PMEP Home Page --> Pesticide Active Ingredient Information --> Herbicides, Growth Regulators and Desiccant --> 1-naphthaleneacetic acid to rimsulfuron --> N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride (PT 807-HCL) --> N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride (PT 807-HCL) Pesticide Tolerance 12/99

N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride (PT 807-HCL) Pesticide Tolerance 12/99


[Federal Register: January 12, 2000 (Volume 65, Number 8)]
[Rules and Regulations]
[Page 1809-1814]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja00-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300964; FRL-6486-2]
RIN 2070-AB78


N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride;
Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for the plant growth
regulator N,N-diethyl-2-(4-methylbenzyloxy)ethylamine hydrochloride
(PT807-HCl), in or on oranges. GMJA Specialties requested this
tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996.

DATES: This regulation is effective January 12, 2000. Objections and
requests for hearings, identified by docket control number OPP-300964,
must be received by EPA on or before March 13, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300964 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: 703-305-7740; and e-mail address: giles-
parker.cynthia@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 Potentially
              Categories                NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                   111  Crop production
                                           112  Animal production
                                           311  Food manufacturing
                                         32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-300964. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of November 10, 1999 (64 FR 61336) (FRL-
6388-3), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP) for a tolerance by
GMJA Specialties. This notice included a summary of the petition
prepared by GMJA Specialties, the registrant. There were no comments
received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for the plant growth regulator N,N-diethyl-2-
(4-methylbenzyloxy)ethylamine hydrochloride, in or on oranges at 0.01
(ppm).

[[Page 1810]]

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of N,N-diethyl-2-(4-
methylbenzyloxy)ethylamine hydrochloride on oranges at 0.01 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows. The term PT807-HCl is equivalent to
N,N-diethyl 2-(4-methylbenzyloxy)ethylamine hydrochloride.

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 PT807-HCl are
discussed in this unit.
     The data base adequately characterizes PT807-HCl as having low
acute oral, dermal and inhalation toxicity. It is Toxicity Category IV
for acute dermal toxicity, acute inhalation toxicity, and primary
dermal irritation; Toxicity Category III for acute oral and primary eye
irritation; and it is not a dermal sensitizer.
    1. Subchronic mouse feeding study. A subchronic mouse feeding study
with a No Observed Adverse Effect Level (NOAEL) = 7,000 ppm (1,004/
1,272 miligrams/kilograms/day (mg/kg/day), in male and females
respectively; limit dose). Due to faulty dose concentration analyses,
the regulatory usefulness of the NOAEL is in doubt.
    2. Subchronic gavage rat study. A subchronic gavage rat study with
a NOAEL = 30 mg/kg/day and a Lowest Observed Adverse Effect Level
(LOAEL) = 300 mg/kg/day based on increased mortality; hyperactivity,
hyper-reflexivity, lack of coordination, tremors, convulsions, and
increased salivation in males and females, and elevated urinary protein
in males.
    3. Subchronic feeding dog study. A subchronic feeding dog study
with a NOAEL = 2,500 ppm (equivalent to 71/78 mg/kg/day) males and
females respectively and LOAEL = 7,500 ppm (equivalent to 211/233 mg/
kg/day) in males and females respectively, based on pathological
changes to the male reproductive organs and possibly the uterus in
females.
    4. 21 day dermal rat-systemic. A 21-day dermal rat-systemic. NOAEL
greater than 1,000 mg/kg/day (limit dose). Dermal NOAEL = 1,000 mg/kg/
day (nonadverse dermal irritation was observed at 1,000 mg/kg/day).
    5.  Developmental toxicity rat.--Maternal NOAEL = 50 mg/kg/day,
maternal LOAEL = 250 mg/kg/day, based on clinical signs (post-dosing
rooting in the bedding and lethargy) and reduced body weight gains.
Developmental NOAEL = 500 mg/kg/day and developmental LOAEL was not
observed.
    6. Developmental toxicity rabbit. Developmental toxicity rabbit-
Maternal NOAEL = 10 mg/kg/day, maternal LOAEL = 100 mg/kg/day, based on
increased mortality in the mid-and high-dose animals. Developmental
NOAEL greater than 200 mg/kg/day and developmental LOAEL was not
observed.
    7. Reproductive toxicity rat. Reproductive toxicity rat-systemic
NOAEL = 14.1 mg/kg/day, systemic LOAEL = 114 mg/kg/day based upon
decreased body weight and body weight gains. Reproductive NOAEL = 14.1
mg/kg/day for both sexes. Reproductive LOAEL = 114 mg/kg/day for both
sexes based on decreased pup body weight and body weight gains, delayed
sexual development, reductions in absolute and relative uterus and
ovary weights, and histological changes in the uterus, vagina, and
ovaries in the females.
    8. Chronic toxicity dog. Chronic toxicity dog-NOAEL greater than
5,000 ppm. (135.7/151.5 mg/kg/day), males and females. LOAEL was not
observed.
    9. 18 month carcinogenicity study--mouse. The NOAEL was 7,000 ppm
(1,010/1,250 mg/kg/day), males and females. No LOAEL was observed. Mice
were dosed at greater than the limit dose of 1,000 mg/kg/day with no
evidence of carcinogenic potential.
    10. Chronic toxicity/Carcinogenicity-- rat. The NOAEL was 500 ppm
(20/28 mg/kg/day, males and females. The LOAEL was 5,000 ppm (213/308
mg/kg/day), males and females based on decreased body weight and body
weight gains. There was no clear evidence of carcinogenic potential.
    11. Acute neurotoxicity--rats. The neurotoxicity NOAEL was 50 mg/
kg/day and the neurotoxicity LOAEL was 200 mg/kg/day based on slight
ataxia in 1 of 11 males. Neurotoxicity at 400 mg/kg included increases
in Functional Observation Battery (FOB) clinical signs and decreases in
motor activity.
    12. Subchronic neurotoxicity--rats. Neurotoxicity NOAEL is greater
than 5000 ppm. (323/386 mg/kg/day; male and female. Neurotoxicity LOAEL
was not observed.

