition, improved Information
on fate and partitioning of TBTs, especially
from sediments and biofilma, should be
compiled.
For the Chairman. Certified es an accurate
report of Findings: Stephen!. Johnson. . '
Executive Secretary. FIFRA Scientific
Advisory Panel Date: December 23,1987.
The Agency's response to the release
rate issues raised by the SATs
comments Is noted In Units ID-find VD^sf
this Notice, h brief, the Agency is no
longer normalizing release rate data and
is considering the usefulness of other
way* of dealing with variability to its
continuing analysis of the release rate
methodology. The Agency has Initiated
experimentation at EPA's
Environmental Chemistry Laboratory at
Bay St. Louis, Mississippi to identify
sources of error in the current
methodology, to design modifications to
reduce this error, and to test these
modifications. It Is anticipated that a
final method will be Jointly approved by
ASTM and EPA by late 1990. In the
interim. OPP and ASTM are making
minor changes to the draft method
which are expected to increase the
precision without altering the magnitude
of the measured release rates.
In regard to the SAP's last comment
the Agency will require TBT registrants
to monitor water quality and .
environmental health to determine
existing TBT levels and the impact of
OAPCA's restrictions and the :
requirements contained herein.
Additional environmental fate and ....:.
aquatic toxidty data required by the ;.
July 29,1966 Dd will be submitted td
the Agency within 2 to 4 yean. If these
or any other data suggest that the risks..
to aquatic non-target organisms have
not been adequately reduced, the ; s
Agency may take further regulatory >
action. .'' : . :
B. Comments of the Secretary of ".
Agriculture "'"
The comments of the UJJ. Department
of Agriculture in response to the Notice.
of Preliminary Determination, Draft
Notice of Intent to Cancel and the ....
Technical Support Document, dated .
October 7,1987, an printed in full. ;,..'..
below: .'. ., \
Mr. Douglas Campt Director. ' '
Office ofPetUclae Program* (TS-TOTC), US.
Environmental Protection Agtaey,
Wathlngton. DC 80480.
Dear Mr. Campt This Is m response to your
letter of October IB containing the
antifoullng paints. The Department
Interposes no objection to the consummation
of this proposal. _
Sincerely. '.'"''
Charles L Smith.
Coordinator, Pesticides and Pesticide
Assessment ' -' i
C Other Comments on the Proposed ,
Regulatory Actions ..'.'' '"
1. Several respondents commented .
that aluminum outdrive and engine ;
components should have the aame ;
exemption as aluminum hulled vessels ,
and that TBT antifoulant products for .
anch use.-eominonly 16 ounce
pressurized containers, should not be . :
classified as restricted use. : "'
Response: The restriction on vessel '
length for the use of TBT antifouling
paints on non-aluminum hulled vessels
was not intended to exclude the use of
TBT antifouling paints on aluminum
outdrive and engine components as long
as these paints meet the release rate
requirements. OAPCA. which mandated
the vessel length restriction, allows for
use of such paints. The Agency believes
that TBT antifouling paints which meet
the release rate restriction can be used ..
on aluminum outdrive and engine
components without resulting in an
adverse effect to non-target aquatic ': ''
organisms.
The Agency agrees that use of small .
spray cans of 18 ounces or less of TBT '"
antifouling paint registered for use to '
prevent fouling of outdrives and engine ;
components should not be included in .
the restricted use classification. In the ;
Agency's view, the amount of TBT from
this use is Insignificant when compared ;
to the amount that may be introduced -:
into the environment from the use on.
vessel hulls. These are products of ;
convenience to be used by owners of .
non-aluminum vessels for the treatment
of the underwater components of their
boats. The possibility of misusing these :
products for treatment of hulls is
believed to be very alight because of
their spray-on nature. Classifying these
products as restricted use would be
tantamount to cancellation. However, in
order for these products to be exempt
from the restricted use classification,
they must be labeled for use only on
aluminum outdrive and engine
components. Any other use would be
unlawful. '
2. A few respondents felt that the
proposed restrictions would adversely
affect the U.S. ship repair industry by
forcing shipping companies to have «
work done abroad. '
Response: The Agency does not
anticipate that the restrictions contained
In this Notice will significantly alter the
current situation. The substantial oo* .
valorem tax currently paid by the ship
operators/owners who have their
vessels maintained abroad significantly
exceeds the expected cost of the TBT_
regulation. The expected cost of the TBT
regulation does not appear to be so
excessive that it should cause shipping
companies to have more work done
abroad. Furthermore, effective
antifouling paints will continue to be
available for those vessels maintained
domestically including government
vessels and vessels traveling only in
UA waters.
3. One respondent-stated that the ,'
Navy should be allowed to use any
antifouling paint which they believe will
effectively prevent fouling for the -
maximum period of time. ' ;'
Response: Prior to the initiation of the
Special Review, the Navy planned to ,
use low release rate paints in its
fleetwide conversion to TBT antifoulant
paints. The Navy has expressed concern
over the availability of copper-free ' ;
paints for use on aluminum hulls. There
are currently 12 copper-free paints with
estimated release rates that tentatively
meet OAPCA's release rate restriction
of4.0pg/cm>/day.
4. Several respondents expressed
concern that if commercial paints are
restricted from use on hulls of vessels ,
under 62 feet in length, boat owners
might manufacture do-it-yourself paints
from widely available TBT-boosters
yielding free association paints with
uncontrolled release rates. Congressman
Walter E Jones, Chairman of the
Merchant Marine and Fisheries '
Committee, asked the Agency to take
action against euch products which -
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Federal Register / Vol. S3. No. 192 / Tuesday. October 4. 1988 / Notices
89035
appear to be unaffected by the Special
Review.
