[Federal Register Volume 65, Number 8 (Wednesday, January 12, 2000)]
[Rules and Regulations]
[Pages 1790-1796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-362]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300962; FRL-6485-4]
RIN 2070-AB78
Mepiquat Chloride; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for mepiquat chloride
regulated as N,N-dimethylpiperidinium chloride in or on grapes and
raisins. BASF Corporation requested these tolerances under the Federal
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection
Act of 1996.
DATES: This regulation is effective January 12, 2000. Objections and
requests for hearings, identified by docket control number OPP-300962,
must be received by EPA on or before March 13, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300962 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: 703 305-7740; and e-mail address: giles-
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 1791]]
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of Potentially
Categories NAICS Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300962. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of November 24, 1999 (64 FR 66181) (FRL-
6396-4), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP) for a tolerance by
BASF Corporation. This notice included a summary of the petition
prepared by BASF Corporation the registrant. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR 180.384 be amended by
establishing tolerances for residues of the plant growth regulator
mepiquat chloride, in or on grapes at 1.0 parts per million (ppm), and
raisins at 5.0 ppm.
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....''
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).
III. Aggregate Risk Assessment and Determination of Safety
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 and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for tolerances for residues of mepiquat chloride in or on
grapes at 1.0 ppm, and raisins at 5.0 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 results of the toxicity studies for mepiquat chloride are
listed below.
1. Subchronic toxicity study-- Rat. The no-observed-adverse- effect
level (NOAEL) for males and females is 4,632 ppm (about 346 mg/kg/day)
and the lowest-observed-adverse-effect level (LOAEL) for males and
females is 12,000 ppm (about 889 mg/kg/day) based on tremors in all
rats; decreased body weight gain, food consumption and food efficiency;
increase in thromboplastin time; decrease in serum calcium, creatinine
glucose, total protein, albumin, globulin and the triglycerides;
reduced grip strength of forelimbs and hindlimbs in both sexes;
prolonged reaction time in the hot-plate test on day 93 in males;
decreased absolute weight of liver, kidneys and adrenals in males, and
liver and adrenals in females; decreased relative weight of liver in
males; and increased relative weight of kidneys and testes in males and
of kidneys in females.
2. Subchronic toxicity study-- dog. The LOAEL is 3,000 ppm (95.3
mg/kg/day), based on clinical signs of toxicity (slight sedation), body
weight loss (up to 14%) and hematological effects (up to 14% reduction
in hemoglobin content and number of erythrocytes and reduced
hematocrit). The NOAEL is 1,000 ppm (32.4 mg/kg/day).
3. Chronic toxicity study--rat. The NOAEL is 2,316 ppm (106 mg/kg/
day). The LOAEL is 5,790 ppm (268 mg/kg/day), based upon decreased body
weights and body weight gains for both males and females, increases in
urinary crystals for males, and pathological
[[Page 1792]]
changes in the adrenal cortex in females.
4. Chronic toxicity Study-- dog. Study 1 and 2. The NOAEL is
1,800 ppm (58.4 mg/kg/day) and the LOAEL is 6,000 ppm (170 mg/kg/day),
based on impaired neurological functions (slight sedation, abdominal/
lateral positioning, spasms, and salivation) and epithelial
vacuolization of the renal distal tubules.
5. Carcinogenicity study--rat. The LOAEL for males (269 mg/kg/day)
and females (370 mg/kg/day) is 5,790 ppm, based upon decreased body
weights, body weight gains, food consumption, food efficiency, and
macroscopic and non-neoplastic findings. The NOAEL for males (105 mg/
kg/day) and females (141 mg/kg/day) is 2,316 ppm. There were no
treatment-related neoplastic findings for males or females treated with
mepiquat chloride. Thus, mepiquat chloride does not exhibit
carcinogenic potential in a 2-year feeding study involving male and
female, rats.
6. Carcinogenicity study-- mice. The NOAEL for mepiquat chloride
administered for 2 years in food is 7,500 ppm for male (1,140 mg/kg/
day) and female (1,348 mg/kg/day) B6C3F1 mice. There were no treatment-
related neoplastic findings for males or females treated with mepiquat
chloride. Thus, mepiquat chloride does not exhibit carcinogenic
potential in a 2-year feeding study involving male and female B6C3F1
mice over this dose range. Based upon the lack of treatment-related
findings, mepiquat chloride was not administered at the Maximum
Tolerated Dose (MTD). However, the high dose (7,500 ppm) for the study
was sufficient to assess carcinogenicity since the limit dose of 1,000
mg/kg/day was exceeded.
