CONTAINING ALDICARB
 AGENCY:  Environmental Protection Agency (EPA).
 ACTIONS  Notice of Special Review.
 SUMMARY:  This Notice announces that EPA is initiating a
 Special Review of. all pesticide products containing the active
 ingredient aldicarb [2-methyl-2-(methylthio)propionaldehyde-
 o-(methylcarbamoyl)oxiraej.  EPA has determined that aldicarb's
 use, which had led to contamination of ground water, may
 pose a substantial question of safety to man or the environment
 as described in 40 CFR 162.11(a)(6).  Accordingly, a Special
 Review of aldicarb-containing products is appropriate to
 determine whether registration of these products should be
 permitted to continue and, if so, under what terms and conditions,
 During the Special Review process, EPA will seek to evaluate
 the adequacy of current or potential actions to limit ground
•water contamination by aldicarb.
 DATE:  Comments,  evidence to rebut the presumptions in this
 Notice, and other relevant information must be received on
 or before (insert date 45 days after publication in the

                              - 2 -
  ADDRESS:   Written comments by mail: to:
       Information Services Section,
       Program Management and Support Division  (TS-757C),
       Office  of Pesticide Programs,
       Environmental Protection Agency,
       401  M St., SW.,
       Washington,  D.C.   20460
       In person, bring  comments to:
       Rra.  236,  CMI2,
       1921  Jefferson Davis Highway,
       Arlington, VA.
       Information  submitted in any comment concerning this
 notice may be  claimed  confidential  by marking any part or all
 of that information as "Confidential Business Information"
 (CBI).  Information so marked will  not be disclosed except in
 accordance with procedures set forth in 40 CFR Part 2.  A
 copy  of the comment that  does not contain CBI must be submitted
 for inclusion  in  the public record.  Information not marked
 confidential may  be disclosed publicly by EPA without prior
. notice to  the  submitter.   All written comments will be
 available  for  public inspection in  Rm. 236 at the address
 given above, from 8 a.m.  to 4  p.m., Monday through Friday,
 excluding  holidays.
       Michael F. Branagan,
       Registration Division (TS-767C),
       Office of Pesticide  Programs,

                             - 3 -
      Environmental Protection Agency,
      401 M St., SW.,
      Washirtgton, D.C.  20460,
      Office  location and telephone number:
      Rn 711-1, CM §2,
      1921 Jefferson Davis Highway,
      Arlington, VA,
 SUPPLEMENTARY INFORMATION:  EPA has determined that a Special
 Review will be conducted for all pesticide products containing
 aldicarb.  The term "Special Review" is the name now being
 used by EPA for the process previously called the Rebuttable
 Presumption Against Registration (RPAR) process.  This name
 and associated modifications in the process will be proposed
' in regulations in the near future.  Until other applicable
 final regulations are adopted, the present Special Review
 will adhere to RPAR procedures now in effect and set forth in
 40 CFR 162.11(a).
      Issuance of this Notice (also called Position Document 1
 [PD1]) means that potential adverse effects associated with
 the use of aldicarb have been identified and will be examined
 further to determine their extent and whether, in light of
 the benefits of aldicarb, such risks are unreasonable.
      A document entitled "Requirements for Interim Registration
 of Pesticide products Containing Aldicarb" has been issued
 and is available to the public from the above-identified
 contact person.  That document explains the basis of EPA's

                              - 4 -
  decision to start this Special Review and also contains
  references, background information, data requirements, and
  other information pertinent to the interim continued
 "reregistration of pesticides containing aldicarb.
       Finally, a meeting of the FIFRA scientific Advisory
  Panel (SAP) was held between June 12 and June 14, 1984 to
  discuss, among other things, EPA's concerns about ground
  water contamination by aldicarb.  The comments of the SAP,
  the registrant and the public will be addressed in the
  Special Review.
                     A.  GENERAL
       Issued under the Federal Insecticide, Fungicide, and
  Rodenticide Act (FIFRA) as amended (7 U.S.C 136-136y),
  40 CFR 162.11 provides that an RPAR (Special Review) shall be
  conducted if  EPA determines that a pesticide meets or exceeds
  any of'the risk criteria relating to the safe use of a
 --pesticide-set-forth-in *0 t!FR 1~6 2. lit*) -«)(!-).  A "Special Tie view
  under that section is also appropriate when it appears that
. evidence available to the Administrator  indicates that a
  pesticide poses a substantial question of safety to man or
  the environment.  In making the determination to initiate a
  Special Review, EPA is guided by section 3(c)(8)  of FIFRA
  which directs EPA to begin an RPAR (Special Review) only if
  it is based on a "validated test or other significant evidence
  raising prudent concerns of unreasonable adverse risk to man
  or the environment."  If such a determination is made, the

