cyromazine (Larvadex,Trigard) Pesticide Tolerances for Emergency Exemptions 11/97
[Federal Register: December 10, 1997 (Volume 62, Number 237)]
[Rules and Regulations]
[Page 65030-65036]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de97-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300588; FRL-5758-2]
RIN 2070-AB78
Cyromazine; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for the
combined residues of cyromazine and its metabolite melamine in or on
lima beans and blackeye peas. This action is in response to EPA's
granting of an emergency exemption under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on lima beans and blackeye peas. This regulation establishes
a maximum permissible level for residues of cyromazine in this food
commodity pursuant to section 408(l)(6) of the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
The tolerance will expire and is revoked on December 31, 1998.
DATES: This regulation is effective December 10, 1997. Objections and
requests for hearings must be received by EPA on or before February 9,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300588], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300588], must also be submitted 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,
bring a copy of objections and hearing requests to Rm. 1132, CM 2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov.
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect 5.1/6.1 file format or ASCII file
format. All copies of objections and hearing requests in electronic
form must be identified by the docket control number [OPP-300588]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic copies of objections and hearing requests on this rule
may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: Crystal Mall 2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 308-9367, e-mail:
ertman.andrew@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
combined residues of the insecticide cyromazine and its metabolite
melamine in or on lima beans at 5.0 part per million (ppm) and blackeye
peas at 5.0 ppm. This tolerance will expire and is revoked on December
31, 998. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a
[[Page 65031]]
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue....''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Cyromazine on Lima Beans and Blackeye
Peas and FFDCA Tolerances
Insect pressure from the leafminer has increased over the past
several years due to the rapid increase in the insect's resistance to
currently registered insecticides and the resulting increase in insect
populations. With the end of the California drought, over wintering has
occurred in leafminer populations and mild weather has added to the
resistance population with outbreaks increasing in the summer and
carrying through the end of the harvest season. The applicant states
that in 1996 some outbreaks were so severe that several fields (both
lima bean and blackeye pea) were abandoned rather than harvested.
Current alternatives for use on blackeye peas have proven
ineffective and there are few registered alternatives for control of
leafminer in lima beans. EPA has authorized under FIFRA section 18 the
use of cyromazine on lima beans and blackeye peas for control of
leafminer in California. After having reviewed these submissions, EPA
concurs that emergency conditions exist for this state.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of cyromazine in or
on lima beans and blackeye peas. In doing so, EPA considered the new
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerances under FFDCA section 408(l)(6) would be consistent
with the new safety standard and with FIFRA section 18. Consistent with
the need to move quickly on the emergency exemptions in order to
address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although these tolerances will expire
and are revoked on December 31, 1998, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on lima beans and blackeye peas after that
date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA. EPA will take action to revoke
these tolerances earlier if any experience with, scientific data on, or
other relevant information on this pesticide indicate that the residues
are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether cyromazine
meets EPA's registration requirements for use on lima beans and
blackeye peas or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of cyromazine by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than California to
use this pesticide on these crops under section 18 of FIFRA without
following all provisions of section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemptions for
cyromazine, contact the Agency's Registration Division at the address
provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to ten times more sensitive to pesticides than
the test animals, and that one person or subgroup of the population
(such as infants and children) could be up to ten times more sensitive
to a pesticide than another. In addition, EPA assesses the potential
risks to infants and children based on the weight of the evidence of
the toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
[[Page 65032]]
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in ground water
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.The
TMRC is a ``worst case'' estimate since it is based on the assumptions
that food contains pesticide residues at the tolerance level and that
100% of the crop is treated by pesticides that have established
tolerances. If the TMRC exceeds the RfD or poses a lifetime cancer risk
that is greater than approximately one in a million, EPA attempts to
derive a more accurate exposure estimate for the pesticide by
evaluating additional types of information (anticipated residue data
and/or percent of crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from Federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (children 1-6
years old) was not regionally based.
IV. 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
these actions, EPA has sufficient data to assess the hazards of
cyromazine and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for the
combined residues of cyromazine and its metabolite melamine on lima
beans at 5.0 ppm and blackeye peas at 5.0 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk.
EPA has also considered available information concerning the
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children. The nature of the toxic
effects caused by cyromazine are discussed below.
1. Acute toxicity. An acute dietary risk endpoint was not
identified and an acute dietary risk assessment is not required.
