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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89028
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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 89028
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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                  Federal Register / Vol. S3.  No. 192 / Tuesday. October 4. 19B8  /  Notices
                                                                     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 I—NUMBER 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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 31)032
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 Prance—evolution
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 Document—Position
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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