[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51841-51848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25984]
[[Page 51841]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300719; FRL-6032-6]
RIN 2070-AB78
Mepiquat Chloride; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of mepiquat chloride, N,N-dimethylpiperidinium chloride) in or
on grapes and raisins. This action is in response to EPA's granting of
an emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
grapes. This regulation establishes a maximum permissible level for
residues of mepiquat chloride in this food commodity pursuant to
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996. The tolerance will
expire and is revoked on March 1, 2000.
DATES: This regulation is effective September 29, 1998. Objections and
requests for hearings must be received by EPA on or before November 30,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300719] must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, [OPP-300719], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300719]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 308-9367, e-mail:
ertman.andrew@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
residues of the plant regulator mepiquat chloride (N,N-
dimethylpiperidinium chloride), in or on grapes at 1.0 part per million
(ppm) and raisins at 6.0 ppm. These tolerances will expire and is be
revoked on March 1, 2000. EPA will publish a document in the Federal
Register to remove the revoked tolerance from the Code of Federal
Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Mepiquat Chloride on Grapes and FFDCA
Tolerances
The applicants state that grape growers in Ohio, New York and
Pennsylvania are facing an emergency situation brought on by freezing
weather conditions that occurred on four days in April 1998. Regional
experts called the frosts the most damaging freeze experienced in the
past 30 years. The effects of the frost on the grapes include poor
fruit set which will thus reduce fruit yield, with estimates of yield
reductions in the 25% range. According to the applicants, there are no
other registered alternative products available
[[Page 51842]]
to address this need other than mepiquat chloride. The use of mepiquat
chloride could result in increased fruit set, and offset some of the
damage caused by the late frost. EPA has authorized under FIFRA section
18 the use of mepiquat chloride on grapes for control of frost damage
in Ohio, New York, and Pennsylvania. After having reviewed the
submission, EPA concurs that emergency conditions exist for this state.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of mepiquat chloride in or on
grapes. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment under section 408(e), as provided in section 408(l)(6).
Although this tolerance will expire and is revoked on March 1, 2000,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on grapes
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by this tolerance at the time of that
application. EPA will take action to revoke this tolerance earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether mepiquat chloride meets
EPA's registration requirements for use on grapes or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of mepiquat chloride by a State for special
local needs under FIFRA section 24(c). Nor does this tolerance serve as
the basis for any State other than Ohio, New York, and Pennsylvania to
use this pesticide on this crop under section 18 of FIFRA without
following all provisions of EPA's regulations implementing section 18
as identified in 40 CFR part 166. For additional information regarding
the emergency exemption for mepiquat chloride, contact the Agency's
Registration Division at the address provided above.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the Final Rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997)(FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action EPA has sufficient data to assess the hazards of mepiquat
chloride and to make a determination on aggregate exposure, consistent
with section 408(b)(2), for a time-limited tolerance for residues of
N,N-dimethylpiperidinium chloride on grapes at 1.0 ppm and raisins at
6.0 ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by mepiquat chloride
are discussed below.
1. Acute toxicity. For acute dietary risk assessment, the results
from two 1-year feeding studies in the dog were combined with the
results from a 90-day feeding study in the dog. The NOAEL for the acute
dietary endpoint is 58.4 milligrams/kilogram/day (mg/kg/day) and the
LOAEL is 95.3 mg/kg/day based on salivation and sedation. In the second
1-year study, salivation (an indicator of impaired neurological
function) was observed in all dogs at 2 hours after each feeding.
Salivation was slight at first, moderate to severe during the next 4
hours and then gradually disappeared. In the subchronic feeding study,
sedation (also a neurotoxic sign) was observed for 1-6 hours after each
dosing with 95.3 mg/kg/day, the LOAEL for the 3 studies combined. Using
the hundredfold uncertainty factor (to account for both inter-species
extrapolation and intra-species variability), the acute Reference dose
(RfD) is calculated to be 0.6 mg/kg/day. This risk assessment will
evaluate acute dietary risk to all population subgroups.
