[Federal Register Volume 64, Number 193 (Wednesday, October 6, 1999)]
[Rules and Regulations]
[Pages 54218-54224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25842]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300927; FRL-6382-3]
RIN 2070-AB78


Imazapic-Ammonium; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
combined residues of imazapic-ammonium, (+)-2-[4,5-dihydro-4-methyl-4-
(1-methylethyl)-5-oxo-1H-imidazol-2- yl]-5-methyl-3-pyridinecarboxylic 
acid, applied as its ammonium salt and its metabolite (+)-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-
hydromethyl-3- pyridinecarboxylic acid both free and conjugated in or 
on grass forage at 30 ppm; grass hay at 15 ppm; milk, fat, meat, meat 
byproducts (except kidney) of cattle, goats, hogs, horses, and sheep at 
0.10 ppm; kidney of cattle, goats, hogs, horses, and sheep at 1 ppm. 
This action is in response to EPA's granting of emergency exemptions 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act authorizing use of the pesticide on pasture/rangeland and land in 
the Conservation Reserve Program. This regulation establishes a maximum 
permissible level for residues of imazapic-ammonium and its metabolite 
in these food commodities. The tolerances will expire and are revoked 
on December 31, 2001.

DATES: This regulation is effective October 6, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300927, 
must be received by EPA on or before December 6, 1999.

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 VII. of the ``SUPPLEMENTARY 
INFORMATION'' section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-300927 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: 703 308-9364; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be potentially 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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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

[[Page 54219]]

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-300927. 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

    EPA, on its own initiative, in accordance with sections 408 (l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing tolerances for combined residues of the [herbicide] 
imazapic-ammonium and its metabolite both free and conjugated, in or on 
grass forage at 30 part per million (ppm); grass hay at 15 ppm; milk, 
fat, meat, meat byproducts (except kidney) of cattle, goats, hogs, 
horses, and sheep at 0.10 ppm; kidney of cattle, goats, hogs, horses, 
and sheep at 1 ppm. These tolerances will expire and are revoked on 
December 31, 2001. EPA will publish a document in the Federal Register 
to remove the revoked tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from 
any provision of FIFRA, if EPA determines that ``emergency conditions 
exist which require such exemption.'' This provision was not amended by 
Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Imazapic-Ammonium on Pasture/
Rangeland and Land in the Conservation Reserve Program and FFDCA 
Tolerances

    The Applicant has stated that picloram can not be used in areas 
with sensitive desirable plants such as trees nor in areas with a 
shallow depth to groundwater; and high rates of 2,4-D have proven 
ineffective in controlling leafy spurge. Economic loss from the 
infestation of leafy spurge is measured in loss of livestock carrying 
capacity. It is estimated the potential economic loss will continue to 
average $5.5 million per year in Nebraska without the use of imazapic. 
EPA has authorized under FIFRA section 18 the use of imazapic-ammonium 
on pasture/rangeland and land in the Conservation Reserve Program for 
control of leafy spurge in Nebraska. After having reviewed the 
submission, EPA concurs that emergency conditions exist for this state.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of (+)-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H- imidazol-2-yl]-5-methyl-3-
pyridinecarboxylic acid applied as its ammonium salt and its metabolite 
(+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-
5- hydromethyl-3-pyridinecarboxylic acid both free and conjugated in or 
on grass forage; grass hay; milk, fat, meat, meat byproducts (except 
kidney) of cattle, goats, hogs, horses, and sheep; and kidney of 
cattle, goats, hogs, horses, and sheep. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerance under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. Consistent with the 
need to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing these tolerances without notice and 
opportunity for public comment as provided in section 408(l)(6). 
Although these tolerances will expire and are revoked on December 31, 
2001, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerances remaining in or on 
grass forage; grass hay; milk, fat, meat, meat byproducts (except 
kidney) of cattle, goats, hogs, horses, and sheep; and kidney of 
cattle, goats, hogs, horses, and sheep after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by these tolerances at the time of that application. EPA will take 
action to revoke these tolerances earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions EPA has not made any decisions about whether imazapic-
ammonium meets EPA's registration requirements for use on pasture/
rangeland and land in the Conservation Reserve Program or whether 
permanent tolerances for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of imazapic-ammonium by a State for special 
local needs under FIFRA section 24(c). Nor do these tolerances serve as 
the basis for any State other than Nebraska to use this pesticide on 
these crops under section 18 of FIFRA without following all provisions 
of EPA's regulations implementing section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemptions 
for imazapic-ammonium, contact the Agency's Registration

[[Page 54220]]

Division at the address provided under the ``ADDRESSES'' section.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of imazapic-
ammonium and to make a determination on aggregate exposure, consistent 
with section 408(b)(2), for time-limited tolerances for combined 
residues of imazapic-ammonium and its metabolite both free and 
conjugated on grass forage at 30 ppm; grass hay at 15 ppm; milk, fat, 
meat, meat byproducts (except kidney) of cattle, goats, hogs, horses, 
and sheep at 0.10 ppm; and kidney of cattle, goats, hogs, horses, and 
sheep at 1 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 imazapic-ammonium 
are discussed in this unit.

