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Mancozeb - Pesticide Tolerances for Emergency Exemptions 9/98

[Federal Register: October 9, 1998 (Volume 63, Number 196)]
[Rules and Regulations]
[Page 54362-54369]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09oc98-17]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300714; FRL-6029-5]
RIN 2070-AB78
Mancozeb; 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 the
combined residues of mancozeb, calculated as zinc
ethylenebisdithiocarbamate, and it's metabolite ethylenethiourea (ETU)
in or on ginseng. 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
ginseng. This regulation establishes a maximum permissible level for
residues of mancozeb and ETU 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, 1999.

DATES: This regulation is effective October 9, 1998. Objections and
requests for hearings must be received by EPA on or before December 8,
1998.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300714], 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-300714], 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 (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-

[[Page 54363]]

docket@epamail.epa.gov. Copies of objections and hearing requests must
be submitted as an ASCII file avoiding the use of special characters
and any form of encryption. Copies of objections and hearing requests
will also be accepted on disks in WordPerfect 5.1/6.1 file format or
ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300714]. No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Daniel Rosenblatt,
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: CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9375, e-mail:
rosenblatt.dan@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
residues of the fungicide mancozeb, calculated as zinc
ethylenebisdithiocarbamate, and it's metabolite (ETU), in or on ginseng
at 2.0 parts per million (ppm). This tolerance will expire and is
revoked on December 31, 1999. EPA will publish a document in the
Federal Register to remove the revoked tolerance from the Code of
Federal Regulations.

I. Background and Statutory Authority

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

II. Emergency Exemption for Mancozeb on Ginseng and FFDCA
Tolerances

    On January 29, 1998, the Wisconsin Department of Agriculture,
Trade, and Consumer Protection requested that EPA consider issuing a
specific emergency exemption under section 18 for the use of mancozeb
on Ginseng (Panax quinquefolium L.) to control leaf and stem blight. In
past years, these problems have resulted in severe yield loss. In
addition, growers have not had satisfactory experience with the
alternative pesticides registered for this use. Analysis suggests that
reliance on the registered alternatives would result in a yield loss of
nearly 40%. Following EPA's assessment that growers in Wisconsin may
experience a severe economic loss without the availability of mancozeb,
the Agency granted an emergency exemption for ginseng growers which
permitted the application of mancozeb in the state this past growing
season.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of mancozeb and ETU in or on
ginseng. In doing so, EPA considered the new safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment under FFDCA section 408(e), as provided in FFDCA
section 408(l)(6). Although this tolerance will expire and is revoked
on October 31, 1999, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on ginseng 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 mancozeb meets EPA's
registration requirements for use on ginseng or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of mancozeb 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 Wisconsin to use this pesticide on this crop under FIFRA
section 18 of without following all provisions of FIFRA section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemption for mancozeb, contact the Agency's Registration
Division at the address provided above.

[[Page 54364]]

III. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the "No Observed Adverse Effect Level" or
"NOAEL").
    Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOAEL
from the study with the lowest NOAEL by an uncertainty factor (usually
100 or more) to determine the Reference Dose (RfD). The RfD is a level
at or below which daily aggregate exposure over a lifetime will not
pose appreciable risks to human health. An uncertainty factor
(sometimes called a "safety factor") of 100 is commonly used since it
is assumed that people may be up to 10 times more sensitive to
pesticides than the test animals, and that one person or subgroup of
the population (such as infants and children) could be up to 10 times
more sensitive to a pesticide than another. In addition, EPA assesses
the potential risks to infants and children based on the weight of the
evidence of the toxicology studies and determines whether an additional
uncertainty factor is warranted. Thus, an aggregate daily exposure to a
pesticide residue at or below the RfD (expressed as 100% or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOAEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This one hundredfold MOE is based on the same rationale
as the one hundredfold uncertainty factor.
    Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low-dose
extrapolations or MOE calculation based on the appropriate NOAEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include "acute," "short-term,"
"intermediate-term," and "chronic" risks. These assessments are
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOAEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in ground water
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.The
TMRC is a "worst case" estimate since it is based on the assumptions
that food contains pesticide residues at the tolerance level and that
100% of the crop is treated by pesticides that have established
tolerances. If the TMRC exceeds the RfD or poses a lifetime cancer risk
that is greater than approximately one in a

