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Maneb - Pesticide Tolerances for Emergency Exemptions 3/99

[Federal Register: March 17, 1999 (Volume 64, Number 51)]
[Rules and Regulations]
[Page 13097-13103]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr99-15]

[[Page 13097]]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300809; FRL-6067-9]
RIN 2070-AB78
Maneb (manganous ethylenebisdithiocarbamate); Pesticide
Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of maneb (manganous ethylenebisdithiocarbamate), calculated as
zinc ethylenebisdithiocarbamate and its metabolite ethylenethiourea in
or on walnuts . This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
walnuts.This regulation establishes a maximum permissible level for
residues of maneb (manganous ethylenebisdithiocarbamate) in this food
commodity pursuant to section 408(l)(6) of the Federal Food, Drug, and
Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
The tolerance will expire and is revoked on December 31, 2000.

DATES: This regulation is effective March 17, 1999. Objections and
requests for hearings must be received by EPA on or before May 17,
1999.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300809], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled "Tolerance Petition Fees" and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, [OPP-300809], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall 2 (CM #2),
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epa.gov. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300809].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Meredith Laws, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 282, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9366,
laws.meredith@epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing a tolerance for
residues of the fungicide maneb (manganous ethylenebisdithiocarbamate),
calculated as zinc ethylenebisdithiocarbamate and its metabolite
ethylenethiourea, in or on walnuts at 0.05 part per million (ppm). This
tolerance will expire and is revoked on December 31, 2000. EPA will
publish a document in the Federal Register to remove the revoked
tolerance from the Code of Federal Regulations.

I. Background and Statutory Findings

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preeamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information." This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to "ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . ."
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that "emergency
conditions exist which require such exemption." This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
    Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.

II. Emergency Exemption for Maneb (manganous
ethylenebisdithiocarbamate) on Walnuts and FFDCA Tolerances

    The California Department of Pesticide Regulation has requested an
emergency exemption under FIFRA section 18 to use maneb on walnuts to
control bacterial blight. Currently,

[[Page 13098]]

copper based bactericides are the only registered products for control
of this disease. The increase of walnut blight since 1992 is attributed
to the development of a tolerance to copper based bactericides. The
state has demonstrated that copper resistant bacteria have become
economically important, with a potential 55,000 acres affected. EPA has
authorized under FIFRA section 18 the use of maneb (manganous
ethylenebisdithiocarbamate) on walnuts for control of bacterial blight
in California. After having reviewed the submission, EPA concurs that
emergency conditions exist for this state.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of maneb (manganous
ethylenebisdithiocarbamate) in or on walnuts. 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 issuing this tolerance
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although this tolerance will expire
and is revoked on December 31, 2000, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on walnuts 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 a level that was authorized
by this tolerance at the time of that application. EPA will take action
to revoke this tolerance earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
    Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether maneb (manganous
ethylenebisdithiocarbamate) meets EPA's registration requirements for
use on walnuts or whether a permanent tolerance for this use would be
appropriate. Under these circumstances, EPA does not believe that this
tolerance serves as abasis for registration of maneb (manganous
ethylenebisdithiocarbamate) by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than 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 maneb
(manganous ethylenebisdithiocarbamate), contact the Agency's
Registration Division at the address provided under the "ADDRESSES"
section.

III. 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 maneb
(manganous ethylenebisdithiocarbamate) and to make a determination on
aggregate exposure, consistent with section 408(b)(2), for a time-
limited tolerance for residues of maneb (manganous
ethylenebisdithiocarbamate), calculated as zinc
ethylenebisdithiocarbamate and its metabolite ethylenethiourea on
walnuts at 0.05 ppm. EPA's assessment of the dietary exposures and
risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by maneb (based on
calculations on its metabolite, ethylenethiourea) are discussed in this
unit.