2. Short - and intermediate - term toxicity. The NOAEL is 58.4 mg/
kg/day and the LOAEL is 95.3 mg/kg/day based on the combined results
from two 1-year feeding studies and one 90-day feeding study in dogs.
This endpoint is the same as that used for acute dietary and chronic
RfD.
3. Chronic toxicity. EPA has established the RfD for mepiquat
chloride at 0.6 (mg/kg/day). This RfD is based on the combined 1-year
and subchronic feeding studies in the dog. The NOAEL is 58.4 mg/kg/day
and the LOAEL is 95.3 mg/kg/day based on clinical signs of toxicity
(salivation, sedation, abdominal and lateral positions, and xonoclonic
spasms), decreased body weight, and hematological changes at 95.3 mg/
kg/day. An uncertainty factor (UF) of 100 was applied to account for
both inter-species extrapolation and intra-species variability. This
risk assessment will evaluate chronic dietary risk to all population
subgroups.
4. Carcinogenicity. EPA has classified mepiquat chloride as a Group
E chemical - ``no evidence of carcinogenicity to humans.''
5. FQPA safety factor. The Agency removed the required 10x safety
factor for all population subgroups except females and children.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.384) for the residues of N,N-dimethylpiperidinium chloride, in
or on a variety of raw agricultural commodities at levels ranging from
3.0 ppm in cotton seed to 0.05 ppm in eggs and milk. Risk assessments
were conducted by EPA to assess dietary exposures and risks from
mepiquat chloride as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1 day or single exposure. The acute RfD = 0.6 mg/kg/day. The acute
dietary (food only) risk assessment used the Dietary Exposure
Evaluation Model (DEEM). In conducting this chronic dietary risk
assessment, EPA has made very conservative assumptions -- 100% of
grapes and all other commodities having mepiquat chloride tolerances
will contain mepiquat chloride residues and those residues would be at
the level of the tolerance -- which result in an overestimation of
human dietary exposure. The results of the DEEM are summarized below.
These estimates
[[Page 51843]]
should be viewed as a conservative risk estimate; further refinement
using anticipated residue values and percent crop-treated data in
conjunction with Monte Carlo analysis would result in a lower acute
dietary exposure estimate. For acute dietary exposure, the Agency
determined that the 10X safety factor is applicable to the
subpopulations females (13+ years), as well as infants and children
because of a lack of developmental toxicity data.
Application of the 10X safety factor to the Acute RfD of 0.6 mg/kg/
day results in an acceptable acute dietary exposure of 10% of the Acute
RfD for the subpopulations females (13+ years old), infants, and
children (1-6 years old). For the general U.S. Population and other
subpopulations to whom the 10X factor does not apply, 100% or less of
the Acute RfD would be acceptable. As shown in the following table 1,
the amount of acute RfD utilized does not exceed HED's level of
concern.
Table 1.--Acute Dietary Exposure and Percent RfD
(Total from new and published tolerances at the 99th percentile)
------------------------------------------------------------------------
TMRC\2\ Percent of
Population of Concern\1\ (mg/kg/ Acute RfD
day) (%)\3\
------------------------------------------------------------------------
U.S. Population................................... 0.0092 2
Children (1-6 years old).......................... 0.024 4
Females (13 + years old).......................... 0.012 2
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\1\ Population for which the Acute RfD applies.
\2\ TMRC - Theoretical Maximum Residue Concentration from DEEM.
\3\ Percentage of reference dose (% RfD) = (TMRC/RfD) x 100%.
ii. Chronic exposure and risk. The chronic RfD = 0.6 mg/kg/day. A
DEEM chronic exposure analysis was performed using tolerance level
residues, and 100% crop treated to estimate the Theoretical Maximum
Residue Concentration (TMRC) for the general population and subgroups
of interest. In conducting this chronic dietary risk assessment, EPA
has made very conservative assumptions -- 100% of grapes and all other
commodities having mepiquat chloride tolerances will contain mepiquat
chloride residues and those residues would be at the level of the
tolerance -- which result in an overestimation of human dietary
exposure. Thus, in making a safety determination for this tolerance,
EPA is taking into account this conservative exposure assessment.
