540/09-90-099
6560-5U
ENVIRONMENTAL PROTECTION AGENCY
IOPP-30000/39)
ALOICARB
SPECIAL REVIEW OP PESTICIDE PRODUCTS
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
FEDERAL REGISTER).
84P-1332
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ADDRESS: Written comments by mail: to:
Information Services Section,
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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.
FOR FURTHER INFORMATION CONTACT: By nailt
Michael F. Branagan,
Registration Division (TS-767C),
Office of Pesticide Programs,
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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,
(703-557-7420).
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
9
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
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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.
I. INITIATION OF A 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
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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
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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
aldicarb.
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,
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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.
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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
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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."
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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
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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.
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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
potatoes.
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:
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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.
II. ADDITIONAL GROUNDS FOR REVIEW
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.
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III. REBUTTAL SUBMISSION PROCEDURES
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.
IV. DUTY TO SUBMIT INFORMATION ON ADVERSE EFFECTS
Registrants are required by law to submit to EPA any
additional information regarding unreasonable adverse
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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
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aldicarb currently in progress, their purpose, the protocol,;-'
the approximate completion date, and a summary of all
results observed to-date.
' V. PUBLIC COMMENTS, INSPECTIONS AND REQUESTS FOR MEETINGS
i
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].
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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".
Date:
Steven Schatzow, Director
Office of Pesticide Programs
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Ufc.11,11 .M.r-U .lui'-l.i, U ith LI iltfi ii
•dubib^uEhQ^e^lit
^^
REPOCT OOCUMENTATION
PAGE
J. REPORT MO.
V.
S. Recipient^ OeciMlon Mo.
4. TWa a*d Sobtme
ALDICARB: Position Document 1
«. Report Oerte
July 1984
7. Author**) - - -. - • .--- -••• • • -
EPA, OPP, REGISTRATION DIVISION
•. Perform!** Organization Rept. No:'
540/09-90-099
9. Performtac Organization NaiiM- «nd Addi«M- - . • '•
ENVIRONMENTAL PPDTECTiai AGENCY
CFFTQ?: C3F PESTICIDE PROGRAMS '
WASHINGTCN, D.C. 20460
la Pra|«a/Ta«liAVor4( UnH No.
11. Contr»ct(C) or Gr*nt(G) No.
(C) .. . -: . ...
(G)
12.
«nU«tlon Nam* «od Addr**«
13. Type of Report A Period Covered
SAME AS #9 .
14.
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
PESTICIDES, STANDARDS, REGUIATIONS, MANUFACTURING, CHEMISTRY, TOXICOLOGY,
RESIDUES, ECOLOGY, PATH OF POLLUTANTS
to. M«rrtlfier»/Open-Cnd«d Term*
COSATI Held/Group
Availability Statement
PUBLICLY AVAILABLE
19. Security Class (This Report)
UNCLASSIFIED
20. Security Class (TMs Pace)
UNCLASSIFIED
21. No. of Pages
15
ZZ. Price
(See ANSI-Z39.18)
See Instruction! on fteverae
OPTIONAL FORM 272 (*-77)
(Formerly NTIS-3S)
Department of Commerct
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