PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> fenitrothion (Sumithion) to methyl parathion --> hydramethylnon --> hydramethylnon (Amdro) Pesticide Tolerances for Emergency Exemptions 2/98

hydramethylnon (Amdro) Pesticide Tolerances for Emergency Exemptions 2/98

  


[Federal Register: March 4, 1998 (Volume 63, Number 42)]
[Rules and Regulations]               
[Page 10537-10543]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04mr98-12]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300606; FRL-5767-1]
RIN 2070-AB78

 
Hydramethylnon; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a time-limited tolerance for 
residues of hydramethylnon in or on pineapple. 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 pineapple. This regulation establishes a 
maximum permissible level for residues of hydramethylnon 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 January 31, 1999.

DATES: This regulation is effective March 4, 1998. Objections and 
requests for hearings must be received by EPA on or before May 4, 1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300606], 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-300606], 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. 119, 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-300606]. 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: Virginia Dietrich, 
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) 308-9359, e-mail: 
dietrich.virginia@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 
residues of the insecticide hydramethylnon, in or on pineapple at 0.05 
part per million (ppm). This tolerance will expire and is revoked on 
January 31, 1999. 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 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 tolerance to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

[[Page 10538]]

II. Emergency Exemption for hydramethylnon on pineapple and FFDCA 
Tolerances

    On May 21, 1997 the state of Hawaii applied for an emergency 
exemption for the use of hydramethylnon to control big-headed and 
Argentine ants in pineapples. These ants are involved in the spread of 
mealy bugs in pineapple fields and the subsequent development of 
mealybug wilt, a devastating disease responsible for the near demise of 
the pineapple industry in the 1920's. Alternate control strategies are 
not effective. Currently registered materials for in-field ant control 
are not effective due to the mobility of the ants. After reviewing the 
submission the EPA authorized under FIFRA section 18 the use of 
hydramethylnon on pineapple for control of big headed and Argentine 
ants in Hawaii.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of hydramethylnon in or on 
pineapple. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance 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 exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on 
January 31, 1999, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on pineapple 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 this tolerance earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether hydramethylnon meets EPA's 
registration requirements for use on pineapple or whether a permanent 
tolerance for this use would be appropriate. Under these circumstances, 
EPA does not believe that this tolerance serves as a basis for 
registration of hydramethylnon by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
State other than Hawaii to use this pesticide on this crop 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 exemption for hydramethylnon, 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 10 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 10 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.
    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.

[[Page 10539]]

 High-end exposures from all 3 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 groundwater 
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 (non-nursing 
infants less than one year 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 
this action, EPA has sufficient data to assess the hazards of 
hydramethylnon and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of hydramethylnon, also known as tetrahydro-5,5-dimethyl-2-
(1H)-pyrimidinoine(3-(4-trifluoromethyl)phenyl)-1- [2-
[4(trifluoromethly)phenyl]ethenyl)-2-propenylidene) hydrazone on 
pineapple at 0.05 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 hydramethylnon are 
discussed below.
    1. Acute toxicity. An acute endpoint has not been identified. This 
risk assessment is not required.
    2. Short - and intermediate - term toxicity. For short-term MOE 
calculations, the Agency's Hazard Identification Committee recommended 
use of the Systemic No Observed Adverse Effect Level (NOAEL) 
(freestanding) of 250 milligrams/kilogram/day (mg/kg/day) from the 21-
day dermal toxicity study in New Zealand white rabbits. Nonadverse 
signs at the NOAEL included decreased food consumption in males and 
females, and thrombocytopenia in females. For intermediate-term MOE 
calculations, the Agency's Hazard Identification Committee recommended 
use of the systemic NOAEL (freestanding) of 250 mg/kg/day from the 21-
day dermal toxicity study in New Zealand white rabbits. Nonadverse 
signs at the NOAEL included decreased food consumption in males and 
females, and thrombocytopenia in females.
    3. Chronic toxicity. EPA has established the RfD for hydramethylnon 
at 0.001 mg/kg/day. This RfD is based on a 6-month feeding study in 
dogs with a NOAEL of 1.0 mg/kg/day based on an increased incidence of 
soft stools, mucoid stools, and diarrhea at the Lowest Observed Adverse 
Effect Level (LOAEL) of 3.0 mg/kg/day. Since a NOEL was not defined in 
this study, an uncertainty factor of 1,000 was used during calculation 
of the RfD instead of the usual 100-fold factor.
    4. Carcinogenicity. Hydramethylnon has been classified as a Group C 
chemical (possible human carcinogen) by the Agency's Cancer Peer Review 
Committee. The Committee recommended using the RfD approach for risk 
assessment.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.395) for the residues of hydramethylnon, in or on a variety of 
raw agricultural commodities. Risk assessments were conducted by EPA to 
assess dietary exposures and risks from hydramethylnon as follows:
    a.  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. The acute dietary (food only) risk 
assessment is not required as the Agency's Hazard Identification 
Committee did not