7. Developmental toxicity study-- rat. 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 NOAEL is greater than or
equal to 300 mg/kg/day, the highest dose tested.
8. Developmental toxicity study--. rabbit. The maternal LOAEL is
150 mg/kg body weight/day, based on reduced body weight gains and
reduced food consumption. The maternal NOAEL is 100 mg/kg body weight/
day. The developmental LOAEL is 150 mg/kg/day, based on increased
skeletal variations. The developmental NOAEL is 100 mg/kg/day.
9. Reproductive toxicity study--two-generation--rat. The LOAEL for
systemic toxicity is 5,000 ppm 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. This dose corresponds to dietary concentrations of 499.3 and
574.5 mg/kg/day, respectively, for F0 and F1
males and 530.0 and 626.5 mg/kg/day, respectively, for F0
and F1 females. The corresponding NOAEL is 1500 ppm. There
were no treatment-related effects on reproductive parameters. The LOAEL
for reproductive toxicity is greater than 5,000 ppm. This study did not
establish a reproductive NOAEL; however, the systemic NOAEL of 1,500
ppm would also be regarded as the reproductive NOAEL.
10. Reverse Gene Mutation Assay. Negative.
11. Structural Chromosome Aberration Assay. Negative.
12. Unscheduled DNA Synthesis Assay. Negative.
13. Metabolism study. Mepiquat chloride did not accumulate in
tissues of rats. Urine, feces and bile samples from various treatments
were used for studies of the metabolic fate of mepiquat chloride. In
all cases, only the unchanged compound could be detected. There was no
biotransformation of mepiquat chloride in vivo. The potential
metabolites, such as 1-methylpiperidine or piperidine, were not
detected.
B. Toxicological Endpoints
The following endpoints were used in the risk assessments for
mepiquat chloride.
1. Acute toxicity. The endpoint for the acute dietary risk
assessment was estimated, based on the 1-year dog feeding study with
the 90-day dog feeding as a supporting study. The NOAEL was 58.4 mg/kg/
day, the Uncertainty Factor (UF) was 100, and the FQPA safety factor
was reduced to 1X and applies to all population subgroups. The
endpoints were impaired neurological functions (salivation, sedation,
spasms, abdominal/lateral positioning), epithelial vacuolation of renal
distal tubules, decrease in body weight, and hematology changes
(decrease in RBC, hemoglobin, and hematocrit). The acute reference dose
(aRfD) was 0.6 mg/kg/day. Since the FQPA safety factor was reduced to
1x the Acute Population Adjusted Dose (aPAD) was 0.6 mg/kg/day.
2. Short- and intermediate-term toxicity. The oral NOAEL of 58.4
mg/kg/day from the combined chronic and subchronic toxicity studies in
dogs was selected for the short- and intermediate-term dermal endpoint.
The LOAEL was 95.3 mg/kg/day, based on clinical signs of toxicity
(sedation, abdominal and lateral positions and tonic/clonic spasms),
decreased body weight, and hematological changes. An oral dose was
selected due to the lack of a dermal toxicity study. An UF of 100 was
selected, based on 10x for interspecies extrapolation and 10x for
intraspecies variability. The Dermal Absorption Factor (DAF) is 25%.
The inhalation absorption factor is 100%..
3. Chronic toxicity. The chronic dietary endpoint is the NOAEL of
58.4 mg/kg/day from the 1-year and the 90-day dog feeding studies for
the general U.S. population. The LOAEL was 95.3 mg/kg/day, based on
clinical signs of toxicity (sedation, abdominal and lateral positions
and tonic/clonic spasms), decreased body weight, and hematological
changes. An UF of 100 was selected, based on 10x for interspecies
extrapolation and 10x for intraspecies variability. The chronic RfD,
0.6 mg/kg/day is the chronic NOAEL divided by the UF which equals 58.4
mg/kg/day divided by 100. Since the FQPA safety factor was reduced to
1x the chronic population adjusted dose (cPAD) equals 0.6 mg/kg/day.
