[Federal Register: February 18, 2004 (Volume 69, Number 32)]
[Rules and Regulations]
[Page 7596-7606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe04-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
OPP-2003-0389; FRL-7341-6]
Aminoethoxyvinylglycine hydrochloride (aviglycine HCl); Pesticide
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
aminoethoxyvinylglycine hydrochloride (aviglycine HCl) in or on apple,
pear and the stone fruits crop group 12, excepting cherries. Valent
BioSciences Corporation requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).
DATES: This regulation is effective February 18, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2003-0389,
must be received on or before April 19, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8263; e-mail
address:greenway.denise@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0389. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public
[[Page 7597]]
docket is the collection of materials that is available for public
viewing at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington,
VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The docket telephone number
is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/ A frequently updated electronic version of 40 CFR part 180 is available at http://.
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html/, a
beta site currently under development. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of November 13, 2003 (68 FR 64343) (FRL-
7333-6), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 6F4632, transferred from Abbott
Laboratories) by Valent BioSciences Corporation, 870 Technology Way,
Libertyville, IL 60048. That notice included a summary of the petition
prepared by Valent BioSciences Corporation, the registrant. There were
no comments received in response to the notice of filing.
In the Federal Register of November 19, 2003 (68 FR 65281) (FRL-
7334-3), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 3F6772) by Valent BioSciences
Corporation, 870 Technology Way, Libertyville, IL 60048. That notice
included a summary of the petition prepared by Valent BioSciences
Corporation, the registrant. There were no comments received in
response to the notice of filing.
The petitions requested that 40 CFR 180.502 be amended by
establishing permanent tolerances for residues of the biochemical
pesticide aminoethoxyvinylglycine hydrochloride (aviglycine HCl),
formerly designated as aminoethoxyvinylglycine (AVG), in or on apple
and pear at 0.08 parts per million (ppm) (PP 6F4632), and in or on the
stone fruits crop group 12, excepting cherries, at 0.170 ppm (PP
3F6772). Data submitted and summarized by Valent BioSciences
Corporation in these petitions include: Domestically and
internationally generated residue data; another acute inhalation
toxicity study; and subchronic toxicity (rat, mouse and dog), and
metabolism (rat and comparative mouse and rat) studies, as well as a
Tier III biochemical pesticide toxicity study (rat carcinogenicity),
and additional studies (rabbit developmental toxicity and rat chronic
toxicity) to refine assessments of subpopulation sensitivities and
carcinogenic potential.
Previously, in support of both time-limited and temporary
tolerances issued by EPA for residues of aviglycine HCl in or on apple,
pear, and the stone fruits crop group 12 (May, 7, 1997, 62 FR 24835,
FRL-5713-3, corrected on October 29, 1997, 62 FR 56089, FRL-5751-5;
June 10, 1999, 64 FR 31124, FRL-6080-4; July 12, 2001, 66 FR 36477,
FRL-6788-7; and July 12, 2001, 66 FR 36481, FRL-6790-7), residue
studies and toxicity data consistent with the Tier I biochemical
pesticide toxicity data requirements, as described in 40 CFR
158.690(c), were submitted. That data included acute oral, dermal and
inhalation toxicity studies; eye and skin irritation studies; dermal
sensitization and one genotoxicity study (Ames test); and subchronic
(immunotoxicity) and developmental toxicity studies in the rat. Several
additional toxicity studies, although not required for biochemical
pesticides, also were submitted previously, including two mammalian
mutagenicity studies (Tier II rat micronuclei and mouse lymphoma) and
subchronic studies (including 21-day dermal toxicity) in the rat. In
addition, a conditionally required 2-generation rat reproduction study
was submitted previously to reduce the uncertainties associated with
the assessment of susceptibility of infants and children to potential
hazards from aviglycine HCl exposure. All of this toxicity data on
aviglycine HCl, both the new data submitted with the new petitions
considered in this final rule and the data previously submitted and
mentioned above has been considered and factored into the action taken
in this final rule.
Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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 of FFDCA 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) of FFDCA, 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) of FFDCA, for tolerances for residues of aviglycine HCl on
apple and pear at 0.08 ppm, and on the stone fruits crop group 12,
excepting cherries, at 0.170 ppm. EPA's assessment of exposures and
risks associated with establishing these tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by aviglycine HCl
[[Page 7598]]
are discussed in Table 1 of this unit as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from the toxicity studies reviewed.
