[Federal Register Volume 65, Number 59 (Monday, March 27, 2000)]
[Rules and Regulations]
[Pages 16143-16149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7416]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300988; FRL-6498-7]

RIN 2070-AB78


Dichlormid; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of the inert ingredient (herbicide safener) dichlormid (N,N-
diallyl dichloroacetamide) in or on corn commodities (forage, grain, 
stover) at 0.05 ppm. Zeneca Ag Products requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996. The tolerances will expire and be 
revoked on March 27, 2002.

DATES: This regulation is effective March 27, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300988, 
must be received by EPA on or before May 26, 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- 300988 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva Alston, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg.,1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone number: (703-308-8373; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

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
           Categories                    NAICS            potentially
                                                       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-300988. 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.

[[Page 16144]]

II. Background and Statutory Findings

    The Agency previously established under the Federal Food, Drug, and 
Cosmetic Act in a Federal Register Notice dated March 18, 1994 (59 FR 
12857), a time-limited tolerances for dichlormid which expired on 
December 31, 1998. These tolerances were for corn, forage (field), at 
0.05 ppm; corn, fodder (field) at 0.05 ppm; and corn, grain (field) at 
0.05 ppm. In the Federal Register of September 16, 1998 (63 FR 49568-
49574) (FRL-6025-8), 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 pesticide petition (PP) 6F03344 for tolerance 
by Zeneca Ag Products, 1800 Concord Pike, Wilmington, DE. This notice 
included a summary of the petition prepared by Zeneca Ag Products, the 
petitioner. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR 180.469 be amended to establish 
again tolerances for residues of the safener dichlormid, in or on field 
corn grain, field corn forage, and field corn fodder at 0.05 ppm. The 
tolerances will expire and be revoked on March 27, 2002.
    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. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings. 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 time limited tolerances for residues of dichlormid on 
corn, field, forage at 0.05 ppm; corn, field, grain, at 0.05 ppm; corn, 
field, stover at 0.05 ppm; corn, pop, grain at 0.05 ppm; corn, pop, 
stover at 0.05 ppm. EPA's assessment of the dietary exposures and risks 
associated with establishing the tolerances 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 dichlormid are 
discussed in this unit.
    1. Acute oral toxicity to the rat. Lethal Dose, LD50, is 
2,146 mg/kg. Clinical signs of neurotoxicity included upward curvature 
of the spine, piloerection, salivation, tip toe gait (Toxicity Category 
III).
    2. Acute dermal toxicity. LD50 < 2,000 mg/kg (limit 
dose) (Toxicity Category III).
    3. Acute inhalation. Lethal Concentration (LC50) is 
greater than 5.5 mg/L limit dose. Clinical signs of neurotoxicity 
included head flicking, paw flicking, and salivation.
    4. Primary eye irritation. Mild Ocular Irritant (Toxicity Category 
IV).
    5. Primary dermal irritation. Severe Dermal Irritant (Toxicity 
Category II).
    6. Skin sensitization. Mild dermal sensitizer.
    7. 90-day feeding study/rat. The no-observed-adverse-effect level 
(NOAEL) is 20 ppm (intake of approximately 1.4 mg/kg/day for males and 
1.6 mg/kg/day for females). Based on minor decreases in body weight 
gains and food efficiency in females and on increased liver weight and 
a slightly increased incidence of liver lipidosis in males, the lowest-
observe-adverse-effect level (LOAEL) is 200 ppm under the conditions of 
this study (intake of approximately 14 mg/kg/day for males and 16 mg/
kg/day for females.
    8. 90-day feeding (capsule) study. The NOAEL is 5 mg/kg/day for 
both sexes in the 90-day dog study. Based on decreased body weight 
gains, hematological and clinical chemistry alterations, liver 
toxicity, and voluntary muscle pathological changes, the LOAEL is 25 
mg/kg/day for both males or females under the conditions of this study.
    9. 90-day inhalation study. The NOAEL is 2 mg/m3 (2 
g/L) in the 90-day rat inhalation study. The LOAEL is 19.9 mg/
m3 (19.9g/L) based on clinical signs, gross 
pathology, opthamology, liver and kidney weights, and non-neoplastic 
histology.
    10. Carcinogenicity in the mouse. Under the conditions of the 
study, there was no evidence of carcinogenic potential. The NOAEL for 
chronic toxicity is 50 ppm (equivalent to 7.0 mg/kg/day for male mice 
and 9.2 mg/kg/day for females). The LOAEL for chronic toxicity is 500 
ppm (equivalent to 70.7 mg/kg/day for male mice and 92.4 mg/kg/day for 
females) based on changes in reproductive organs and kidney changes in 
males.
    11. Combined chronic toxicity/carcinogenicity in the rat. Under the 
conditions of this study, there was no evidence of carcinogenic 
potential. The NOAEL for chronic toxicity is 100 ppm (6.5 mg/kg/day and 
7.5 mg/kg/day for males and females respectively). The LOAEL is 500 ppm 
(32.8 mg/kg/day and 37.1 mg/kg/day in males and females respectively) 
based on liver clinical pathology, liver histopathology, and increased 
liver weight.
    12. Developmental toxicity in the rat. The developmental toxicity 
NOAEL is 40 mg/kg/day. The maternal toxicity NOAEL is 10 mg/kg/day. The 
maternal toxicity LOAEL is 40 mg/kg/day based on decreased mean 
absolute body weights, body weight gains, and food consumption. The 
developmental toxicity LOAEL is 160 mg/kg/day based on a marginal 
increase in skeletal anomalies.
    13. The developmental toxicity in the rabbit. The developmental 
toxicity and the maternal toxicity NOAEL are 30 mg/kg/day. The maternal 
toxicity LOAEL is 180 mg/kg/day based on an increased incidence of 
alopecia and decreased