Response: The tale and use of
tritmtyltin additives to make anttfonling
paints is illegal under OAPCA. OAPCA
specifically prohibits the retail sale,
delivery, purchase, or receipt of any
substance containing organotin for the
purpose of adding the substance to paint
to create an antlfouling palnl The only
tributyltin additive products currently
registered under FIFRA by EPA are
registered for application to paint to be
used as mlldewddes. This Notice
requires these labels to be amended to
specifically prohibit the application of
the product to paint to create antifouling
paint for use on certain listed objects.
(See Section VULB.6.)
5. If EPA's proposed restrictions go
Into effect, then release rates will be -
about one-fifth what they were prior to
regulation. However, If more large
vessels are treated than in the past
(mainly due to theNavy'e conversion of
its entire fleet), TBT concentrations in
harbors may equal or exceed current
levels.
Response: As of 1965, use of TBT
antifoulant paints for military vessels
accounted for 32 percent of the market
The Agency estimates that if the U.S.
Navy converts its entire fleet the
military's market share will increase to
15 percent The Agency feels that the
resultant increase in environmental
loading, especially in ecologically
sensitive shallow water sites Including
estuaries, would be more than offset by
DAPCA's release rate restriction^nd
elimination of use on non-aluminum
vessels less than 82 feet and the
requirements of this Notice pertaining to
the classification of TBT antifoulant
paints as restricted use pesticides, and
the proper use and disposal of TBT
paints. Further, as stated above, if
results of future monitoring suggest that
current restrictions have not reduced
concentrations to reasonable levels, the
Agency may take fur' -egulatory
action to achieve lot vironmental
concentrations.
6. Several respondents stated that the
release rale restrictions were not
developed with regard to achieving any
specific water quality objectives.
Response: OAPCA's release rate
restriction cannot be correlated to any
specific water quality standard.
OAPCA's release rate restriction was
designed to reduce one source of
environmental loading: TBT leaching
from painted surfaces. Congress chose
this as an interim way of regulating TBT
release. II did not choose other means
such ns restricting the number of boats
treated or the number of paints used
7. The Agency's predictions of the
reductions in environmental loading of
TBT that will result from the proposed
regulatory decision are flawed.:
Response: The Agency's estimate that
an approximately five fold reduction hi
release rate from 20 to 4 pg/an*/day
(the level now mandated by OAPCA)
was based on estimated release rates
for BO TBT antifouling paint products
registered when the Special Review was
initiated and not on weighted averages
of the volume of paint sold. On a
weighted average, it Is estimated that
the pre-Spedal Review release rate was
approximately 10 ug/on*/day. Under
OAPCA's release rate restriction and
assuming the same percentage of
distribution as when the Special Review
was initiated, the new weighted average
release rate would be approximately 2
fig/cm'/day (also a five fold reduction).
The Agency also believes that the
market will change due to OAPCA's
vessel length restriction of 82 feet
Because paint registrants may switch
from marketing their products from
small vessel owners to large vessel
owners, the Agency did not attempt to
estimate the weighted average release
rate in the Technical Support Document
However, the Agency does have data to
indicate that approximately 40 percent
of the TBT antlfouling paint has been
used on non-aluminum hulled
commercial and recreational vessels
that are shorter than OAPCA's size
restriction. Therefore, based on those
data, once the effectof OAPCA's
restrictions-Is felt, TBT4oadlng.into the
aquatic environment should be reduced
by at least 40 percent In addition to the
elimination of use on vessels under 82
feet in length, the remaining use will be
with paints that have a lower release
rate (that is certified under OAPCA as
having a release rate of 4.0 fig/on'/day
or less).
8. Several respondents expressed
concern that there would not be a
sufficient number of copper-free
tributyltin antifouling paints with
acceptable release rates available for
use on aluminum hulled vessels. One
respondent recommended that a
maximum release rate of 10 fvg/cm*/day
for aluminum hulls should be
established for an 18 month period
following enactment of the regulations .
to allow for the reformulation of copper-
free antifouling paints. Final release
rates for aluminum hulled vessels
should be B pg/cm'/day. Another
respondent recommended that a
separate release rate restriction for
aluminum hulled vessels should be
established at 6.0 pg/cm*/day to ensure
that efficacious copper-free paints are
available to .irotect Navy ships with
aluminum hulls.
Response: The release rate data
currently available to the Agency
Indicates that 12 copper-free TBT
antifouling paints, suitable for use on
aluminum hulls, have estimated release
rates which tentatively meet OAPCA's
release restriction. At least 6 of these 12
paints are Intended for use on
commercial or military vessels.
Establishing a separate release rate
restriction for copper-free TBT paints Is
DO! necessary, because It appears that in
the short-term a sufficient number of
copper-free TBT paints will be available
under OAPCA's release rate restriction
and existing stocks provisions. This
partly assumes that the registrants for
these paints will provide the Agency
with the additional release rate data,
enabling the Agency to certify these
paints under OAPCA. In the long-term,
new copper-free TBT paints may be
registered which should provide
additional market options.
9. A respondent stated that the
maximum permitted release rate of
tributyltin should be the lowest release
rate shown to be effective as an
antifoulant. He has information
indicating that manufacturers can
reformulate antifoulants to be effective
at a release rate of 3.0 to 3.5 fig/cm1.
Another respondent stales that 5 fig/
cm*/day was the lowest effective rate.
Response: Neither respondent
included supporting efficacy data with
their comment The Agency does not
liave data to suggest'thelowest effective
release rate; however, It plans to require
registrants to submit such data. Until
these data are available, the Agency
believes that it in conjunction with
OAPCA's requirements, Is taking
regulatory action that should
significantly reduce environmental
loading of TBT and thereby lessen the
possibility of effects occurring to non-
target aquatic organisms.
