[Federal Register Volume 66, Number 184 (Friday, September 21, 2001)]
[Rules and Regulations]
[Pages 48577-48585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23608]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301162; FRL-6797-2]
RIN 2070-AB78


Propamocarb Hydrochloride; Pesticide Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation revises time-limited tolerances for residues 
of propamocarb hydrochloride in or on tomato and tomato, paste and 
revokes the time limited tolerance for residues of propamocarb 
hydrochloride in or on tomato, puree. This action is in response to 
EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on tomatoes. This regulation revises maximum 
permissible levels for residues of propamocarb hydrochloride in these 
food commodities. The revised tolerances will expire and are revoked on 
December 31, 2003.

DATES: This regulation is effective September 21, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301162, 
must be received by EPA on or before November 20, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301162 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703 308-9364; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected 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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301162. 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, 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

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is revising the tolerances for residues of the fungicide 
propamocarb hydrochloride, propyl [3-(dimethylamino)propyl] carbamate 
monohydrochloride, by increasing the residue levels in or on tomato and 
tomato, paste, to 2 and 5 ppm, respectively, and removing the level for 
tomato, puree. These revised tolerances will expire and are revoked on 
December 31, 2003. EPA will publish a document in the Federal Register 
to remove the revoked tolerances from the Code of Federal Regulations.
    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. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to 
establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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

[[Page 48578]]

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 the Food Quality Protection Act (FQPA). EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Propamocarb hydrochloride on Tomato 
and FFDCA Tolerances

    Failure to control late blight in tomatoes with the registered 
fungicides have been caused almost exclusively by immigrant strains of 
late blight (Phytophthora infestans), which are resistant to the 
control of choice, metalaxyl. Before the immigrant strains of late 
blight arrived, all of the strains in the United States were previously 
controlled by treatment with metalaxyl. Presently, there are no 
fungicides registered in the United States that will provide adequate 
control of the immigrant strains of late blight. EPA has authorized 
under FIFRA section 18 the use of propamocarb hydrochloride on tomato 
for control of late blight in California. After having reviewed the 
submission, EPA concurs that an emergency condition exists for this 
State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of propamocarb hydrochloride 
in or on tomato and tomato paste. In doing so, EPA considered the 
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 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 revising these tolerances without notice and 
opportunity for public comment as provided in section 408(l)(6). 
Although these tolerances will expire and are revoked on December 31, 
2003, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerances remaining in or on 
tomato and tomato paste after that date will not be unlawful, provided 
the pesticide is applied in a manner that was lawful under FIFRA, and 
the residues do not exceed the levels that were authorized by these 
tolerances at the time of that application. EPA will take action to 
revoke these tolerances earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether propamocarb 
hydrochloride meets EPA's registration requirements for use on tomato 
or whether permanent tolerances for this use would be appropriate. 
Under these circumstances, EPA does not believe that these tolerances 
serve as a basis for registration of propamocarb hydrochloride by a 
State for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for any State other than California to 
use this pesticide on this crop under section 18 of FIFRA without 
following all provisions of EPA's regulations implementing section 18 
as identified in 40 CFR part 166. For additional information regarding 
the emergency exemption for propamocarb hydrochloride, contact the 
Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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).
    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 
propamocarb hydrochloride and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for time-limited 
tolerances for residues of propamocarb hydrochloride in or on tomato 
and tomato paste at 2 and 5 ppm, respectively ppm. EPA's assessment of 
the dietary exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (NOAEL) from the 
toxicology study identified as appropriate for use in risk assessment 
is used to estimate the toxicological endpoint. However, the lowest 
dose at which adverse effects of concern are identified (LOAEL) is 
sometimes used for risk assessment if no NOAEL was achieved in the 
toxicology study selected. An uncertainty factor (UF) is applied to 
reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    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 level of concern (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 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.

[[Page 48579]]

 To estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated. A 
summary of the toxicological endpoints for propamocarb hydrochloride 
used for human risk assessment is shown in the following Table 1:

    Table 1.--Summary of Toxicological Dose and Endpoints for Propamocarb hydrochloride for Use in Human Risk
                                                   Assessment
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                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   NOAEL = 150 mg/kg/day    FQPA SF = 1X             Rabbit Developmental
 age                                   UF = 100...............  aPAD = acute RfD.......   LOAEL = 300 mg/kg/day
                                       Acute RfD = 1.5 mg/kg/   FQPA SF = 1.5 mg/kg/day   based on increased
                                        day.                                              post-implantation loss
----------------------------------------------------------------------------------------------------------------
Acute dietary general population       NOAEL = 200 mg/kg/day    FQPA SF = 1X             Acute neurotoxicity
 including infants and children        UF = 100...............  aPAD = acute RfD.......   screening battery-Rat
                                       Acute RfD = 2.0 mg/kg/   FQPA SF = 2.0 mg/kg/day   LOAEL = 2,000 mg/kg/
                                        day.                                              day based on decreased
                                                                                          body weight gain and
                                                                                          decreased motor
                                                                                          activity
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL= 12 mg/kg/day      FQPA SF = 1X             Carcinogenicity study-
                                       UF = 100...............  cPAD = chronic RfD.....   Mouse LOAEL = 95 mg/kg/
                                       Chronic RfD = 0.12 mg/   FQPA SF = 0.12 mg/kg/     day based on decreased
                                        kg/day.                  day.                     body weight and body
                                                                                          weight gain in females
----------------------------------------------------------------------------------------------------------------
Short-term (1 to 7 days) and           Dermal study NOAEL= 150  LOC for MOE = 100        21-day dermal toxicity
 Intermediate-term (1 week-several      mg/kg/day                (Occupational)           study-Rabbit
 months)                                                        LOC for MOE = 100        LOAEL = 525 mg/kg/day
Dermal (occupational/residential)....                            (Residential).           based on decreased
                                                                                          body weight gain in
                                                                                          females
----------------------------------------------------------------------------------------------------------------
Short-term (1 to 7 days) and           Inhalation (or oral)     LOC for MOE = 100        Developmental toxicity
 Intermediate-term (1 week-several      study NOAEL= 150 mg/kg/  (Occupational)           study-Rabbit
 months)                                day (inhalation         LOC for MOE = 100        Developmental LOAEL =
Inhalation (occupational/residential)   absorption rate =        (Residential).           300 mg/kg/day based on
                                        100%)                                             increased post-
                                                                                          implantation loss
                                                                                         Maternal LOAEL = 300 mg/
                                                                                          kg/day based on
                                                                                          decreased body weight
                                                                                          gain
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``Not likely''           Not applicable           Acceptable oral rat and
                                                                                          mouse carcinogenicity
                                                                                          studies; no evidence
                                                                                          of carcinogenic or
                                                                                          mutagenic potential
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.499) for the residues of propamocarb 
hydrochloride, in or on potatoes. Time-limited tolerances for 
inadvertent residues have been established in or on wheat and wheat by-
products. In addition, time-limited tolerances for residues in or on 
tomato and tomato, paste, and puree have also been established at 
levels lower than those described in this document. Risk assessments 
were conducted by EPA to assess dietary exposures from propamocarb 
hydrochloride in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1 day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: Acute analyses were performed for females 13-50 
years old and the general U.S. population (including infants and 
children); the acute risk was analyzed at the 95th percentile. The aPAD 
for females 13-50 years old and the general U.S. population (including 
infants and children) are 1.5 mg/kg/day and 2.0 mg/kg/day, 
respectively. For acute dietary risk estimates, EPA's level of concern 
is >100% aPAD. The results of the acute analysis indicate that the 
acute dietary risk estimates for the general U.S. population and all 
population subgroups (at the 95th percentile) associated with the 
proposed uses of propamocarb hydrochloride do not exceed EPA's level of 
concern.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment, the DEEM\TM\ analysis evaluated the individual food 
consumption as reported by respondents in the USDA 1989-1992 nationwide 
CSFII and accumulated exposure to the chemical for each commodity. The 
following assumptions were made for the chronic exposure assessments: A 
chronic

[[Page 48580]]