[[Page 16145]]

mean maternal body weight gains and food consumption. The developmental 
toxicity LOAEL is 180 mg/kg/day based on increases in post-implantation 
loss accompanied by an increased number of resorptions per doe (both 
early and late resorptions), a decreased number of fetuses per litter, 
and slightly decreased mean fetal body weights.
    14. Mutagenicity/gene mutation. Dichlormid was negative for 
mutagenic activity in Salmonella typhimurium strains TA 1535 ,TA 1537, 
TA 98, & TA 100 in both the absence and presence of metabolic 
activation up to cytotoxic doses. Dichlormid was positive for mutagenic 
activity both in the absence and presence of metabolic activation in 
vitro L5178Y Mouse Lymphoma Cells at doses that extend to the cytotoxic 
range.
    15. Mutagenicity/structural chromosomal aberration. Dichlormid was 
negative for mutagenicity in an in vitro cytogenetic assay in human 
lymphocytes in the presence and absence of S-9 up to cytotoxic doses. 
Dichlormid was not clastogenic or anugenic mutagenicity in an in vivo 
mouse micronucleus assay up to 2,000 mg/kg.
    16. Mutagencity/other. Dichlormid was negative for induced 
unscheduled DNA synthesis in rat primary hepatocytes.

B. Toxicological Endpoints

    1. Acute dietary toxicity. For an acute dietary risk assessment, 
the Agency selected a maternal toxicity NOAEL of 10 mg/kg/day from the 
developmental toxicity study in the rat. The LOAEL is 40 mg/kg/day 
based on decreased body weight gain and food consumption (most 
significant on days 7-10 of dosing).
    2. Short-term dermal toxicity. For a short-term dermal risk 
assessment the Agency selected the maternal toxicity NOAEL of 10 mg/kg/
day. The LOAEL of 40 mg/kg/day was based on decreased body weight gain 
and food consumption. This dose was also selected for the acute 
toxicity. The duration of the short term dermal scenarios for 
dichlormid are comparable to the duration of exposure in the rat 
developmental toxicity study.
    3. Intermediate and long term dermal toxicity. For intermediate and 
long-term dermal risk assessment, the Agency selected a NOAEL of 6.5 
mg/kg/day (100 ppm) from a 2-year chronic toxicity/carcinogenicity rat 
feeding study. The LOAEL of 32.8 mg/kg/day (500 ppm) was based on an 
increased incidence of liver clinical pathology/histopathology and 
increased liver weight in the 2-year study in rats.
    4. Inhalation (all durations). For an inhalation risk assessment, 
the Agency selected an inhalation NOAEL of 2 g/L based on 
clinical signs, increased liver and kidney weight, gross pathology 
findings and non-neoplastic histopathology at the LOAEL of 19.9 
g/L (14-week inhalation study).
    5. Chronic dietary toxicity. For a chronic dietary risk assessment 
the Agency selected a NOAEL of 6.5 mg/kg/day (100 ppm) from a 2-year 
chronic toxicity/carcinogenicity rat feeding study. The LOAEL of 32.8 
mg/kg/day (500 ppm) was based on an increased incidence of liver 
clinical pathology/histopathology and increased liver weight in the 2-
year study in rats.
    6. Carcinogenicity. There is no evidence of carcinogenic potential 
in the rat and mouse carcinogenicity studies based on evaluation of the 
above described studies.
    7. Dermal penetration. Dermal penetration could not be determined 
due to the absence of appropriate dermal studies and therefore a value 
of 100% dermal penetration was used.
    8. Safety factors. The Agency will use the above NOAELs and LOAELs 
levels to assess the risks of using dichlormid to the general 