[[Page 54365]]

million, EPA attempts to derive a more accurate exposure estimate for
the pesticide by evaluating additional types of information
(anticipated residue data and/or percent of crop treated data) which
show, generally, that pesticide residues in most foods when they are
eaten are well below established tolerances.
    Percent of crop treated estimates are derived from Federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations,
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (non-nursing
infants less than a year old) was not regionally based.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with FFDCA 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 mancozeb
and to make a determination on aggregate exposure, consistent with
FFDCA section 408(b)(2), for a time-limited tolerance for residues of
mancozeb and ETU on ginseng at 2.0 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by mancozeb and ETU
are discussed below.
    1. Acute toxicity. For acute dietary risk assessment, the Agency
recommends use of the oral developmental NOAEL for ETU of 5 milligrams/
kilogram/day (mg/kg/day) from the rat developmental study. The effect
observed at the NOAEL is a threshold finding of delayed ossification in
the fetal skeletal structures.
     2. Short- and intermediate-term toxicity. For short and
intermediate term MOE calculations, EPA recommends the use of the
maternal NOAEL of 30 mg/kg/day for mancozeb from the rabbit
developmental toxicity study. At the maternal Lowest Effect Level (LEL)
of 80 mg/kg/day, there were deaths, ataxia, and abortions.
    3. Chronic toxicity. EPA has established the RfD for ETU at 0.003
mg/kg/day. This RfD is based on a 90-day oral dog toxicity study with a
NOAEL of 3 mg/kg/day and an uncertainty factor of 1,000 based on
decreased weight gain and hypogenesis of the prostate at the LEL of 30
mg/kg/day.
    4. Carcinogenicity. Mancozeb has been classified as a Group B2,
probable human carcinogen, by the Cancer Peer Review Committee
(Committee) and Science Advisory Panel based on evidence of thyroid
tumors in mice. The Committee recommended using the Q* approach. The Q*
is 0.0601 (mg/kg/day)**-1 and is based on ETU.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.176) for the residues of mancozeb, in or on a variety of raw
agricultural commodities at levels ranging from 0.1 ppm in corn to 65.0
ppm in sugar beet tops. There are no livestock feed items associated
with this section 18 use, so no additional livestock dietary burden is
expected. Risk assessments were conducted by EPA to assess dietary
exposures and risks from mancozeb and ETU 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. Because it is a minor crop, ginseng is
not uniquely identified in the data system which the Agency uses to
calculate acute and chronic dietary risk. However, in conjunction with
the EPA's assessment of a separate registration action involving an
ethylenebisdithiocarbamate (EBDC)-pesticide, the chemical family to
which mancozeb belongs, the Agency has recently conducted a
comprehensive analysis for EBDCs and ETU. That risk assessment
evaluated the chronic, acute, and cancer risks associated with the
EBDCs and ETU. For that review, EPA used the dietary endpoint for ETU
of 5 mg/kg/day. The resulting estimate of high-end dietary exposure for
the population subgroup of concern, females 13-plus years old, results
in an MOE of 5,000. Maximum field trial data values were used to
calculate the MOE. This is considered a partially refined risk
estimate; further refinement using anticipated residue values and
percent crop-treated data in conjunction with Monte Carlo analysis
would result in a lower acute dietary exposure estimate. Thus, in EPA's
judgement, the additional dietary burden associated with consumption of
ginseng would not lower the MOE to a level that poses a concern.
    ii. Chronic exposure and risk. In conjunction with the
comprehensive EBDC evaluation mentioned above, EPA calculated exposures
for the U.S. population and various subgroups including infants and
children. For the subgroup U.S. population (48 states), EPA concluded
that the anticipated residue contribution (ARC) from food for ETU would
be 0.000020 mg/kg/day. This results in an exposure equal to 24% of the
RfD. The highest exposure level was calculated for non-nursing infants
(< 1 year old) exposed at 78% of the RfD.
    This assessment used anticipated residue refinement and percent
crop treated data for selected commodities. Thus, this assessment
should be viewed as partially refined. Further refinement would lower
dietary exposure estimates. As mentioned above, although ginseng
consumption data was not included in the referenced assessment, the
increased exposures associated with this tolerance would not be
expected to trigger a level of concern through chronic consumption of
treated foods.
    2. From drinking water. Submitted environmental fate studies
suggest that mancozeb has moderate potential to leach into ground
water; thus, mancozeb could potentially leach to ground water and
runoff to surface water under certain environmental conditions. There
are no established Maximum Contaminant Levels (MCL) for residues of
mancozeb in drinking water. No Health Advisories (HA) for mancozeb 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.
     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