The existing mepiquat chloride tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in a TMRC that
is equivalent to the percentages of the Chronic RfD listed the
following table 2 below. Application of the 10X safety factor to the
Chronic RfD of 0.6 mg/kg/day results in an acceptable chronic dietary
exposure of 10% or less of the chronic RfD for the subpopulations
females (13+ years old), infants, and children (1-6 years old). For the
general U.S. Population and other subpopulations to whom the 10X factor
does not apply, 100% or less of the chronic RfD would be acceptable. As
shown in the following table 2, the amount of chronic RfD utilized does
not exceed HED's level of concern.
Table 2.--Chronic Dietary Exposure and Percent of RfD
------------------------------------------------------------------------
TMRC Percentage
Population of Concern\1\ (mg/kg/ of Chronic
day)\2\ RfD (%)\3\
------------------------------------------------------------------------
U.S. Population (48 States)....................... 0.0010 <1 nursing="" infants=""><1 year="" old).....................="" 0.0011=""><1 non-nursing="" infants=""><1 year="" old).................="" 0.0024=""><1 children="" (1-6="" years="" old)..........................="" 0.0034=""><1 females="" (13="" years="" +,="" nursing).....................="" 0.0014=""><1 ------------------------------------------------------------------------="" \1\="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" the="" chronic="" rfd="" applies="" to="" all="" popuplation="" subgroups.="" \2\="" tmrc="" -="" theoretical="" maximum="" residue="" concentration="" from="" deem.="" \3\="" percentage="" of="" reference="" dose="" (%="" rfd)="(TMRC/RfD)" x="" 100%.="" 2.="" from="" drinking="" water.="" mepiquat="" chloride="" is="" stable="" to="" hydrolysis="" and="" photolysis.="" soil="" and="" aqueous="" photolysis="" are="" not="" routes="" of="" dissipation.="" under="" aerobic="" conditions,="" mepiquat="" chloride="" appears="" to="" degrade="" rapidly="" to="">2. Under anaerobic conditions, it
appears stable. Based on study results, mepiquat chloride is considered
to be relatively non-mobile, and is not expected to accumulate in fish.
Since the other mepiquat chloride metabolites also degrade rapidly to
CO2, parent mepiquat chloride is the only residue of
concern. There are no established Maximum Contaminant Levels or health
advisory levels for residues of mepiquat chloride in drinking water.
Furthermore, mepiquat chloride is considered to have limited potential
for groundwater contamination. Because of mepiquat chloride's low usage
rate and its rapid degradation, significant migration to surface water
is not expected.
i. Acute exposure and risk. Drinking water levels of concern
(DWLOC) for acute and chronic dietary exposure are included as the
following Tables 3 and 4.
Table 3.-- Drinking Water Levels of Concern (DWLOC) for ACUTE Dietary Exposure
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Acute
RfD Acute RfD Acute Max Water Acute
Population\7\ (mg/ with FQPA Dietary Exposure\3\ DWLOC4,5,6
kg/ factor\1\ Exposure\2\ (mg/kg/day) (g/
day) (mg/kg/day) (mg/kg/day) L)
----------------------------------------------------------------------------------------------------------------
U.S. Population..................................... 0.6 0.6 (FQPA
factor does
not apply) 0.0092 0.59 21,000
Females 13 years +.................................. 0.6 0.06 0.012 0.048 1,400
Children/Infants.................................... 0.6 0.06 0.024 0.036 360
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\1\ Acute RfD with FQPA factor = Acute RfD/FQPA Safety Factor (10x).
\2\ Acute Dietary Exposure from DEEM analysis.
[[Page 51844]]
\3\ Max Water Exposure = Acute RfD with FQPA factor - Acute Dietary Exposure (mg/kg/day).
\4\ Acute DWLOC(g/L) = Max. water exposure (mg/kg/day) * body wt (kg)/(10-3 mg/g) * water
consumed daily (L/day).
\5\ HED Default body weights are 70 kg for General US Population; 60 kg for females 13+ and 10 kg for infants
and children.