2. Short--and intermediate--term toxicity. For short-term
[[Page 65033]]
Margin of Exposure (MOE) calculations, the Agency used a systemic
NOEL of 0.75 milligrams/kilogram/day (mg/kg/day) from a 6-month dog
feeding study. At the lowest effect level (LEL) of 7.5 mg/kg/day, there
were changes in hematological parameters.
3. Chronic toxicity. EPA has established the RfD for cyromazine at
0.0075 mg/kg/day. This RfD is based on a 6-month feeding study in the
dog with a NOEL of 0.75 mg/kg/day and a LEL of 7.5 mg/kg/day based on
pronounced effects on hematological parameters and an uncertainty
factor of 100.
4. Carcinogenicity. Cyromazine has been classified as a Group
E (evidence of non-carcinogenicity for humans) chemical by the
Agency's Cancer Peer Review (CPR) Committee.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.414) for the combined residues of cyromazine, in or on a
variety of raw agricultural commodities at levels ranging from 1.0 ppm
in tomatoes to 10 ppm in leafy vegetables.
Currently there are tolerances for residues of cyromazine and its
metabolite melamine on the meat fat and meat by-products of chickens
from the use of cyromazine as a feed-through. Risk assessments were
conducted by EPA to assess dietary exposures and risks from cyromazine
as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. An acute dietary risk endpoint was not
identified and an acute risk assessment is not required.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made very conservative assumptions including
100% of crop treated for lima bean and blackeyed pea and most other
commodities having cyromazine tolerances. The Agency used percent crop
treated on such crops as tomatoes, peppers and lettuce and assumed all
crops will contain cyromazine residues and those residues would be at
the level of the tolerance. This will result in an overestimate of
human dietary exposure. Thus, in making a safety determination for this
tolerance, EPA is taking into account this conservative exposure
assessment.
The existing cyromazine tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in an
Anticipated Residue Contribution (ARC) that is equivalent to the
following percentages of the RfD:
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Subgroup Percent
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U.S. population (48 States)................................ 34
Nursing infants (<1 year old).............................. 12
Non-nursing infants (<1 year old).......................... 53
Children (1-6 years old)................................... 54
Children (7-12 years old).................................. 44
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The subgroups listed above are: (1) the U.S. population (48
states); (2) those for infants and children; and, (3) the other
subgroups for which the percentage of the RfD occupied is greater than
that occupied by the subgroup U.S. population (48 states).
2. From drinking water. Based on information available to the
Agency, cyromazine is persistent and relatively mobile. There are
no established Maximum Contaminant Levels for residues of cyromazine in
drinking water. No health advisory levels for cyromazine in drinking
water have been established.
Chronic exposure and risk. Because the Agency lacks sufficient
water-related exposure data to complete a comprehensive drinking water
risk assessment for many pesticides, EPA has commenced and nearly
completed a process to identify a reasonable yet conservative bounding
figure for the potential contribution of water-related exposure to the
aggregate risk posed by a pesticide. In developing the bounding figure,
EPA estimated residue levels in water for a number of specific
pesticides using various data sources. The Agency then applied the
estimated residue levels, in conjunction with appropriate toxicological
endpoints (RfD's or acute dietary NOEL's) and assumptions about body
weight and consumption, to calculate, for each pesticide, the increment
of aggregate risk contributed by consumption of contaminated water.
While EPA has not yet pinpointed the appropriate bounding figure for
exposure from contaminated water, the ranges the Agency is continuing
to examine are all below the level that would cause cyromazine to
exceed the RfD if the tolerance being considered in this document were
granted. The Agency has therefore concluded that the potential
exposures associated with cyromazine in water, even at the higher
levels the Agency is considering as a conservative upper bound, would
not prevent the Agency from determining that there is a reasonable
certainty of no harm if the tolerance is granted.
3. From non-dietary exposure. Cyromazine is not registered for use
on residential non-food sites.
4. Cumulative exposure to substances with 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.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether cyromazine has a common mechanism
[[Page 65034]]
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, cyromazine 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 cyromazine has a common
mechanism of toxicity with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
Chronic risk. Using the conservative ARC exposure assumptions
described in Unit IV.B.1.ii. of this preamble, and taking into account
the completeness and reliability of the toxicity data, EPA has
calculated that dietary exposure to cyromazine from food will utilize
34% of the RfD for the U.S. population. The Agency generally has no
concern for exposures below 100% of the RfD because the RfD represents
the level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. Despite the
potential for exposure to cyromazine in drinking water, EPA does not
expect the aggregate exposure to exceed 100% of the RfD. Under current
Agency guidelines, the registered non-dietary uses of cyromazine do not
constitute a chronic exposure scenario. The Agency concludes that there
is a reasonable certainty that no harm will result from chronic
aggregate exposure to cyromazine residues.