4. Carcinogenicity. Mepiquat chloride is classified as a ``not
likely'' human carcinogen.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.384) for the residues of mepiquat chloride, in or on cotton
seed, cotton forage, meat, milk, poultry and eggs. Tolerances are
proposed on grapes and raisins. Risk assessments were conducted by EPA
to assess dietary exposures 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 Dietary Exposure Evaluation Model
(DEEM) detailed acute analysis estimates the distribution of single
exposures for the overall U.S. population and certain subgroups. The
analysis evaluates individual food consumption as reported by
respondents in the USDA 1989-1992 Continuing Survey of Food Intake by
Individuals (CSFII) and accumulates exposure to the chemical for each
commodity. Each analysis assumes uniform distribution of mepiquat
chloride in the commodity supply.
A Tier 1 (assumptions: tolerance level residues and 100 percent
crop treated,) acute dietary risk assessment was
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conducted via DEEM. The DEEM processing factor was set at 1.00 for
grape juice, based on the lack of concentration of residues therein;
the default ratio of 3.0 was applied to grape juice concentrate. The
commodities included in the acute DEEM analysis were: cottonseed (meal,
oil); grapes (grapes, juice, juice concentrate, leaves, raisins, wine
and sherry); and, the meat, fat, and meat by-products of cattle, goats,
hogs, horses (meat only), and swine. Milk, egg, and poultry tolerances
were not included, as these have recently been revoked, based upon the
Regegistration Eligibility Determinations that the data indicate no
finite residues are likely to occur in these commodities (40 CFR
180.6a(3)).
The resulting dietary food exposures (95th percentile) occupy up to
1.5% of the aPAD for the most highly exposed population subgroup
(Children 1-6 years). These results should be viewed as conservative,
health protective risk estimates. Refinements such as taking into
account that only two grape varieties are to be treated; the percent-
treated of their market share; and, Monte Carlo analysis, would yield
even lower estimates of acute dietary exposure.
ii. Chronic exposure and risk. A Tier 1, chronic dietary risk
assessment was conducted via DEEM. The DEEM processing factor settings
for grape juice (1.0) and grape juice concentrate (3.0), and the
commodities included in the chronic DEEM analysis, were exactly the
same as those included in the acute DEEM analysis.
The resulting dietary food exposures occupy up to 0.3% of the cPAD
for the most highly exposed population subgroup (Children 1-6 years).
These results should be viewed as conservative, health protective risk
estimates. Refinements such as taking into account that only two grape
varieties are to be treated; the percent-treated of their market share;
and, anticipated residues would yield even lower estimates of chronic
dietary exposure.
iii. Cancer dietary risk from food sources. Mepiquat chloride was
classified as a ``not likely human carcinogen.'' Therefore, a cancer
risk assessment was not conducted.
2. From drinking water. EPA does not have monitoring data available
to perform a quantitative drinking water risk assessment for mepiquat
chloride. In the absence of reliable, available monitoring data, EPA
uses models which incorporate chemical-specific data on the
characteristics in question to estimate concentrations of pesticides in
ground and surface water. A drinking water estimate for mepiquat
chloride in ground water was generated by the screening concentratin in
ground water (SCI-GROW) model. Conservative assumptions were built into
the ground water scenario used by the SCI-GROW model, such as assuming
shallow ground water, coarse soils and high levels of irrigation. The
estimate from SCI-GROW (0.004 parts per billion (ppb)) represents an
upper bound on the concentration of mepiquat chloride in ground waters
as a result of agricultural use.
Estimates of concentrations of mepiquat chloride in surface water
were made using the generic expected environmental concentration
(GENEEC) model. The peak estimate for mepiquat chloride using the
GENEEC model is 1.86 ppb. The 56-day average for mepiquat chloride is
1.06 ppb.
A Drinking Water Level of Comparison (DWLOC) is a theoretical upper
limit of a pesticide's concentration in drinking water in light of
total aggregate exposure to that pesticide in food and through
residential uses. A DWLOC will vary depending on the toxic endpoint,
consumption and body weight. Different populations will have different
DWLOCs. EPA uses DWLOCs internally in the risk assessment process as a
surrogate measure of potential exposure associated with pesticide
exposure through drinking water. In the absence of monitoring data for
pesticides, the DWLOC is used as a point of comparison against
conservative model estimates of potential pesticide concentration in
water. DWLOC values are not regulatory standards for drinking water.
EPA has calculated DWLOCs for acute and chronic (non-cancer) exposure
to mepiquat chloride for the U.S. population and selected subgroups.
