United States
Environmental Protection Office of Water EPA 81 1 -Z-92-001
. 4601 May 1992
&EPA 40 CFR, PARTS 141,142,143
NATIONAL PRIMARY DRINKING
REGULATIONS; ALDICARB,
ALDICARB SULFOXIDE, AND
ALDICARB SULFONE;
i
POSTPONEMENT OF CERTAIN
PROVISIONS OF FINAL RULE
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22178 Federal Register / Vol. 57. No. 102 / Wednesday. May 27, 1992 / Rule* and Regulations
Dated: May 12.1992.
Patrick M. Tobin,
Acting Regional Administrator.
[FR Doc. 92-12178 Filed 5-26-92,'8r45 am]
BIU.ING COO£ 6SW-M-M
40 CFR Part 141
[WH-FRL-4T3S-1)
Drinking Water, National Primary
Drinking Water Regulations: Aldicarb,
Aidicarb Sulfoxfde, and Aldicarb
Sulfone
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice of postponement of
certain provisions of final rule.
SUMMARY: On July 1.1991, EPA
established maximum contaminant level
goals (MCLGs} and promulgated
National Primary Drinking Water
Regulations (NPDWRs] for aldicarb,
aldicarb sulfoxide, and aldicarb sulfone
pursuant to section 1412 of the Safe
Drinking WatefcAct (SDWA) (56 FR
30286, July 1,1991}. Today's action
postpones the January 1,1993 effective
date for the regulations for these three
compounds pending EPA's
reconsideration of the MCLGs and
maximum contaminant levels (MCLs).
.EFFECTIVE DATE Effective May 27. 1992,
EPA is postponing the effective date of
§ 141.&l(c> {2J. (3)> and (4> pending
agency reconsideration of these rules.
EPA will publish the final decision in the
Federal Register. The amendment to
§ 141.6(g)"is also effective May 27.1992.
The amendment to 5 141.24(h) is
effective July 30,1992.
FOR FURTHER INFORMATtOM CONTACT:
Al Havings, Drinking Water Standards
Division. Office of Ground Water and
Drinking Water [WH-550], US.
Environmental Protection Agency, 401M
Street, SW, Washington DC, 20460, teL
202-260-5555. General information may
also be obtained from the EPA Drinking
Water Hotline. The toll-free number is
1-600-426-4791.
SUPPLEMENTARY INFORMATION: In
August 1991, Rhone-PouleneAg
Company (Rhone-Poulenc), the
manufacturer of the pesticide aldicarb,
filed a petition with the D.C Circuit
seeking review of the MCLGs and MCLs
for aldicarb, aldicarb sulfoxide, and
aldicarb sulfone. (D.C. Cir. No. 81-1419).
In December 1991, Rhone-Poulenc filed a
petition with the Administrator for
reconsideration of the MCLGs and
MCLs and for a stay of the January 1,
1993 effective date of the regulations
pending reconsideration and judicial
review. The Administrator's letter
granting Rhone-Poulenc's petition
appears below as an Attachment
Pursuant to section 705 of th*
Administrative Procedure Art (APA). 5 U.S.C.
705. "when an agency finds that justice so-
requires, it may postpone the effective date of
actions taken by it pending judicial review."
In addition, section 553 of the APA, 5 U.S.tX
553. provides that when an agency finds good
cause to exist it may issue a rule without
first providing notice and comment and make
the rale immediately effective. This Notice
will be a basis for deferring a pending legal
challenge to the MCLGs and MCLs for the
aldicarb compounds while the Agency
reviews its determinations of those
regulations; it ii in the public interest to avoid
unnecessary litigation. Further this action
avoids the possibility that some public water
systems would be required to comply with
regulations that may be determined to be too
stringent. For these reasons, the Agency finds
there is good cause not tc urficit comment on
this notice and to have the postponement
immediately effective.
List of Subjects in 40 C/R Part 141
Chemicals, Water supply.
William K.R«iUy.
Administrator.
Datedr May £1982.
For the reasons set out in the
preamble, part 141 of title 40 of the Code
of Federal Regulations is amended is
follows:
1. The authority citation for part 141
continues to read as follows:
Authority: 42 US.C. 300t 300g-l. 3COg-2,
300g-3. 300g-4, 300g-5, 3OOg-«. 300fr-» and
300J-9.
