[Federal Register Volume 65, Number 161 (Friday, August 18, 2000)]
[Rules and Regulations]
[Pages 50431-50438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21081]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301032; FRL-6599-4]
RIN 2070-AB78


Fosetyl-Al; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY:  This regulation establishes a tolerance for residues of 
fosetyl-Al in or on cranberries. Interregional Research Project Number 
4 (IR4) requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act, (FFDCA) as amended by the Food Quality Protection Act of 
1996.

DATES: This regulation is effective August 18, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301032, 
must be received by EPA on or before October 17, 2000.

ADDRESSES:  Written objections and hearing requests may be submitted by

[[Page 50432]]

mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301032 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT  By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301032. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 21, 2000 (65 FR 38535) (FRL-6558-
9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the Food Quality Protection Act of 1996 (FQPA) 
(Public Law 104-170) announcing the filing of a pesticide petition (PP) 
for tolerance by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 
08902-3390. This notice included a summary of the petition prepared by 
Aventis, the registrant. There were no comments received in response to 
the notice of filing.
    The petition requested that 40 CFR 180.415 be amended by 
establishing a tolerance for residues of the fungicide fosetyl-Al, 
aluminum tri(O-ethyl phosphonate), in or on cranberries at 0.5 part per 
million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that`` there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for a tolerance for residues of fosetyl-Al on cranberries at 
0.5 ppm. EPA's assessment of 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 fosetyl-Al are 
discussed in this unit as well as the no observed adverse effect level 
(NOAEL) and the lowest observed adverse effect level (LOAEL) from the 
toxicity studies reviewed.

[[Page 50433]]



             Table 1-Subchronic, Chronic and Other Toxicity
------------------------------------------------------------------------
               Study Type                            Results
------------------------------------------------------------------------
21-Day Dermal Toxicity-Rat               NOAEL =1,500 mg/kg/day highest
                                          dose tested (HDT)
                                         LOAEL = 1,500 mg/kg/day
3-Month Oral-Rat                         NOAEL = 482 mg/kg/day 5,000 ppm
                                         LOAEL = 1,250 mg/kg/day 25,000
                                          ppm, based on a slight
                                          increase in extramedullary
                                          hematopoiesis of the spleen.
3-Month Oral-Dog                         NOAEL =250 mg/kg/day 10,000 ppm
                                         LOAEL = 1,250 mg/kg/day 50,000
                                          ppm, based on decreased serum
                                          potassium levels at the HDT.
Chronic Feeding- 2-Year- Dog             NOAEL = 250 mg/kg/day
                                         LOAEL = 500 mg/kg/day, based on
                                          testicular degeneration
                                          (spermatocytic and/or
                                          spermatidic giant cells in the
                                          lumen of the seminiferous
                                          tubules.
Chronic toxicity/Carcinogenicity-Rat     NOAEL = 400 mg/kg/day
                                         LOAEL = 1,500 mg/kg/day,
                                          increased urine protein and
                                          urinary bladder pathology
                                          (tumors).
Carcinogenicity-Mouse                    NOAEL (systemic)= 409 mg/kg/day
                                          2,500 ppm
                                         LOAEL (systemic)= 1672 mg/kg/
                                          day 5,000 ppm, based on slight
                                          increases in white blood
                                          cells.
Developmental Toxicity-Rabbits           Maternal NOAEL = 125 mg/kg/day
                                         LOAEL = 250 mg/kg/day, based on
                                          decreased mean body weight
                                         Developmental NOAEL = 500 mg/kg/
                                          day HDT
                                         LOAEL > not established
Developmental Toxicity-Rats              Maternal NOAEL = 1,000 mg/kg/
                                          day
                                         LOAEL = 4,000 mg/kg/day, based
                                          on decreased mean body weights
                                          and body weight gain, and
                                          increased maternal death
                                         Developmental NOAEL = 1,000 mg/
                                          kg/day
                                          LOAEL = 4,000 mg/kg/day, based
                                          on decreased litter and mean
                                          fetal body weight, increased
                                          resorptions, malformations and
                                          skeletal variations.
3-Generation Reproductive Toxicity-Rats  Parental/Systemic NOAEL = 300
                                          mg/kg/day
                                         LOAEL = 600 mg/kg/day, based on
                                          decreased body weight gains of
                                          the F2b generation, and
                                          urinary tract changes in
                                          adults
                                         Reproductive (offspring) NOAEL
                                          = 300 mg/kg/day
                                         Reproductive (offspring) LOAEL
                                          = 600 mg/kg/day, based on
                                          decreased litter and pup body
                                          weight (Day 8) in both matings
                                          of each generation.
                                          In utero (developmental) NOAEL
                                          is > 1,200 mg/kg/day at the
                                          HDT.
Gene Mutation-Salmonella                 Non-mutagenic ()
                                          activation.
DNA Repair- E. Coli                      Non-mutagenic and negative (+)
                                          activation.
Point Mutation UDS-Hamster               Non-mutagenic ()
                                          activation.
Micronucleus Assay Mice                  Non-mutagenic
Reverse mutation-S. Cerevisiae           Non-mutagenic
Metabolism-Rat                            First study: (Fosetyl-Al
                                          tech.): rapidly metabolized to
                                          give mainly carbon dioxide
                                          (60%) recovered from exhaled
                                          air. About 26% was excreted in
                                          the urine containing a larger
                                          mount of the metabolite
                                          phosphite (phosphorus acid).
                                          Only 3-4% was in the feces as
                                          the phosphite metabolite.
                                          Second study: (Phosphorous
                                          acid phosphite metabolite):
                                          mainly excreted in the urine
                                          (59-65%) and feces (30-32%).
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for intra 
species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE)= NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of