\6\ HED Default Daily Drinking Rates are 2 L/day for Adults and 1 L/day for infants and children.
\7\ Within each of these categories, the subgroup with the highest food exposure was given.
Table 4.--Drinking Water Levels of Concern (DWLOC) for CHRONIC Dietary Exposure
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Chronic RfD with Chronic Dietary Max Water
Population Chronic RfD (mg/ FQPA factor\1\ Exposure\2\ (mg/ Exposure\3\ (mg/ Chronic DWLOC4,5,6,7
kg/day) (mg/kg/day) kg/day) kg/day) (g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population.................................... 0.6 0.6 (FQPA factor
does not apply) 0.0010 0.599 21,000
Females 13 years +................................. 0.6 0.06 0.0014 0.0586 1,800
Children/Infants................................... 0.6 0.06 0.0034 0.0566 570
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\1\ Acute RfD with FQPA factor = Acute RfD/FQPA Safety Factor (10x).
\2\ Acute Dietary Exposure from DEEM analysis.
\3\ Max Water Exposure = Acute RfD with FQPA factor - Acute Dietary Exposure (mg/kg/day).
\4\ Chronic DWLOC(g/L) = Max. water exposure (mg/kg/day) * body wt (kg)/(10-3 mg/g) * water consumed daily (L/day).
\5\ HED Default body weights are 70 kg for General US Population; 60 kg for females 13+ and 10 kg for infants and children.
\6\ HED Default Daily Drinking Rates are 2 L/day for Adults and 1 L/day for infants and children.
\7\ Within each of these categories, the subgroup with the highest food exposure was given.
ii. Chronic exposure and risk. ``The Interim Guidance for
Conducting Drinking Water Exposure and Risk Assessments`` issued on
November 24, 1997 was followed for this assessment. Thus, the generic
expected environmental concentration (GENEEC) model and the SCI-GROW
model were run to produce estimates of mepiquat chloride concentrations
in surface and ground water, respectively. The primary use of these
models is to provide a coarse screen for sorting out pesticides for
which EPA has a high degree of confidence that the true levels of the
pesticide in drinking water will be less than the human health drinking
water levels of concern (DWLOCs). A DWLOC is the concentration of a
pesticide in drinking water which would be acceptable as an upper limit
in light of total aggregate exposure to that chemical from food, water,
and non-occupational (residential) sources.
The DWLOC is the concentration in drinking water as a part of the
aggregate chronic exposure that occupies no more than 100% of the RfD.
The Agency's default body weights and water consumption values used to
calculate DWLOCs are as follows: 70 kg/2L (adult male), 60 kg/2L (adult
female), and 10 kg/1L (child).
For chronic (non-cancer) exposure to mepiquat chloride in surface
and ground water, the drinking water levels of concern are 21,000
g/L for the U.S. population, 1,800 g/L for females
(13+ years old), and 570 g/L for children (1-6 years old). To
calculate the DWLOC for chronic (non-cancer) exposure relative to a
chronic toxicity endpoint, the chronic dietary food exposure (from
DEEM) was subtracted from the RfD to obtain the acceptable chronic
(non-cancer) exposure to mepiquat chloride in drinking water. DWLOCs
were then calculated using default body weights and drinking
consumption figures.
Estimated average concentrations of mepiquat chloride in surface
and groundwater are 1.99 parts per billion (ppb) and 0.008 ppb,
respectively. The DWLOCs are as stated above. The estimated average
concentrations of mepiquat chloride in surface and groundwater are less
than OPP EPA's level of concern for mepiquat chloride in drinking water
as a contribution to chronic aggregate exposure.
3. From non-dietary exposure. Mepiquat Chloride is currently not
registered for use on any sites that present a risk of non-
occupational, non-dietary exposure.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether mepiquat chloride has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
mepiquat chloride does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that mepiquat chloride has a
common mechanism of toxicity with other substances. For more
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see the Final Rule for Bifenthrin Pesticide Tolerances
(62 FR 62961, November 26, 1997).
