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prometryn (Caparol, Prometrex, Primatol Q) Pesticide Tolerances 2/98

  

[Federal Register: February 25, 1998 (Volume 63, Number 37)]
[Proposed Rules]               
[Page 9494-9499]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe98-34]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300619; FRL-5772-7]
RIN 2070-AB78

 
Prometryn; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish tolerances for residues of prometryn 
in or on carrots under its own initiative to harmonize tolerances with 
Canada under the Federal Food, Drug and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1966 (Pub. L. 104-170).

DATES: Comments, identified by the document control number [OPP-
300619], must be received on or before March 27, 1998.
ADDRESSES: By mail, submit written comments to: Public Response and 
Program Resources Branch, Field Operations Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, M St., SW, 
Washington, DC 20460. In person, bring comments to: Rm. 119, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Comments and data may also be submitted electronically to: opp-
docket@epamail.epa.gov. Follow the instructions under Unit V. of this 
document.
    Information submitted as a comment concerning this notice may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR part 2. A copy of the comment 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. All 
written comments will be available for public inspection in Rm. 119 at 
the address given above, from 8 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT:  By mail: James A. Tompkins, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Crystal Mall #2, 
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-5697, e-mail: 
tompkins.james@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA is proposing under its own initiative 
that 40 CFR 180.222 be amended by establishing tolerances for residues 
of the herbicide prometryn, 2,4-bis(isopropylamino)-6-methylthio-s-
triazine in or on carrots at 0.1 parts per million (ppm) without a U.S. 
registration under the Federal Insecticide Fungicide Act (FIFRA), as 
amended for carrots imported from Canada.

I. Risk Assessment and Statutory Findings

    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes

[[Page 9495]]

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.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3 
sources are not typically added because of the very low probability of 
this occurring in most cases, and because the other conservative 
assumptions built into the assessment assure adequate protection of 
public health. However, for cases in which high-end exposure can 
reasonably be expected from multiple sources (e.g. frequent and 
widespread homeowner use in a specific geographical area), multiple 
high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and

[[Page 9496]]

children. The TMRC is a ``worst case'' estimate since it is based on 
the assumptions that food contains pesticide residues at the tolerance 
level and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (non-nursing 
infants >1 year old) was not regionally based.

II. 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 
prometryn, and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a tolerance for residues of 
prometryn and its metabolite on carrots at 0.1 ppm. EPA's assessment of 
the dietary exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by prometryn are 
discussed below.
    1. A rat acute oral study with a LD<INF>50</INF> of 1,802 
milligrams/kilogram (mg/kg) for males and a LD<INF>50</INF> of 2,076 
mg/kg for females
    2. A 28-day mice pilot feeding study with a No Observed Effect 
Level (NOEL) of 450 milligrams/kilogram/day (mg/kg/day) and a Lowest 
Observed Effect Level (LOEL) of 1,500 mg/kg/day based on decreased body 
weights.
    3. A 21-day dermal toxicity study with a NOEL and LOEL greater than 
of 1,000 mg/kg/day the highest dose tested (HDT).
    4. A 102-week chronic feeding/carcinogenicity study in mice with a 
Systemic NOEL of 100 mg/kg/day for females and a Systemic LOEL of 300 
mg/kg/day for females based on decreased body weight gain. No effects 
were observed in males. Although significant toxicity was observed only 
in females, the Health Effects Division Reference Dose (RfD) committee 
considered the study adequate since (1) levels were close to one-half 
the limit dose in mice; (2) no effects were noted in the study to 
warrant repeating the study at high dose levels; and (3) all tumors 
noted with other members of the s-triazine class were mainly in rats 
and not mice.
    5. A 2-year rat chronic feeding/carcinogenicity study with a 
Systemic NOEL of 29.45 mg/kg/day for males and 37.25 mg/kg/day for 
females and a Systemic LOEL of 60.88 mg/kg/day for males and 80.62 mg/
kg/day for females based on decreased body weight and body weight gain 
and an increase in the incidence of renal lesions (mineralized 
concretions) in males. prometryn was not oncogenic under the conditions 
of the study.
    6. A 106-week dog feeding study with a NOEL of 3.75 mg/kg/day and a 
LOEL of 37.5 mg/kg/day based on degenerative hepatic changes, renal 
tubule degeneration, and bone marrow atrophy. Prometryn was not 
oncogenic under the conditions of the study.
    7. A developmental toxicity study in rats with a Maternal and 
Developmental NOEL of 50 mg/kg and a Maternal LOEL of 250 mg/kg based 
on salivation and decreases in body weight and food consumption. The 
Developmental LOEL is 250 mg/kg/day based on significantly decreased 
and incomplete ossification in the sternebrae and metacarpals.
    8. A developmental toxicity study in rabbits with a Maternal and 
Developmental NOEL of 12 mg/kg/day and a Maternal LOEL of 72 mg/kg 
based on based on decreased food consumption, and the Developmental 
LOEL of 72 mg/kg/day, based on increased fetal resorptions.
    9. A two-generation reproduction study in rats with a Parental 
Systemic NOEL of 0.6 mg/kg/day in males and 0.7 mg/kg/day in females 
and a Parental Systemic LOEL of 47.8 mg/kg/day in males and 53.6 mg/kg/
day in females based on decreased food consumption, body weight and 
body weight gain. The Reproductive Systemic NOEL is 0.65 mg/kg/day and 
the Reproductive Systemic LOEL is approximately 50 mg/kg/day, based on 
decreased pup weight.
    10. An Ames salmonella  test, prometryn was negative for gene 
mutation up to cytotoxic solubility limits (1,000-2,000 <greek-m>g/
plate). A chromosomal aberration in vivo Chinese hamster bone marrow 
test, prometryn was negative for nuclear anomalies (micronuclei) when 
animals were dosed orally up to 5,000 mg/kg. Prometryn was negative for 
bacterial DNA repair and gene mutation up to precipitating levels 
(1,000 <greek-m>g/plate). An unscheduled DNA synthesis test prometryn 
was negative (measured as UDS) in rat hepatocytes cultured in vitro up 
to cytotoxic levels (156.25 <greek-m>g/mL).
    11. Rat metabolism studies showed that radio labeled prometryn is 
distributed in blood greater than spleen greater than lungs (the three 
highest tissues measured). Distribution is not dosage-dependant. It is 
extensively metabolized with less than 2% of recovered <SUP>14</SUP>C 
radioactivity representing the parent compound. Twenty-eight 
metabolites were identified in the urine, and 28 in the feces. Ten 
metabolites were identified in both urine and feces. Prometryn is 
excreted predominantly in the urine and feces, with slightly higher 
concentrations in the urine. The 7-day recovery of <SUP>14</SUP>C 
radioactivity averaged 95% for all dosing groups.