B. Toxicological Endpoint

    1. Acute toxicity. For acute dietary risk assessment, the no-
observed adverse effect level (NOAEL) of 175 milligrams/kilogram/day 
(mg/kg/day), based on developmental effects increased incidence of 
fetuses with rudimentary ribs at the lowest observed adverse effect 
level (LOAEL) of 350 mg/kg/day, from the developmental study in rabbits 
was used. Pregnant females 13+, is the population subgroup of concern. 
The acute dietary population adjusted dose (aPAD) is defined as the 
Reference Dose (RfD)/FQPA safety factor. The acute RfD of 1.75 mg/kg 
day is based on the developmental NOAEL of 175 mg/kg/day and the usual 
100x uncertainty factor for intra- and inter-species differences and 
variations. The acute dietary aPAD is 0.175 mg/kg/day, based on the RfD 
of 1.75 mg/kg/day, and an additional uncertainty factor of 10x to 
account for potential pre- and post-natal toxicity and completeness of 
the data with respect to exposure and toxicity to infants and children 
(based on the determination of developmental effects below the level of 
maternal toxicity in the rabbit developmental study). There is no acute 
dietary aPAD for other population subgroups, including infants and 
children.
    2. Short- and intermediate-term toxicity. For short-term margin of 
exposure (MOE) calculations, the developmental NOAEL of 175 mg/kg/day 
from the developmental study in rabbits was used. At the LOAEL of 350 
mg/kg/day, there were increased rudimentary ribs below a level of 
maternal toxicity. The short term NOAEL can be used for both dermal and 
inhalation. An MOE of 100 is required for both dermal and inhalation 
exposure. For intermediate-term dermal exposures, the LOAEL of 137 mg/
kg/day lowest dose tested (LDT) from the one year feeding study in dogs 
was used. At the LOAEL of 137 mg/kg/day, there was skeletal muscle 
degeneration in both sexes. The intermediate term LOAEL can be used for 
both dermal and inhalation exposures. An MOE of 300 is required for 
both dermal and inhalation exposure and is based on the usual 100x 
safety factor for intra- and inter-species differences and an addtional 
3x safety factor for the absence of a NOAEL in the critical study.
    3. Chronic toxicity. EPA has established the RfD for imazapic- 
ammonium at 0.5 mg/kg/day. This RfD is based on a one year feeding 
study in dogs with a LOAEL of 137 mg/kg/day (LDT) based on skeletal 
muscle degeneration. A NOAEL was not established in the study. An 
uncertainty factor of 3000x was recommended and was based on 10x for 
interspecies differences, 10x for intraspecies variations, 10x for 
infants and children, and 3x for absence of a NOAEL.
    4. Carcinogenicity. Imazapic has been classified as a Group ``E'' 
(evidence of non- carcinogenicity for humans) chemical.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.490) for the combined residues of imazapic-ammonium and its 
metabolite both free and conjugated, in or on peanut nutmeat at 0.1 
ppm. Risk assessments were conducted by EPA to assess dietary exposures 
and risks from imazapic-ammonium as follows:
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. The acute dietary (food only) risk 
assessment used the TMRC (theoretical maximum residue contribution). At 
the 95th percentile of exposure for user- days and per-capita days, the 
Tier 1 acute DEEM analysis predicts an exposure level of 0.000494 mg/
kg/day for the females (13+, pregnant, not nursing) population 
subgroup, which is equivalent to 0.3% of the aPAD. This should be 
viewed as a conservative risk estimate; refinement using anticipated 
residue values and percent crop-treated data in conjunction with Monte 
Carlo analysis would result in a lower acute dietary exposure estimate.
    ii. Chronic exposure and risk. In conducting the chronic dietary 
risk assessment, conservative assumptions -- 100% of all commodities 
having imazapic tolerances will contain imazapic residues and those 
residues would be at the level of the tolerance -- were used, which 
results in an overestimation of human dietary exposure. The existing 
imazapic tolerances (published and pending result in a Theoretical 
Maximum Residue Contribution (TMRC) that is equivalent to the following 
percentages of the RfD:

 
------------------------------------------------------------------------
                 Subgroup                            Percentage
------------------------------------------------------------------------
U.S. Population (48 States)...............  0.5
Nursing Infants (<1 year old).............  0.3
Non-Nursing Infants (<1 year old).........   1.3
Children (1-6 years old)..................  1.4
Children (7-12 years old).................  0.9
Hispanics.................................  0.6
Males 13-19 yrs...........................  0.6
------------------------------------------------------------------------

The subgroups listed above are: (a) The U.S. population (48 states); 
(b) those for infants and children; and, (c) the other subgroups for 
which the percentage of the RfD occupied is greater than that occupied 
by the subgroup U.S. population (48 states).
    2. From drinking water. Acute and chronic (56-day) DWECs (drinking 
water estimated concentration) for surface water were calculated by 
GENEEC (GENeric Expected Environmental Concentration) screening model 
to be 7.57 and 4.16 ppb, respectively. According to HED drinking water 
guidance (HED SOP 98.4) the 56-day GENEEC value may be divided by 3 to

[[Page 54221]]

obtain a value for chronic risk assessment calculations. Therefore, the 
Tier 1 chronic surface water value is 1.39 ppb. A ground water estimate 
was made using the SCI-GROW (Screening Concentration In GROund Water) 
screening model based on actual ground water monitoring data collected 
from small-scale prospective ground water monitoring studies for the 
registration of a number of pesticides that serve as benchmarks for the 
model. The DWEC for imazapic in ground water was calculated at 5.95 
ppb. This concentration may be used for both the acute and chronic 
scenarios.
    3. From non-dietary exposure. Imazapic-ammonium is not currently 
registered for sites that would result in non-dietary, non-occpational 
exposure. Therefore, such exposures are not expected and have not been 
included in this risk assessment.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Imazapic is a member of the imidazolinone class of 
pesticides. Other members of this class include imazapyr, imazethapyr, 
imazaquin, and imazamethabenz-methyl. 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 imazapic-ammonium 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, 
imazapic-ammonium does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of these tolerance 
actions, therefore, EPA has not assumed that imazapic-ammonium has a 
common mechanism of toxicity with other substances. For more 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see the final rule for Bifenthrin Pesticide Tolerances 
(62 FR 62961, November 26, 1997).

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

    1. Acute risk. For the population subgroup of concern, pregnant 
females 13+ years, the acute aggregate exposure includes food and 
water. For pregnant females, 13+, 0.3% of the aPAD is occupied by 
dietary (food) exposure. The estimated maximum concentrations of 
imazapic-ammonium in surface and ground water are less than the DWLOC 
for imazapic-ammonium in drinking water as a contribution to acute 
aggregate exposure. Therefore, EPA concludes with reasonable certainty 
that the acute aggregate risks resulting from residues of imazapic- 
ammonium in food and drinking water are below EPA's level of concern.
    2. Chronic risk. For the U.S. population, 0.5% of the cPAD is 
occupied by dietary (food) exposure. Other highly exposed population 
subgroups include children 1-6 years (1.4% cPAD), hispanics (0.6% 
cPAD), pregnant females 13+ (0.4% cPAD) and males 13-19 years (0.6% 
cPAD). EPA generally has no concern for exposures below 100 percent of 
the cPAD, because the cPAD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. The estimated average concentrations of 
imazapic-ammonium in surface and ground water are less than the DWLOC 
for imazapic- ammonium in drinking water as a contribution to chronic 
aggregate exposure. Therefore, EPA concludes with reasonable certainty 
that the chronic aggregate risks resulting from residues of imazapic-
ammonium in food and drinking water are below EPA's level of concern.
    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 
non-dietary, non-occupational exposure. Since there are no registered 
uses for imazapic-ammonium that would result in such exposures, both 
short- and intermediate term aggregate risk assessments are not 
required.
    4. Aggregate cancer risk for U.S. population. A cancer risk 
assessment was not conducted, since imazapic has been classified as a 
Group ``E'' non-carcinogenicity for humans based on a negative 
tumorigenic potential in two acceptable animal studies.
    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 imazapic- ammonium 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 imazapic-ammonium, 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 pre- and post-natal toxicity and the 
completeness of the data base unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard MOE 
and uncertainty factor (usually 100 for combined inter- and intra-
species variability) and not the additional tenfold MOE/uncertainty 
factor when EPA has a complete data base under existing guidelines and 
when the severity of the effect in infants or children or the potency 
or unusual toxic properties of a compound do not raise concerns 
regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. In the developmental study in 
rats, the maternal (systemic) NOAEL was 1,000 mg/kg/day highest dose 
tested (HDT). The developmental (fetal) NOAEL was 1,000 mg/kg/day 
(HDT).
    In the developmental toxicity study in rabbits, the maternal 
(systemic) NOAEL was 350 mg/kg/day, based on decreased body weight and 
food consumption at the LOAEL of 500 mg/kg/day. The developmental 
(fetal) NOAEL was 175 mg/kg/day, based on increased incidence of 
rudimentary ribs at the LOAEL of 350 mg/kg/day.
    iii. Reproductive toxicity study. In the 2-generation reproductive 
toxicity study in rats, the maternal (systemic) NOAEL was 1,484 mg/kg/
day (HDT). The developmental (pup) NOAEL was 1,484 mg/kg/day (HDT). The 
reproductive NOAEL was 1,484 mg/kg/day (HDT).
    iv. Pre- and post-natal sensitivity. The toxicological data base 
for evaluating pre- and post-natal toxicity for imazapic-ammonium is 
complete with respect to current data requirements. There appears to be 
extra-sensitivity