VL Risk/Benefit Analysis
FIFRA requires EPA to weigh the risks
against the benefits of the use of
pesticides to determine whether
continued registration would cause
unreasonable adverse effects on man
and the environment The Agency has
determined that with current label
restrictions and formulation of products,
the risks posed to nontarget organisms
from the use of TBT entlfoullng paints
outweigh the benefits. Detailed ;
discussion of the risk and benefit
components of this action (Including
consideration of possible alternative
regulatory options) appears in the
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89036
Federal Register / Vol. 53. No. 192 / Tuesday. October 4. 1988 / Notices
previous Unlit of this Notice and in the
Technical Support Document
TBThai been shown to be highly
toxic to aquatic organisms at or near .
0.02 ppb. In particular, TBT has been
shown to be persistent in the >
environment end to bioaccumulate In
ftnimnf §jjj plant tfitpf potentiBl TBT
exposure to naoteget organisms is high
fai area* of boating and chipping activity
and also may to Ugh in sensitive
ecologically productive areei because of
aaoveaeat of TBT residues via current!
nd fides. TBT binding to sediments and
particulate suggests the potential for
TBT bioavailabihty among filter and
deposit feeding organiimi. TBT residues
have been found m UA waters at levels
comparable to the values that have
caused population effects in Europe and
and to the values that have been shown
to cause effects to nontarget organisms
during laboratory experiments. Recent
reports in the United States link TBT
exposure to adversely affected oyster
beds in Coos Bay. Oregon. The Agency
believes that there is adequate
information available to support the set
of regulatory actions required herein,
which are designed to reduce
environmental loading of TBT and
thereby lessen the possibility of effect*
occurring to populations of non-target
aqua lie organisms.
The lolul annual benefits of TBT
utifoulant nse are estimated to be $170
million compared with using the next
best alternative, either copper ablative
or copper cooveaflaaal paints depending
upon what the user it currently
applying. However, the benefits are
highest for.those.Bsen Jaking advantage
of the extended dry docking schedule
offered by TBT copoiymer/ablative
paints. In moat cases, recreational boat
owners using TBT copolymer/ablative
paints incur an additional cost from
which they appear not to benefit
compared to using leu expensive .
copper based paints, because they
generally do not take advantage of me
extended dry docking schedule.
The Agency baUevea the risks
resulting from the ase of TBT antifouling
Befits for most commercial and
military users through the use of TBT
anUfouling paints which release less
TBT into the aquatic environment, whde
complying with the requirements
provided herein. It fa believed that many
recreational vessel owners will save
money fay use of noo-TBT alternatives.
While there may be costs to states for '
training certified applicators and costs
to user groups who must become
certified under restricted use and
comply with certain application,
disposal, and removal requirements, the
Agency believes that the benefits of
reducing the environmental loading of
TBT outweigh the costs. .
in order to reduce the concentrations
of TBT in the aquatic environment the
Agency announces by this Notice that it
will cancel all TBT antifouling paint
registrations which:
(1) Do not comply with OAPCA's
average daily release rate limit of 4.0 ug
organotin/cm'/day.
(2) Do not comply with OAPCA's
prohibition on the use of TBT antifouling
paints on all non-aluminum vessels
under 82 feet (or 26 meters) in length (on
deck).
(3) Are not classified as restricted use
pesticides, restricting their sale to
certified commercial applicators and
their use to persons under the direct
supervision of an on-slte certified
commercial applicator (except for
products packaged in 16 ounce or less
spray-can containers which are labeled
for use only on outboard motors,
propellers, and other non-hull
underwater aluminum components).
(4) Do not have labeling which
requires compliance with applicable
OSHA regulations and with the
following directions for use:
(a) During and after paint removal
end/or application of new TBT puinl,
employ methods designed to prevent
Introduction of TBT paints into aquatic
environments.
(b) Following removal of TBT paint
and/or application of new TBT paint all
paint chips and spent abrasives, paint
containers, unused paint and any other
-waste products from paint removal or -
application must be disposed of in a
sanitary landfill
(5) Do not limit certain uses for some
types of products, as specified herein.
In addition to the other measures
which should reduce risk, risk reduction
should result from the restricted use
classification while still maintaining the
benefits of TBT use. The Agency's
restricted use classification for TBT
antifouling paints requires that
applicators or their supervisors "__
trained In matters such as proper TBT
antifouling paint application, disposal
and removal, and the consequences of
misuse of TBT antifouling paint This
framing will help ensure that applicators
follow appropriate requirements for
application, clean-up, and disposal If
the appropriate procedures are followed,
the risk from inadvertent aquatic
contamination should be reduced. The .
restricted use classification further
ensures that applicators adhere to the
recordkeeping requirements regarding
TBT paint application and disposal of
TBT paint wastes. It also helps to ensure
that applicators will adhere to
OAPCA's size restriction as stated on
the label.
The Agency has determined that it
would take approximately nine months
to develop a prototype training program
for the use/disposal/and removal of
TBT paints and paint wastes. Therefore.
the Agency is requiring that the
registrants develop and submit a -
prototype program within 180 days from
the date of their application for
conditional registration. The Agency has
allowed an additional three months for
Agency review of the program and an
additional 6 months for the states to
train and certify. After considering these
time periods, the Agency is designating
March 1.1990 as the effective date for
the restricted use classification.
The Agency has determined that the
costs of meeting its requirements (that
is. those pertaining to the incorporation
of label language to: Reflect
classification as restricted use and
associated requirements for
development of training specifications
and materials: require adherence to
certain work practices; and refer to pre-
existing OSHA and OAPCA
requirements) do not exceed the benefits
of use of products which comply.
Cnmpliunco with Iliovii nxjnirwiienti
will serve to reduce environmental
loading of TBT and the exposure of non-
target aquatic organisms.