D. Endocrine Disrupter Effects
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) ``may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect....'' The Agency is
currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement this program.
Congress has allowed 3 years from the passage of FQPA (August 3,
1999) to implement this program. At that time, EPA may require further
testing of this active ingredient and end use products for endocrine
disrupter effects.
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 cyromazine, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from pesticide exposure during prenatal development
to one or both parents. Reproduction studies provide information
relating to effects from exposure to the pesticide on the reproductive
capability of mating animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter-and intra-
species variability) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. From the rat developmental
study, the maternal (systemic) NOEL was 100 mg/kg/day, based on
increased incidence of clinical signs and decreased body weight at the
lowest observed effect level (LOEL) of 300 mg/kg/day. The developmental
(pup) NOEL was 300 mg/kg/day, based on increased incidence of skeletal
variations at the LOEL of 600 mg/kg/day.
From the rabbit developmental study, the maternal (systemic) NOEL
was 10 mg/kg/day, based on decreased weight gain and food consumption
at the LOEL of 30 mg/kg/day. The developmental (pup) NOEL was 60 mg/kg/
day, the highest dose tested (HDT).
iii. Reproductive toxicity study. From the rat reproduction study,
the maternal (systemic) NOEL was 50 mg/kg/day, based on body weight
loss at the LOEL of 150 mg/kg/day. The reproductive/developmental (pup)
NOEL was 50 mg/kg/day, based on decreased pup growth, decreased number
of pups per litter, and increased fetotoxicity at the LEL of 150 mg/kg/
day.
iv. Pre-and post-natal sensitivity. The toxicological data base for
evaluating pre-and post-natal toxicity for cyromazine is complete with
respect to current data requirements. There are no pre-or post-natal
toxicity concerns for infants and children, based on the results of the
rat and rabbit developmental toxicity studies and the 2-generation rat
reproductive toxicity study.
v. Conclusion. The Agency concludes that reliable data support use
of the standard 100-fold margin of exposure/uncertainty factor and that
an additional margin/factor is not needed to protect infants and
children.
2. Chronic risk. Using the conservative exposure assumptions
described in Unit IV.B.1.ii. of this preamble, EPA has concluded that
the percentage of the RfD that will be utilized by dietary (food)
exposure to residues of cyromazine ranges from 53% for non-nursing
infants less than one year old, up to 54% for children 1-6 years old.
EPA generally has no concern for exposures below 100% of the RfD
because the RfD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. Despite the potential for exposure to cyromazine in
drinking water and from non-dietary, non-occupational exposure, EPA
does not expect the aggregate exposure to exceed 100% of the RfD. EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to cyromazine residues.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants and animals is adequately
understood.
The residue of concern is parent cyromazine and the metabolite
melamine as specified in 40 CFR 180.414.
B. Analytical Enforcement Methodology
Adequate enforcement methodology for crops (HPLC with UV detector)
is available in PAM II to enforce the tolerance expression.
C. Magnitude of Residues
Residues of cyromazine and its metabolite melamine are not expected
to exceed 5.0 ppm in/on either lima beans or blackeyed peas as a result
of this section 18 use. Secondary residues in animal commodities are
not expected to exceed existing tolerances as a result of this section
18 use.
[[Page 65035]]
D. International Residue Limits
There are no CODEX, Canadian, or Mexican MRL's for cyromazine on
lima beans or blackeyed peas.
E. Rotational Crop Restrictions
Crops with permitted uses on the federal label may be planted as
rotational crops, additionally sweet corn and radishes may be planted
as rotational crops 3 months after the last application to beans.
VI. Conclusion
Therefore, the tolerance is established for combined residues of
cyromazine in lima beans at 5.0 ppm and blackeye peas at 5.0 ppm.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by February 9, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is 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 in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). 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.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300588] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section
408(l)(6). 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) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
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 in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the tolerances 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. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
[[Page 65036]]
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 25, 1997.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.414, in paragraph (b) by alphabetically adding the
following commodities to the table to read as follows:
Sec. 180.414 Cyromazine; tolerances for residues.
* * * * *
(b) * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Beans, lima............................................... 5.0 12/31/98
* * * * * * *
Peas, blackeyed........................................... 5.0 12/31/98
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. 97-32039 Filed 12-9-97; 8:45 am]
BILLING CODE 6560-50-F
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criticism of unnamed products implied. Most of this information is historical
in nature and may no longer be applicable.
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