B. Toxicological Endpoint

    1. Acute toxicity. The acute dietary risk assessment is being
conducted for ethylenethiourea (ETU) rather than maneb, since the no
observed adverse effect level (NOAEL) for acute dietary risk for ETU is
4 times lower (5 milligrams/kilogram/day (mg/kg/day)) than the NOAEL
for acute dietary risk for maneb (20 mg/kg/day). Therefore, an
acceptable margin of exposure (MOE) for ETU will also be protective of
exposure to maneb. The oral developmental NOAEL in rats for ETU is 5
mg/kg/day, based on a threshold finding of delayed ossification in the
fetal skeletal structures at the NOAEL. The NOAEL is more correctly
identified as a slightly lower dose level which is close to a threshold
NOAEL in the developmental study. The EBDC PD-4 stated that MOEs could
be calculated from the 5 mg/kg/day NOAEL, which was close to the NOAEL,
and was the lowest dose tested.
    2. Short - and intermediate - term toxicity. EPA recommends use of
the systemic NOAEL of 100 mg/kg/day from the 3-week dermal toxicity
study in rabbits. At the lowest observed adverse effect level (LOAEL)
of 300 mg/kg/day, there were slightly increased thyroid weights and
follicular cell hypertrophy of the thyroid.
    3.  Chronic toxicity. EPA has established the Reference Dose (RfD)
for ETU at 0.00008 mg/kg/day. This RfD is based on the LOAEL of 0.25
mg/kg/day due to thyroid hyperplasia in a 2-year rat feeding study,
with an uncertainty factor of 3,000. The uncertainty factor of 3,000
was based on a factor of 3 for absence of a NOAEL for ETU, a factor of
10 for data gaps for ETU, and a factor of 100 to take into account
inter- and intra-species variability.
    4. Carcinogenicity. Maneb has been classified as a Group B2,
probable human carcinogen, based on evidence of thyroid tumors in rats
and liver tumors. The Q1* for quantitation of human oral risk is 0.0601
(mg/kg/day)-1 for the carcinogenic metabolite, ETU.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.110) for the residues of maneb (manganous
ethylenebisdithiocarbamate), calculated as zinc
ethylenebisdithiocarbamate and its metabolite ethylenethiourea, in or
on a variety of raw agricultural commodities including almonds at 0.1
ppm. Risk assessments were conducted by EPA to assess dietary exposures
and risks from maneb (manganous ethylenebisdithiocarbamate) as follows:
    i.  Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. The high end dietary exposure for the
population subgroup of concern, females 13+ years

[[Page 13099]]

old, is 0.000036 mg/kg/day, which results in an MOE of 5,000. Maximum
field trial residue values were used to calculate the MOE. This is
considered a partially refined risk estimate.
    ii. Chronic exposure and risk. The chronic exposure estimate for
the general population is 0.000020 mg/kg/day and the anticipated
residue contribution (ARC) as percentage of the RfD is 24.4%.
    Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of percent crop treated as required by the section 408(b)(2)(F), EPA
may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    In the Dietary Risk Evaluation Model (DEEM), it was assumed that
100% of the walnut crop would be treated under this emergency
exemption. Refined percent crop treated values were used for some
commodities such as 10% for cranberries, 50% for apples, 15% for pears,
and 10% for almonds. The DEEM run did not use refined percent crop
treated values for all registered uses, however, 100% crop treated was
used for a number of commodities such as tomatoes, cucurbits, peppers,
broccoli, onions, potatoes, and corn.
    The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in
assessing chronic dietary risk findings, have been met. The PCT
estimates are derived from Federal and private market survey data,
which are reliable and have a valid basis. Typically, a range of