The acute toxicity studies indicated low toxicity for technical
aviglycine HCl, placing it into Toxicity Category III for dermal
toxicity, and Toxicity Category IV for oral toxicity and eye and skin
irritation. A new acute inhalation toxicity study considered as part of
this action changed the technical grade material's classification from
Toxicity Category III to Toxicity Category IV. Dermal sensitization
studies also indicated that aviglycine HCl is a non-sensitizer.
Finally, in order to comply with the statutory requirements under FIFRA
section 6(a)(2) and EPA's data requirements (40 CFR section
158.690(c)), any incident of hypersensitivity associated with use of
aviglycine HCl must be reported to the Agency.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 2.2
toxicity-rat milligram/kilogram/
day (mg/kg/day)
for females, 9.2
mg/kg/day (highest
dose tested) for
males
LOAEL = 9.4 mg/kg/
day (the highest
dose tested for
females) based on
reduced body
weight gain, food
consumption and
food efficiency;
increased severity
and incidence of
reversible kidney
and liver effects;
and discoloration
of the liver
-----------------------------------------------------
870.3100 90-Day oral NOAEL = 0.4 mg/kg/
toxicity-rat day for males and
females
LOAEL = 4.0 mg/kg/
day for males and
females, based on
increased
incidence of
periportal
hepatocellular
vacuolation in the
liver
-----------------------------------------------------
870.3100 90-Day oral NOAEL = 9.5 mg/kg/
toxicity-mouse day for males and
9.6 mg/kg/day for
females
LOAEL = 23.4 mg/kg/
day for males and
23.2 mg/kg/day for
females based on
clinical signs in
both sexes,
decreased mean
body weight and
body weight gain
in males,
decreased relative
spleen and kidney
weights in males,
histopathology in
the adrenal glands
of females, and
increased
testicular atrophy
in males
-----------------------------------------------------
870.3150 90-Day oral NOAEL = 0.6 mg/kg/
toxicity-dog day
LOAEL = 1.2 mg/kg/
day based on
decreased body
weight gain, food
consumption,
uterine weights,
and liver
pathology
-----------------------------------------------------
870.3200 21-Day dermal NOAEL = 1,000 mg/kg/
toxicity-rat day (limit dose)
A LOAEL was not
determined. Limit
doses are as high
a dose level as
can practically be
tested; when there
are no effects, a
LOAEL is not
needed
-----------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental-rat 1.77 mg/kg/day
LOAEL = 8.06 mg/kg/
day based on
decreased body
weight gain, food
consumption,
defecation, and
the presence of
perinasal red
material
Developmental NOAEL
= 1.77 mg/kg/day
LOAEL = 8.06 mg/kg/
day based on
decreased mean
fetal body weights
and developmental
skeletal variants
-----------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental- 0.4 mg/kg/day
rabbit LOAEL = 0.7 mg/kg/
day based on
decreased body
weight gains and
food consumption
Developmental NOAEL
= 0.2 mg/kg/day
LOAEL = 0.4 mg/kg/
day based on the
presence of
developmental
malformations
-----------------------------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects- NOAEL = 0.8 mg/kg/
rat day for males, 2.5
mg/kg/day for
females
LOAEL = 2.5 mg/kg/
day based on
decreased absolute
body weight and
body weight gain,
and periportal
hepatocellular
vacuolation in the
liver in F0 and F1
adult males; 4 mg/
kg/day for females
based on decreased
absolute body
weights, body
weight gain and
food consumption
in F1 generation
Reproductive NOAEL
= 4 mg/kg/day
LOAEL = 8 mg/kg/day
based on decreased
testicular weight,
changes in sperm
morphology, etc.,
and increased
incidence of
testicular
histopathology
Offspring NOAEL =
2.5 mg/kg/day
LOAEL = 4 mg/kg/day
based on decreased
viability of F1
pups and retarded
growth in F1 and
F2 pups
-----------------------------------------------------
[[Page 7599]]
870.4100 Chronic toxicity- NOAEL = 0.7 mg/kg/
rat (1-year day for males and
feeding) females
LOAEL = 7.0 mg/kg/
day for males and
females based on
the increased
incidence of
testicular atrophy
in males and
chronic renal
nephropathy in
females, and
decreased food
consumption and
body weight gain
in both sexes
-----------------------------------------------------
870.4200 Carcinogenicity- NOAEL = 0.7 mg/kg/
rat day
LOAEL = 7.0 mg/kg/
day based on
decreased absolute
body weights, body
weight gains, and
food consumption,
decreased survival
and earlier deaths
in males, clinical
signs (unkempt
coat, hunched
posture, rolling
gait,
piloerection, and/
or walking on tip
toes), cataracts,
adverse effects on
male reproductive
organs (testicular
degeneration,
atrophied seminal
vesicles, and
decreased prostate
weight), adverse
effects on the
exocrine pancreas
in females
(lobular/acinar
cell atrophy,
focal hyperplasia,
and focal
basophilic
alteration), and
an increased
incidence of focal
medullary cell
hyperplasia of the
adrenal gland in
females. For
further
discussion, see
Unit III.C.iii. of
this final rule.