[[Page 50434]]

occurrence of additional cancer cases (e.g., risk is expressed as 1 x 
10\\-\6\ or one in a million). Under certain specific circumstances, 
MOE calculations will be used for the carcinogenic risk assessment. In 
this non-linear approach, a ``point of departure'' is identified below 
which carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer= point of departure/exposures) is calculated.

       Table 2-Summary of Toxicological Dose and Endpoints for Fosetyl-Al for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and level of
          Exposure scenario               Dose used in risk         concern for risk     Study and toxicological
                                            assessment, UF             assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          None                     None                     None
Chronic Dietary (Non-Cancer)           NOAEL=250 mg/kg/day      FQPA SF= 1x cPAD =       2-Year Chronic in Dogs.
                                        UF=100 Chronic RfD=2.5   chronic RfD/FQPA SF=     Based on testicular
                                        mg/kg/day                2.5 mg/kg/day            degeneration
                                                                                          (spermatocytic and or
                                                                                          spermatidic giant
                                                                                          cells in the lumen of
                                                                                          the seminiferous
                                                                                          tubules) in 2/6 males.
Short-Term Dermal (1 to 7 days)        None                     None                     21-Day dermal in the
 (Residential)                                                                            Rat. No dermal or
                                                                                          systemic toxicity was
                                                                                          seen at the Limit-Dose
                                                                                          following repeated
                                                                                          dermal applications to
                                                                                          Rats.
Intermediate-Term Dermal (1 week to    None                     None                     21-Day dermal in the
 several months) (Residential)                                                            Rat. No dermal or
                                                                                          systemic toxicity was
                                                                                          seen at the Limit-Dose
                                                                                          following repeated
                                                                                          dermal applications to
                                                                                          Rats.
Long-Term Dermal (several months to    dermal (or oral) study   None                     2-Year Chronic in Dogs.
 lifetime) (Residential)                NOAEL= 250 mg/kg/day                              Based on testicular
                                        (dermal absorption                                degeneration
                                        rate 17%)                                         (spermatocytic and or
                                                                                          spermatidic giant
                                                                                          cells in the lumen of
                                                                                          the seminiferous
                                                                                          tubules) in 2/6 males.
Inhalation (Any time period)           inhalation (or oral)     None                     2-Year Chronic in Dogs.
 (Residential)                          study NOAEL= 250 mg/kg/                           Since the dose
                                        day                                               identified is from an
                                                                                          oral study (chronic
                                                                                          dog), route-to-route
                                                                                          extrapolation (CCC)
                                                                                          should be followed
                                                                                          based on use and
                                                                                          application rate.
Cancer (oral, dermal, inhalation)      Fosetyl-Al is unlikely   None
                                        to pose a carcinogenic
                                        hazard to humans. The
                                        RFD approach is used
                                        for quantification of
                                        human risk which is
                                        identical to the
                                        chronic assessment.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.415) for the residues of fosetyl-Al, in or on a 
variety of raw agricultural commodities (RACs) with tolerances ranging 
from 0.1 ppm for asparagus, caneberries, ginseng, and pineapples to 100 
ppm for leafy vegetables (excluding Brassica). Other significant 
registrations include Brassica leafy vegetables, citrus, cucurbits, 
strawberries, and tomatoes. In addition, a timelimited tolerance is 
currently in effect for blueberries (40 ppm) in conjunction with an 
emergency exemption under section 18 of FIFRA. Risk assessments were 
conducted by EPA to assess dietary exposures from fosetyl-Al in food as 
follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a fooduse 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. A toxicological endpoint for acute dietary toxicity 
was not selected. Therefore, a risk assessment for dietary food 
exposure was not conducted.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1991 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: The cPAD used for the chronic dietary analysis was 2.5 mg/
kg/day. As the 10X safety factor was removed, the cPAD is equal to the 
RfD.
    Dietary exposure for various subgroups of the U.S. population was 
estimated through the use of the (DEEM\TM\) software. As the risk 
estimate was low for even the most highly exposed subpopulation, no 
anticipated residues were used. EPA assumed 100% crop treated and 
tolerance level residues for all crops with tolerances as well as for 
the crops which are being evaluated in this action (i.e., cranberries).
    iii. Cancer. Fosetyl-Al is unlikely to pose a carcinogenic hazard 
to humans. Therefore, a cancer risk assessment was not conducted.
    2. Dietary exposure from drinking water. Fosetyl-Al is not expected 
to reach ground or surface water under most conditions. If it does 
reach surface water, it is expected to degrade rapidly. In ground 
water, it could persist because of potentially low microbial content. 
Biodegradation is the only apparent means of fosetyl-Al dissipation. 
Fosetyl-Al rapidly degrades in both aerobic and anaerobic soil to 
degradates that are widespread in nature (Al\+\\3\, phosphate, and 
ethanol). Under almost all uses, the degradation is expected to be so 
rapid that fosetyl-Al will not have time to move in soil, despite being 
highly soluble in water (120 g/L) and potentially mobile in soil. As it 
is stable to abiotic hydrolysis, fosetyl-Al could persist in pristine 
receiving waters with low microbial content.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
fosetyl-Al in drinking water. Because the Agency does not have 
comprehensive monitoring data, drinking water concentration estimates 
are made by reliance on simulation or modeling