population and certain subgroups of the general population. However, 
the Agency first modifies these values numerically downward by dividing 
the NOAEL by two or more safety factors. The safety (uncertainty) 
factors used are: a 10-fold factor to account for intraspecies 
variability (the differences in how the test animals reacted to the 
test substance) and a 10-fold factor to account for interspecies 
variation (the use of animal studies to predict human risk).
    FFDCA Section 408 provides that the Agency 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 the Agency 
determines that a different margin of safety will be safe for infants 
and children. As noted, the Agency has added an additional ten fold 
factor to both the acute and chronic dietary risk assessment due to the 
qualitative evidence of increased susceptibility demonstrated following 
in utero exposure in the prenatal developmental toxicity study in 
rabbits; and the incompleteness of the toxicity database. There are 
data gaps for the 2-generation reproduction study in rats, and acute 
and subchronic neurotoxicity studies.
    i. Acute dietary toxicity. The Agency divided the NOAEL by 1,000 
(10x interspecies extrapolation, 10x intraspecies variation and 10x 
safety factor) to address additional susceptibility in the fetus and 
data gaps. The acute Population Adjusted Dose (aPAD) is equal to 0.010 
mg/kg/day.
    ii Chronic dietary toxicity. The Agency divided the NOAEL of 6.5 
mg/kg/day by 3,000 (10x interspecies extrapolation, 10x intraspecies 
variation, 10x for additional susceptibility and the data gap for the 2 
generation reproductive study, and 3x for the data gap for the chronic 
toxicity study in dogs). The chronic Population Adjusted Dose (cPAD) is 
equal to 0.0022 mg/kg/day.

C. Exposures and Risks

    1. From food and feed uses. Time-limited tolerances were previously 
established in 40 CFR 180.469 for residues of dichlormid at 0.05 ppm, 
in or on corn. Risk assessments were conducted by EPA to assess dietary 
exposures from dichlormid 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. In performing the acute dietary risk 
assessment, the Agency's level of concern is for exposures greater than 
100% aPAD. For all population groups, including U.S. Population, 
infants and children, the acute dietary exposures are less than the 
Agency's level of concern at the 95th percentile using tolerance level 
residues and assuming 100%CT. The population groups with the highest 
dietary exposures are all infants (> 1 year) (5 %), non nursing infants 
(> 1 year) (5%), and children (1-6 years of age) (4%), children (7-12 
years of age) (3%).
    ii. Chronic exposure and risk. In performing the chronic dietary 
risk assessment, the Agency's level of concern is for exposures greater 
than 100% cPAD. Using tolerance level residues and assuming 100%CT, the 
population groups with the highest percentages are all infants (> 1 
year) (7%), non-nursing infants (> 1 year) (9%), Children (1-6 years 
old) (7%), children (7-12 years old) (5%), and males (13-19 years)(4%).
    2. From drinking water. A Drinking Water Level of Comparison 
(DWLOC) is a theoretical exposure to a pesticide in food, drinking 
water, and through residential uses. A DWLOC will vary depending on the 
toxic endpoint, with drinking water consumption, and body weights. 
Different populations will have different DWLOCs. The Agency uses 
DWLOCs internally in the risk assessment process as a surrogate measure 
of potential exposure