VD. Future Activities Regarding
Tributyltin Antlfoulant Paints
The Agency believes that the
regulatory steps taken at 4his time under
this Special Review and OAPCA should
have a significant impact on reducing
the environmental loading of TBT and
the adverse effects on non-target aquatic
species. However, the Agency also
recognizes that there is a need to pursue
further study of this environmental issue
for at least two reasons. First it is not
clear that these regulatory actions will
go far enough in protecting non-target
aquatic species and, second OAPCA
clearly establishes research
requirements on environmental^
monitoring and alternatives to TBT
antifoulant paints. As a result of future
studies, the Agency may determine that
additional regulatory actions are
necessary in order to further reduce
environmental loading and effects on
non-target aquatic species. Therefore,
the following areas of research are being
pursued. . - __
, Over the next 2 to 4 years. TBT and ;
TPT registrants will be conducting
additional ecological effects studies in '
response to DCls already issued by the
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Federal Register / Vol. S3. No. 192 / Tuesday. October 4. 1988 / Notices
89037
Agency. These todies include
aJdlUiinal research on acute and
chronic toddty to freshwater, marine.
and esroariae organisms and effect* of
TDTon eojBaticfood <^°i"f TNft*
registrants wfll also be conducting .
*n*yirotnniTfTtal fate wtwtiftff including *
degradation *"d metabolism studies,
hsnconcfntration in oysters. Registrants
wffl also be generating data to ,.
characterize potential toddty and
exposure to humans. Thesestudies_ '
elude residue studies of TBT and TFT
ta edible fish and shellfish, and
exposure studies of TBT to paint ' .!!.
.applicators, as well as acute. - .' " ;
AOu CtlfOOIC Dl&flUO&IlAO *
stadie* AD of these studies
have been required by Data Call-in
Notices issued January 31. 1085, July 28,
1886. and August 2a 1887.
The Agency will issue an additional
Data Call-In Notice by late 1988, which
will require TBT registrant* to conduct
multiyear and multifile monitoring .
studies which will provide additional
information on the extent. -
concentration, and fate of organotin
residues in the aquatic environment and
the impact of these organotin residues
on indicator organisms in situ. These
studies wiO develop data for
representative dry docks, marinas, and
other sensitive areas m order to provide
information needed to evaluate the
impact of the regulatory action
contained fan this Notice and of
OAPCA's requirements on
environmental concentrations of TBT.
Also,. the Agency 4s continuing its efforts
to model Norfolk Harbor, Virginia as
discussed hi Unit 0 of this Notice. This
model will examine environmental
concentration* under several loading
levels and attempt to estimate the
Impact of various regulatory approaches
on TBT concentrations. This modeling
information may be useful to the Agency
if it needs jo take additional regulatory
action on TBT.
The Agency also plans to require from
TBT and TFT registrants data that will
.enable the Agency to determine the
fewest efficacious TBT and TPT release
rate levels. This information may allow
the Agency to better assess the Impact
on benefits of any future regulatory
action and provide a guide for a further
reduction of release rates if the Agency
finds that this is necessary. Also, the
Agency wfll be consulting with the U.S.
Navy in regard to initiating Joint
research on chemical and nonchemlcal ''
alternatives to organotin antifouling
paints as required by OAPCA. ......
A more precise release rate
methodology is desirable and may be a
requirement for future action. The
current ASTM/EPA method yields
results with a relatively high variance. If
monitoring studies indicate that
additionafre auction of TBT loading in
the environment is necessary, then the
release rate restriction may be lowered.
If the present ASTM/EPA method
cannot be modified to give more
consistency, then a more precise method
might have to be developed that could
' be relied on to distinguish between
paints that have very similar release .
, rates.
. . EPA is actively working to improve
the precision of the current method
' However, the laboratory research
needed to investigate the sources of
error In the current method will require
12 to 18 months to complete. To provide
the best available methodology in the
interim, the Agency in a Joint effort with
ASTM is making minor modifications to
the method. These modifications are
primarily aimed at tightening
specifications and simplifying certain
procedures. The purpose of such
changes is to improve the precision of
the release rate measurements. A
revised draft ASTM/EPA release rate
method is expected to be published in
the Fall of 1988.
A research program to improve the
release rate methodology has been
initiated at EPA's Environmental
Chemistry Laboratories. The objectives
of this program are to: (1) Identify
aspects of the methodology that
significantly contribute to the
variability, (2) design method
-modifications thaj Increase the precision
of the release rate measurements, (3)
compare the relative precision obtained
from individual modifications, and (4)
select those modifications which will
maximize the overall precision of the
method. i
Laboratory testing by the Agency will
continue until appropriate modifications
have been designed and tested. The
Agency, in cor'"Action with ASTM, will
use the result iese tests to finalize a
method. Testu 0 -< the method by other
laboratories (so called "round robin"
testing) is anticipated before adoption
as an official ASTM method. The extent
to which the final method differs from
the current method cannot be estimated
t this time. . ' - .
The Agency may issue a final
'determination regarding the release of
organotin into the aquatic environment.
which would supersede the OAPCA
release rate restriction if data submitted
to the Agency indicates any of the
following: (1) That release rates
measured by the final method are
..: substantially different from those
estimated by the current method, (2) that
additional restriction of TBT loading in
the environment is necessary, or (3) that
the current release rate restriction is not
the lowest efficacious rate.
Vin. Compliance With This Notice
A. Definitions
The following terms are defined for
tfie purposes of this Unit
1. "Manufacturer" refers to any
registrant who, as defined, sells, or
distributes an anUfouling paint
(pesticide) product containing
tributyltin.
2. "Distribute and sell" and
grammatical variants refer to the
distribution, sale, offering for sale,
holding for sale, shipping, delivering for
shipment, or receiving and (having so
received) delivering or offering to
deliver a pesticide product
\B. Requirements for Complying With
\ This Notice
A manufacturer of any antifouling
paint product containing tributyltin must
submit an application to amend the
registration of their product within 30
days of publication in the Federal
Register or receipt of this Notice.
whichever is later, to be allowed to
continue to sell and distribute the
product Similarly, applicants for a
registration subject to this final notice
must file an amended application for
registration within the applicable 30-day
period to avoid denial of their
application. The application must *
propose to amend the registration of the
product to include the following terms
and conditions and modifications:
-7* 1. A manufacturer must include a
declarative statement that he has
submitted appropriate release rate data
for this product and the results
demonstrate that the product has a
release rate of organotin which does not
exceed OAPCA's average dally release
rate limit of 4.0 ug organotin/cm'/day.