estimates are supplied and the upper end of this range is assumed for
the exposure assessment. By using this upper end estimate of the PCT,
the Agency is reasonably certain that that the percentage of the food
treated is not likely to be underestimated. The regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which maneb may be applied in a particular area.
    2. From drinking water. Submitted environmental fate studies
suggest that maneb has moderate potential to leach into ground water;
thus maneb could potentially leach to ground water and runoff to
surface water under certain environmental conditions. There are no
established Maximum Contaminant Levels (MCLs) for residues of maneb in
drinking water. No Health Advisories (HA) for maneb in drinking water
have been established. However, EPA has considered the carcinogenic
risk resulting from a maximum theoretical drinking water residue of 1.0
parts per billion (ppb) for ETU. ETU, which is highly soluble in water,
is assumed to be persistent and highly mobile.
     Chronic exposure and risk. Because the Agency lacks sufficient
water-related exposure data to complete a comprehensive drinking water
risk assessment for many pesticides, EPA has commenced and nearly
completed a process to identify a reasonable yet conservative bounding
figure for the potential contribution of water-related exposure to the
aggregate risk posed by a pesticide. In developing the bounding figure,
EPA estimated residue levels in water for a number of specific
pesticides using various data sources. The Agency then applied the
estimated residue levels, in conjunction with appropriate toxicological
endpoints (RfD's or acute dietary no observed adverse effect levels
(NOAEL's)) and assumptions about body weight and consumption, to
calculate, for each pesticide, the increment of aggregate risk
contributed by consumption of contaminated water. While EPA has not yet
pinpointed the appropriate bounding figure for exposure from
contaminated water, the ranges the Agency is continuing to examine are
all below the level that would cause maneb (manganous
ethylenebisdithiocarbamate) to exceed the RfD if the tolerance being
considered in this document were granted. The Agency has therefore
concluded that the potential exposures associated with maneb (manganous
ethylenebisdithiocarbamate) in water, even at the higher levels the
Agency is considering as a conservative upper bound, would not prevent
the Agency from determining that there is a reasonable certainty of no
harm if the tolerance is granted.
    3. From non-dietary exposure. Maneb (manganous
ethylenebisdithiocarbamate) is currently registered for use on the
following residential non-food sites: turf, lawn, trees, and shrubs.
Maneb is not registered for indoor uses. While EPA does not consider
that these types of outdoor residential uses constitute a chronic
residential exposure scenario, EPA acknowledges that there may be
short- and intermediate-term non-occupational exposure scenarios. The
Agency has identified toxicity endpoints for short- and intermediate-
term residential risk assessments. For this action, the risk to public
health from the use of maneb is calculated based on it's metabolite/
degradate ETU. However, no acceptable reliable exposure data to assess
these potential risks are available at this time. Given the time-
limited nature of this request, the need to make emergency exemption
decisions quickly, the significant scientific uncertainty at this time
about how to aggregate non-occupational exposure with dietary exposure,
the Agency will make it's safety determination for these tolerances
based on those factors which it can reasonably integrate into a risk
assessment.
    i. Chronic exposure and risk. The Agency has concluded that a
chronic residential exposure scenario does not exist for non-
occupational uses of maneb.