2. Part 141 is amended by revising the
last sentence of S 141.6{g} to read as
follows:
Effective dates.
(g) * * * The regulations contained in
the revisions to sections 141.32(e) (16J,
(25) through (27) and (46]; 141.61(c)(16);
and 141.62(b)(3) are effective January 1.
1993. The effective date of regulations
contained in section 141.61(c) (2), (3).
and (4) is postponed.
3. Part 141 is amended in S 141.24 by
adding the following footnote 7 to the
end of the introductory text of
paragraph (h):
T Monitoring for the contaminants
aldicarb, aldicarb sulfoxide, and
aldicarb sulfone shall be conducted in •
accordance with § 141.40.
Editorial Note: This letter will not appear in
the Code of Federal Regulations,
H. Derrick Peterson. Esq.,
Bryan. Cave. McPheeters & McRoberts. TOO
Thirteenth Street ffW.. Washington, DC
2OO05-396O.
Re: Petition far Reconsideration and Request
for Stay
Dear Mr. Peterson: This responds to your
request on behalf of Rhone-Poulenc Ag
Company (Rhone-Poulenc) for
reconsideration of the regulations issued by
the Environmental Protection Agency (EPA or
the Agency) for aldicarb, aldicarb sulfoxide.
and aldicarb sulfone under the Safe Drinking
Water Act (SDWA). 56 FR 30286 (July 1.
1991). Rhone-Poulenc asks for
reconsideration of the maximum contaminant
level goals (MCLGs) and maximum
contaminant levels (MCLs). You have
requested a stay of the effective date of these
regulations pending such reconsideration and
judicial review.
In July 1991. EPA promulgated an MCLG at
0.001 mg/I for each of the aldicarbs. based on
clinical signs of toxicity in animal* and
humans. EPA had earlier proposed MCLG4
for aldicarb based on a Reference Dose (RfD)
that reflected both cholinesterase inhibition
(ChEI) and clinical effects in animals and
humans following exposure to aldicarb. Se«
56 FR 3605 (January 30.1991). The Agency
received a number of comments from tbe
public on the proposal arguing that ChEI is a
marker of exposure to aldicarb. no*, an
adverse effect, and should not be a factor in
setting the RfD. Moreover, Agency advisory
bodies also recommended that plasms and
blood ChEI be regarded a» • marker of
exposure and not signs of toxicity and that
the Agency rely on- other mdiciea for risk
assessment. Report of SAB/SAP Joint
Committee on the Review of ChEI and1 its-
Effects. (EPA. 1990], In response to these
comments and since the Agency's rhEl
policy was still under development, the
Agency relied on the clinical effects of
aldicarb to set the final MCLGs.
Among the studies the Agency cornidervd
in determining the clinical effects of exposure
to aldicarb was * one-year dog study
sponsored by Rhone-Poulence (the Hazlc&a *
study. 1988).The study indicated that then
were treatment related clinical effects suck
as diarrhea and soft stools in the test «nim.ff
exposed to aldfcarb. EPA's analysis of ttw
dog- study confirmed that conclusion. Bassi
on the clinical data from the Hazlelon (tody.
EPA determined that there were no advert*
effects from exposure to aldicarb at • tovcl at*
0.02 mg/kg/day and used this no-effect levci
to calculate theMCLG of OJJ01 mg/L Tke,
Agency used human data from s controlled
human clinical study (the Haines study) tad
from reported clinical effects folfowinf An*
separate incidents involving aldicarb
exposure in California (th* Goldman Mae»
to support qualitatively the MCLG
determination 5ft FR 30266 (Jury 1. W*U Tto
data base oa clinical effects was also wet Is
set the MCLGa for aldicarb sulfone aad
sulfoxide.
Rhone-Poulenc seeks reconsideration •fife*
aldicarb regulations based on its conicscsa
that EPA overstated the toxicity of th*
aldicarb- compounds tit setting the MCLGs.
Rfcone-Ponlence states that the MCLG far
aldicarb sulfone is too stringent becaecs CM
used data from the more toxic tkfccart ••£
aldicarb *u)foxide to determine the MOO.
rather than available data ea mlfon* mt&.