[[Page 16146]]

associated with exposure through drinking water. In the absence of 
monitoring data for pesticides, it is used as a point of comparison 
against conservative model estimates of a pesticide's concentration in 
water. DWLOC values are not regulatory standards for drinking water. 
They do have an indirect regulatory impact through aggregate exposure 
and risk assessments.
    Dichlormid is relatively short-lived in aerobic soil. Carbon 
dioxide was the only major identified aerobic soil metabolite. 
Significant amounts of other soil degradates were resistant to harsher 
extraction and presumably remain as bound residues. Dichlormid was 
stable against hydrolysis and photolysis in soil and water. 
Dichlormid's low sorptivity to soil indicates high mobility. Based on 
its low sorptivity to soil, high solubility in water (4.4 g/L), and low 
octanol to water partitioning ratio, bioconcentration is not 
anticipated.
    Drinking water exposure estimates are based on degradation and 
transport factors for dichlormid coupled with the Agency's current 
GENEEC (surface water) and SCI-GROW (groundwater) screening models for 
surface and ground water, respectively. Model results are for an 
application rate of dichlormid of 0.5 lbs/acre.
    For ground water, the Agency used its SCI-GROW (Screening 
Concentration in Ground Water) screening model and environmental fate 
data to determine the Estimated Environmental Concentration (EEC) of 
dichlormid in ground water. SCI-GROW is an empirical model based upon 
actual ground water monitoring data collected for the registration of a 
number of pesticides that serve as benchmarks for the model. The 
current version of SCI-GROW appears to provide realistic estimates of 
pesticide concentrations in shallow, highly vulnerable ground water 
sites (i.e., sites with sandy soils and depth to ground water of 10 to 
20 feet). The SCI-GROW ground water screening concentration is 0.046 
ppb.
    For surface water, the Agency used its GEENEC (Generic Estimated 
Environmental Concentration) screening model and environmental fate 
data to determine the EECs of dichlormid in surface water. GENEEC 
simulates a 1 hectare by 2 meter deep edge-of-the-field farm pond which 
receives pesticide runoff from a treated 10 hectare field. GENEEC can 
substantially overestimate true pesticide concentrations in drinking 
water. It has certain limitations and is not the ideal tool for use in 
drinking water risk assessments. However, it can be used in screening 
calculations and does provide an upper bound on the concentration of 
true drinking water concentrations. It will be necessary to refine the 
GENEEC estimate when the level of concern is exceeded. In those 
situations where the level of concern is exceeded and the GENEEC value 
is a substantial part of the total exposure, the Agency can use a 
variety of methods to refine the exposure estimates.
    Using the GENEEC model and available environmental fate data, EPA 
calculated the following Tier 1 EECs for dichlormid:

      Peak (Acute) EEC: 27.29 ppb
      Average (Chronic) EEC 26.93 ppb

    However, the interim Agency policy allows the average (chronic) 
GENEEC value to be divided by 3 to obtain a value of 8.98 ppb for use 
in chronic risk assessment calculations. It is current Agency policy 
that the following subpopulations be addressed when calculating 
drinking water levels of concern: U.S. Population (48 States), any 
other adult populations whose %PAD is greater than that of the U.S. 
population, and the Female and Infant/Children subgroups (1 each) with 
the highest food exposure. The subgroups which are listed below are 
those which fall into these categories.
    i. Acute exposure and risk. Based on the acute dietary exposure 
estimates, an acute drinking water level of comparison (DWLOC) for 
dichlormid was calculated to be 340 ppb and 95 ppb for the U.S. 
population and non-nursing infants (> 1 year old) respectively.
    ii. Chronic exposure and risk. Based on the chronic dietary 
exposure estimates, chronic drinking water levels of comparison (DWLOC) 
for dichlormid was calculated to be 75 ppb and 20 ppb for the U.S. 
population and non-nursing infants (> 1 year old), respectively.
    iii. Drinking water risks. The modeled groundwater and surface 
water concentrations are less than the DWLOCs for dichlormid in 
drinking water for acute and chronic aggregate exposures. Thus, the 
Agency is able to screen out dichlormid drinking water risks.
    3. From non-dietary exposure. There are no existing residential 
uses for dichlormid; therefore, no assessment was performed for 
residential exposure.
    4. Cumulative exposure to substances with a 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 dichlormid 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, 
dichlormid 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 dichlormid has a common mechanism of toxicity 
with other substances. For 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).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. High-end dietary exposure estimates through food 
were calculated for the U.S. Population and other subgroups. The % 
aPADs for the U.S. population and all other subgroups were > 5% which 
is below the Agency's level of concern of 100% at the 95th 
percentile. The acute estimated concentrations of dichlormid in surface 
and ground water are less than the Agency's DWLOCs for dichlormid. 
Therefore, EPA does not expect the aggregate risk to exceed 100% of the 
aPAD.
    2. Chronic risk. There are no registered residential uses for 
dichlormid. Chronic aggregate exposure will include food and water 
only. Using tolerance level residues and 100% crop treated assumptions, 
the percent cPADS for the U.S. population and all other subgroups were 
> 9%. The estimated chronic dietary risk from food is below the 
Agency's level of concern (100%). The estimated average concentrations 
of dichlormid in surface and ground water are less than the Agency's 
DWLOCs for dichlormid in drinking water. Therefore, EPA does not expect 
the aggregate risk to exceed 100% of the cPAD.
    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 exposure. There are no existing residential uses for 
dichlormid; therefore, no short-term or intermediate-term risk 
assessment was performed.

[[Page 16147]]

    4. 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 dichlormid 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 dichlormid, EPA considered data from 
developmental toxicity studies in the rat and rabbit. The developmental 
toxicity studies are designed to evaluate adverse effects on the 
developing organism resulting from maternal pesticide exposure 
gestation.
    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) 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. Conclusion. An additional safety factor is to be retained at 
10x since: (1) There is qualitative evidence of increased 
susceptibility in the rabbit developmental study; and (2) the toxicity 
database is incomplete. There are data gaps for the 2-generation 
reproduction study in rats, and acute and subchronic neurotoxicity 
studies.
    2. Acute risk. From the acute dietary risk assessments, high-end 
exposure estimates were calculated for the U.S. Population and other 
subgroups. At the 95 th percentile the highest dietary 
exposure for infants < 1 year and non-nursing infants (< 1 year old) is 
5% aPAD. The estimated acute dietary risk associated with the use of 
dichlormid on corn is below the Agency's level of concern. The maximum 
estimated concentrations of dichlormid in surface and ground water are 
less than the Agency's DWLOCs for dichlormid. Therefore, EPA does not 
expect the acute risk to exceed 100% of the aPAD.
    3. Chronic (non cancer) risk. There are no registered residential 
uses for dichlormid. Therefore, chronic aggregate exposure will include 
food and water only. Using tolerance level residues and 100% crop 
treated assumptions, the highest exposure is from an infants and 
children subgroup, non-nursing infants(< 1year old), with an estimated 
dietary exposure of 9% cPAD. The estimated chronic dietary risk 
associated with the use of dichlormid on corn is below the Agency's 
level of concern. The estimated average concentrations of dichlormid in 
surface and groundwater are less than the Agency's DWLOCs for 
dichlormid in drinking water. Therefore, EPA does not expect the 
chronic risk to exceed 100% of the cPAD.
    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 exposure. There are no existing residential uses for 
dichlormid, therefore, no short and intermediate term risk assessment 
was performed.
    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 dichlormid residues.