This release rate must be supported
by a validated release rate study using
the ASTM/EPA release rate method.
Within 90 days of the Agency's receipt
of data, the Agency will determine if the
study is valid and. if so. whether the
Agency can certify that the product
meets OAPCA's release rate restriction.
~7> 2, A manufacturer must commit in
writing to submit prototype .--..
specifications and materials for a , ,
certification and training progranVfor
the use/disposal/and removal of TBT
antifouling paints and paint wastes. The
actual prototype specifications and
materials for the program will be ...
required to be submitted within 160 daya
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89038 Federal Register / Vol. 63. No. 192 / Tuesday. October 4. 198ft /Notices
from the (Lite of nppncBtion for
conditional Registration. Once
submitted the program will be reviewed
by a committee comprised of the
Agency's Office of Pesticide Programs
Staff, including the Certification and
Training Staff. Additionally, die Agency
will ask for osaanentifroni
representatives of the State FIFRA
Issues Research and Evaluation Group
(SFIREG). After final acceptance by EPA
it will be passed on to the State* for
oversight and certification
responsibilities. This program wID
facilitate the applicator's achievement of
"commercial certified applicator's
status" as prescribed by the certifying
State Lead Ageacy (SLA). The certified
applicator most meet as a minimum, the
certification requirements of FIFRA and
all pertinent Federal regulations under
40 CFR Part in. Applicators trained by
this program wffl be considered eligible
only for the status of certified
commercial applicator of TBT products
in the Federal aquatic pest control
category or the slate equivalent category
or subcategory.The effective date of the
restricted use classification is March 1,
1990. Training for this limited
certification of competency shall
include, at a miniipitm, sections on the
following topics.
a. Overview. A general, practical
overview of the principles and practices
of using antifoaiiBg materials.
b, Labels. 1. Pesticide label and
labeling comprehension.
2. The general format and terminology
of pesticide labels.
3. The understanding of instructions,
warning terms, symbols, and other
information commonly appearing on
pesticide labels.
4. The meaning of the terms
"restricted use" and "general use".
5. Necessity for "use consistent with
the la her.
a Safety. 1. Pesticide toxidty In
general and potential tributyltln hazards
to humans via common exposure routes.
2. Using antifouling paints as an
example, common types and causes of
pesticide exposures/accidents.
3. Precautions necessary to avoid
application exposures to antifouling
chemicals such as triburyltin.
4. Need for. and use of. protective
clothing and equipment in the
application and removal of TBT
containing products.
B. Symptoms of pesticide poisoning in
general
& Emergency procedures to be
followed in case of excessive exposure
to TBT antifoulant paint.
: d. Storage, handling, and disposal. 1.
Proper identification, storage.
transportation, handling, mixing
procedures and disposal methods for
tribntyltin containing compounds.
2. Proper disposal methods for paint
chips and dusts suspected of g«ttt«ininfl
tributyltin compounds.
8. Proper disposal methods for unused
antifouling compounds containing TBT.
associated wastes, spent sand-blasting
frit, and containers.
a. Environment. The potential
environmental consequences of the use/
misuse or iuipiupur disposal of
pesticides containing TBT as may be
Influenced by factors such as:
1. Precipitation, wind, and other
climatic factors that may Influence sita
tun-off, drift, drying times, and the
release of TBT-containlng compounds.
X. Types of terrain/drainage, soil, and
other work site conditions that
contribute to application/removal/
disposal site runoff or leaching.
9. Presence of fish, shellfish.
Invertebrate and other beneficial non-
target organisms.
4. Description, solubility, absorbency.
and/or persistence as related to the
exposure of TBT to non-target spedes.
I. Pests and pesticide! properties. I.
The Inhibition of specified pests and
method of action must be demonstrated.
2. Common features of aquatic/marine
pests and relevant life cycles.
g. AnUfouling product properties. 1.
Dilution procedures if any.
2. General understanding of pesticide!
properties such as "What is a herbicide,
bioclde, mildewdde, (aquatic and
otherwise). . .
3. Types of formulations.
4. Factors that Influence effectiveness.
~h. -Application -techniques. -Methods/
procedures/equipment used in applying
tributylttn-containing compounds
including the advantages and
disadvantages of each.
1. Maintenance, cleaning, and
calibration of equipment
2. Relationship of discharge and
placement of pesticide to proper use,
unnecessary use, and misuse.
3. Prevention of drift overs pray, and
ether exposures to humans and
endangered species.
L Laws ana regulations. 1. Applicable
State. Federal and local pesticide
disposal laws and regulations.
2. Levels and requirements of
supervision associated with the
application of tributyltin restricted use
products.
J. Recordkeeping. Certified
commercial applicators or users of
tributyltin will be required to maintain,
at a minimum, for 2 years, records of .
kinds of the products, uses, dates, and
application sites of restricted use
products containing tributyltin. For
purposes of this regulatory action "uses"
will to dude Uui disposal site of.'
triburyltuvcontalning dust chips, or
other waste. Therefore the location and
dates of disposal will be a
recordkeeping requirement Fo;
purposes of this regulatory action.
"application site" is determined to be
not only the geographic location of the
application site, but also the
Identification of the vessel receiving the
application.
italement
5> 3. The following required s
added to the label:
It Is unlawful to use this product on
nonaluminum hulled vessels less than 82
feet (26 meters) in length (on deck)
except for the outboard motor or lower .
drive unit of such vessel.