-----------------------------------------------------
870.5100 Ames Gene mutation There was no
mutagenic activity
-----------------------------------------------------
870.5300 Mouse lymphoma Gene mutation There was no
mutagenic activity
-----------------------------------------------------
870.5395 Micronuclei Cytogenetics There was no
evidence of
chromosomal damage
-----------------------------------------------------
870.7800 Immunotoxicity-rat NOAEL = 5 mg/kg/day
LOAEL = 15 mg/kg/
day based on the
decreased primary
antibody (IgM)
response to sheep
red blood cells;
decreased absolute
and relative
thymus weights;
decreased body
weight, food
consumption and
food efficiency at
the high dose
level. (While this
study did not
fully meet the
requirements
outlined in the
Pesticide
Assessment
Guidelines
Subdivision M
OPPTS Series 152-
18, because a
NOAEL and LOAEL
were determined,
and found to be
consistent with
those from other
repeat-dose
studies, EPA
determined that
the study need not
be repeated.)
-----------------------------------------------------
Special studies: No significant
Reporter Gene changes in the
Assays Using level of reporter
Human Estrogen activity was
and Androgen associated with
Receptors, Non- any concentration
guideline Study of aviglycine HCl
when tested with
or without
estrogenic or
androgenic
inhibitors.
Aviglycine HCl was
not cytotoxic at
any concentration.
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of
[[Page 7600]]
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). Under certain specific
circumstances, MOE calculations will be used for the carcinogenic risk
assessment. In this non-linear approach, a ``point of departure'' is
identified below which carcinogenic effects are not expected. The point
of departure is typically a NOAEL based on an endpoint related to
cancer effects though it may be a different value derived from the dose
response curve. To estimate risk, a ratio of the point of departure to
exposure (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for aviglycine HCl used
for human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Aviglycine HCl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk Special FQPA SF1 and Study and Toxicological
Exposure Scenario Assessment, UF LOC for Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary NOAEL = 0.2 mg/kg/day FQPA SF = 1X Rabbit Developmental
(Females 13-49 years of age)2........ UF = 100............... aPAD = acute RfD / FQPA Toxicity
Acute RfD.............. SF. Developmental LOAEL =
= 0.002 mg/kg/day...... = 0.002 mg/kg/day...... 0.4 mg/kg/day based on
increased occurrence
of developmental
malformations (i.e.
lobular agenesis of
right lung) in the
high and medium dose
groups
----------------------------------------------------------------
Acute Dietary NOAEL = 0.2 mg/kg/day FQPA SF = 1X Endpoints from rabbit
(General population including infants UF = 100............... aPAD = acute RfD / FQPA developmental study
and children). Acute RfD.............. SF. utilized as a worst
= 0.002 mg/kg/day...... = 0.002 mg/kg/day...... case estimate, even
though no acute
toxicological
endpoints resulting
from a single dose
were identified for
populations other than
females 13-49 years of
age.
----------------------------------------------------------------
Chronic Dietary NOAEL= 0.8 mg/kg/day FQPA SF = 1X Rat 2-generation
(All populations).................... UF = 100............... cPAD = chronic RfD / Reproductive Toxicity
Chronic RfD............ FQPA SF. LOAEL = 2.5 mg/kg/day
= 0.008 mg/kg/day...... = 0.008 mg/kg/day...... based on decreased
absolute body weight
and body weight gain,
and periportal
hepatocellular
vacuolation in the
liver in F0 and F1
adult males.