B. Toxicological Endpoints

    1. Acute toxicity. The developmental NOEL of 12 mg/kg/day from a 
developmental study was recommend for the acute dietary risk 
assessment.
    2. Short - and intermediate - term toxicity. The developmental NOEL 
of 12 mg/kg/day from a developmental study was recommend for the short- 
and intermediate- term dermal and inhalation risk assessments.
    3. Chronic toxicity. EPA has established the RfD for prometryn at 
0.04 mg/kg/day. This RfD is based on upon the chronic feeding study in 
dogs with a NOEL of 3.75 mg/kg/day with a 100-fold safety factor to 
account for interspecies extrapolation and intraspecies variability.
    4. Carcinogenicity. The Health Effects Division Reference Dose 
(RfD) Committee classified prometryn as a

[[Page 9497]]

Group E chemical (no evidence of human carcinogenic potential).

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.222(a)) for the residues of prometryn, 2,4-bis(isopropylamino)-
6-methylthio-s-triazine, in celery at 0.5 ppm; corn forage, fresh corn 
and corn grain at 0.25 ppm; cotton at 1 ppm: cottonseed at 0.25 ppm; 
and pigeon peas at 0.25 ppm.. Tolerances with regional registration 
have been established (40 CFR 180.222(b)) for the residues of prometryn 
in dill at 0.3 ppm and parsley at 0.1 ppm. Risk assessments were 
conducted by EPA to assess dietary exposures and risks from prometryn 
as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are 
performed for a pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Margin of Exposure (MOE) value for females (13 
years and older) was 1,200,000. This value is significantly higher than 
the Agency's level of concern of 100 which is adequate to ensure 
protection for females 13 and older..
    ii. Chronic exposure and risk. Assuming 100% of the crop are 
treated and residues are at tolerance levels the theoretical maximum 
residue contribution (TMRC) from the established and proposed 
tolerances is 0.000056 mg/kg/day and utilizes less than 1% of the RfD 
for the U.S. Population. For exposure of the most highly exposed 
subgroup in the population, non-nursing infants, the TMRC is 0.0016 mg/
kg/day which utilizes less than 1% of the RfD.
    2. From drinking water. Despite the potential for exposure through 
drinking water, EPA has concluded that the percentage of the RfD that 
will be utilized by dietary exposure (including drinking water 
exposure) to residues of prometryn does not exceed 100% for any of the 
population subgroups. Considering food only, the population subgroup 
with the largest percentage of the RfD occupied is 0.0000056 mg/kg/day 
at < 1% of the RfD. Therefore taking into account the completeness and 
reliability of the toxicity data and the conservative exposure 
assessment, EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
prometryn residues.
    3. From non-dietary exposure. Prometryn is currently not registered 
for residential use such as turf and ornamentals. Therefore there is no 
expectation of non-occupational residential exposures.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Prometryn is a member of the triazine class of pesticides. 
Other members of this class include atrazine, simazine, cyanazine, 
prometon, propazine, metribuzin, hexazinone, ametryn, terbutryne, 
dipropetryn, and ethiozin.
    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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether prometryn has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. The Agency has determined that there are no metabolites of 
toxicological concern associated with prometryn. For the purposes of 
this tolerance action, therefore, EPA has not assumed that prometryn 
has a common mechanism of toxicity with other substances.

D. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of prometryn, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from pesticide exposure during prenatal development 
to one or both parents. 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 database 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 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 and reproductive toxicity studies. The pre- and 
post-natal toxicology data base for prometryn is complete with respect 
to current toxicological data requirements. The results of these 
studies indicate that infants and children are not more

[[Page 9498]]

sensitive to exposure, based on the results of the oral rat and rabbit 
developmental toxicity studies and the 2-generation reproductive 
toxicity study in rats. The developmental studies in rats and rabbits 
both have the maternal NOELs and LOELs, respectively, and demonstrate 
that no prenatal extra sensitivity is present. However, based on the 
developmental effects observed in rabbits, an acute dietary risk 
assessment was performed for women age 13 and older. The MOE was 
calculated as 1,200,000. Therefore, EPA concludes that reliable data 
support use of the standard 100-fold margin of exposure/uncertainty 
factor and that an additional tenfold safety factor is not needed to 
protect infants and children.
    2. Acute risk. The acute aggregate dietary MOE was calculated to be 
1,200,000 for females age 13 and older (accounts for both maternal and 
fetal exposure), the population subgroup of concern. The MOE 
calculations were based on the developmental NOEL in rabbits of 12 mg/
kg. This risk assessment assumed 100% of the crop was treated with 
tolerance level residues on all treated crops consumed, resulting in a 
significant over estimate of dietary exposure. The large acute dietary 
MOE calculated for females age 13 and older provides assurance the 
there is a reasonable certainty of no harm for infants and children to 
prometryn.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to prometryn 
from food will utilize less than 1% of the RfD for infants and 
children. EPA generally has no concern for exposures below 100% of the 
RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. There are no chronic exposure scenarios of non-
dietary uses of prometryn which would contribute to the aggregate risk. 
Taking into account the completeness and reliability of the toxicity 
data and the conservative exposure assessment, EPA concludes that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to prometryn residues.

III. Other Considerations

A. Metabolism In Plants and Animals

    The metabolism of prometryn in plants and animals is adequately 
understood for purposes of this tolerance.

B. Analytical Enforcement Methodology

    An adequate analytical method, gas chromatograph is available in 
PAM Vol. II, for plant to enforce the tolerance expression.

C. Magnitude of Residues

    The nature of the residue in plants is adequately understood for 
the purposes of this tolerance. Secondary residues in animals 
commodities are not expected to exceed existing tolerances as result to 
this use in Canada.

D. International Residue Limits

    There are no Codex or Mexican limits for prometryn on carrots. This 
proposal will harmonize tolerances with 0.1 pm Canadian maximum limit 
for residues in carrots.

E. Rotational Crop Restrictions

    Since the use is on carrots grown in Canada, rotational crop issues 
are not relevant.

IV. Conclusion

    There are presently no actions pending against the continued 
registration of this chemical. Based on the information and data 
considered, the Agency has determined that the tolerance established by 
amending 40 CFR 180.222 would protect the public health. Therefore, it 
is proposed that tolerances be established for residues of prometryn in 
carrots at 0.1 ppm.

V. Public Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300619] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    opp-docket@epamail.epa.gov.


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any from of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper from. Accordingly, 
EPA will transfer any copies of comments received electronically into 
printed, paper from as they are received and will place the paper 
copies in the official rulemaking record which will also include all 
comments submitted directly in writing. The official rulemaking record 
is the paper record maintained at the Virginia address in ``ADDRESSES'' 
at the beginning of this document.

VI. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to all the requirements of the Executive Order (i.e., 
Regulatory Impact Analysis, review by the Office of Management and 
Budget (OMB)). Under section 3(f), the order defines ``significant'' as 
those actions likely to lead to a rule (1) having an annual effect on 
the economy of $100 million or more, or adversely and materially 
affecting a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities (also known as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs; or (4) raising novel legal or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in this Executive Order. Pursuant to the terms of 
this Executive Order, EPA has determined that this proposed rule is not 
``significant'' and is therefore not subject to OMB review. Pursuant to 
the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 
Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that 
regulations establishing new tolerances or raising tolerance levels or 
establishing exemptions from tolerance requirements do not have a 
significant economic impact on a substantial number of small entities. 
A certification statement to this effect was published in the Federal 
Register of May 4, 1981 (46 FR 24950).

List of Subjects in 40 CFR Part 180

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


[[Page 9499]]


    Dated: February 17, 1998.

James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR Part 180 be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. In Sec. 180.222 by amending paragraph (a) by alphabetically 
adding the following commodity to the table to read as follows:


Sec. 180.222  Prometryn; tolerances for residues.

    (a) *      *      *      

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
            *      *      *      *      *      *      *                 
Carrots<SUP>1...................................................         0.1 
                                                                        
           *      *      *      *      *      *      *                  
------------------------------------------------------------------------
\1\There are no U.S. registrations as of February 25, 1998 for use on   
  carrots.                                                              

*      *      *      *      *      

[FR Doc. 98-4804 Filed 2-24-98; 8:45 am]
BILLING CODE 6560-50-F