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prometryn (Caparol, Prometrex, Primatol Q) Pesticide Petition Filing 1/00



[Notices]
[Page 2612-2617]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja00-61]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-913; FRL-6486-4]


Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.

DATES:  Comments, identified by docket control number PF-913, must be
received on or before February 17, 2000.

ADDRESSES:  Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-913 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.

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 codes         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 PF-913. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, 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 (CM 2), 1921 Jefferson Davis Highway, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-913 in the subject line on the
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, CM 2, 1921 Jefferson Davis
Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The PIRIB telephone
number is (703) 305-5805.

    3. Electronically. You may submit your comments electronically by
e-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-913. Electronic comments may
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be

[[Page 2613]]

disclosed except in accordance with procedures set forth in 40 CFR part
2. In addition to one complete version of the comment that includes any
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public version of the official record. Information not marked
confidential will be included in the public version of the official
record without prior notice. If you have any questions about CBI or the
procedures for claiming CBI, please consult the person identified under
``FOR FURTHER INFORMATION CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. What Action is the Agency Taking?

     EPA has received pesticide petitions as follows proposing the
establishment and/or amendment of regulations for residues of certain
pesticide chemicals in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that these petitions contain data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petitions. Additional data
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: January 6, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed
below as required by section 408(d)(3) of the FFDCA. The summaries of
the petitions were prepared by the petitioner and represents the view
of the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summaries announce the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.


2. Interregional Research Project Number 4

 9E6059

    EPA has received a pesticide petition (9E6059) from the
Interregional Research Project Number 4 (IR-4), New Jersey Agricultural
Experiment Station, P. O. Box 231 Rutgers University, New Brunswick, NJ
08903 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C.
346a(d), to amend 40 CFR part 180 by establishing a tolerance for
residues of prometryn in or on the raw agricultural commodity cilantro
at 0.1 ppm. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of
the FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
petition. Additional data may be needed before EPA rules on the
petition. This notice includes a summary of the petition prepared by
IR-4.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of prometryn in plants is
adequately understood for purposes of this tolerance.
    2. Analytical method. Method, gas chromatography is available in
PAM Vol. II for plants to enforce the tolerance expression.
    3. Magnitude of residues. The nature of the residue in plants is
adequately understood for the purposes of this tolerance. Secondary
residues in animal commodities are not expected to exceed existing
tolerances as result of this use.

B. Toxicological Profile

    1. Acute toxicity. A rat acute oral study with a LD50 of
1,802 mg/kg for males and a LD50 of 2,076 mg/kg for females.
    2. Genotoxicity. An Ames salmonella test, prometryn was negative
for gene mutation up to cytotoxic solubility limits (1,000-2,000
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 g/plate). In an unscheduled DNA
synthesis test, prometryn was negative (measured as UDS) in rat
hepatocytes cultured in vitro up to cytotoxic levels (156.25
g/mL).
    3. Reproductive and developmental toxicity. A developmental
toxicity study in rats with a maternal and developmental NOAEL of 50
mg/kg and a maternal LOAEL of 250 mg/kg based on salivation and
decreases in body weight and food consumption. The developmental LOAEL
is 250 mg/kg/day based on significantly decreased and incomplete
ossification in the sternebrae and metacarpals. A developmental
toxicity study in rabbits with a maternal and developmental NOAEL of 12
mg/kg/day and a maternal LOAEL of 72 mg/kg based on decreased food
consumption, and the developmental LOAEL of 72 mg/kg/day, based on
increased fetal resorption.
    A 2-generation reproduction study in rats with a parental systemic
NOAEL of 0.6 mg/kg/day in males and 0.7 mg/kg/day in females and a
parental systemic LOAEL 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 NOAEL is 0.65 mg/kg/day and the
reproductive systemic LOAEL is approximately 50 mg/kg/day, based on
decreased pup weight.
    4. Subchronic toxicity. A 28-day mice pilot feeding study with a
NOAEL of 450 mg/kg/day and a LOAEL of 1,500 mg/kg/day based on
decreased body weights.
    5. Chronic toxicity. A 102-week chronic feeding/carcinogenicity
study in mice with a systemic NOAEL of 100 mg/kg/day for females and a
systemic LOAEL of 300 mg/kg/day for females based on decreased body
weight gain. No effects were observed in males.
     A 2-year rat chronic feeding/carcinogenicity study with a systemic
NOAEL of 29.45 mg/kg/day for males and 37.25 mg/kg/day for females and
a systemic LOAEL 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 carcinogenic under the conditions of the
study.
    6. Animal metabolism. The metabolism of prometryn in animals is
adequately understood for purposes of this tolerance.
    7. Metabolite toxicology. 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-

[[Page 2616]]

dependant. It is extensively metabolized with less than 2% of recovered
\14\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 \14\C radioactivity
averaged 95% for all dosing groups.

C. Aggregate Exposure

    1. Dietary exposure--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 1-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.
    2. 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 chronic population
adjusted dose (cPAD) 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 cPAD.
    i. Food. 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.
    ii. Drinking water. Despite the potential for exposure through
drinking water, the percentage of the cPAD 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 cPAD occupied is 0.0000056 mg/kg/day at  1% of the
cPAD. Therefore taking into account the completeness and reliability of
the toxicity data and the conservative exposure assessment, there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to prometryn residues.
    2. 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.

D. Cumulative Effects

    Cumulative exposure to substances with a 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 considers
``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. IR-4 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. Since there are not
metabolites of toxicological concern associated with prometryn, IR-4
has not assumed that prometryn has a common mechanism of toxicity with
other substances.

E. Safety Determination

    1. U.S. population-- Acute risk. The acute aggregate dietary MOE
was estimated to be greater than 1,000,000 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 NOAEL 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 that there is a reasonable
certainty of no harm for infants and children to prometryn.
    2. Chronic risk. Using the conservative exposure assumptions
described above, the aggregate exposure to prometryn from food will
utilize less than 1% of the cPAD for infants and children. EPA
generally has no concern for exposures below 100% 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. There are no chronic exposure scenarios for 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, IR-4 concludes that there is a
reasonable certainty that no harm will result from aggregate exposure
to prometryn residue's.
    3. Infants and children-safety factor--i. In general. In assessing
the potential for additional sensitivity of infants and children to
residues of prometryn, data were considered from the 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
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 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 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 interspecies and
intraspecies variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental and reproductive toxicity studies. The prenatal
and postnatal 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 sensitive
to exposure, based on the

[[Page 2617]]

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 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 estimated greater than 1,000,000.
Therefore, IR-4 concludes that reliable data support use of the
standard 100-fold MOE/uncertainty factor and that an additional tenfold
safety factor is not needed to protect infants and children.

F. International Tolerances

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

[FR Doc. 00-1064 Filed 1-14-00; 8:45 am]
BILLING CODE 6560-50-F