----------------------------------------------------------------
Carcinogenicity (general population) Non-linear Effects FQPA considerations Rat carcinogenicity
NOAEL = 0.7 mg/kg/day.. have been accounted LOAEL = 7.0 mg/kg/day
UF = 1,000 (includes for in discussions based on increased
10X for database involving threshold incidence of benign
uncertainty3). non-carcinogenic testicular
Cancer RfD = 0.0007 mg/ effects3 interstitial cell
kg/day. adenomas, benign
adrenal
pheochromocytoma, and
adrenal medullary cell
hyperplasia. Decreased
number of animals with
tumors, with benign
tumors, and with
malignant tumors were
also observed. These
decreases were evident
as mammary
fibroadenomas, thyroid
C-cell adenomas, and
anterior pituitary
adenomas.
----------------------------------------------------------------------------------------------------------------
1 The reference to the FQPA safety factor refers to any additional safety factor retained due to concerns unique
to the FQPA. (See discussion on FQPA safety factor under Unit III.B. of this Final Rule.)
2 The only acute endpoint was identified in pregnant rabbits; therefore, it applies to females 13-49 years of
age, which includes potentially pregnant individuals. Fetal malformations observed in the developmental study
are presumed to occur after maternal exposure to a single dose. Utilization of the acute developmental
endpoint for other populations (general U.S., children 1-2 years old, etc.) substantially over-estimates risk
because resultant malformations are unique to particular stages of fetal development and will not occur in
these other populations.
3 Data are inadequate for the determination of human carcinogenic potential. As a result, an additional 10X
uncertainty factor (UF) was incorporated into hazard estimates for aviglycine HCl's threshold carcinogen
effects in order to compensate for this inadequacy, increasing the overall UF to 1,000. When applied to the
NOAEL of 0.7 mg/kg/day, it resulted in a cancer RfD of 0.0007 mg/kg/day. Justification for the utilization of
an additional 10X uncertainty factor for database insufficiencies in cancer risk assessments included: (i) A
cancer study in a second species (mouse) was absent, (ii) carcinogenic properties were associated with
excessive toxicity, (iii) tumor evidence was inconsistent/equivocal, (iv) carcinogenicity potential was not
confirmed with mutagenicity, endocrine, or immunotoxicity studies, and (v) resultant tumors were not
associated with target organ (liver) or mechanism of action (pyridoxal 5'-phosphate-dependent enzyme
inhibition).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.502) for the residues of aviglycine HCl, in or
on a variety of raw agricultural commodities. Time-limited tolerances
for apple and pear, and a temporary tolerance for the stone fruits crop
group 12 (all expired on December 21, 2003), were established
previously (July 12, 2001, 66 FR 36481, FRL-6790-7 (apple and pear) and
July 12, 2001, 66 FR 36477, FRL-6788-7 (stone fruits crop group12)). In
response to Valent BioSciences Corporation's petitions for permanent
tolerances, an updated risk assessment was conducted by EPA to assess
dietary exposures from aviglycine HCl in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide, if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary
[[Page 7601]]
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID\TM\), which incorporates food consumption data as
reported by respondents in the USDA 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the acute exposure assessments: The residue
of concern for the acute analysis is aviglycine HCl. The assessment
assumed 100% of the proposed crops were treated, and that all treated
crops had residues of concern at the requested tolerance levels.
Anticipated residues were not used. Acute dietary risks for the 95th
percentile of females 13-49 years old and the general U.S. population
were minimal and did not exceed EPA's LOC. Acute dietary risks for
children 1-2 years old technically exceeded EPA's LOC by a small
margin. These risks represented a worst case scenario using toxicologic
endpoints that only occurred in utero. Therefore, the calculated risks
were illustrative at best. See footnote 2 of Table 2 for further
explanation of acute endpoint utilized by EPA.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: The residue of concern for the chronic analysis
is aviglycine HCl. Conservative chronic dietary assessments utilized
tolerance-level concentrations for crops (i.e., 0.08 ppm for apple and
pear and 0.170 ppm for stone fruits crop group 12, excepting cherries).