Rhone-Poulenc also states that EPA's UOCs
were based on the dbg: study, and lb*t
reexarnioation of that study has revcafarf Ami
there were no treatment-related clinic*!
effects at any dose level. With its pcwca.
Rhone-Poulenc submitted previously
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Federal Register / Vol. 57, No. 102 / Wednesday. May 27, 1992 / Rules and Regulations 2217S
uncompiled pretreatment data (base-line data
on the dogi before the treatment began) to
explain why the study originally appeared to
•hour a treatment related effect Rhone-
Poulenc Indicates thatlne pretreatment data
thow that dogt with clinical signs in the
study generally bad higher rate* of soft stools
even before exposure to aldicarb. Rhone-
Poulenc concludes that by relying on the
mUreported treatment effect EPA overstated
the clinical no-effect level and therefore the
toxidty of aldicarb and aldicarb sulfoxide by
at least a factor of ten. Since aldicarb and
sulfoxide were used as surrogates for sulfone,
its toxidty was also overstated.
Rhone-Poulenc further argues that EPA
should cot have used the Goldman study to
support its MCLG decision when the Hainea
study provided mud) better human data.
Rhone-Poulenc provides statements from its
panel of experts that are critical of the
Goldman study and urj-3» EPA to reconsider
it i dediion not to use the Haines study to
Calculate the RfD and MCLG.
In establishing the MCLGs for the aldicaibs
in the Jinal rule, the Agency appropriately
relied on the data in the record. In"
accordance with its SDWA processes. EPA
calculated the no-effect level from data
"reported-*? it by Rhone-Poulenc (the Hazleton
study). Rhone-Poulenc has now come forward
with what appear to be significant
pretreatment data that were not available to
the Agency during its rulemaking. Rhone-
Poulenc seems to explain the failure to
provide these data during the rulemaking by
arguing that the Agency's proposed rules
focused on ChEI and therefore it could not
have known that EPA would base the
regulations on clinical effects. While ChEI
was a prominent element in the Agency's
proposed regulations, dinical effects were
also included. Indeed, in its comments on the
January 1891 reproposal of the aldicarb
regulations. Rhone-Poulenc specifically
discussed the Agency's statements that there
was an increase in dinical symptoms in dogs
treated with aldicarb.
In the drinking water program, the Agency
must determine * concentration level of a
contaminant at which no known or
anticipated adverse health effects would
occur, allowing an adequate margin of safety.
For the aldicarb*. the Agency used the data
in the dog study to calculate the level at
which no adverse health effects appeared.
Rhone-Poulenc's newly submitted data
purport to show that the dogs that exhibit
dinical signs after exposure to aldicarb
showed similar signs even before exposure to
aldicarb. From these pretreatment data.
Rhone-Poulenc condudes that in fact there is
no clinical effect from aldicarb administered
at any level. The data therefore call into
question the Agency's determination of the
level at which there was no adverse effect in
the test animals from exposure to aldicarb.
Since the no-effect level is used to calculate
the MCLGs and MCLs. those levels are also
in doubt In light of this new information, I
agree to reconsider the Agency's
determination of the aldicarbs' MCLGs and
MCLs. The Agency still contends that the
human studies were considered appropriately
and therefore, does not accept Rhone-
Poulenc's conclusions as to the use of the
human studies. However, as part of
reconsidering the regulatory levels, we will -
also reexamine our use of the studies and
others in setting the MCLGs for all three of
the compounds.
Rhone-Poulenc also requests a stay of the
January 1,1993 effective date of the aldicarb
regulations. An administrative stay of the
regulation constitutes extraordinary relief
that requires the petitioner to show sufficient
harm to justify the stay. I do not find that
Rhone-Poulenc has demonstrated such harm
because of its daimed expenditures for
compensation for treatment costs. Moreover,
I believe the Agency's MCLG* and MCLs
were supported by the record available to the
Agency at the time of our initial decision.
However. I believe it is not in the public
interest to require public water systems to
comply with the aldicarb MCLs if there is a
real possibility that those regulations may be
too stringent and may be revised. Therefore, !
am staying the efFectivs dcte of the MCLs-for
aldicarb. aldicarb Sulfoxide and aldicarb
sulfone.