                            - 5 -
registrant(s) will be notified by certified mail and afforded
an opportunity to submit evidence in rebuttal to EPA'a
presumption.  Registrants have been sent, by certified mail,
copies of document entitled "Requirements for Interim
Registration of Pesticide Products Containing Aldicarb."  In
addition, any registrant may voluntarily petition EPA to
cancel the registration of its product(s).
     Following the initiation of the Special Review, the
pesticide use or uses of concern will enter the public
discussions stage of the Special Review process.  Registrants
and interested members of the public may discuss the Agency's
proposed actions and/or other proposals for additional or
alternative actions.  Specifically, registrants must submit
information indicating that aldicarb does not pose a health
risk to man or the environment and/or that the benefits
exceed the risks associated with aldicarb use.  Interested
members of the public may submit information concerning the
risks and benefits associated with the use of aldicarb.
Requests for all meetings for these purposes should be made
in accordance with directions described in Unit V, below.
     If risk issues cannot be fully resolved during the
public comment period, EPA will proceed to evaluate the risks
and benefits of aldicarb and to propose a regulatory solution
in a Position Document 2/3 (PD 2/3).  After obtaining comments .
from the Scientific Advisory Panel, the Secretary of Agriculture,
registrants, and the public on PD 2/3, EPA would issue a
Position Document 4 (PD 4) containing EPA's final regulatory
position.  If EPA determines that the risks of use exceed the

                             - 6 • -
 benefits, EPA would issue a notice of intent to cancel the  '   .*
 registration of products intended for such use.  The notice may'
 identify for specific uses certain changes in the composition,
 p'ack aging, application methods and/or labeling of the product :
 which would reduce the risks to levels that EPA would consider
 acceptable.  Cancellation would become effective unless,
 within 30 days of issuance of the notice, the registrant
 either requests a hearing to challenge the cancellation or
 submits an application to amend the product's registration in
 a manner prescribed in the notice of intent to cancel.
      It is emphasized that a Notice initiating a Special  Review
 is not a notice of intent to cancel the registration of a
 pesticide, and a Special Review may or may not lead to cancel-
 lation.  Rather, such a Notice is an announcement of EPA's
 concern about the safe use of a pesticide and, only after
 carefully considering the risks and benefits of a pesticide
 and determining that the pesticide would cause unreasonable
 adverse effects on -the -environment, would -EPA - Issue ..a. .notice
 of intent to cancel.  Commenters may also submit, for
.consideration, data on benefits which they believe are relevant
 to registration or continued registration of products containing
                    B.  PRESUMPTION
      EPA has determined that use of pesticide products
 containing aldicarb may meet or exceed 'the risk criteria  in
 40 CFR 162.11(a)(6)(i).  That section provides that a Notice
 of Intent to cancel a pesticide may be issued if "... based
 on toxicological data, epidemiological studies, use history,