[[Page 10540]]

identify any acute dietary risk endpoints.
    b. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment, HED has made very conservative assumptions -- 100% of 
pineapple commodities will contain hydramethylnon residues and those 
residues will be at the level of the required tolerance -- which 
results in an overestimate of human dietary exposure. Thus, in making a 
safety determination for this tolerance, HED is taking into account 
this conservative exposure assessment. The hydramethylnon Section 18 
tolerance results in a TMRC that is equivalent to the following 
percentages of the RfD:

                                                                        
------------------------------------------------------------------------
            Population Subgroup                         % RfD           
------------------------------------------------------------------------
U.S. Population...........................  <1%                         
Nursing Infants...........................  <1%                         
Non-Nursing Infants (<1 year old).........  2%                          
Children (1-6 years old)..................  1%                          
Children (7-12 years old).................  <1%                         
------------------------------------------------------------------------


    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 that Agency has in 
files, hydramethylnon and its degradates are not expected to leach to 
groundwater. Information on its persistence is inconclusive. There are 
no established Maximum Contaminant Levels (MCLs) for residues of 
hydramethylnon in drinking water and no health advisory levels for this 
active ingredient in drinking water have been issued.
    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 hydramethylnon 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 hydramethylnon 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. Hydramethylnon is currently 
registered for use on the following residential non-food sites: 
recreational areas, ornamental plants, lawns, turf, and household or 
domestic dwellings. However, the Agency currently lacks sufficient 
residential-related exposure data to complete a comprehensive 
residential risk assessment for many pesticides, including 
hydramethylnon.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Hydramethylnon is a member of the amidinohydrazones class of 
pesticides. There are no other members of this class of pesticides. 
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 hydramethylnon has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
hydramethylnon 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 hydramethylnon has a common 
mechanism of toxicity with other substances.

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

    1. Acute risk. An acute endpoint has not been identified. The 
Agency's Hazard Identification Committee determined that this risk 
assessment is not required.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to hydramethylnon from 
food will utilize <1% of the RfD for the U.S. population. 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 hydramethylnon 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

[[Page 10541]]

result from aggregate exposure to hydramethylnon residues. According to 
Agency policy, the residential uses of hydramethylnon do not fall under 
a chronic exposure scenario. The Agency concludes that there is a 
reasonable certainty that no harm will result from chronic aggregate 
exposure to hydramethylnon residues.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. Although hydramethylnon has residential uses, the 
Agency currently lacks sufficient residential-related exposure data to 
complete a comprehensive residential risk assessment for many 
pesticides, including hydramethylnon.

D. Aggregate Cancer Risk for U.S. Population

    Hydramethylnon has been classified as a Group C chemical (possible 
human carcinogen) by the Cancer Peer Review Committee . The Committee 
recommended using the RfD approach for risk assessment. Thus, the 
cancer risk estimate is the same as our estimate of chronic aggregate 
risk, which is discussed above. Based upon the discussion of the 
chronic aggregate risk estimate, we conclude the cancer risk estimate 
does not exceed HED's level of concern.