Chronic dietary risk for the U.S. population, and children 1-2 years
old did not exceed 1.6%, and 10.5%, respectively, of the chronic
Population Adjusted Dose (cPAD, 0.008 mg/kg/day). Therefore, chronic
dietary risks were minimal and did not exceed EPA's LOC.
iii. Carcinogenicity. Conflicting evidence for carcinogenicity has
been reported for aviglycine HCl. Mutatgenicity, immunotoxicology,
endocrine, subchronic, and chronic feeding studies strongly suggest
that aviglycine HCl does not induce cancer. Effects observed in the
carcinogenicity study, such as a threshold-response and reduction in
the number of animals with tumors, with benign tumors, and with
malignant tumors also support non-carcinogenic conclusions. In
contrast, increased incidence of benign testicular interstitial cell
adenomas, benign adrenal pheochromocytoma, and adrenal medullary cell
hyperplasia suggest that aviglycine HCl may induce cancer. These
effects, however, were seen only at an excessively toxic dose and may
have been mediated indirectly through generic toxic mechanisms such as
glutathione depletion and resultant oxygen radical-induced cell damage,
rather than by aviglycine HCl. Dosing with excessive aviglycine HCl,
therefore, weakened support for carcinogenic activity.
In the end, weight-of-evidence suggests that aviglycine HCl is non-
carcinogenic. However, definitive statements of carcinogenicity can not
be made at the current time, because information meeting rigorous
criteria for defining it as non-carcinogenic (such as a second cancer
study in a different species and strong non-conflicting evidence) is
absent. These studies are not typically required in the testing of
biochemical pesticides. To account for this, an additional database
uncertainty factor of 10X was integrated with other UFs (100X)
(increasing the overall uncertainty factor to 1,000) and the NOAEL
established in the carcinogenesis study (0.7 mg/kg/day) to
conservatively account for this deficiency (RfD = 0.0007 mg/kg/day).
Carcinogenic dietary risks for the U.S. population did not exceed
18.3% of the cancer RfD. The cancer risks from chronic exposure to
aviglycine HCl in food and surface or ground water, therefore, were not
unreasonable.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for aviglycine HCl in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of aviglycine HCl.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and screening concentration in ground water (SCI-GROW), which
predicts pesticide concentrations in ground water. In general, EPA will
use GENEEC (a Tier I model) before using PRZM/EXAMS (a Tier II model)
for a screening-level assessment for surface water. The GENEEC model is
a subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. GENEEC incorporates a farm pond scenario,
while PRZM/EXAMS incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a screen for sorting out pesticides for which it is
unlikely that drinking water concentrations would exceed human health
LOC.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water. EECs derived from these models are
used to quantify drinking water exposure and risk as a %RfD or %PAD.
Instead drinking water levels of comparison (DWLOCs) are calculated and
used as a point of comparison against the model estimates of a
pesticide's concentration in water. DWLOCs are theoretical upper limits
on a pesticide's concentration in drinking water in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Since DWLOCs address total aggregate exposure to aviglycine HCl they
are further discussed in the aggregate risk sections in Unit E.
Based on the GENEEC and SCI-GROW models, the EECs of aviglycine HCl
acute peak exposures are estimated to be 0.582 parts per billion (ppb)
for surface water and 0.00028 ppb for ground water. The EECs for
chronic 90 day exposures are estimated to be 0.0194 ppb for surface
water and 0.00028 ppb for ground water. Acute EECs did not exceed
DWLOCs for the subpopulation females 13-49 years of age (49.05 ppb) or
for the general U.S. population (47.32 ppb). Acute DWLOCs were not
calculated for other subpopulations because of a lack of relevance to
the sensitive developmental endpoint. EECs also did not exceed DWLOCs
for any population considered in chronic (Table 4) or cancer estimates
(Table 5). Aggregate cancer risks and the risks from aggregate acute or
chronic exposure to aviglycine HCl in food and surface or ground water,
therefore, are not unreasonable.