                            - 7 -
accident data, monitoring data, or such other evidence as is
available to the Administrator, the pesticide may pose a
substantial question of safety to man or the environment..."
Aldicarb has an extremely high acute oral toxicity» however,
based on a fairly complete range of test results, aldicarb
does not cause adverse chronic health effects.  Aldicarb has
been found in ground water in a large number of States.
     On the basis of the scientific studies and information
summarized in this PD1, EPA has concluded that aldicarb and
its two degradation products of toxicological concern, aldicarb
sulfoxide and aldicarb sulfone, are mobile in soil.  These
chemicals also persist longer in soil under anaerobic conditions
(generally greater than 2 to 3 feet underground) than under
aerobic soil conditions (at depths from zero to 2 to 3 feet
underground).   Aldicarb residues have been found in water
from wells near treated fields at concentrations ranging from
10 to 200 ppb, levels which exceed the health advisory level
of 10 ppb (HAL) established by the Office of Drinking Wa.ter (ODW)
of EPA, in the following states:  Californial, Maine,
Massachusetts, Missouri, New Jersey, New York, Wisconsin,
Virginia.  Levels up to 500 ppb have been found in New York.
Concentrations between 1 to 10 ppb have been found in the
following States: Arizona, .Connecticut, Florida, Washington,
South Carolina, Texas, North Carolina, and possibly other
States.  Because aldicarb residues have 'half-lives as long
as several years, under conditions typically found in ground
water, the time required for degradation of aldicarb ground
water residues to non-toxi-c compounds will be long.

                               -  8  -»*•
       The Office  of  Pesticide Programs  (OPP)  currently estimates
  a Theoretical Maximum  Residue  Contribution  (TMRC) to the      "'
  daily diet  for aldicarb  and  its  metabolites  of 0.1120 mg/dy
  from residues of aldicarb  in or  on  raw agricultural commodities
  resulting from treatment with  aldicarb.  The TMRC estimate
  is a maximum dietary exposure  to a  pesticide approved for
  use on a specific set  of agricultural  commodities.  In preparing
  its TMRC estimate,  EPA assumed that each individual consumes
  a 1.5 kg daily diet consisting of typical amounts of the
  agricultural commodities containing the maximum residues (or
  tolerances) of the  pesticide and its metabolites permissible
  under 40 CFR 180.269.  The TMRC  utilizes 62  percent of the
  Allowable Daily  Intake (ADI) for aldicarb of 0.003 mg/kg/dy.
       The ADI for aldicarb and  its metabolites has undergone
  extensive critical  review within the last few years.  ODW
  has used a proposed ADI  of 0.001  mg/kg/dy, based on recom-
  mendations of the National Academy  of  Sciences Safe Drinking
  -Water -committee  in  W77 -and  i$fl3 -to -derive its -HAL. "More
  recently, EPA's  Environmental  Criteria and Drinking Hater
' Office (Cincinnati) prepared a preliminary toxicological
  analysis of aldicarb proposing an ADI of 0.0012 mg/kg/dy.
  In 1982, the World  Health Organization re-evaluated the ADI
  for aldicarb and recommended a value ranging from 0 to
  0.005 mg/kg/dy.  Additionally, a  report issued by the
  Institute for Comparative and  Environmental  Toxicology at
  Cornell University  in  1983,  suggested  "a reasonable range
  for the ADI to be 0.003  to 0.01 mg/kg/dy, the OPP currently
  accepted value of 0*.003  mg/kg/dy  being the most

                             - 9 -
 conservative and the upper value of .01 mg/kg/dy being a
 dose that causes a depression of whole blood cholinesterase
 approximating the range of normal intra-individual variation."
 OPP considers it prudent, at this time, not to alter its
 established ADI of 0.003 mg/kg/dy.
      In light of the extent to which permissible residues of
 aldicarb are found in foodstuffs, consumption of contaminated
 ground water presents an additional source of dietary exposure
 which must be carefully considered by the Agency.
      In response to the current ground water contamination
 situation. Union Carbide Corporation, the sole registrant for.
 technical aldicarb has installed activated carbon water
 filtration units on wells on Long island which contain aldicarb
 residues above 7 ppb.  The current label for aldicarb includes
 geographical and temporal restrictions which are thought to
 reduce the likelihood of drinking water contamination.
 Utilizing information from past, present and future studies
 of ground water contamination., the. Special..Review will consider
 the utility, practicality and enforceability of these and
' other labeling restrictions that would permit the continued
 use of aldicarb, while preventing unreasonable adverse effects
 on the environment from ground water contamination with
 aldicarb and its degradation products.
      In conducting this Special Review, the Agency will
 consult State and Local agencies responsible for maintenance
 and protection of underground drinking water sources in an
 effort to assess the impact of further aldicarb contamination
 on their responsibilities.  In conjunction with the Agency's

