[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Rules and Regulations]
[Pages 13097-13103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6383]



[[Page 13097]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300809; FRL-6067-9]
RIN 2070-AB78


Maneb (manganous ethylenebisdithiocarbamate); Pesticide 
Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

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

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

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

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

I. Background and Statutory Findings

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

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

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

[[Page 13098]]

copper based bactericides are the only registered products for control 
of this disease. The increase of walnut blight since 1992 is attributed 
to the development of a tolerance to copper based bactericides. The 
state has demonstrated that copper resistant bacteria have become 
economically important, with a potential 55,000 acres affected. EPA has 
authorized under FIFRA section 18 the use of maneb (manganous 
ethylenebisdithiocarbamate) on walnuts for control of bacterial blight 
in California. After having reviewed the submission, EPA concurs that 
emergency conditions exist for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of maneb (manganous 
ethylenebisdithiocarbamate) in or on walnuts. In doing so, EPA 
considered the safety standard in FFDCA section 408(b)(2), and EPA 
decided that the necessary tolerance under FFDCA section 408(l)(6) 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment under section 408(e), 
as provided in section 408(l)(6). Although this tolerance will expire 
and is revoked on December 31, 2000, under FFDCA section 408(l)(5), 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on walnuts after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA, and the residues do not exceed a level that was authorized 
by this tolerance at the time of that application. EPA will take action 
to revoke this tolerance earlier if any experience with, scientific 
data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether maneb (manganous 
ethylenebisdithiocarbamate) meets EPA's registration requirements for 
use on walnuts or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
tolerance serves as abasis for registration of maneb (manganous 
ethylenebisdithiocarbamate) by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
State other than to use this pesticide on this crop under section 18 of 
FIFRA without following all provisions of EPA's regulations 
implementing section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for maneb 
(manganous ethylenebisdithiocarbamate), contact the Agency's 
Registration Division at the address provided under the ``ADDRESSES'' 
section.

III. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of maneb 
(manganous ethylenebisdithiocarbamate) and to make a determination on 
aggregate exposure, consistent with section 408(b)(2), for a time-
limited tolerance for residues of maneb (manganous 
ethylenebisdithiocarbamate), calculated as zinc 
ethylenebisdithiocarbamate and its metabolite ethylenethiourea on 
walnuts at 0.05 ppm. EPA's assessment of the dietary exposures and 
risks associated with establishing the tolerance follows.

A. Toxicological Profile

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

B. Toxicological Endpoint

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

C. Exposures and Risks

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

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

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    ii. Short- and intermediate-term exposure and risk. The amortized 
ETU cancer risk for the U.S. population for short- and intermediate-
term exposure to the turf use of maneb has been calculated to be 2.2 x 
10-7.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether maneb (manganous ethylenebisdithiocarbamate) has a common 
mechanism of toxicity with other substances or how to include this 
pesticide in a cumulative risk assessment. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, maneb (manganous ethylenebisdithiocarbamate) 
does not appear to produce a toxic metabolite produced by other 
substances, other than ETU, a metabolite common to the EBDC pesticides. 
For more information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the final rule for Bifenthrin 
Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

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

[[Page 13101]]

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

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

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

IV. Other Considerations

A. Metabolism In Plants and Animals

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

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available for maneb in the 
Pesticide Analytical Manual (PAM) II Method III.

C. Magnitude of Residues

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

D. International Residue Limits

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

V. Conclusion

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

VI. Objections and Hearing Requests

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

[[Page 13102]]

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

VII. Public Record and Electronic Submissions

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


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

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any special considerations 
as required by Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(l)(6), such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

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

[[Page 13103]]

 Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: March 5, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


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


Sec. 180.110  Maneb; tolerances for residues.

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

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

*    *    *    *    *    

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