The DWLOCs for acute and chronic risk range from 6,000 ppb for
infants and children to 21,000 ppb for the U.S. population. The
estimated concentration of mepiquat chloride in ground water is 0.004
ppb and 1.86 ppb in surface water, which are less than the DWLOCs as a
contribution to acute and chronic exposure. The estimated
concentrations of mepiquat chloride in ground and surface water are
considered conservative estimates. Therefore, EPA concludes with
reasonable certainty that residues of mepiquat chloride in food and
drinking water would not result in an unacceptable estimate of acute or
chronic (non-cancer) aggregate human health risk.
3. 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 information
regarding EPA 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).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. The acute aggregate risk is the sum of exposures
resulting from acute dietary food and acute dietary drinking water.
This acute aggregate risk assessment was conducted for all population
subgroups, and the aPAD (0.6 mg/kg/day) was applied in determining
exposures to all population subgroups. The Estimated Environmental
Concentrations (EEC) for assessing acute aggregate dietary risk are
0.004 ppb (in ground water, based on SCI-GROW) and 1.9 ppb (in surface
water, based on the GENEEC peak value). The back-calculated DWLOCs for
assessing acute aggregate dietary risk range from 6,000 ppb for the
most highly exposed population subgroup (Non-nursing infants, < 1 year
old, and Children, 1-6 years old) to 21,000 ppb for the U.S. population
(all seasons).
The SCI-GROW and GENEEC acute EEC values are less than the Agency's
level of concern (the acute DWLOC value for each population subgroup)
for mepiquat chloride residues in drinking water as a contribution to
acute aggregate exposure. The Agency thus concludes with reasonable
certainty that residues of mepiquat chloride in drinking water will not
contribute significantly to the aggregate acute human health risk and
that the acute aggregate exposure from mepiquat chloride residues in
food and drinking water will not exceed the Agency's level
[[Page 1794]]
of concern (100% of the aPAD) for acute dietary aggregate exposure by
any population subgroup. EPA generally has no concern for exposures
below 100% of the aPAD. This risk assessment is considered high
confidence, conservative, and protective of human health.
2. Chronic risk. Chronic (non-cancer) aggregate risk is the sum of
exposures resulting from chronic dietary food, chronic dietary drinking
water and chronic residential uses. Mepiquat chloride has no registered
residential uses. Therefore, this risk assessment is the aggregate of
chronic dietary food and chronic dietary drinking water exposures only.
This chronic aggregate risk assessment was conducted for all population
subgroups, and the cPAD was applied in determining exposures to all
population subgroups.
The EECs for assessing chronic aggregate dietary risk are 0.004 ppb
(in ground water, based on SCI-GROW) and 1.1 ppb (in surface water,
based on the GENEEC 56-day average value). The back-calculated DWLOCs
for assessing chronic aggregate dietary risk range from 6,000 ppb for
the most highly exposed population subgroup (Non-nursing infants and
Children, 1-6 years old) to 21,000 ppb for the U.S. population (all
seasons).
The SCI-GROW and GENEEC chronic EEC values are less than the
Agency's level of concern (the chronic DWLOC value for each population
subgroup) for mepiquat chloride residues in drinking water as a
contribution to chronic aggregate exposure. The Agency thus concludes
with reasonable certainty that residues of mepiquat chloride in
drinking water will not contribute significantly to the aggregate
chronic human health risk and that the chronic aggregate exposure from
mepiquat chloride residues in food and drinking water will not exceed
the Agency's level of concern (100% of the cPAD) for chronic dietary
aggregate exposure by any population subgroup. EPA generally has no
concern for exposures below 100% of the cPAD, because it is a level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to the health and safety of any population
subgroup. This risk assessment is considered high confidence,
conservative, and protective of human health.
3. Short- and intermediate-term risk. These aggregate risk
assessments take into account chronic dietary exposure from food and
water, considered to be a background exposure level, plus short- and/or
intermediate-term indoor and outdoor residential exposures, as
applicable.
The Agency selected a dose and toxicological endpoint for
assessments of short- and intermediate-term dermal and inhalation risk.
However, since there are no residential uses for mepiquat chloride,
either established or pending, at this time there is no exposure.
Therefore, short-term and intermediate risk were not performed.
4. Aggregate cancer risk for U.S. population. Cancer aggregate risk
is the sum of exposures resulting from chronic dietary food, chronic
drinking water and chronic residential uses. Mepiquat chloride is
classified as a ``not likely'' human carcinogen and thus not expected
to pose a concer risk to humans.