[[Page 13100]]

    ii. Short- and intermediate-term exposure and risk. The amortized
ETU cancer risk for the U.S. population for short- and intermediate-
term exposure to the turf use of maneb has been calculated to be 2.2 x
10-7.
    4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider "available information" concerning the cumulative effects of
a particular pesticide's residues and "other substances that have a
common mechanism of toxicity."
    EPA does not have, at this time, available data to determine
whether maneb (manganous ethylenebisdithiocarbamate) 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, maneb (manganous ethylenebisdithiocarbamate)
does not appear to produce a toxic metabolite produced by other
substances, other than ETU, a metabolite common to the EBDC pesticides.
For more 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. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. The MOE for females 13+ years was calculated to be
5,000. Therefore, aggregate acute risk estimates do not exceed the
Agency's level of concern.
    2. Chronic risk. Using the ARC exposure assumptions described in
this unit, EPA has concluded that aggregate exposure to maneb
(manganous ethylenebisdithiocarbamate) from food will utilize 24.4% of
the RfD for the U.S. population. The major identifiable subgroup with
the highest aggregate exposure is non-nursing infants (<1 year old)
discussed below. EPA generally has no concern for exposures below 100%
of the RfD because the RfD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. Despite the potential for exposure to maneb
(manganous ethylenebisdithiocarbamate) in drinking water and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate
exposure to exceed 100% of the RfD.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
    Although surface and ground water monitoring data are limited,
maneb does have the potential to leach into groundwater and run off to
surface water. California monitoring programs have picked up one detect
of .725 ppb, in three years of sampling (1986-89). Subsequent sampling
4 - 5 months later showed no residues. California has not found ETU
when surveying high EBDC use areas. There were two detections in the
U.S. EPA's National Pesticide Survey. The MOE for the U.S. population
exceeds the desired MOE, therefore, EPA has no short- or intermediate-
term aggregate risk concerns.
    4. Aggregate cancer risk for U.S. population. The aggregate dietary
cancer risk for maneb is based on ETU. The dietary cancer risk is
calculated using the Q* for ETU, 0.601 mg/kg/day-1. EPA
calculated that the dietary cancer risk for the EBDC pesticides,
including this use on walnuts is 1.2 x 10-6. This risk
assessment is partially refined; incorporation of percent crop treated
information for all commodities would result in a lower dietary
exposure estimate. The cancer risk from the residential uses of EBDC
pesticides is approximately 10-7. The aggregate cancer risk
estimate would not exceed EPA's acceptable level unless the drinking
water concentration exceeds 1 ppb. The availability of surface-water
and ground-water monitoring data for maneb and ETU is limited. EPA is
not aware of any surface-water monitoring data for either maneb or ETU,
and it does not have any ground-water monitoring data for maneb.
However, EPA has ground-water monitoring data which indicates that ETU
has leached into the ground water; some of which are direct drinking
water sources.
    In California from 1986 to 1989, 65 wells were monitored for ETU.
One well in San Joaquin County during March 1988 had an ETU
concentration of 0.725 ppb. The remainder of the samples had no ETU
detections (limit of detection (LOD) of 0.5 ppb). The California
Department of Food and Agriculture concluded that this ETU
concentration in the ground water did not represent a legal agriculture
use based upon another sampling event where this well and five nearby
wells in a predominantly walnut orchard use area were sampled 125 days
or more subsequent to the March sampling event. ETU was not detected in
any of these ground-water samples at that later date.
    There were two ETU detections in the ground water in the U.S. EPA's
statistically designed National Pesticide Survey (NPS). The NPS
analyzed a statistically representative sample of wells to provide a
national assessment of the presence of pesticides in drinking water
wells. On the basis of this study, EPA estimated that nationally, 8,470
rural domestic wells could contain ETU over the NPS reporting limit of
4.5 ppb. The 95% confidence interval ranged from 1 to 111,000 wells.
One quantified ETU detection of 16.0 ppb was obtained from a rural well
in Warren County, Illinois. A second detection, described as a
"trace" detection, was reported in Iowa. For this compound in the
NPS, samples containing ETU at concentrations greater than 9.0 ppb were
quantified; samples containing concentrations between 4.5 and 9.0 ppb
were reported as "trace"; and no detections were reported if
concentrations were below 4.5 ppb. The source of the ETU was not
determined; however, both agricultural and industrial practices may
contribute to ETU contamination of the ground water.
    These limited sampling results indicate some potential for ETU to
be found in ground water. However, there are significant uncertainties
associated with using these data in quantitative carcinogenic risk
assessment for purposes of national tolerance-setting. EPA is uncertain
as to whether a significant subpopulation would be exposed to high
enough concentrations of ETU (greater than 1 ppb) for a long enough
period of time to pose a significant carcinogenic risk. For example, in
the ground-water sampling conducted in San Joaquin County between 1986-
1989, the single contaminated well (out of 65 tested) subsequently was
found 4 months later to have no detectable levels of ETU. Additionally,
although the NPS results show two detections of ETU in ground water, it
is not clear whether agricultural or industrial practices were the
source of the ETU. If the source of the ETU was industrial and not
agricultural use, it is likely that contamination of ground water with
ETU would be less widespread than is suggested by the statistical
analysis of the NPS results. EPA does not believe that the available
data demonstrate that a significant subpopulation would be exposed to
residues of ETU in drinking water greater than 1 ppb; therefore, EPA
does not believe that the aggregate cancer risk associated with the
granting

[[Page 13101]]