It is the Agency'* intent to proceed as
expeditiously as possible to reexamine our
determination of the aldicarb MCLGs and to
solicit additional public comment on the
appropriateness of changing the MCLGs or
MCLs. I am authorizing the Assistant
Administrator for Water to publish a notice
in the Federal Register soliciting public
comment on these issues as soon as the
Agency i* able. Because of our intent to move
quickly on this matter. I am requesting that
Rhone-Poulenc respond promptly to any
information requests that the Agency might
make.
Since EPA intends to reestablish MCLGs
and MCLs for. the aldicarbs very quickly.
public water systems will be required to
monitor for the aldicaibs effective January 1,
1993. However, since the MCLs are stayed.
such monitoring will be conducted during the
stay in accordance with 40 CFR 141.40 rather
then 141.24(h). With this monitoring
information, public water systems will have a
more complete data base on which to judge
the necessity for treatment Further, I will
consider all options, including establishing an
effective date that reflects the time that
public water systems have already had to
prepare for implementing the regulations, to
avoid additional delay in implementing the
regulations. The Assistant Administrator for
Water will seek public comment on such
options in the forthcoming Federal Register
notice.
Conclusion
For the above reasons. I am granting '
Rhone-Poulenc's petition for reconsideration
of the MCLG* and MCLs for the three •
aldicarbs. I am also staying the effective date
of the MCL pending completion of the
Agency'* reconsideration.
Sincerely yours.
William K. Reilly.
Administrator.
[FR Doc. 92-12136 Filed 5-26-92:8:45 am]
•IUJNO cooe «S40-so-*i
40 CFR Part 180
(PP OF3870/R1151; FRL-4068-3]
BIN 2070-AB78
Pesticide Tolerance for Imazethapyr
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule. _ .
SUMMARY: This rule establishes
tolerances for the sum of the residues of
the herbicide imzethapyr, 2-[4.5-dihydro-
4-methyl-4-{l-methylethyl}-5-oxQ-l//-
imidazol-2-yl]-S-ethyl-3-pyridine
carboxylic acid, as its ammonium salt
and its metabolite, 2-[4.5-dihydro-4-
methyl-Hl-methylethyl)-5-oxo-lfY-
pyj >dine carboxylic acid in or on corn
grain, fodder, and forage at O.i part per
million (ppm). The regulation was
requested by American Cyanaaiid Co.
and establishes the maximum
permissible level for residues of the
herbicide in or on corn. This tolerance
expires on May 27, 1994.
EFFECTIVE DATE: Effective on May 27,
1992.
ADDRESSES: Written objections,
identified by the document control
number, [PP OF3870/R1151], may be
submitted to: Hearing Clerk (A-110), Rm.
M37C8. Environmental Protection
Agency. 401 M SL, S W., Washington, DC
20460.
FOR FURTHER INFORMATION CONTACT: By
mail: Robert J. Taylor, Product Manger
(PM) 25, Registration Division.
Environmental Protection Agency, 401 M
St. S W., Washington. DC 20460. Office
location and telephone number: Rm. 245.
CM #2, 1921 Jefferson Davis Highway.
Arlington, VA 22202. (703}-3OS-€800.
SUPPLEMENTARY INFORMATION: EPA
issued a notice, published in the Federal
Register of July 18. 1990 (55 FR 29288).
which announced that the American
Cyanamid CoH P.O. Box 400, Princeton.
NJ 08540. had submitted pesticide
petition PP OF3870 to EPA proposing that
40 CFR part 180 be amended by
establishing a tolerance under section
408 of the Federal Food. Drug, and
Cosmetic Act, 21 U.S.C 348a. for
residues of the herbicide imaxethapyr. 2-
[4,5-dihydro-t-methyl-4-{l-methylethyl}-
5-oxo-i//-imadzol-2-yl]-5-ethyl-*-
pyridine carboxylic acid, as iu
ammonium salt in or on con at 0.1 ppm.
There were no comments or requests
. for referral to an advisory committee
received in response to the notice of
filing.
The petitioner subsequently amended
the petition by submitting a new Section
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