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 residues.
E. 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 2-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 prenatal and postnatal 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 uncertainty factor (usually 100 for combined
interspecies and intraspecies 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.
The Agency determined that the FQPA safety factor for mepiquat
should be reduced to 1x for both acute and chronic risk assessments for
all population subgroups, because:
\ The toxicology database is complete for the assessment of the
effects following in utero and/or postnatal exposure to mepiquat
chloride.
\ The toxicity data provided no indication of quantitative or
qualitative increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure.
\ The requirement of a developmental neurotoxicity (DNT) study is
not based on the criteria reflecting some special concern for the
developing fetuses or young which are generally used for requiring a
DNT study and an FQPA safety factor (e.g.: neuropathy in adult animals;
CNS malformations following prenatal exposure; brain weight or sexual
maturation changes in offspring; and/or functional changes in
offspring) and therefore does not warrant an FQPA safety factor. This
is an interim step towards accordance with the proposed safety factors
for use in the tolerance-setting process which was presented to the
FIFRA SAP meeting in May, 1999 and placed in the Docket for Public
Comment (64 FR 37001, July 8, 1999; Docket No. 37001).
\ The exposure assessments will not underestimate the potential
dietary (food and water) exposures for infants and children from the
use of mepiquat chloride (currently, no residential exposure is
expected).
2. Short-or intermediate-term risk. For a discussion of aggregate
acute, chronic, and short- or intermediate-term risk to infants and
children refer to Unit III.D. on Aggregate Risks and Determination of
Safety of U.S. population.
3. 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 residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
Acceptable studies in cotton plants, grapes ruminants, and poultry
have previously been submitted and evaluated. Residues of mepiquat
chloride are systemic, with the residue of concern in plant and animal
commodities being mepiquat chloride per se.
B. Analytical Enforcement Methodology
The analytical method (GLC/NPD) used for analysis of mepiquat
chloride
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residues in grapes, grape juice, and raisins is the enforcement
procedure submitted for the Pesticide Analytical Manual, Volume II.
This procedure has previously undergone a successful Agency validation
using plant and animal matrices. The reported limit of quantitation is
0.05 ppm in grapes, 0.10 ppm in grape juice, and 0.25 ppm in raisins.
The method is adequate to enforce the tolerance expression. A copy of
the method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460; telephone number: (703) 305-5229; e-
mail address: [email protected].
C. Magnitude of Residues
Crop field trials. The grape field trials are adequate in number,
geographically representative, and reasonably reflect the proposed use
pattern. Residues of mepiquat chloride ranged from < 0.05 to 0.76 ppm.
The data support the proposed 1.0 ppm tolerance for grapes.
Processed commodities. No concentration of residues was reported in
grape juice; no tolerance is required. Residues concentrated up to 5X
in raisins. The data support the proposed 5.0 ppm tolerance for
raisins.
D. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) established for mepiquat chloride. Harmonization is thus not an
issue at this time.
E. Rotational Crop Restrictions
Not applicable. Grape vines are long-lived perennials.
V. Conclusion
Therefore, tolerances are established for residues of mepiquat
chloride in or on grapes at 1.0 ppm, and raisins at 5.0 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300962 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before March 13,
2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-300962, 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 or
by courier, bring a copy to the location of the PIRIB described in Unit
I.B.2. You may also send an electronic copy of your request via e-mail
to: [email protected]. Please use an ASCII file format and avoid the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 file format or ASCII file format. Do not
include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
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(s) in the manner sought
by the
[[Page 1796]]
requestor would be adequate to justify the action requested (40 CFR
178.32).
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. 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) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19,1998); 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 or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances 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. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
VIII. 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 this final rule in the Federal Register. This final
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: December 21, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180 [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), (346a) and 371.
2. In Sec. 180.384, by revising the section heading, paragraph (a)
introductory text and by alphabetically adding entries for grapes and
raisins to the table in paragraph (a) to read as follows:
Sec. 180.384 Mepiquat chloride; tolerances for residues.
(a) General. Tolerances are established for residues of the plant
growth regulator mepiquat chloride, N,N-dimethylpiperidinium chloride
in or on the following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Grapes..................................................... 1.0
* * * * *
Raisins.................................................... 5.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 00-362 Filed 1-11-00; 8:45 am]
BILLING CODE 6560-50-F