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. The acute risk for ``food only'' does not exceed
EPA's level of concern. Since estimates of mepiquat chloride in
drinking water do not exceed acute drinking water levels of concern
(DWLOC) listed in Table 3 of this preamble, the Agency does not expect
the acute aggregate risk to exceed the level of concern.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to mepiquat chloride
from food will utilize < 1%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" discussed="" below.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" mepiquat="" chloride="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" uses.="" there="" are="" no="" registered="" residential="" uses="" of="" mepiquat="" chloride.="" therefore,="" a="" [[page="" 51845]]="" short-="" and="" intermediate-term="" aggregate="" risk="" assessment="" is="" not="" applicable.="" 4.="" aggregate="" cancer="" risk="" for="" u.s.="" population.="" the="" agency="" has="" classified="" mepiquat="" chloride="" as="" a="" group="" e="" chemical,="" ``no="" evidence="" of="" carcinogenicity="" to="" humans.''="" therefore,="" a="" risk="" assessment="" is="" not="" required.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" mepiquat="" chloride="" residues.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--="" i.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" mepiquat="" chloride,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" during="" gestation.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" data="" base="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" margin="" of="" exposure="" (moe)="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-species="" variability)="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.--a.="" rats.="" in="" a="" developmental="" toxicity="" study,="" wistar="" rats="" were="" dosed="" by="" oral="" gavage="" at="" levels="" of="" 0,="" 50,="" 150,="" or="" 300="" mg/kg/day="" during="" gestation="" days="" 6="" through="" 15.="" based="" on="" the="" clinical="" signs="" of="" toxicity="" and="" decreases="" in="" the="" food="" consumption="" and="" body="" weight="" gains,="" the="" maternal="" toxicity="" loael="" is="" 300="" mg/kg/day="" and="" the="" maternal="" toxicity="" noael="" is="" 150="" mg/kg/day.="" since="" developmental="" toxicity="" was="" not="" observed="" in="" this="" study,="" the="" developmental="" toxicity="" noel="" is=""> 300 mg/kg/day (Hight Dose Tested).
b. Rabbits. In a developmental toxicity study, mepiquat chloride
was administered to Himalayan rabbits at dose levels of 0 (untreated
control), 0 (vehicle control), 50, 100 and 150 mg/kg/day during
gestation days 6-18. The maternal NOAEL is 50 mg/kg/day (borderline
value) and the LOAEL is 100 mg/kg/day based on body weight loss and
decreased body weight gain; decreased food consumption; amber-colored
liquid in the abdomens of six rabbits; diarrhea, trembling and apathy
in one rabbit; and six abortions. Developmental effects were not
observed in the 50 mg/kg group. Because of the high abortion rate in
the 100 mg/kg group (37.5%) and high death and abortion rate in the 150
mg/kg group (58.8%), inadequate numbers of fetuses in the mid-dose and
high-dose groups preclude the meaningful evaluation of developmental
toxicity in this study. In order to evaluate developmental toxicity in
the rabbit, the current study was to be considered with another study
in which two doses of mepiquat chloride (75 and 100 mg/kg) were tested.
However, because the results were reported only in the form of a brief
summary, the second study cannot be presently evaluated. The
developmental toxicity study in the rabbit is classified as
supplementary/unacceptable and does not satisfy the guideline
requirement 83-3b (OPPTS 870.3700). The study is upgradable following
the review and acceptance of the second study.
iii. Reproductive toxicity study.-- Rats. In the 2-generation
reproductive toxicity study, groups of 25 male and 25 female Wistar
rats were fed mepiquat chloride in their diets at concentrations of 0,
500, 1,500, or 5,000 ppm for 10 weeks (F0) or 14 weeks
(F1) before mating, and during mating, gestation, and
lactation. The doses corresponding to the dietary concentrations are
51.2 and 48.6, 153.1 and 146.6, and 499.3 and 574.5 mg/kg/day,
respectively for F0 and F1 males and 54.0 and
53.3, 163.6 and 162.0, and 530.0 and 626.5 mg/kg/day, respectively for
F0 and F1 females.
