[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

[[Page 1793]]

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

[[Page 1795]]

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