3. From non-dietary exposure. The term ``residential exposure'' is
used in
[[Page 7602]]
this document to refer to non-occupational, non-dietary exposure (e.g.,
for lawn and garden pest control, indoor pest control, termiticides,
and flea and tick control on pets). Aviglycine HCl is not registered
for use on any sites that would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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 aviglycine HCl has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to aviglycine
HCl and any other substances and aviglycine 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
aviglycine 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 policy statements
released by EPA's OPP concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA 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 database on toxicity and exposure
unless EPA determines based on reliable data 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. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. EPA initially had concern
for aviglycine HCl-induced prenatal and postnatal toxicity. This
concern arose from 5 incidents of fetal toxicity (developmental
malformations) that occurred at doses lower than that which induced
maternal toxicity in rabbits (LOAEL = 0.4 mg/kg/day versus 0.7 mg/kg/
day) and from an apparent increase in the severity of effects in rat
offspring when compared to similarly dosed adults. A Degree of Concern
Analysis was initiated to further investigate these issues and
determine if an additional FQPA safety factor should be applied to risk
equations to account for differential prenatal or postnatal
sensitivities.
After investigation, the degree of concern was determined to be low
for prenatal and postnatal aviglycine HCl-induced toxicity. This
determination was justified for prenatal effects by:
i. The observation that the same number of similar fetal
malformations in rabbits (5) also occurred at maternally toxic doses
(0.7 mg/kg/day);
ii. The conclusion that 0.4 and 0.7 mg/kg/day dose differences in
the rabbit study were more-than-likely without biological significance;
and
iii. The utilization of the developmental endpoint (i.e., females
aged 13-49), an endpoint relevant to prenatal toxicity, as a means for
risk comparison. This determination also was justified for postnatal
effects by:
a. The observation that toxic doses for adult rats were ultimately
less than that for offspring (LOAEL = 2.5 versus 4.0 mg/kg/day);
b. The observation that increased severity of effects noticed in
rat offspring may have been due to an inexplicable total loss of three
litters;
c. The observation that offspring LOAELs were partially influenced
by body weight decrements in parents; and
d. The observation that increased prenatal or postnatal
sensitivities were not evident in rat developmental studies.
In summary, adequate characterization of prenatal and postnatal
effects and the choice of a sensitive developmental endpoint for
comparison to exposure data satisfied our concerns related to prenatal
and postnatal effects.
3. Conclusion. There is a complete toxicity database for aviglycine
HCl and exposure data are complete or are estimated based on data that
reasonably accounts for potential prenatal and postnatal exposures to
offspring and parents. A developmental NOAEL of 0.2 mg/kg/day was
established in a rabbit study based on fetal effects at a dose of 0.4
mg/kg/day which was below the maternal LOAEL of 0.7 mg/kg/day. The
maternal and developmental LOAELs were the same in the rat
developmental study indicating no differences in susceptibility to
aviglycine HCl toxicity. The multigeneration reproduction study also
showed no differences in susceptibility of parents and their offspring
(LOAEL = 2.5 mg/kg/day). All of these studies indicate that the special
FQPA safety factor can be reduced to 1X for purposes of the current
assessment.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against EECs. DWLOC values are
not regulatory standards for drinking water. DWLOCs are theoretical
upper limits on a pesticide's concentration in drinking water in light
of total aggregate exposure to a pesticide in food and residential
uses. In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable water exposure (mg/kg/day) = PAD -
(average food + residential exposure)). This allowable exposure through
drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable
[[Page 7603]]
data) would not result in unacceptable levels of aggregate human health
risk at this time. Because EPA considers the aggregate risk resulting
from multiple exposure pathways associated with a pesticide's uses,
levels of comparison in drinking water may vary as those uses change.
If new uses are added in the future, EPA will reassess the potential
impacts of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
aviglycine HCl will occupy18.25 % of the aPAD for females 13-49 years
old. As a worst case estimate, dietary risks for the general U.S.
population and population subgroups were also estimated using the acute
developmental endpoint (0.002 mg/kg/day). Exposures to aviglycine HCl
were marginally above EPA's LOC for children 1-2 years old (163%), but
below for the general U.S. population (32.4%). The risks posed to
children 1-2 years old represented a worst case scenario using
toxicologic endpoints that only occurred in utero. Therefore, the
calculated risks were demonstrative at best. In addition, there is
potential for acute dietary exposure to aviglycine HCl in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface water and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD, as shown in Table 3 of this unit.