The LOAEL for parental (systemic) toxicity is 5,000 ppm (499 mg/kg/
day) for male and female rats based on neurological impairment,
decreased body weight and body weight gain in the adults, and retarded
growth of F1 and F2 pups. The parental (systemic)
NOAEL is 1,500 ppm (147 mg/kg/day). There were no treatment-related
effects on reproductive parameters. The NOAEL for reproductive toxicity
is > 5,000 ppm (499 mg/kg/day).
iv. Pre- and post-natal sensitivity. The toxicological data base
for evaluating pre- and post-natal toxicity for mepiquat chloride is
incomplete with respect to current data requirements. There are no pre-
or post-natal toxicity concerns for infants and children, based on the
results of the rat developmental toxicity study and the 2-generation
rat reproductive toxicity study. However the developmental toxicity
study in rabbits was unacceptable and requires a new study.
v. Conclusion. Based on the above, the Agency determined that the
10X safety factor for protection of infants and children should be
retained and applied to all population subgroups involving women and
children.
2. Acute risk. The acute risk for food and drinking water do not
exceed EPA's level of concern and therefore the acute aggregate risk
does not exceed the Agency's level of concern.
3. Chronic risk. Using the exposure assumptions described above,
EPA has concluded that aggregate exposure to mepiquat chloride from
food will utilize < 1%="" of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" 4.="" short-="" or="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" uses.="" there="" are="" no="" registered="" residential="" uses="" of="" mepiquat="" chloride.="" therefore,="" a="" short-="" and="" intermediate-term="" aggregate="" risk="" assessment="" is="" not="" applicable.="" 5.="" determination="" of="" safety.="" based="" on="" these="" risk="" assessments,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" mepiquat="" chloride="" residues.="" iv.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" a="" previously="" submitted="" study="" of="" the="" metabolism="" of="" mepiquat="" chloride="" in="" grapes="" was="" found="" to="" be="" adequate.="" the="" residue-of-concern="" in="" grapes="" is="" considered="" to="" be="" the="" parent="" compound="" only.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" no="" feed="" items="" are="" associated="" with="" this="" section="" 18="" use.="" b.="" analytical="" enforcement="" methodology="" the="" analytical="" method="" gas="" chromatography/nitrogen="" phosphorus="" [[page="" 51846]]="" detector="" (gc/npd)="" for="" mepiquat="" chloride="" in/on="" grapes="" was="" previously="" reviewed="" and="" found="" to="" be="" adequate="" for="" tolerance="" enforcement.="" the="" limit="" of="" quantification="" (loq)="" for="" this="" method="" was="" reported="" as="" 0.05="" ppm="" in="" grapes,="" 0.1="" ppm="" in="" grape="" juice,="" and="" 0.25="" ppm="" in="" raisins.="" c.="" magnitude="" of="" residues="" the="" grape="" residue="" data="" provided="" with="" this="" action="" appear="" to="" be="" a="" summary="" of="" the="" data="" that="" were="" supplied="" with="" a="" previously="" submitted="" petition="" (pp="" 1f3955/1h5610).="" in="" support="" of="" that="" petition,="" 28="" field="" trials="" in="" 8="" different="" states="" (california,="" new="" york,="" pennsylvania,="" oregon,="" michigan,="" new="" jersey,="" ohio,="" and="" georgia)="" were="" conducted="" in="" 1984="" and="" 1985.="" residues="" of="" mepiquat="" chloride="" in/on="" grapes="" ranged="" from="">< 0.05="" to="" 0.76="" ppm="" with="" phis="" ranging="" from="" 77="" to="" 135="" days.="" the="" highest="" value,="" 0.76="" ppm,="" is="" from="" a="" 0.4="" lb/a="" treatment="" (1.6="" times="" the="" recommended="" rate)="" and="" was="" found="" 106="" days="" after="" application.="" in="" ohio,="" residues="" of="" mepiquat="" chloride="" were="" 0.1="" and="" 0.15="" ppm="" for="" phis="" of="" 112="" and="" 106="" days,="" respectively.="" a="" time-limited="" tolerance="" of="" 1="" ppm="" for="" residues="" of="" mepiquat="" chloride="" in/on="" grapes="" will="" be="" established="" for="" purposes="" of="" this="" section="" 18="" use="" only.="" grapes="" processed="" from="" the="" field="" trials="" indicate="" that="" production="" of="" raisins="" resulted="" in="" a="" sixfold="" increase="" in="" mepiquat="" chloride="" residues.="" mepiquat="" chloride="" did="" not="" concentrate="" in="" grape="" juice.="" a="" time-="" limited="" tolerance="" of="" 6="" ppm="" for="" residues="" of="" mepiquat="" chloride="" in/on="" raisins="" will="" be="" established="" to="" support="" this="" section="" 18="" use.