B. Toxicological Endpoints

    1. Acute toxicity. The acute Reference Dose (RfD) is 0.5 mg/kg/day.
The systemic NOAEL of 50 mg/kg/day in the acute neurotoxicity study in
rats is based on slight ataxia in males at the LOAEL of 200 mg/kg/day.
The FQPA safety factor for protection of infants and children was
reduced to 1X. The Acute RfD is identical to the acute population
adjusted dose (aPAD). This aPAD applies to all population subgroups.
    2. Short- and intermediate-term toxicity. There are no registered
residential uses of PT807-HCl.
    3. Chronic toxicity. EPA has established the Chronic RfD at 0.14
mg/kg/day. This RfD is based on the systemic NOAEL of 14.1 mg/kg/day in
the reproductive toxicity study in rats, the lowest NOAEL in the most
sensitive species. The FQPA safety factor for protection of infants and
children was reduced to 1X. The chronic RfD is identical to the chronic
population

[[Page 1811]]

adjusted dose (cPAD). This cPad applies to all population subgroups.
    4. Carcinogenicity. This chemical has been classified as a ``not
likely human carcinogen.''

C. Exposures and Risks

    1. From food and feed uses. Tolerances are being established (40
CFR 180.558) for N,N-diethyl-2-(4-methylbenzyloxy)ethylamine
hydrochloride, at 0.01 ppm, in or on oranges. No other tolerances have
been established for this chemical. Risk assessments were conducted by
EPA to assess dietary exposures from the use on oranges.
    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. For the acute dietary food exposure
analyses, tolerance level residues and 100% crop treated (%CT) were
used. The Dietary Exposure Evaluation Model (DEEM) acute dietary risk
analysis estimates the distribution of single-day exposures for the
overall U.S. population and certain subgroups. The analysis evaluates
individual food consumption as reported by respondents in the USDA
1989-92 Continuing Survey of Food Intake by Individuals (CSFII) and
accumulates exposure to the chemical for each commodity. Each analysis
assumes uniform distribution of PT807-HCl in the commodity supply.
     The acute exposures from food are all less than 1% of the aPAD.
This acute risk estimate should be viewed as conservative since these
calculated exposures are based on tolerance level residues and 100% CT.
Therefore, any additional refinements could reduce estimates
significantly.
    ii. Chronic exposure and risk. The DEEM chronic analysis evaluates
food consumption as reported by respondents in the USDA 1989-91 CSFII
and accumulates exposure to the chemical for each commodity.
     A DEEM chronic exposure analysis was performed using tolerance
level residues and 100% CT to estimate the Tier I exposure for the
general population and subgroups of interest. Exposures for all
population subgroups are less than 1% of the cPAD, and the Agency's
level of concern is greater than 100% of cPAD.
    2. From drinking water. This chemical is very soluble in water and
stable in the environment. Based on its chemical properties it is
likely that this chemical will move to surface water and groundwater,
and it may accumulate in the environment. According to information
included in the proposed Ecolyst label, the maximum application rate
for this chemical is 0.013 lbs. active ingredient/acre/year. The
surface water acute Estimated Environmental Concentrations (EEC) is 4.0
parts per billion (ppb). The surface water chronic EEC is 3.9 ppb.
These values represent the 1- in 10-year peak surface concentration and