                             -  10  --
 broader  initiatives on  ground  water  contamination, OPplwill    C'
 consult  with  the  ODW and the newly created Office of Groundwater
 Protection  (OGP)  during the  Special  Review.  ODW is also
 conducting  a  review of  aldicarb as a potential candidate for
 regulation.   ODW, OGP and OPP  will work together during
 their respective  reviews to  assure resolution of potential
 differences in approaches and  for development of consensus on
 any issues.   The  Agency will consider the results of an ongoing
 comprehensive assessment of  the environmental fate and potential
 health impacts of the nematicide  uses of aldicarb on Florida
 citrus.  This assessment is  expected to be completed in
early 1985.  Finally, the Agency  has an application for a
pesticide, called aldoxycarb,  that has toxicity characteristics,
potential for ground  water contamination and use sites which
 are similar to aldicarb.  Aldoxycarb is a metabolite of
aldicarb.  The Agency will consider  the toxicity of aldoxycarb
and its ability to  reach ground water resources when used as
an active ingredient.   The Agency will use the conclusions .of
 this Special Review in  making  its decision on the pending
application for aldoxycarb registration.
                    C.   REBUTTAL CRITERIA
     All registrants, applicants  for registration, and other
interested members  of the public  are invited to submit evidence
either to support or  to rebut  the presumption (as listed in
Unit I.B. of this Notice) that the use of aldicarb products
may cause adverse health effects  via ground water contamination.

                          - 11 -
                D.  BENEFITS INFORMATION
     The Agency will perform a benefits analysis for aldicarb
during Special Review.  The following information briefly
summarizes the market status of aldicarb.
     Onion Carbide is the sole manufacturer of technical
aldicarb and estimates of domestic production are considered
as trade secret or proprietary under sections 7(d) and 10 of
FIFRA.  Aldicarb, an irisecticide/nematicide registered for
use on a variety of sites, is used primarily on cotton,
potatoes, peanuts, soybeans and pecans, with these five
sites comprising approximately 90 percent of annual usage
of aldicarb.  Minor usage sites include ornamentals, sugar
beets, citrus, sugar cane, sorghum, edible beans and sweet
     In addition to submitting evidence to rebut the presump-
tion of risk in the Special Review, 40 CFR 162.11(a)(5)(iii)
provides that a registrant or applicant " may submit evidence
as to whether the economic, social and environmental benefits
of the use of the pesticide subject to the presumption out-
weigh the risk of use.*  If the presumption of risk is not
rebutted, the benefits evidence submitted by registrants,
applicants* and other interested persons will be considered
by the Administrator when determining the appropriate
regulatory action.
     Registrants, applicants,  or other interested persons
who desire to submit benefits  information should consider
submitting information on the  following subjects along with
any other relevant information they desire to submit:

                           - 12 -
      1.   Identification of the economically important uses   ;?r
 of aldicarb, including market studies and  estimated quantities
 applied  for those uses.
      2.   Identification of alternative chemical and non-     ;
 chemical methods for all registered uses and application
 techniques, including any associated  health effects and
 potential for ground water contamination.
      3.   Determination of the change  in costs  to aldicarb
 users of obtaining equivalent pest control  with available
 substitute products or management techniques.
      4.   Assessment of the expected changes in level of
 pest  damage (if  any)  and environmental impacts associated
 with  the use of  alternative control measures.
      5.   Assessment of the long term  effects (health,
 decontamination  costs,  etc.)  of continued aldicarb use.
      In  addition,  EPA is requiring, pursuant to section
 3(c)(2)(B)  of FIFRA,  that additional  testing of the
 toxicological, ecological and environmental fate properties
'of aldicarb be conducted.   Upon receipt of  these studies,
 they  will be reviewed to determine the  extent to which
 other adverse effects may be  associated with the use of
 this  chemical.   EPA expects to receive  toxicological studies
 by April,  1985,  and ecological and environmental studies by
 April, 1986.