[[Page 54366]]

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 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 mancozeb or ETU 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 mancozeb or ETU 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 --i. Mancozeb is currently registered
for use on the following residential non-food sites: turf, lawn, trees
and shrubs. Mancozeb 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 assessment. For this action, the
risk to public health from the use of mancozeb 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.
    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 mancozeb 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." The Agency believes that "available
information" in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of toxicity will be assumed).
    Mancozeb is a member of the EBDC class of pesticides. Other members
of this class include among others: maneb, metiram, and nabam. EPA does
not have, at this time, available data to determine whether mancozeb
has a common mechanism of toxicity with other non-EBDC 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, mancozeb does not appear to
produce a toxic metabolite produced by other substances.

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

    1. Acute risk. EPA concludes that the MOE for ETU for the
population subgroup of concern (females 13-plus years and older) is
5,000. This MOE is well above the Agency's level of concern for acute
dietary exposure.
    2. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to ETU from food will
utilize 24% of the RfD for the U.S. population. The major identifiable
subgroup with the highest aggregate exposure is non-nursing infants
less than a year old at 78% of the RfD. A complete discussion of the
risks posed by mancozeb and ETU to children is presented 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 mancozeb in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes
that there is a reasonable certainty that no harm will result from
aggregate exposure to mancozeb or ETU residues.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. Although residential exposure data are not
available for ornamental lawn uses of mancozeb, EPA notes that large
MOEs were calculated for occupational exposure, greater than 19,000 for
the most highly exposed group. EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to mancozeb
residues.

D. Aggregate Cancer Risk for U.S. Population

    The cancer risk for mancozeb is based on ETU. The dietary cancer
risk is calculated using the Q1* for ETU, 0.0601 mg/kg/
day**-1. EPA calculated that the dietary cancer risk for the
EBDC pesticides, including this use on ginseng, is approximately
10**-6. This risk assessment is partially refined;
incorporation of percent crop treated information for all commodities
would

[[Page 54367]]

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. Although
surface and ground water monitoring data are limited, California has
analyzed 65 wells for ETU from 1986-89, some of which were in maneb (an
EBDC) use areas. Only one detection of .725 ppb was reported; however,
residues were not present at a subsequent sampling 4 or 5 months later.
A single detect of 16 ppb from an area in Illinois of no known EBDC use
is believed to be an anomaly and may be derived from a point source.
Regardless of this detection above 1 ppb, there is little evidence that
any significant subpopulation is exposed at levels above 1 ppb for a
significant period of time. Thus, a very conservative estimate of the
aggregate (dietary + residential + drinking water) cancer risk from the
EBDCs would be 10**-6. In EPA's best scientific judgement, the
potential exposure from residues on ginseng and in water would not
increase cancer risk estimates above EPA's level of concern.