analysis was performed for the general U.S. population and all 
population subgroups. The cPAD for the general U.S. population and all 
subgroups is 0.12 mg/kg/day. For chronic dietary risk estimates, EPA's 
level of concern is >100% cPAD. The results of the chronic analysis 
indicate that the chronic dietary risk estimates for the general U.S. 
population and all population subgroups associated with the proposed 
uses of propamocarb hydrochloride do not exceed EPA's level of concern.
    iii. Cancer. There is no concern for mutagenic potential, and there 
is no evidence of carcinogenic potential in either the rat or mouse. 
Propamocarb hydrochloride has been classified as ``not likely to be 
carcinogenic in humans.'' Therefore, a cancer dietary exposure analysis 
was not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for propamocarb hydrochloride in 
drinking water. Because the Agency does not have comprehensive 
monitoring data, drinking water concentration estimates are made by 
reliance on simulation or modeling taking into account data on the 
physical characteristics of propamocarb hydrochloride.
    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 percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a 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 propamocarb hydrochloride, 
they are further discussed in the aggregate risk sections below.
    Based on the GENEEC and SCI-GROW models the EECs of propamocarb 
hydrochloride for acute exposures are estimated to be 1,030 parts per 
billion (ppb) for surface water and 2.08 ppb for ground water. The EECs 
for chronic exposures are estimated to be 340 ppb for surface water and 
2.08 ppb for ground water.
    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).
    Propamocarb hydrochloride is currently registered for use on the 
following residential non-dietary sites: Turfgrass and ornamentals at 
residential, recreational and golf course sites. However, the usage 
information in the 1995 Reregistration Eligibility Decision (RED) for 
propamocarb hydrochloride and the label statement that only protected 
handlers may be present in the treated area during application, 
indicate that only commercial applicators will apply the registered 
end-use product Banol (EPA Registration Number 432-942, contains 66.5% 
propamocarb hydrochloride) mainly on golf courses and there will be no 
use on residential or recreational turf. The risk assessment was 
conducted using the following residential exposure assumptions: An MOE 
of 100 is adequate to ensure protection from propamocarb hydrochloride 
via the dermal and inhalation routes for residential exposures. The 
high-end scenario for residential post-application exposure is the golf 
course use. The post-application risk assessment is based on generic 
assumptions as specified by the newly proposed Residential Standard 
Operating Procedures (SOPs) and recommended approaches by Health 
Effects Division's (HED's) Exposure Science Advisory Committee. Short-
term post-application exposures are expected for the adult and 
adolescent golfer. Golfer exposure is expected through minimal hand 
contact with the golf ball and dermal contact to the lower legs from 
treated plant surfaces. Since it is assumed that the adolescent golfer 
would have a proportionally similar exposure to adults, a dermal post-
application assessment was performed for the adult golfer only. The 
calculated MOE for the golfer is 980 and, therefore, does not exceed 
EPA's level of concern. Since the short- and intermediate-term 
toxicological endpoints are the same, the golfer post-application 
exposure assessment is expected to provide adequate exposure estimates 
for both the short- and intermediate-term. In the event of 
intermediate-term exposure, propamocarb hydrochloride residues are 
expected to dissipate over time. Therefore, this assessment is expected 
to present a high-end conservative estimate of actual exposure.
    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 propamocarb hydrochloride 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, 
propamocarb hydrochloride 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 propamocarb hydrochloride 
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).

C. Safety Factor for Infants and Children

    1. Safety factor for infants and children.--i. In general. FFDCA 
section

[[Page 48581]]

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 margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. There is no evidence of 
quantitative or qualitative enhanced susceptibility to infants and 
children. In the rat, developmental effects occur only at doses that 
cause mortality in the dams. The maternal LOAEL of 740 milligrams 
active ingredient/kilogram/day (mg a.i./kg/day) is based on mortality. 
The maternal NOAEL is 221 mg a.i./kg/day. The developmental LOAEL of 
740 mg a.i./kg/day is based on increased gestation day (GD) 20 fetal 
death and a possible increase in minor skeletal anomalies. The 
developmental NOAEL is 221 mg a.i./kg/day. In the rabbit, developmental 
effects occur only at doses where there is maternal toxicity. EPA 
believes that the post implantation loss is actually due to the 
increased abortions in the does. The maternal LOAEL of 300 mg a.i./kg/
day is based on decreased body weight gains for GD 6-18 and possible 
increased abortions. The maternal NOAEL is 150 mg a.i./kg/day. The 
developmental LOAEL of 300 mg a.i./kg/day is based on increased post-
implantation loss. The developmental NOAEL is 150 mg a.i./kg/day. In 
the reproduction toxicity study, offspring effects only occurred at 
levels resulting in maternal toxicity. The LOAEL for systemic/parental 
toxicity is 8,000 ppm based on decreased body weights of F0 
and F1 adults. The systemic/parental toxicity NOAEL is 1,250 
ppm.
    2. Conclusion. There is a complete toxicity data base for 
propamocarb hydrochloride and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. EPA determined that the 10X safety factor to protect infants 
and children should be removed. The FQPA factor is removed because the 
prenatal and postnatal toxicology data base is complete and there is no 
indication of increased susceptibility. A developmental neurotoxicity 
study is not required. The dietary (food and drinking water) exposure 
assessments will not underestimate the potential exposures for infants 
and children from the use of propamocarb hydrochloride.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to propamocarb hydrochloride in drinking water (when 
considered along with other sources of exposure for which EPA has 
reliable data) would not result in unacceptable levels of aggregate 
human health risk at this time. Because EPA considers the aggregate 
risk resulting from multiple exposure pathways associated with a 
pesticide's uses, levels of comparison in drinking water may vary as 
those uses change. If new uses are added in the future, EPA will 
reassess the potential impacts of propamocarb hydrochloride on drinking 
water as a part of the aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
propamocarb hydrochloride will occupy 1% of the aPAD for the U.S. 
population, 1% of the aPAD for females 13 years and older, 3% of the 
aPAD for all infants (< 1 year old); and 3% of the aPAD for children 1-
6 years old. In addition, despite the potential for acute dietary 
exposure to propamocarb hydrochloride in drinking water, after 
calculating DWLOCs and comparing them to conservative model EECs of 
propamocarb hydrochloride in surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the aPAD, as shown in 
the following Table 2:

               Table 2.--Aggregate Risk Assessment for Acute Exposure to Propamocarb hydrochloride
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 aPAD (mg/      % aPAD     Water EEC    Water EEC   Acute DWLOC
                                                     kg)         (Food)       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
 All infants (< 1 year old)                              2.0            3        1,030         2.08       19,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 2.0            3        1,030         2.08       19,000
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                1.5            1        1,030         2.08       45,000
----------------------------------------------------------------------------------------------------------------
General U.S. population                                  2.0            1        1,030         2.08       69,000
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
propamocarb hydrochloride from food will utilize 7% of the cPAD for the 
U.S. population; 9%

[[Page 48582]]

of the cPAD for all infants < 1 year old; and 23% of the cPAD for 
children 1-6 years old. It has been assumed that there are no 
residential uses for propamocarb hydrochloride that result in chronic 
residential exposure to propamocarb hydrochloride. Based on the use 
pattern, chronic residential exposure to residues of propamocarb 
hydrochloride is not expected. In addition, despite the potential for 
chronic dietary exposure to propamocarb hydrochloride in drinking 
water, after calculating DWLOCs and comparing them to conservative 
model EECs of propamocarb hydrochloride in surface and ground water, 
EPA does not expect the aggregate exposure to exceed 100% of the cPAD, 
as shown in the following Table 3:

        Table 3.-Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Propamocarb Hydrochloride
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.12            7          340         2.08        3,900
----------------------------------------------------------------------------------------------------------------
Infants (< 1 year old)                                  0.12            9          340         2.08        1,100
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                0.12           23          340         2.08          920
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                               0.12            5          340         2.08        3,400
----------------------------------------------------------------------------------------------------------------

    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). Propamocarb 
hydrochloride is currently registered for use(s) that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for propamocarb hydrochloride.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 950, 1,100 and 1,100 for females 
13-50 years old, males 13-19 years old and the general U.S. population, 
respectively. The short-term aggregate risk assessment estimates risks 
likely to result from 1-7 day exposure to propamocarb hydrochloride 
residues in food, drinking water, and residential pesticide uses. High-
end estimates of the residential exposure are used in the short-term 
assessment. Average values are used for food and drinking water 
exposure.
    For short-term aggregate exposure risk, the oral and dermal 
exposures can be combined since both are based on the same toxicity 
endpoint (decreased body weight). An MOE of 100 is adequate to ensure 
protection from propamocarb hydrochloride via the dermal route for 
residential exposures.
    According to the 1995 RED for propamocarb hydrochloride (Estimated 
Usage of Pesticide, p. 3), ``almost all usage of propamocarb 
hydrochloride in the United States is concentrated on golf courses with 
approximately 100,000 to 200,000 pounds (lb) active ingredient (ai) 
applied per year.'' The label for Banol states that only protected 
handlers may be present in the treated area during application. For 
these reasons, it is assumed that this product will be used by 
commercial applicators, mainly on golf courses. The high-end scenario 
for residential post-application exposure is the golf course use of 
Banol. Therefore, in aggregating short-term risk, the Agency considered 
background chronic dietary exposure (food and drinking water) and 
short-term golfer dermal exposure. These aggregate MOEs do not exceed 
the Agency's level of concern for aggregate exposure to food and 
residential uses. In addition, short-term DWLOCs were calculated and 
compared to the EECs for chronic exposure of propamocarb hydrochloride 
in ground water and surface water. After calculating DWLOCs and 
comparing them to the EECs for surface and ground water, EPA does not 
expect short-term aggregate exposure to exceed the Agency's level of 
concern, as shown in the following Table 4:

             Table 4.-Aggregate Risk Assessment for Short-Term Exposure to Propamocarb Hydrochloride
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                950          100        1,030         2.08       40,000
----------------------------------------------------------------------------------------------------------------
Males (13-19 years old)                                1,100          100        1,030         2.08       63,000
----------------------------------------------------------------------------------------------------------------
General U.S. population                                1,100          100        1,030         2.08       63,000
----------------------------------------------------------------------------------------------------------------

    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). The short-term aggregate assessment adequately addresses both 
the short- and intermediate-term golfer dermal exposures. The short- 
and intermediate-term dermal endpoints were chosen from the 21-day 
dermal rabbit toxicity study. The short-term golfer exposure was 
calculated assuming 1-7 day exposure to propamocarb hydrochloride. The 
intermediate-term aggregate risk assessment estimates risks likely to 
result from 7 days to 3 months exposure. In the event of intermediate-
term exposure, propamocarb hydrochloride residues are expected to 
dissipate over time. Therefore, the short-term aggregate assessment is 
expected to present a high-end conservative estimate of intermediate-
term risk. As the short-term aggregate risk assessment represents the 
high-end scenario, an

[[Page 48583]]

intermediate-term assessment was not performed.
    5. Aggregate cancer risk for U.S. population. An aggregate cancer 
risk analysis was not performed since there is no concern for mutagenic 
potential and there is no evidence of carcinogenic potential in either 
the rat or mouse. Propamocarb has been classified as ``not likely to be 
carcinogenic in humans.''
    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 propamocarb hydrochloride residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    A gas chromatography method was utilized for the determination of 
propamocarb hydrochloride residues in/on raw agricultural commodity 
samples collected from the potato field study and field rotational crop 
study. The reported limit of quantitation was 0.05 ppm. The method 
validation and concurrent method recovery data indicate that this 
method is adequate to support the time-limited tolerances associated 
with this action. An identical method is proposed for tolerance 
assessment. The proposed method has undergone a successful independent 
lab validation and petition validation method. EPA concludes that the 
requirements for a plant enforcement method have been fulfilled.
    A ruminant feeding study is required. Conclusions about the need 
for livestock tolerances and appropriate enforcement analytical method 
are deferred until receipt of the ruminant feeding study and 
determination of the residues of concern in livestock.
    The method may be requested from: Calvin Furlow, PRRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-5229; e-mail address: [email protected].

B. International Residue Limits

    A CODEX MRL of 1 mg/kg has been established for residues of 
propamocarb per se in/on tomatoes. The use pattern used for determining 
the CODEX MRL differs from that in this section 18 exemption (maximum 
use rate overseas is 3.2 lb a.i./acre per application, the maximum use 
rate in the United States is 0.9 lb a.i./acre. No Canadian or Mexican 
residue limits have been established.

C. Conditions

    The conditions of registration will include submission of a 
livestock feeding study (which determines the metabolites N-oxide 
propamocarb, 2-hydroxy propamocarb and oxazolidine) and storage 
stability data from the livestock feeding study. The need for a 
livestock analytical enforcement method and livestock tolerances will 
be determined after receipt of the ruminant feeding study and 
determination of the residues of concern in livestock. A corrosion 
characteristics study must be submitted as soon as completed.

VI. Conclusion

    Therefore, the tolerances are revised for residues of propamocarb 
hydrochloride, propyl [3-(dimethylamino)propyl]carbamate 
monohydrochloride, in or on tomato and tomato, paste at 2 and 5 ppm, 
respectively. In addition, the tolerance for residues of propamocarb 
hydrochloride in or on tomato puree is hereby revoked.

VII. 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-301162 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 November 
20, 2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
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.

[[Page 48584]]

    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.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 the docket control number OPP-301162, 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 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).

VIII. Regulatory Assessment Requirements

    This final rule revises and revokes time-limited tolerances under 
FFDCA section 408. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under FFDCA section 408, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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).
    For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.''

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 10, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

[[Page 48585]]


    2. In Sec. 180.499, the table in paragraph (b) is amended by 
revising the entry for Tomato, paste, by removing the entries for 
Tomato, puree and Tomatoes, and by adding an entry for Tomato to read 
as follows:


Sec. 180.499  Propamocarb hydrochloride; tolerances for residues.

* * * * *
    (b)     *    *    *

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     revocation
                                               million         date
------------------------------------------------------------------------
                  *        *        *        *        *
Tomato                                               2.0        12/31/03
Tomato, paste                                        5.0        12/31/03
                  *        *        *        *        *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-23608 Filed 9-20-01; 8:45 am]
BILLING CODE 6560-50-S