="" secondary="" residues="" are="" not="" expected="" in="" animal="" commodities="" as="" no="" feed="" items="" are="" associated="" with="" this="" section="" 18="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" tolerances="" established="" for="" mepiquat="" chloride="" on="" grapes.="" thus,="" international="" harmonization="" is="" not="" an="" issue="" for="" these="" time-limited="" tolerances.="" e.="" rotational="" crop="" restrictions="" since="" grapes="" are="" not="" rotated="" to="" other="" crops,="" a="" discussion="" of="" rotational="" crop="" restrictions="" is="" not="" germane="" to="" this="" action.="" v.="" conclusion="" therefore,="" the="" tolerance="" is="" established="" for="" residues="" of="" n,n-="" dimethylpiperidinium="" chloride="" in="" grapes="" at="" 1.0="" ppm="" and="" raisins="" at="" 6.0="" ppm.="" vi.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" november="" 30,="" 1998,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" cbi.="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" 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.="" vii.="" public="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300719]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 119="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c)="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VIII.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under FFDCA section 408
(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive
[[Page 51847]]
Order 12875, entitled Enhancing the Intergovernmental Partnership (58
FR 58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
under FFDCA section 408 (l)(6), such as the tolerance in this final
rule, do not require the issuance of a proposed rule, the requirements
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not
apply. Nevertheless, the Agency has previously assessed whether
establishing tolerances, exemptions from tolerances, raising tolerance
levels or expanding exemptions might adversely impact small entities
and concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a
regulation that is not required by statute and that creates a mandate
upon a State, local or tribal government, unless the Federal government
provides the funds necessary to pay the direct compliance costs
incurred by those governments. If the mandate is unfunded, EPA must
provide to the Office of Management and Budget (OMB) a description of
the extent of EPA's prior consultation with representatives of affected
State, local and tribal governments, the nature of their concerns,
copies of any written communications from the governments, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 12875 requires EPA to develop an effective process
permitting elected officials and other representatives of State, local
and tribal governments ``to provide meaningful and timely input in the
development of regulatory proposals containing significant unfunded
mandates.''
Today's rule does not create an unfunded federal mandate on State,
local or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian Tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 18, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. In Sec. 180.384 as follows:
i. By designating the existing text as paragraph (a) and adding a
paragraph heading.
ii. By adding paragraph (b) and by adding and reserving with
headings paragraphs (c) and (d).
The added text reads as follows:
Sec. 180.384 N,N-Dimethylpiperidinium chloride; tolerances for
residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time limited tolerances are
established for residues of the plant growth regulator mepiquat
chloride, N,N-Dimethylpiperidinium chloride under section 18 emergency
exemptions granted by EPA when used on the commodities in the table
below. The tolerances will expire and are revoked on the dates
specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Grapes.......................... 1.0 3/1/00
Raisins......................... 6.0 3/1/00
------------------------------------------------------------------------
[[Page 51848]]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
PART 186-- [AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows;
Authority: 21 U.S.C. 348.
Sec. 186.2275 [Partially Redesignated and Removed]
b. In Sec. 186.2275 by transfering the entry for ``cottonseed''
from the table and adding it alphabetically to the table in newly
designated paragraph (a) of Sec. 180.384, and by removing the remainder
of Sec. 186.2275.
[FR Doc. 98-25984 Filed 9-28-98; 8:45 am]
BILLING CODE 6560-50-F