of this tolerance would exceed acceptable levels.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to maneb (manganous ethylenebisdithiocarbamate)
residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children --i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of maneb (manganous ethylenebisdithiocarbamate),
EPA considered data from developmental toxicity studies in the rat and
a 2-generation reproduction study in the rat. The developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from maternal pesticide exposure during
gestation. Reproduction studies provide information relating to effects
from exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard MOE and uncertainty factor (usually 100 for combined
inter- and intra-species variability) and not the additional tenfold
MOE/uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. From the rat developmental
study for ETU, the oral developmental NOAEL is 5 mg/kg/day, based on a
threshold finding of delayed ossification in the fetal skeletal
structures at the NOAEL.
    iii. Reproductive toxicity study. There is no reproduction study
with ETU available. In the rat reproduction study for maneb, the
parental (systemic) NOAEL was 6.0 mg/kg/day, based on decreased body
weight and food consumption at the LOAEL of 25 mg/kg/day. The
developmental (pup) NOAEL was 6.0 mg/kg/day, based on increased startle
response at the LOAEL of 25 mg/kg/day.
    iv. Pre- and post-natal sensitivity. The rat developmental study
with ETU demonstrated a special prenatal sensitivity for infants and
children. The results of the rat reproduction study with maneb do not
demonstrate any additional special post-natal sensitivity for infants
and children, since the NOAEL and LOAEL for parental toxicity and pup
toxicity occur at the same doses and the pup effects are not of unusual
concern.
    v. Conclusion. In the absence of a complete data base for ETU, EPA
is assuming an additional tenfold safety factor to account for the
possibility of special prenatal sensitivity for infants and children.
    2. Acute risk. The acute dietary risk assessment for ETU residues
demonstrated an MOE of 5,000 based on the NOAEL of 5 mg/kg/day in the
rat developmental study. Therefore, this calculated MOE for ETU for
females 13+ years of age shows that the MOEs for this population
subgroup are far in excess of the required dietary MOE of 1,000 due to
ETU data gaps. Therefore, the acute dietary risks for ETU to females
13+ years of age are below EPA's level of concern. The RfD for ETU
incorporates an uncertainty factor of 3,000. The uncertainty factor was
based on a factor of 3 for absence of a NOAEL for ETU, a factor of 10
for data gaps needed to assess extra sensitivity to infants and
children for ETU, and the normal factor of 100 for converting between
and within species (EBDC PD/4, 3/2/92).
    3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to maneb (manganous
ethylenebisdithiocarbamate) from food will utilize 78.4% of the RfD for
nonnursing infants (<1 year old). EPA generally has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. Despite the potential for
exposure to maneb (manganous ethylenebisdithiocarbamate) in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD.
    4. Short- or intermediate-term risk. The MOEs for infants and
children exceed the desired MOE, therefore, EPA has no short- and
intermediate-term aggregate risk concerns.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to maneb (manganous
ethylenebisdithiocarbamate) residues.

IV. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants is adequately understood. The
residues of concern are the fungicide maneb, calculated as zinc
ethylenebisdithiocarbamate, and its metabolite ethylenthiourea.
Secondary residues are not expected in animal commodities as no feed
items are associated with this use.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available for maneb in the

Pesticide Analytical Manual (PAM) II Method III.

C. Magnitude of Residues

    Residues of maneb (manganous ethylenebisdithiocarbamate) calculated
as zinc ethylenebisdithiocarbamate and its metabolite ethylenethiourea
are not expected to exceed 0.05 ppm in or on walnuts as a result of
this proposed use. Secondary residues are not expected in animal
commodities as no feed items are associated with this use.

D. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue levels have been
established for residues of maneb in/on walnuts.

V. Conclusion

    Therefore, the tolerance is established for residues of maneb
(manganous ethylenebisdithiocarbamate), calculated as zinc
ethylenebisdithiocarbamate and its metabolite ethylenethiourea in
walnuts at 0.05 ppm.

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process
for persons to "object" to a tolerance regulation issued by EPA under
new section 408 and (l)(6) as was provided in the old section 408 and
in section 409. However, the period for filing objections is 60 days,
rather than 30 days. EPA currently has procedural regulations which
govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.

[[Page 13102]]

    Any person may, by May 17, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the "ADDRESSES" section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). 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 tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
    If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.

VII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket
control number [OPP-300809] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Rm. 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to
EPA at:
    opp-docket@epa.gov.

    E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of

encryption.
    The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in "ADDRESSES" at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any special considerations
as required by Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
    In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), 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. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments "to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates."
    Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of

[[Page 13103]]

 Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not

issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments "to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities."
    Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do 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 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 the rule in the Federal Register. This 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: March 5, 1999.

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. In Sec. 180.110, by revising paragraph (b) to read as follows:

Sec. 180.110  Maneb; tolerances for residues.

*    *    *    *    *
    (b) Section 18 emergency exemptions. A time-limited tolerance is
established for residues of the fungicide maneb (manganous
ethylenebisdithiocarbamate), calculated as zinc
ethylenebisdithiocarbamate, and its metabolite ethylenethiourea in
connection with use of the pesticide under a section 18 emergency
exemption granted by EPA. The tolerance will expire and is revoked on
the date specified in the following table:

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
Walnuts.........................  0.05                12/31/00
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-6383 Filed 3-16-99; 8:45 am]
BILLING CODE 6560-50-F