»> 4. The following required statement
added to the label:
Restricted Use Pesticide due to
toxidty to Aquatic Organisms Including
shellfish: For sale only to certified
commercial applicators and for use only
by persons under the direct supervision
of an on-site (at the work site) certified
commercial applicator. These
restrictions become effective on March.
1.1990.
-7>6. The following required statements
added to the label-
During and after paint removal and/or
application of new TBT paint methods
must be employed which are designed to
prevent release of TBT paints Into the
aquatic environment Following removal
of oldJBT paint and/or application of
new TBT paint all paint chips and spent
abrasives, paint containers, unused
paint, and any other waste products
.fromnaint removal or application must
be disposed of in a sanitary landfill
?> B. The following required statement
added to the label:
Users must comply with all applicable
OSHA requirements.
-T^. Products that are formulated in
pressurized containers of 16 ounces or
less and are registered solely for use on
outboard motor and/or lower drive units
of vessels must meet the following terms
and conditions:
a. Release rate requirements specified
In Unit Vffl J.I. of this Notice.
b. The following required label
statement
For use only on outboard motor and/
or lower drive units of vessels. Any
other use Is unlawful
c. The label statement in Unit VULBi.
of this Notice.
d. The label statement in Unit VULB.6.
of this Notice.
~-T> 8. Products containing an organotin
compound as an active Ingredient and
which are to be used as a paint additive
to prevent or control mildew must have
the following label prohibition:
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Federal Register / Vol. S3. No. 192 / Tuesday. October 4. 1988 / Notices
39039
It IB unlawful to ado this product to
palnti to create an antlfoulant paint for
me on hnOj of vessels, outboard motors,
lower drive anils, crab pots, buoys,
docks, fiflh nets or any other object or
structure (bat contacts or me/ contact
marine or fresh water.
Applications which conform to the
terms and conditions Included in this
Notice of Intent to Cancel which are
found by the Agency to be acceptable
will be granted conditional
registrations. Among other things, a
condition of such registrations will be
that acceptable specifications and
materials for a prototype certification
and training program must be submitted
to the Agency within 180 days from the
date of application for conditional
registration.
C Existing Stoda and Disposal
Provisions
Pursuant to FIFRA section 6{B)(1). "the
Administrator may permit the continued
sale and use of existing stocks of a
pesticide whose registration (is
cancelled pursuant to this Notice] to
such extent, under such conditions, and
for such uses as he may specify, if he
determines that such sale or use is not
.inconsistent with FIFRA and will not
have unreasonable adverse effects on
the environment." The Agency has
determined that limited sale and use of
certain existing slocks of tributyltin
antifoulant paints Is not inconsistent
with FIFRA and will not cause
unreasonable adverse effects on the
environment
OAPCA established en existing stocks
provision for all'TBT antifoulant paint
products that were in existence on the
dale of enactment. These existing slocks
provisions continued In effect for any
product which did not comply with
OAPCA's release rate certification
requirement or vessel length restriction.
The maximum deadlines established by
OAPCA were December 16. 1908, for
ale, delivery, purchase, and receipt and
June IB, 1989. for use. EPA was given
authority to provide shorter time frames.
In taking its action, the Agency has built
upon the requirements of OAPCA. in
that OAPCA's release rate restriction
and existing stocks provisions remain in
effect. The Agency has deferred a final
decision on the release rate issue, as
discussed earlier. In a letter dated
September 1 ». 1WW. TBT rrRinlrnntfl
were notified that none of Hie existing
TBT antlfoulanl paint products passed
the Initial OATCA certification review
end thus they remained subject to
OAPCA 's existing stocks provisions. In
that letter the Agency concurred in the
maximum OAPCA provision for sale
and use of existing stocks. Only after
satisfying the requirements for "~
certification, would these products no
longer be subject to OAPCA's existing
stocks deadlines. The Agency has
determined that these same existing
stocks dates should apply to any
product which does not meet the
additional requirements of this Notice.
Aside from allowing for smoother
transition and less confusion in the
channels of trade by not establishing a
different set of existing stocks dates,
this would be consistent with the risk
reduction scheme under OAPCA as well
u that required by this Notice. Use of
existing stocks for the maximum time
.allowed by OAPCA rather than for a
shorter period allows users and
registrants a smoother transition to
products which comply with OAPCA
and this Notice while not increasing the
risk to non-targel organisms beyond
levels considered acceptable by
Congress.
Accordingly, under the authority of
OAPCA and FIFRA section Ofa)(l). EPA
will permit the continued sale and use of
existing stocks of tributyltin antifoulant
paint whose registrations are cancelled
pursuant to this Notice, subject to the
following conditions and limitations. For
purposes of this Notice. EPA defines the
term "existing stocks" to mean any
quantity of tributyltin antifoulant paint
product in the United States on the date
of cancellation pursuant to this Notice of
Intent to Cancel or through voluntary
cancellation that has been formulated.
packaged, and labeled for use and Is
being held for shipment or release, or
-has been ohipped or released-into
commerce.
EPA will allow the sale and
distribution of existing stocks of TBT
antlfoullng paint products until
December 16,1988. EPA wUl also allow
use of those existing stocks until June 16,
1989. EPA requires registrants to relabel
with stickers, existing stocks in their
possession or control, to indicate the
time limitations on distribution, sale and
use. These stickers must stale the
following:
Any sale, delivery, purchase, or
receipt after December IB, 1988 Is
unlawful. Any use after June 18,1989 is
unlawful.