1- in 10-year mean yearly concentration. The ground water screening
concentration, calculated using SCI-GROW is 0.02 ppb. While there may
be some potential for PT807-HCl to accumulate in drinking water, EPA
believes these values nevertheless represent very conservative exposure
estimates because they represent peak concentrations, and because of
the conservative nature of the models. Even assuming these conservative
estimates, the Agency does not expect the exposures to exceed our level
of concern.
    The maximum concentrations of PT807-HCl in drinking water is well
below the drinking water level of comparison (DWLOC's) and there is
reasonable certainty that no harm will result to adults, infants, and
children from acute and chronic aggregate exposures.
    i Acute exposure and risk. The maximum acute EECs of PT807-HCl in
surface and groundwater for acute exposure, and the highest value (4.0
ppb) is well below the Agency's calculated DWLOC, which ranged from
5,000 ppb for children (1-6 years) to 18,000 ppb for the U.S.
population. The Agency concludes that there is a reasonable certainty
that no harm will result to adults, infants and children from acute
aggregate exposure to PT807-HCl residues.
    ii. Chronic exposure and risk. The maximum chronic EECs of PT807-
HCl in surface and groundwater for chronic exposure is 3.9 ppb which is
very small compared to the DWLOC, which ranged from 1,400 ppb for
children (1-6 years) to 4,900 ppb for the U.S. population.
    3. From non-dietary exposure. Currently, there are no registered
uses that could result in residential exposures. Therefore, a
residential exposure risk assessment is not required.
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine
whether PT807-HCl 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,
PT807-HCl does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that PT807-HCl has a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

    1. Acute risk. Acute aggregate risk estimates do not exceed the
Agency's level of concern. Using the most conservative Tier I approach,
acute dietary risk estimates for PT807-HCl from food for the general
U.S. population, infants, and children are less than 1% of the aPAD.
The Agency had provided maximum EECs for PT807-HCl in surface and
groundwater for acute exposure, and the highest value (4.0 ppb) is well
below the Agency's calculated DWLOC, which ranged from 5,000 to 18,000
ppb for various population subgroups. The Agency does not expect the
aggregate exposure from water and food to exceed 100% of the aPAD for
all U.S. populations.
    2. Chronic risk. Using the conservative analysis described above,
it is estimated that the chronic exposure to PT807-HCl from food for
the general U.S. population, infants, and children will utilize less
than 1% of the cPAD. Despite the potential for exposure of PT807-HCl in
drinking water, the Agency does not expect the aggregate exposure to
exceed 100% of the cPAD. The maximum concentration of PT807-HCl in
surface and groundwater for chronic exposure is expected to be very
small compared to DWLOC.
    3. Short-and intermediate-term risk. There are no registered
residential uses of PT807-HCl. Therefore, no exposure is expected via
this route of exposure.
    4. Aggregate cancer risk for U.S. population. PT807-HCl has been
classified by the Agency as a ``not likely human carcinogen'' and is
thus not expected to pose a cancer risk to humans.

[[Page 1812]]

    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to residues of PT807-HCl.

