[Federal Register Volume 63, Number 196 (Friday, October 9, 1998)]
[Rules and Regulations]
[Pages 54362-54369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27268]


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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]]

[email protected]. 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: 
[email protected].

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 it's 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:
    [email protected].

    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