In addition, EPA is also requiring
registrants to contact immediately
conimrrclfll distributors of TBT
aiitiluuling paint products to inform
them of the time limitations on
distribution, sale, and use. and to
provide supplemental sticker labels
reflecting the time limitations for
existing stocks in the possession of the
commercial distributors. Upon
expiration of the time limitation for sale
be arranged for by the person holding or
possessing such stocks end must be in
accordance with the Federal State and
local requirements. Any existing stocks
provisions involved in voluntary
cancellation of a TBT antifoullng paint
product prior to the publication of the
final Notice is not affected by this
provision, except that the maximum
length of such existing stocks provisions
cannot exceed the time allowed
pursuant to OAPCA and such products
must be restickered as noted above.
DL Procedural Matters
This Notice announces ETA's intent to
cancel the registrations of TBT
antifouling paint products. This unit
explains how current registrants may
apply to amend their registrations to
comply with the terms and conditions
discussed in Unit VII of this Notice.
Under sections 6(b) and 3(c)(6) of
FIFRA. applicants, registrants, and
certain other adversely affected persons
are also entitled to respond to this
Notice by requesting a hearing on the
actions that EPA is initiating. Unless a
hearing is properly requested with
regard to a particular registration or
application, this action will become final
by operation of law.
This unit of the Notice explains how
such persons may request a hearing on
EPA's final cancellation and denial
Notice (and the consequences of
requesting a bearing or failing to request
a hearing In accordance with these
procedures).
A. Procedure for Amending the Terms
and Conditions of Registration to Avoid
Cancellation or Denial of Application
Registrants affected by the
cancellation actions set forth in this
Notice may avoid cancellation by filing
an application for en amended
registration which contains the
ennMcabIe label modifications,
'lance with OAPCA release rate
& vire requirements, and certification
and training program requirements
detailed in Unit VIII.B. of this Notice.
This application must be filed within 30
days of receipt of this Notlca or within
30 days from the publication of this
Notice, whichever occurs later.
Applicants for a rrjrlslrarion subject to
this Notice must file an amended
application for registration within the
applicable 30-day period to avoid denial
of their pending application.
Applications must be submitted to:
John H. Lee, Product Manager.
Registration Division (TS-767C), Office
of Pesticide Programs, Environmental
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89040 Federal Register / Vol. 53. No. 192 / Tuesday/October 4. 1988 / Notices
Protection Agency. 401M Street 8W,
Washington, DC 20460, (703-657-0485).
B. Procedures for Requesting a Hearing
To contest the cancellation action tet
forth in this Notice, Federal registrants
or applicants may request a hearing
within 30 days of receipt of this Notice.
or within 30 days from publication of
this Notice, whichever occurs later. Any
other person adversely affected by the
action described in this Notice may
request a hearing within 30 days of
publication of this Notice In the Federal
Register.
AregU
L registrant or other adversely
fleeted party who requests a hearing
must file the request in accordance with
the procedures established by FIFRA
and BPA's Rules of Practice Governing
Hearings under 40 CFR Part 164. These
procedures require, among other 'M"fl«.
that all requests must Identify the
specific pesticide product(s) for which a
hearing is requested, and that all
requests must be received by the
Hearing Clerk within the applicable 30-
day period Failure to comply with these
requirements may result in denial of the
request for a hearing. Requests for a
hearing should also be accompanied by
objections that are specific for each use
of each pesticide product(s) for which a
hearing is requested.
Requests for a hearing must be
submitted to: Hearing Clerk (A-110).
Environmental Protection Agency. 401M
Street SW, Washington. DC 20460.
1. Consequence* of filing a timely and
effective hearing request. If a hearing on
the action initiated by this Notice is
requested in a timely and effective
manner, the hearing will-be governed by
EPA's Rules of Practice for hearings
under FIFRA section 6 (40 CFR Part 104).
as modified below. The hearing will b«
limited to the specific uses and specific
product registrations for which the
hearing is requested.
In the event of a hearing, the specific
use or uses of the specific registered
product which is the subject of the
hearing request will not be cancelled
except pursuant to an order of the
Administrator at the conclusion of the
hearing.
2. Consequence* of failure of file in a
timely and effective manner. If a hearing
concerning the registration of a specific
pesticide product subject to this Notice
Is not requested by the end of the
applicable 30-day period, registration of
that product will be cancelled, unless
the registrant files a request for an
amended or conditional registration
within the statutory period provided
herein (see Unit VIU of this Notice).
If the registration of a product covered
by this Notice Is cancelled by operation
of law, the sale and distribution of
existing stocks will be governed by the
provisions of Unit VIII of this Notice.
C Separation of Functions
EPA's Rules of Practice forbid anyone
who may take part in deciding this case,
at any stage of the proceeding, from
discussing the merits of the proceeding
exports with any party or with any
person who has been connected with
the preparation or presentation of the
proceeding as an advocate or in any
Investigative or expert capacity, or with
ny of their representatives (40 CFR
164.7).
Accordingly, the following EPA
offices, and the staffs thereof, are
designated as the judicial staff to
perform the judicial function of EPA in
any administrative hearing arising from
this Notice of Intent to Cancel* the
Office of the Administrative Law fudge.
the Office of the Judicial Officer, the
Administrator, and the Deputy
Administrator. None of the persona
designated as the Judicial staff may
have any ex parte communication on the
merits of any of the issues involved in
this proceeding, with the trial staff or
any interested person not employed by
EPA. without fuDy complying with the
applicable regulations.
X. Public Docket
Pursuant to 40 CFR 154.15, the Agency
has established a public docket (OPP-
80000/49A) for the Tributyltin Special
Review. This public docket includes (1)
this Notice; (2) any other notices
pertinent to the Tributyltin Special
Review; (3) non-CBI documents and
-copies-of-wrUten-comment* or-other
materials submitted to the Agency in
response to this Notice, and any other
Notice, regarding TBT antifouling paints
submitted at any time during the Special
Review process by any person outside
government; (4) a transcript of any
public meeting held by the Agency for
the purpose of gathering information on
trlbutyltin antifouling paints; (5)
memoranda describing each mec-Unjj
held during the Special Review process
between Agency personnel and bay
person outside government pertaining to
tributyltin antifouling paints; and (6) a
current index of materials in the
tributyltin public docket
On a monthly basis, the Agency will
distribute a compendium of indices for
newly received comments and
documents that have been placed in the
public docket for this Special Review.