[[Page 54222]]

based on the pre-natal results in the rabbit developmental study. The 
developmental NOAEL was 175 mg/kg/day based on the increased incidence 
of rudimentary ribs at the LOAEL of 350 mg/kg/day. In contrast, the 
maternal NOAEL was 350 mg/kg/day based on decreased body weight and 
food consumption at the LOAEL of 500 mg/kg/day. Therefore, pre-natal 
developmental toxicity occurred at a dose level 350 mg/kg/day, which 
did not demonstrate any maternal toxicity. Based on the above, EPA 
concludes that reliable data support use of a 1,000-fold MOE/
uncertainty factor to protect infants and children. Based on the 
conclusions of the rabbit developmental study, EPA used the FQPA Tier I 
approach which retains the 10X safety factor.
    v. Conclusion. There is a complete toxicity database for imazapic-
ammonium and exposure data is complete or is estimated based on data 
that reasonably accounts for potential exposures.
    2. Acute risk. The aPAD only applies to pregnant females, 13+ and 
is not required for infants (<1 year), non-nursing infants, and 
children (1-6 years). For pregnant females, 13+, dietary exposure 
utilized 0.4% of the aPAD. The estimated average concentrations of 
imazapic- ammonium in surface and ground water are less than EPA's 
level of concern for imazapic- ammonium in drinking water as a 
contribution to acute aggregate exposure.
    3. Chronic risk. The %cPAD utilized for chronic dietary exposure 
were 1.3% for non- nursing infants, 1.4% for children 1-6 years, and 
1.0% for all infants (<1 year). The estimated average concentrations of 
imazapic-ammonium in surface and ground water are less than EPA's level 
of concern for imazapic-ammonium in drinking water as a contribution to 
chronic aggregate exposure.
    4. Short- or intermediate-term risk. Since there are no registered 
uses for imazapic-ammonium which would result in non-dietary, non-
occupational exposure, contributions to the aggregate risk from both 
short- and intermediate non-dietary exposures are not expected.
    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 imazapic-ammonium 
residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants and livestock has been 
adequately defined for this time-limited tolerance. The residues of 
concern in grass are imazapic-ammonium and its hydroxymethyl 
metabolite, both free and conjugated. Based on the results of a goat 
metabolism study, the residues of concern in ruminants were identified 
as imazapic-ammonium and its hydroxymethyl metabolite. For the purposes 
of this time-limited tolerance only, the residues of concern in animals 
are imazapic and its hydroxymethyl metabolite.

B. Analytical Enforcement Methodology

    An adequate analytical enforcement method is available to enforce 
the grass forage and hay tolerances for imazapic-ammonium and its 
hydroxymethyl metabolite. American Cyanamid Company submitted an 
Independent Laboratory Validation (ILV) of a Capillary Electrophoresis 
determinative method (Method M3114) for determination of residues in 
grass.
    Adequate analytical enforcement methods are available to enforce 
the animal commodity tolerances for imazapic-ammonium and its 
hydroxymethyl metabolite. American Cyanamide Company submitted 
Independent Laboratory Validations (ILVs) of Capillary Electrophoresis 
determinative and LC/MS confirmatory methods (Methods M3118; M3222; and 
M3233) for determination of residues in milk; cattle muscle, kidney, 
and liver tissue; and bovine milk fat and tissue fat, respectively.
    The methods may be requested from: Calvin Furlow, PRRIB, 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

    Residues of imazapic-ammonium and its hydroxymethyl metabolite, 
free and conjugated, are not expected to exceed 30 and 15 ppm in/on 
grass forage and hay, respectively, as a result of this emergency use. 
Secondary residues in animal commodities are not expected to exceed 
0.10 ppm in milk, meat, fat, or meat byproducts (except kidney); or 1.0 
ppm in kidney as a result of this emergency use. There are no processed 
food/feed items resulting from this emergency use.