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

    1. Safety factor for infants and children --i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of mancozeb, EPA considered data from
developmental toxicity studies in the rat and rabbit 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 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. For mancozeb, developmental
toxicity information indicated that the maternal NOAEL was 32 mg/kg/
day, based on decreased food consumption at the lowest observed effect
level (LOEL) of 128 mg/kg/day. The developmental (fetal) NOAEL was 128
mg/kg/day, based on dilated ventricles, spinal cord hemorrhage, delayed
and incomplete ossification of skull, and ribs at the LOEL of 512 mg/
kg/day. In the rabbit developmental toxicity study for mancozeb, the
maternal (systemic) NOAEL was 30 mg/kg/day, based on death, ataxia, and
abortion at the LOEL of 80 mg/kg/day. The developmental (fetal) NOAEL
was greater than 80 mg/kg/day Highest Dose Tested (HDT).
    For ETU, there is no adequate rabbit developmental toxicity study
available. In the rat, 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. From the rat reproductive study,
the maternal (systemic) NOAEL for mancozeb was 1.5 mg/kg/day, based on
increased liver weight in males and renal pigment in both sexes at the
LOEL of 6.0 mg/kg/day. The reproductive (pup) NOAEL was 60 mg/kg/day at
the HDT. There is no adequate rat reproduction study for ETU.
    iv. Pre- and post-natal sensitivity. For this assessment, EPA used
the developmental NOAEL of 5 mg/kg/day from the oral developmental
study on ETU in the rat to evaluate pre- and post-natal sensitivity.
The effect observed involved delayed ossification in the fetal skeletal
structures at the NOAEL. However, there is no adequate rabbit
developmental toxicity study available. For this reason, EPA is
applying an additional tenfold safety factor and requiring a minimum
MOE of 1,000. The calculated MOE is 5,000 based on the NOAEL of 5 mg/
kg/day. In EPA's judgement, this MOE does not suggest a level of
concern.
    v. Conclusion. As mentioned above, due to the fact that a data gap
exists for ETU, EPA has concluded that the risk assessment for
developmental and reproductive toxicity should use an additional safety
factor in order to protect the population subgroup of concern, females
13+ years old. For this assessment, EPA has determined that a minimum
MOE of 1,000 is necessary. Based on the NOAEL of 5 mg/kg/day described
above, EPA calculates that the MOE is 5,000. Therefore, in EPA's
judgement, the calculated exposure does not suggest a level of concern.
    2. Acute risk. The acute risk assessment for infants and children
used the dietary endpoint for ETU of 5 mg/kg/day. The MOE for the
population subgroup of concern, females 13+ years old, is 5,000.
Maximum field trial data values were used to calculate the MOE. This is
considered a partially refined risk estimate.
    3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to ETU from
food will utilize 78% of the RfD for infants and children. EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to mancozeb and ETU in
drinking water and from non-dietary, non-occupational exposure, EPA
does not expect the aggregate exposure to exceed 100% of the RfD. EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to mancozeb or ETU
residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residues of mancozeb and ETU are adequately
understood. The regulable residue listed at 40 CFR 180.176 lists the
parent compound only, calculated as zinc ethylenebisdithiocarbamate.
EPA concludes the residues of concern to be the fungicide mancozeb,
calculated as zinc ethylenebisdithiocarbamate, and it's metabolite ETU.
There are no animal feed items associated with ginseng, therefore a
discussion of animal metabolism is not germane to this action.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available in the Pesticide
Analytical Manual (PAM II, Method III) to enforce the current tolerance
expression for EBDCs. An enforcement method is also available for ETU.
The residues of mancozeb or ETU are not expected to exceed 2.0 ppm in/
on ginseng as a result of this FIFRA section 18 use.

[[Page 54368]]

C. Magnitude of Residues

    EPA concludes that the combined regulable residues of mancozeb and
ETU are not expected to exceed 2.0 ppm in or on ginseng as a result of
this section 18 use. Secondary residues are not expected in animal
commodities as no feed items are associated with this FIFRA section 18
use.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican international residue
limits, established for residues of mancozeb on ginseng.

E. Rotational Crop Restrictions

    Ginseng is not rotated to other crops, therefore, there is no
concern for inadvertent residues in rotated crops.

VI. Conclusion

    Therefore, a time-limited tolerance is established for the combined

residues of mancozeb, calculated as zinc ethylenebisdithiocarbamate,
and its metabolite (ETU) in ginseng at 2.0 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process
for persons to "object" to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
    Any person may, by December 7, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the information that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.

VIII. Public Docket and Electronic Submissions

    EPA has established a record for this rulemaking under docket
control number [OPP-300714] (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 Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    opp-docket@epamail.epa.gov.

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

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a time-limited tolerance under FFDCA
section 408(d) in response to a petition submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). This final rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since these tolerances and exemptions that are
established 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 has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance acations published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

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

[[Page 54369]]

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 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 to 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.

X. 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 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.

    September 30, 1998.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180 -- [AMENDED]

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

    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.176 is amended by revising the section heading,
designating the existing text as paragraph (a) and adding a paragraph
heading, adding new paragraph (b), and adding and reserving paragraphs
(c) and (d) with headings to read as follows:

Sec. 180.176  Mancozeb; tolerances for residues.

    (a) General. *        *        *

    (b) Section 18 emergency exemptions. A time-limited tolerance is
established for combined residues of the fungicide mancozeb, calculated
as zinc ethylenebisdithiocarbamate and it's metabolite ETU 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 dates specified in the following table.

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Ginseng.........................  2.0                 12/31/99
------------------------------------------------------------------------

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

[FR Doc. 98-27268 Filed 10-8-98; 8:45 am]
BILLING CODE 6560-50-F