This compendium will be distributed by
mall to those members of the public who
have specifically requested such
material for this Special Review.
pursuant to 40 CFR 164.15(f)(3).
XL References
The following list of references -
Includes all documents cited in this .
Notice. These documents are part of the
public docket for this Special Review
(OPP-30000/49B). The Agency will
continue to supplement the public
docket with additional information as it
is received.
(1) Key. D.; Nunny. US.: Davidson. P.E.;
Leonard. M.A. (1076) Abnormal *heU growth
In the Pacific oytter Crotsostreo gigat. Some
preliminary results from experiment*
undertaken In 1076. ICES Paper CM 1B76/
KM.
(2) Waldock. M.J.; Tbaln. J.B. (1963) Shell
thickening in Crastostrea gigor. Organotln
antifouling or sediment induced Mar. Poll.
Bull. (14)11:411-415.
(3) Alxieu, Claude. (1086) TBT detrimental
effects In oyiter culture In Pranceevolution
since antifouling paint regulation. Ocean* 86
Conference Record. Volume 4, Washington.
DC. September 23-25.1086.4:1130-1134.
(4) Waldock. M.J.; Miller. D. (1883) The
determination of total (organotln) and
tributyllin In leawater and oyster* in area* of
blqh pleasure craft activity. International
Council for the Exploration of the Sea. E.12.
(5) Tbaln. I.E.; Waldock. M.).; Walte. M.R
1087. Toxlclly and degradation studies of
tributyllin (TBT) and dibulyllin (DBT) in the
aquatic environment. Proceedings Oceans 87,
International Organotln Symposium. Halifax,
Nova Scotia, Canada. September 28-October
1,1088.4:1308-1404.
(8) Smith. D.It; Stephenson. MJX; Coetzel.
J.; Ichikawa, G.J Martin. M. 1087. The use of
transplanted juvenile oyster* to monitor the
toxic effect* of Iributyltin in California
water*. Proceedings Ocean 87. International
Organotln Symposium. Halifax, Nova Scotia,
Canada. September 28-October 1,1088.
4:1511-1516.
f7) Lee. RT^Vafkln, A.G.; Sellgman, P5,
1087. Fate of tributyllin in eduarine water*.
Proceeding* Ocean* 87, International
Organotln Symposium. Halifax, Nova Scotia,
Canada. September 28-October 1,1088.
4:1411-1416.
(8) M ft T Chemical Co. (June 1078b)
Hydrolyil* Study with TBTO. Unpublished
tudy. EPA Acceidon No. 2387SS.
(0) Magulre. R.J.: Wong. P.T.S.; Rhamey. ]&.
(1084) Accumulation and metabolism of trl-
n-butyllin cation by a green algae.
Ankistfodeiaiut folcatut. Can. J. FUh. Aqu.
Sd. (41)3:637^40.
(10) Walsh. C.E. (1088) Organotin toxlclty
studies conducted with selected marine
organitms at EPA's Environmental Research
Laboratory, Gulf Breeie, FL Oceans 86
Conference Record, Volume 4. Washington.
DC September 23-24. 4:1210-1212.
(11) Barug, D. (1081) Microblal degradation
of bls(trlbutyllln) oxide. Chemosphere.
10:1145-1164.
(12) Blunden, 8.J.: Chapman, A.H. (1082)
The environmental degradation of organotin
compound*a review. Environmental
Technology Letter*. 3267-272.
(13) Brinckman. F.E. (1081) Environmental
organotin chemistry today: experience* in the
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Federal Register / Vol. S3. No. 192 / Tuesday. October 4, 1988 / Notices
39041
field and laboratory. |. Orgaoooet Chen. Ids.
1*343-378.
(14) Salazar. M Ji; Salazar. SAL (1865)
Ecological evaluation of oiganotin-
cdntamlnaled sediment Technical Report
1050. Naval Ocean Systems Center. Ban
Diego, CA.
(IS) Chilamcndtch, TJ>^ Kuha C (1077)
Behavteoal baematologkal and histological
todies on acnte toxWty of bis(W-nbutyltln)
oxide oe Salmo gairdneri Richardson and
Tilapia rmdolli Boulenger. J. Fish. BloL
10575-85.
(16) Evans. D.W^ Leitghlln, RA (1984)
Acenmulabon of bU(trtbnt>ian) oxide by the
Bud crab, MHtirotxmoeua harriiii.
Chemosphere. 13(1)213-219.
(17) Sellgman, ff.. Crovnoug. J.G^ Richter,
ICE (1988a) Measurement of butyltina In San
Diego Bay. CA. A monitoring strategy.
Qrganotin Symposium of the Oceans 88
Confer;nce end Exposition. Washington. DC.
September 23-24.4:1288-1298.
(18) Slephenson, M.D. 1988. Personal
communication to Mike Rexrode, UAEPA,
Washington. DC July 12,1987.
(19) Singerman. H.H. (1988) Head Chemical
and Physical Processes Division. David
Taylor Naval Ship Research and
Development Center Headquarter*.
Supplemental Comments on Tributyltin
Technical Support DocumentPosition
Document 2/3, October 7,1987.
(20) Cologer. C.P.: Prieser, H.S. (1984)
Fouling and paint behavior on Naval Surface
Ships after multiple underwater cleaning
cycles. J.D. Costlow and R.C. Tipper. Marine
Biodeterioration: An Interdisciplinary Study.
Naval Institute Press, Annapolis, MD. pp.
a3-219.
Dated: September 23,1988.
John A. Moon.
Acting Deputy Administrator.
[FR Doc. 88-22810 Filed 10-3-88; 8:45 am]
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