The risks from acute aggregate exposure to aviglycine HCl in food and
surface or ground water, therefore, are not unreasonable.
Table 3. --Aggregate Risk Assessment for Acute Exposure to Aviglycine HCl
----------------------------------------------------------------------------------------------------------------
Dietary Surface Ground
Population Subgroup Exposure % aPAD Water EEC Water EEC Acute DWLOC
(mg/kg/day) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
General U. S. Population1 0.000648 32.4 0.582 0.00028 47.32
---------------------------------------------------------------------------
Females 13-49 years old 0.000365 18.25 0.582 0.00028 49.05
---------------------------------------------------------------------------
Children 1-2 years old1 0.003266 163
----------------------------------------------------------------------------------------------------------------
1 These exposure estimates and risk characterizations exaggerate the risk because the majority of individuals in
the general population and in this subpopulation are not likely to be susceptible to aviglycine HCl's
developmental effects (i.e., not likely to be pregnant).
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
aviglycine HCl from food will utilize 1.6% of the cPAD for the U.S.
population, 10.1% of the cPAD for all infants (<1 year old), and 10.5%
of the cPAD for children 1-2 years old, as shown in Table 4 of this
unit. There are no uses for aviglycine HCl that result in chronic
residential exposure to aviglycine HCl. There is potential for chronic
dietary exposure to aviglycine HCl in drinking water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect the aggregate exposure to exceed 100% of the cPAD, as
shown in Table 4 of this unit. The risks from chronic aggregate
exposure to aviglycine HCl in food and surface or ground water,
therefore, are not unreasonable.
Table 4. --Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Aviglycine HCl
----------------------------------------------------------------------------------------------------------------
Dietary Surface Ground
Population Subgroup Exposure mg/ % cPAD Water EEC Water EEC Chronic
kg/day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.000128 1.6 0.0194 0.00028 0.276
--------------------------------------------------------------
All Infants (<1 year old) 0.000807 10.1 0.0194 0.00028
--------------------------------------------------------------
Children 1-2 years old 0.000840 10.5 0.0194 0.00028 0.072
--------------------------------------------------------------
Children 3-5 years old 0.000503 6.3 0.0194 0.00028
--------------------------------------------------------------
Children 6-12 years old 0.000186 2.3 0.0194 0.00028
--------------------------------------------------------------
Youth 13-19 years old 0.000064 0.8 0.0194 0.00028
--------------------------------------------------------------
Adults 20-49 years old 0.000049 0.6 0.0194 0.00028
--------------------------------------------------------------
Adults 50+ years old 0.000072 0.9 0.0194 0.00028
--------------------------------------------------------------
Females 13-49 years old 0.000058 0.7 0.582 0.00028 0.238
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Aviglycine HCl is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which do not exceed the Agency's
LOC.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).Aviglycine HCl
is not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum
[[Page 7604]]
of the risk from food and water, which do not exceed the Agency's LOC.
5. Aggregate cancer risk for U.S. population. Using the exposure
assumptions generated from cancer endpoints (RfD = 0.0007 mg/kg/day)
and chronic durations of exposure, EPA has concluded that exposure to
aviglycine HCl from food will utilize 18.3% of the cancer RfD for the
U.S. population. There are no uses for aviglycine HCl that result in
carcinogenic residential exposure. There is, however, the potential for
exposure to aviglycine HCl in drinking water. After calculating a
cancer DWLOC and comparing it to EECs for surface water and ground
water, EPA does not expect the aggregate exposure to exceed 100% of the
cancer RfD, as shown in Table 5 of this unit. The cancer risks from
chronic aggregate exposure to aviglycine HCl in food and surface water
or ground water, therefore, are not unreasonable.
Table 5.--Aggregate Cancer Risk Assessment for Exposure to Aviglycine HCl
----------------------------------------------------------------------------------------------------------------
Dietary Surface
Population Subgroup Exposure mg/ % of Cancer Water EEC Cancer
kg/day RfD (ppb) DWLOC
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.000128 18.3 0.0194 20.02
----------------------------------------------------------------------------------------------------------------
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to aviglycine HCl residues at the established tolerance
levels.