[[Page 50435]]

taking into account data on the physical characteristics of fosetyl-Al.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in ground water. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a % crop area factor as an adjustment to account for the 
maximum percent crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to fosetyl-Al they are further 
discussed in the aggregate risk sections in Unit III. E. of this 
preamble.
    Based on the GENEEC and SCI-GROW2 models the estimated EECs of 
fosetyl-Al for chronic exposures are estimated to be 9.0 ppb for 
surface water and 0.00038 ppb for ground water. The chronic GENEEC 
value is adjusted (divided) by a factor of three when comparing the EEC 
for surface water to nonacute DWLOCs. This results in a chronic 
exposure estimate for surface water at 3 ppb.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Fosetyl-Al is 
currently registered for use on the following residential non-dietary 
sites: lawn, turf, and ornamental plants. The risk assessment was not 
conducted using the following residential exposure assumptions: Under 
the brand names CHIPO Aliette WDG and Aliette HG. 
CHIPO Aliette WDG, the above uses are sold to professional 
applicators only which includes lawn care operators (LCO). For this 
reason, all residential uses of CHIPO Aliette WDG are applied 
by the LCO. The use of Fosetyl-Al directly by the homeowner constitutes 
a minor use of the product since only small quantities of 
Aliette HG are sold in the market. Short-term and 
intermediate-term exposures may occur for residential handlers and for 
post-application activities. Because the EPA did not select applicable 
short-term and intermediate-term dermal endpoints, a dermal risk 
assessment is not required. Long-term or chronic dermal exposure is not 
expected for residential uses.
    In addition, EPA did not recommend a risk assessment for incidental 
hand-to-mouth ingestion by toddlers. While incidental ingestion of 
residues by toddlers may occur, no acute RfD was identified. Risk from 
intermediate-term incidental ingestion by toddlers is assessed by 
comparing exposure to the NOAEL from an oral study selected for either 
short or intermediate-term dermal or inhalation risk assessment. 
However, EPA reviews indicated that incidental hand-to-mouth ingestion 
is not a concern because the chronic oral endpoint (testicular 
degeneration) is unlikely to be relevant to toddlers and chronic oral 
exposure because fosetyl-Al has a relatively short half-life. EPA does 
not believe that the criteria for a quantitative risk has been met, 
therefore, no assessment of incidental ingestion was conducted.
    Inhalation risk for non-occupational (e.g., residential) handlers 
is possible from mixing, loading and applying fosetyl-Al to turf using 
a lowpressure handwand. A risk assessment was conducted which assumes 
an application rate of 0.42 lb/ai per 1,000 ft\2\ and 10,000 ft\2\ area 
treated per day. The unit exposure was calculated at 0.03 (g/
lb/ai) with an absorption factor of 100% and a body weight of 70 kg. 
The daily dose, which is equal to the application rate x area treated x 
unit exposure x absorption factor /body weight, is 0.0018 mg/kg/day. 
The short- and intermediate-term MOE equal to the short-term and 
intermediate-term NOAEL/ daily dose is 1.4 million for this activity, 
and is below EPA's level of concern for nonoccupational inhalation 
risk.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether fosetyl-Al 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, 
fosetyl-Al 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 fosetyl-Al has a common mechanism of toxicity 
with other substances. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 provides that EPA shall apply an additional tenfold margin 
of safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure 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.
    ii. Pre-natal and post-natal sensitivity. A three generation 
reproduction study in rats and developmental toxicity studies in rats 
and rabbits did not indicate any concern for pre-natal or post-natal 
effects in