D. International Residue Limits

    There are no CODEX, Canadian, or Mexican maximum residue limits for 
imazapic on pastures/rangeland.

VI. Conclusion

    Therefore, the tolerances are established for [combined residues] 
of imazapic- ammonium, (+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-
oxo-1H-imidazol-2-yl]-5- methyl-3-pyridinecarboxylic acid, applied as 
its ammonium salt and its metabolite (+)-2- [4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-hydromethyl-3- 
pyridinecarboxylic acid both free and conjugated in grass forage at 30 
ppm; grass hay at 15 ppm; milk, fat, meat, meat byproducts (except 
kidney) of cattle, goats, hogs, horses, and sheep at 0.10 ppm; and 
kidney of cattle, goats, hogs, horses, and sheep at 1 ppm.

VII. 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-300927 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 December 
6, 1999.
    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

[[Page 54223]]

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 
Room 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 be 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.'' (cite). 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 VII.A. of 
this preamble, you should also send a copy of your request to the PIRB 
for its inclusion in the official record that is described in Unit 
I.B.2. of this preamble. Mail your copies, identified by the docket 
number OPP-300927, 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 PRIB described in Unit I.B.2. of this preamble. You may 
also send an electronic copy of your request via e-mail to: opp-
[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 requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under section 408 of the 
FFDCA. 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 prior consultation with 
State, local, and tribal government officials as specified by Executive 
Order 12875, entitled Enhancing the Intergovernmental Partnership (58 
FR 58093, October 28, 1993) and Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19,1998), or special consideration of environmental justice 
related issues under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994) or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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 12612, entitled Federalism (52 FR 41685, October 30, 
1987). This action 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 the Federal Food Drug 
Cosmetic Act, 21 U.S.C. section 346a(b)(4). 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). In addition, 
since tolerances and exemptions that are established under FFDCA 
section 408(l)(6), such as the tolerance in this final rule, do not 
require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

[[Page 54224]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 23, 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), 346(a), and 371.

    2. Section 180.490 is revised to read as follows:


Sec. 180.490  Imazapic-ammonium; tolerances for residues.

    (a) General. Tolerance is established for residues of the 
herbicide; (+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5-methyl-3-pyridinecarboxylic acid applied as its 
ammonium salt and its metabolite (+)-2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-hydromethyl-3-pyridinecarboxylic 
acid both free and conjugated; in or on the following food commodity:

 
------------------------------------------------------------------------
                Commodities                       Parts per million
------------------------------------------------------------------------
Peanut nutmeat............................  0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for combined residues of the herbicide imazapic-ammonium, 
(+)-2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H-imidazol-2-yl]-
5-methyl-3-pyridinecarboxylic acid, applied as its ammonium salt and 
its metabolite (+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H- 
imidazol-2-yl]-5-hydromethyl-3-pyridinecarboxylic acid both free and 
conjugated in connection with use of the pesticide under section 18 
emergency exemptions granted by EPA. The tolerances are specified in 
the table.

 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
Cattle, fat.....................  0.10                12/31/01
Cattle, kidney..................  1.0                 12/31/01
Cattle, mbyp (except kidney)....  0.1                 12/31/01
Cattle, meat....................  0.1                 12/31/01
Goats, fat......................  0.1                 12/31/01
Goats, kidney...................  1.0                 12/31/01
Goats, mbyp (except kidney).....  0.1                 12/31/01
Goats, meat.....................  0.1                 12/31/01
Grass, forage...................  30                  12/31/01
Grass, hay......................  15                  12/31/01
Hogs, fat.......................  0.1                 12/31/01
Hogs, kidney....................  1.0                 12/31/01
Hogs, mbyp (except kidney)......  0.1                 12/31/01
Hogs, meat......................  0.1                 12/31/01
Horses, fat.....................  0.1                 12/31/01
Horses, kidney..................  1.0                 12/31/01
Horses, mbyp (except kidney)....  0.1                 12/31/01
Horses, meat....................  0.1                 12/31/01
Sheep, fat......................  0.1                 12/31/01
Sheep, kidney...................  1.0                 12/31/01
Sheep, mbyp (except kidney).....  0.1                 12/31/01
Sheep, meat.....................  0.1                 12/31/01
------------------------------------------------------------------------

    (c) Tolerances with reginal registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 99-25842 Filed 10-5-99; 8:45 am]
BILLING CODE 6560-50-F