IV. Other Considerations

A. Endocrine Disruptor Effects

    FQPA requires the Agency to develop a screening program to 
determine whether certain substances (including all pesticides and 
inerts or active ingredients) ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect...'' The Agency has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
the inert ingredient dichlormid for endocrine effects may be required.

B. Metabolism in Plants and Animals

    No data pertaining to the metabolism of dichlormid have been 
submitted. The nature of the residue in corn was previously found to be 
understood based on the published metabolism studies of N,N-diallyl-2-
chloroacetamide. It was concluded that the metabolism of dichlormid 
would follow the pathway of N,N-dially-2-chloroacetamide.

C. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

D. Magnitude of Residues

    Crop field trial data for dichlormid were submitted and reviewed. 
The submitted data support the time-limited tolerance level of 0.05 ppm 
for all corn commodities.

E. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits 
for residues of dichlormid in corn commodities.

V. Conclusion

    Therefore, the time limited tolerances are established for residues 
of the inert ingredient herbicide safener, N,N-diallyldichloracetamide 
in corn, field, forage at tolerance level of 0.05 ppm; corn, field, 
grain at a tolerance level of 0.05 ppm; corn, field, stover at a 
tolerance level of 0.05 ppm; corn, pop, grain at a tolerance level of 
0.05 ppm; and corn, pop, stover at a tolerance level of 0.05 ppm. The 
tolerances will expire and be revoked 2 years from the date of this 
publication. These tolerances are being established on a time-limited 
basis due to an incomplete data base. The following toxicological data 
gaps (OPPTS Harmonized Test Guideline) have been identified (1) Chronic 
Feeding Study in Dogs, Test Guidelines 870.4100; (2) 2-Generation 
Reproductive Study in Rats, Test Guideline 870.3800; (3) General 
Metabolism Study, Test Guideline 870.7485; (4) Acute Neurotoxicity 
Study, Test Guideline 870.6200; and (5) Subchronic Neurotoxicity Study, 
Test Guideline 870.6200.
    The following product and residue chemistry data were also 
identified: (1) Product Chemistry Data-color, Test Guideline 830.6302; 
physical state, Test Guideline 830.6303; odor, 830.6304; melting point, 
Test Guideline 830.7200; boiling point, Test Guideline 830.7220; water 
solubility, Test Guideline 830.7840; and stability, Test Guideline 
830.6313; (2) Plant Metabolism Study, Test Guideline 860.1300; (3) 
Animal Metabolism Studies, Test Guideline

[[Page 16148]]

860.1300; (4) Crop Field Trials, 860.1500; (5) Rotational Crop Study, 
Test Guideline 860.1850 (Confined Study). The toxicological, product 
chemistry and residue chemistry data gaps as identified must be 
addressed before a permanent tolerance can be established.

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-300988 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 May 26, 
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, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., 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, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
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, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., 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-300988, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
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 6.1/8.0 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 requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a time-tolerance 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

[[Page 16149]]

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 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. 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: March 16, 2000
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. Section 180.469 is revised to read as follows:


Sec. 180.469  N,N-diallyl dichloroacetamide; tolerances for residues.

    (a) General. Tolerances are established for residues of dichlormid; 
N,N-diallyl dichloroacetamide (CAS Reg. No. 37764-25-3) when used as an 
inert ingredient (safener) in pesticide formulations in or on the 
following food commodities:

------------------------------------------------------------------------
                                   Parts
            Commodity               per      Expiration/Revocation Date
                                  million
------------------------------------------------------------------------
Corn, field, forage.............     0.05                March 27, 2002
Corn, field, grain..............     0.05                March 27, 2002
Corn, field, stover.............     0.05                March 27, 2002
Corn, pop, grain................     0.05                March 27, 2002
Corn, pop, stover...............     0.05                March 27, 2002
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 00-7416 Filed 3-24-00; 8:45 am]
BILLING CODE 6560-50-F