IV. Other Considerations
A. Endocrine Disruptors
Incubation with aviglycine HCl did not change reporter gene
activity induced by estradiol (estrogen) and dihydrotestosterone
(androgen) and inhibited by 4-hydroxytamoxifen (anti-estrogen) and
hydroxyflutamide (anti-androgen) at non-cytotoxic doses. Aviglycine
HCl-induced pathologies of organs associated with the endocrine system
were not observed consistently at non-toxic doses. Aviglycine HCl,
therefore, was qualified as a non-endocrine disrupting compound.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography-fluorescence detector) that has been EPA-validated is
available to enforce the apple and pear tolerance expression. The
method may be requested from: Christine Olinger, Acting Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
In addition, enforcement methodologies are available to enforce the
stone fruits crop group 12, excepting cherries, tolerance expression.
Preliminary review of the proposed enforcement methods for residues of
aviglycine HCl on stone fruits crop group 12, excepting cherries, has
indicated that they appear to be suitable for enforcement purposes.
Given that the methods for the stone fruits crop group 12, excepting
cherries, reflect only minor modification of the EPA-validated method,
and that the registrant has provided the Agency with concurrent
fortification data to demonstrate that the methods are adequate for
data collection purposes and with an independent Laboratory Validation,
coupled with the EPA's preliminary review, EPA concludes that the
methods are suitable as enforcement methods to support tolerances
associated with this action. Those methods may be requested from:
Sheryl K. Reilly, Chief, Biochemical Pesticides Branch, Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460-0001, telephone number: (703) 308-
8269; e-mail address: reilly.sheryl@epa.gov.
C. International Residue Limits
There are no Codex Alimentarius Commission (CODEX) maximum residue
levels for residues of aviglycine HCl.
D. Conditions
Time-limited tolerances (May 7, 1997, 62 FR 24835, FRL-5713-5 and
July 12, 2001, 66 FR 36481, FRL-6790-7) were established for the
biochemical pesticide aviglycine HCl in connection with conditional
section three registrations (June 13, 1997, 62 FR 32325, FRL-5721-4).
All tolerances were time-limited because of the existence of a rat 2-
generation reproduction study data gap. The time-limitation allowed for
development and review of the data. Based on the available
toxicological data, the thousandfold uncertainty factor, and the levels
of exposure, the EPA determined at that time that there was a
reasonable certainty that no harm would result to the U.S. population,
including infants and children, from aggregate exposure to aviglycine
HCl and its residues during the period of the time-limited tolerances.
The rat 2-generation reproduction study, imposed by EPA to augment the
results of the rat developmental toxicity study, was submitted to the
Agency by Abbott Laboratories on September 27, 1999. It has now been
reviewed and found by EPA to satisfy the 1997 condition of
registration. Therefore, there currently are no data gaps associated
with aviglycine HCl. A new database uncertainty factor applied to
carcinogenic endpoints has now been established and is based on a
review of submitted cancer data. This additional uncertainty factor has
not affected current tolerance levels or crop uses. Additional cancer
studies may be required in the future, however, should the registrant
propose to alter tolerance levels, crop uses, application rates, pre-
harvest intervals, or other factors important to human exposure.
V. Conclusion
Therefore, establishment of tolerances for residues of aviglycine
HCl, in or on apple and pear at 0.08 ppm, and in or on the stone fruits
crop group 12, excepting cherries, at 0.170 ppm, is appropriate.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
[[Page 7605]]
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. 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 ID number OPP-2003-0389 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 April 19,
2004.
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 (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
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, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
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, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
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.1. Mail your
copies, identified by docket ID number OPP-2003-0389, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. 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 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. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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 special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or 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 section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input
[[Page 7606]]
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 section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Congressional Review Act
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: February 5, 2004.
Sheryl K. Reilly
acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
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2. Section 180.502 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 180.502 Aminoethoxyvinylglycine hydrochloride (aviglycine HCl);
tolerances for residues.
(a) General. Tolerances are established for residues of
aminoethoxyvinylglycine hydrochloride (aviglycine HCl) in or on the
following food commodities:
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Commodity Parts per million
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Apple................................................ 0.08
Fruit, stone, group 12, except cherry................ 0.170
Pear................................................. 0.08
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[FR Doc. 04-3371 Filed 2-17-04; 8:45 am]
BILLING CODE 6560-50-S