                         - 13 -
     All registrants and applicants for registration are
being notified by certified mail of the Special Review that is
being initiated on their products containing aldicarb.
     The registrants and applicants for registration will
have 45 days from the date this notice is received or until
(insert date 45 days after publication in the FEDERAL REGISTER)
(whichever is later) to submit evidence in the rebuttal to
EPA's presumption.  Other interested persons may submit
comments during the same period.  EPA is interested in a
prompt resolution of this Special Review and therefore will
not grant an extension of the comment period unless good
cause is shown.
     Registrants are required by law to submit to EPA any
additional information regarding unreasonable adverse
effects on man or the environment which comes to their
attention at any 'time, pursuant to section 6(a)(2) of FIFRA.
Registrants of aldicarb products must immediately submit
any published or unpublished information, studies, reports,
analyses, or reanalyses regarding ground water contamination,
any aldicarb effects in animal species or humans, and claimed
or verified accidents to humans, domestic animals, or wildlife
which have not been previously submitted to EPA.  These data
must be submitted with a cover letter specifically identifying
the information as being submitted under section 6(a)(2) of
FIFRA.  Registrants should notify EPA of any studies on

                              - 14 - '
  aldicarb currently in progress, their purpose,  the protocol,;-'
  the approximate completion date, and a summary  of all
  results observed to-date.
       During the time allowed for submission of  rebuttal
  evidence, specific comments on the presumptions set forth
  in this Notice and on the  material in the Guidance Document
  for interim registration are solicited from the public.  In
 particular,  any documented episodes of adverse  effects on
 humans  or domestic animals should be submitted  to EPA as
 soon as possible.   Any information as to any laboratory
 studies in progress or completed should be  submitted to EPA
 as  soon as possible with a statement as to  whether those
 studies are  in compliance  with the Good Laboratory Practicies
 specified in 48  FR 53946.   Specifically, information on any
 adverse effects  from ground water contamination or ways to
 reduce  ground water contamination through labeling or other
 means is solicited.   Similarly,  submission  of any studies
 or  comments  on the benefits from the use of aldicarb is
. requested.   All  comments and information and analysis
 thereof,  which come to the attention of EPA,  may serve as a
 basis for final  determination of regulatory position
 following the Special Review.
      All comments  and information should be sent to the
 address given above,  preferrably in triplicate,  to facilitate
 the work of  EPA  and others interested in inspecting them.
 The comments and information should bear the identifying
 notation [OPP-30000/39].

                           - 15 -
     During the rebuttal comment period, interested members
of the public or registrants may request a meeting to
discuss the risk issues, methods of reducing risks, or
other relevant natters.  Requests for such meetings should
be directed to the contact person listed in this Notice.
Any records pertaining to such meetings, including minutes,
agendas, and comments received, will' be filed under docket
number "OPP-30000/39".
                                 Steven Schatzow, Director
                                 Office of Pesticide Programs

Ufc.11,11 .M.r-U .lui'-l.i, U ith LI iltfi ii
                            J. REPORT MO.
                                                                              S. Recipient^ OeciMlon Mo.
    4. TWa a*d Sobtme
                              ALDICARB:  Position  Document  1
                                                                         «. Report Oerte
                                                                            July  1984
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                                                                         •. Perform!** Organization Rept. No:'
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       WASHINGTCN, D.C.   20460
                                                                          la Pra|«a/Ta«liAVor4( UnH No.
                                                                         11. Contr»ct(C) or Gr*nt(G) No.

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                «nU«tlon Nam* «od Addr**«
                                                                              13. Type of Report A Period Covered
      SAME AS  #9 .
    IS. Supplementary Notes
    16. Abctrect (Limit: 2OO wordi)

            Tnis Position Document  addresses the riaks 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 Analjnli  a. Descriptors

      to. M«rrtlfier»/Open-Cnd«d Term*
       COSATI Held/Group
      Availability Statement

                                                         19. Security Class (This Report)
                                                             20. Security Class (TMs Pace)
21. No. of Pages

                                                                                        ZZ. Price
  (See ANSI-Z39.18)
                                            See Instruction! on fteverae
                                                                                   OPTIONAL FORM 272 (*-77)
                                                                                   (Formerly NTIS-3S)
                                                                                   Department of Commerct