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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:

                                                                        
------------------------------------------------------------------------
                          Subgroup                             Percent  
------------------------------------------------------------------------
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
------------------------------------------------------------------------

    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