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 hydramethylnon, 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 --a. Rats. In the developmental 
study in rats, the maternal (systemic) NOEL was 3 mg/kg/day. The 
maternal (systemic) NOAEL was 10 mg/kg/day, based on an 8% decrease in 
body weight and yellowish discoloration of the fat. The maternal 
(systemic) LOAEL was 30 mg/kg/day based on a 16% decrease in body 
weight; increased incidence of nasal mucus, alopecia, soft stool, and 
staining of the ano-genital fur; and yellowish discoloration of the fat 
and small thymus. The developmental (fetal) NOEL was 10 mg/kg/day, 
based on decreased mean fetal weights and the increased incidence of 
rudimentary structures and incompletely ossified supraoccipitals at the 
LOAEL of 30 mg/kg/day.
    b. Rabbits. In the developmental toxicity study in rabbits, the 
maternal (systemic) NOEL could not be defined. The maternal (systemic) 
NOAEL was 5 mg/kg/day, based on decreased body weight gain 
(<difference>6%), soft stool, and reduced amount of stool. The maternal 
LOAEL was 10 mg/kg/day based on soft stool, reduced amount of stool, 
and anogenital matting and discharge. The developmental (fetal) NOEL 
could not be defined. The developmental (fetal) NOAEL was 5 mg/kg/day 
based on decreased fetal weight (8%). The developmental (fetal) LOAEL 
was 10 mg/kg/day based on decreased fetal weight (16%).
    iii. Reproductive toxicity study. In the 2-generation reproductive 
toxicity study in rats, the maternal (systemic) NOEL was 25 ppm (1.66 / 
2.01 mg/kg/day, (male/female)), based on degeneration of the germinal 
epithelium and aspermia at the LOAEL of 50 ppm (3.32 / 4.13 mg/kg/day, 
(male/female)). No adverse effects were observed in the pups.
    iv. Pre- and post-natal sensitivity. The toxicology data base for 
hydramethylnon is complete with respect to current toxicological 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 reproductive 
toxicity study in rats.
    v. Conclusion. Based on the above, HED concludes that reliable data 
support use of the standard 100-fold uncertainty factor and that an 
additional factor is not needed to protect infants and children. 
However, because a NOEL was not established in the chronic toxicity 
study, an additional uncertainty factor of 10 was added.
    2. Acute risk. There is no reliable endpoint that can be attributed 
to an acute exposure. Therefore, this risk assessment is not 
appropriate.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
hydramethylnon from food ranges from <1% for several population 
subgroups to 2% for non-nursing infants (<1 year old) of the RfD for 
infants and children. 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 hydramethylnon 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 hydramethylnon residues.

F. Endocrine Disruptor 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 disruptor effects.

[[Page 10542]]

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants is adequately understood for 
this section 18 use. The Agency's Metabolism Committee determined that 
the residue of concern in grass is hydramethylnon per se. The Agency 
believes that this conclusion can be translated to pineapple.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available in PAM II (Method I) 
to enforce the tolerance expression. A confirmatory method has recently 
been submitted to the FDA for inclusion in PAM II.

C. Magnitude of Residues

    Residues of hydramethylnon are not expected to exceed 0.05 ppm in/
on pineapple. Residues are not expected to concentrate in pineapple 
processed products. The Agency is establishing a time-limited tolerance 
at this level. Secondary residues of hydramethylnon are not expected in 
animal commodities as a result of this section 18 use. Tolerances for 
secondary residues of hydramethylnon in livestock commodities are not 
currently established.

D. International Residue Limits

    There are no Codex, Canadian or Mexican residue limits established 
for hydramethylnon in/on pineapple. Thus, harmonization is not an issue 
for this section 18.

E. Rotational Crop Restrictions

    Pineapple is not typically rotated. Thus, rotational crop 
restrictions are not required.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
hydramethlynon in pineapple at 0.05 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 May 4, 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 Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300606] (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 Rm. 119 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 Highway, 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 a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (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 on the basis of a petition under FFDCA section 408 (d), 
such as the tolerance in this final rule, do not require the issuance 
of a proposed rule, the requirements of the

[[Page 10543]]

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 acations 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).

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 20, 1998.

James Jones,
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. Section 180.395 is amended as follows:
    a. By revising the section heading.
    b. By designating the existing text as paragraph (a) and adding a 
paragraph heading.
    c. By adding paragraph (b).
    d. By adding and reserving paragraphs (c) and (d).

Sec. 180.395 Hydramethylnon; tolerances for residues.

    (a) General.      *      *      *

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the insecticide hydramethylnon; tetrahydro-
5,5-dimethyl-2-(1H)-pyrimidinoine(3-(4-trifluoromethyl)phenyl)-1-[2-
[4(trifluoromethly)phenyl]ethenyl)-2-propenylidene) hydrazone in 
connection with the use of the pesticides under section 18 emergency 
exemptions granted by EPA. The tolerance will expire and is revoked on 
the date specified in the following table.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Pineapple.......................  0.05                1/31/99           
------------------------------------------------------------------------


    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 98-5417 Filed 3-3-98; 8:45 am]
BILLING CODE 6560-50-F