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 PT807-HCl, 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 gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. EPA believes that reliable data
support using the standard uncertainty factor (usually 100 for combined
interspecies and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
    ii. Developmental toxicity studies. In the developmental toxicity
study in rats, there was an increased incidence of enlarged ventricles
in pups at 500 mg/kg/day. The incidences were within historical limits,
however, and occurred at a dose far in excess of the maternal NOAEL of
50 mg/kg/day. No developmental effects were seen in rabbit pups at 200
mg/kg/day, whereas the maternal NOAEL was 10 mg/kg/day.
    iii. Reproductive toxicity study. In the rat reproductive study,
the systemic and reproductive LOAELs were both 114 mg/kg/day at which
the parents exhibited decreased body weight and body weight gains, and
the pups had decreased body weight and body weight gains, delayed
sexual development, reductions in absolute and relative uterus and
ovary weights, and histological changes in the uterus, vagina and
ovaries in the females.
    iv. Prenatal and postnatal sensitivity. There is no evidence of
increased development or neurological susceptibility in the prenatal
pre/postnatal studies.
    v. Conclusion. There is a complete toxicity data base for PT807-
HCl and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. Therefore, the FQPA safety
factor was reduced to 1X for the following reasons:
    a. The toxicology database is complete for the assessment of the
effects following in utero and/or postnatal exposure to PT807-HCl.
    b. The toxicity data provided no indication of quantitative or
qualitative increased susceptibility of rats or rabbits to in utero
and/or postnatal exposure.
    c. The requirement of a developmental neurotoxicity study is not
based on the criteria reflecting some special concern which are
generally used for requiring a DNT study and an FQPA safety factor
(e.g.: neuropathy in adult animals; CNS malformations following
prenatal exposure; brain weight or sexual maturation changes in
offspring; and/or functional changes in offspring) and therefore does
not warrant an FQPA safety factor.
    d. The exposure assessments will not underestimate the potential
dietary (food and water) exposures for infants and children from the
use of PT807-HCl (currently no residential exposure is expected).
Specifically, as to residue in drinking water, EPA took into account
that residues may accumulate over time.
    2. Acute risk. It is estimated that the acute exposure to PT807-HCl
from food for infants and children as well as the general U.S.
population will utilize less than 1% of the aPAD. EPA generally has no
concern for exposures below 100% of the aPAD. Despite the potential for
exposure to PT807-HCl in drinking water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD.
    3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to PT807-HCl 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. Despite the potential for exposure to PT807-HCl in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

     The qualitative nature of the residue in oranges is adequately
understood for purpose of this use on oranges. Future uses on crops
other than tree fruit will require additional plant metabolism studies.
The residue of concern in plants is parent compound only.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (HPLC-uvdetection) is available to
enforce the tolerance expression. The method may be requested from:
Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

 C. Magnitude of Residues

     Based on the available crop field trials, residues in oranges are
not expected to exceed 0.01 ppm provided a preharvest interval of 14
days is observed. The submitted orange processing data are adequate. At
5X application rate, residues of PT807-HCl were less than the limit of
quantitation (LOQ) (0.01 ppm) in/on whole oranges harvested at 19 days
PHI. Residues were below the analytical method's LOQ in orange juice
and oil processed from the treated oranges. In dried pulp, residues
ranged from 0.015 ppm to 0.017 ppm from the 5X application rate. No
tolerances are required for orange processed commodities.

D. International Residue Limits

     The Codex Alimentarius Commission, Mexico and Canada have not
established maximum residue limits (MRLs) for residues of PT807-HCl in/
on plant and animal commodities.

E. Rotational Crop Restrictions

     No confined or field rotational crop studies were submitted. The
Agency has determined that rotational crop studies are not required for
uses of pesticides on oranges as they are not routinely rotated to
other crops.

V. Conclusion

    Therefore, the tolerance is established for residues of N,N-
diethyl-2-(4-

[[Page 1813]]

methylbenzyloxy)ethylamine hydrochloride on oranges at 0.01 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300964 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before March 13,
2000.
     1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-300964, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person or
by courier, bring a copy to the location of the PIRIB described in Unit
I.B.2. You may also send an electronic copy of your request via e-mail
to: opp-docket@epa.gov. Please use an ASCII file format and avoid the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not
include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require OMB review or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not

[[Page 1814]]

require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
In addition, the Agency has determined that this action will not have a
substantial direct effect on States, on the relationship between the
national government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

    Dated: December 29, 1999.

Joseph J. Merenda,

Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority:  21 U.S.C. 321(q), 346a and 371.

    2. Section 180.558 is added to read as follows:

Sec. 180.558  N,N-diethyl-2-(4-methylbenzyloxy)ethylamine
hydrochloride; tolerances for residues.

    (a) General. A tolerance for residues of the plant growth regulator
N,N-diethyl-2-(4-methylenzyloxy)ethylamine hydrochloride in or on raw
agricultural commodities is established as follows:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Oranges....................................................         0.01
------------------------------------------------------------------------

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

[FR Doc. 00-737 Filed 1-12-00; 8:45 am]
BILLING CODE 6560-50-F