[[Page 50436]]

offspring or for reproductive effects. Therefore, there was no evidence 
of increased sensitivity due to pre-natal or post-natal exposure to 
fosetyl-Al.
    iii. Conclusion. There is a complete toxicity data base for 
fosetyl-Al and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The FQPA Safety 
Factor Committee determined that the 10X factor should be removed from 
fosetyl-Al for several reasons, including the facts that the toxicology 
data base is complete and there is no indication of increased 
susceptibility of rat or rabbit fetuses to in utero and/or post-natal 
exposure in the developmental and reproductive toxicity studies.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Acute aggregate risk is based upon the estimated 
risks from the combined exposures of food and drinking water sources. 
The EPA did not recommend an acute dietary endpoint for fosetyl-Al, 
therefore no acute aggregate risk assessment was conducted, and there 
is no expectation of acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to fosetyl-
Al from food will utilize 3.1% of the cPAD for the U.S. population, 
2.7% of the cPAD for females (13-50) years, 6.3% of the cPAD for 
children 1-6 years old, and 4.2% of the cPAD for Non-Hispanic (other 
than black or white). Based on the use pattern, chronic residential 
exposure to residues of the fosetyl-Al is not expected. In addition, 
there is potential for chronic dietary exposure to fosetyl-Al in 
drinking water. After calculating the DWLOCs and comparing them to the 
EECs for surface and ground water, EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD.

                    Table 3. Summary of DWLOC Calculations for Fosetyl-Al for Aggregate Risk
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                          2.5          3.1            3      0.00038       84,000
Females (13-50 years)                                    2.5          2.7            3      0.00038       72,000
Children (1-6 years)                                     2.5          6.3            3      0.00038       23,000
Non-Hispanic (other than black or white)                 2.5          4.2            3      0.00038       84,000
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Though residential 
exposure could occur with the use of fosetyl-Al, no toxicological 
effects have been identified for short-term toxicity. Therefore, the 
aggregate risk do not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Though 
residential exposure could occur with the use of fosetyl-Al, no 
toxicological effects have been identified for intermediate-term 
toxicity. Therefore, the aggregate risk is the sum of the risk from 
food and water, which do not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Fosetyl-Al is 
classified non-carcinogenic and is unlikely to pose a carcinogenic 
hazard to humans. Therefore, no cancer aggregate exposure assessment 
was done.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fosetyl-Al residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A detailed description of Rhone-Poulenc's ``Method of Analysis for 
Fosetyl-Al Residues in Citrus,'' was provided. This procedure is 
identical to that described in the Pesticide Analytical Manual, Volume 
II (PAM II). The studies reported in the subject petition validate the 
method on cranberries fortified at 0.05 ppm, 0.5 ppm and 5.0 ppm. The 
recoveries ranged from 70 to 91%. The limit of quantitation (LOQ) was 
reported at 0.05 ppm. EPA concludes that the available GC/FPD-P 
methodology (PAM II) is adequate for enforcing tolerances and 
collecting residue data on fosetyl-Al residues in/on cranberries.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican international residue 
limits established for fosetyl-Al; therefore, the magnitude of the 
residue is not of concern for this action.

V. Conclusion

    Therefore, the tolerance is established for residues of fosetyl-Al, 
aluminum tris(O-ethyl phosphonate), in or on cranberries at 0.5 ppm.

VI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301032 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before October 
17, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing

[[Page 50437]]

is requested, the requestor's contentions on such issues, and a summary 
of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1,900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301032, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

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

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

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and LowIncome Populations 
(59 FR 7629, February 16, 1994); or require OMB review or any Agency 
action under Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This action does not involve any technical standards that 
would require Agency consideration of voluntary consensus standards 
pursuant to section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note). Since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other

[[Page 50438]]

requirednformation to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated:August 3, 2000.

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. 321(q), (346a) and 371.

    2. Section 180.415 is amended by adding the commodity ``cranberry'' 
to the table in paragraph (a) to read as follows:


Sec. 180.415  Aluminum tris (O-ethylphosphonate); tolerances for 
residues.

    (a) General. * * *

----------------------------------------------------------------------------------------------------------------
                Commodity                 Parts per million               Expiration/Revocation Date
----------------------------------------------------------------------------------------------------------------
                                       *        *      *        *        *
Cranberry                                               0.5                                                 None
                                       *        *      *        *        *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 00-21081 Filed 8-17-00; 8:45 am]
BILLING CODE 6560-50-S