[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Rules and Regulations]
[Pages 49918-49925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25097]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300545; FRL-5741-2]
RIN 2070-AB78


Maneb; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of maneb (manganous ethylenebisdithiocarbamate), calculated as 
zinc ethylenebisdithiocarbamate, and its metabolite ethylenethiourea in 
or on walnuts. This action is in connection with a crisis exemption 
declared by the state of California under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of the 
pesticides on walnuts in California. This regulation establishes a 
maximum permissible level for residues of maneb 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 June 15, 1998.

DATES: This regulation is effective September 24, 1997. Objections and 
requests for hearings must be received by EPA on or before November 24, 
1997.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300545], 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-300545], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), 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. 1132, 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 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 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-300545]. 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: Libby Pemberton, 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: Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 308-9364, 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 tolerances 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 June 15, 1998. 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 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 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 (61 FR 58135, November 13, 1996)(FRL-5572-9).

[[Page 49919]]

    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 Maneb on Walnuts and FFDCA Tolerances

    On February 24, 1997, the California Department of Pesticide 
Regulation availed itself of the authority to declare the existence of 
a crisis situation within the state, thereby authorizing use under 
FIFRA section 18 of maneb on walnuts for control of bacterial blight. 
Currently, 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 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 (calculations based 
on its metabolite ethylenethiourea) and its metabolite in or on 
walnuts. 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 section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on June 
15, 1998, 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. 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 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 a basis for 
registration of maneb 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 section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for maneb, contact the Agency's Registration Division at the address 
provided above.

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 effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL 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 NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.

[[Page 49920]]

    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 NOEL) 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 3 
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/NOEL 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 groundwater 
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 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 (<1 year old) was not regionally based.

IV. Aggregate Risk Assessment and Determination of Safety

    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 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 below.
    1. Acute toxicity. The acute dietary risk assessment is being 
conducted for ethylenethiourea (ETU) rather than maneb, since the NOEL 
for acute dietary risk for ETU is 4 times lower (5 mg/kg/

[[Page 49921]]

day) than the NOEL for acute dietary risk for maneb (20 mg/kg/day). 
Therefore, an acceptable MOE for ETU will also be protective of 
exposure to maneb. The oral developmental NOAEL (No-observed-adverse-
effect-level) 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 NOEL is more correctly identified as a slightly lower dose 
level which is close to a threshold NOAEL in the developmental study. 
The EDBC PD-4 stated that MOEs could be calculated from the 5 mg/kg/day 
NOAEL, which was close to the NOEL, and was the lowest dose tested.
     2. Short - and intermediate - term non-dietary toxicity. OPP 
recommends use of the systemic NOEL of 100 mg/kg/day from the 3-week 
dermal toxicity study in rabbits. At the LOEL 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 RfD for ETU at 0.00008 
milligrams/kilogram/day (mg/kg/day). This RfD is based on the LOEL 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 NOEL for ETU, a 
factor of 10 for data gaps for ETU, and a factor of 100 to take into 
accoutn 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.

B. 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, 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 and maneb 
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 one day or single exposure. The high end dietary exposure for the 
population subgroup of concern, females 13+ years old, is 0.000036 mg/
kg/day, which results in an MOE of 5,000. Maximum field trial residue 
data 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 apercentage of the RfD is 24.4%.
    2. From drinking water. There is no established Maximum 
Concentration Level (MCL) for residues of maneb in drinking water. No 
drinking water health advisory levels have been established for maneb. 
Environmental fate studies suggest that maneb is moderately persistent 
and has moderate potential to leach into ground water. Maneb could 
potentially leach to groundwater and run off to surface water under 
certain environmental conditions.
     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 NOEL'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 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 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 is currently registered for use 
on the following residential non-food sites: turf, lawn, trees, and 
shrubs.
     i. Acute exposure and risk. EPA generally will not include 
residential or other non-dietary exposure as a component of the acute 
exposure assessment. Theoretically, it is also possible that a 
residential, or other non-dietary, exposure could be combined with the 
acute total dietary exposure from food and water. However, the Agency 
does not believe that aggregating multiple exposure to large amounts of 
pesticide residues in the residential environment via multiple products 
and routes for a one day exposure is a reasonably probable event. It is 
highly unlikely that, in one day, an individual would have multiple 
high-end exposures to the same pesticide by treating their lawn and 
garden, treating their house via crack and crevice application, 
swimming in a pool, and be maximally exposed in the food and water 
consumed. Additionally, the concept of an acute exposure as a single 
exposure does not allow for including post-application exposures, in 
which residues decline over a period of days after application. 
Therefore, the Agency believes that residential exposures are more 
appropriately included in the short-term exposure scenario discussed 
below.
     ii. Chronic exposure and risk. The Agency has concluded that a 
chronic residential exposure scenario does not exists for non-
occupational uses of maneb.
    iii. Short- and intermediate-term exposure and risk.  There are 
residential uses of maneb and EPA acknowledges that there may be short 
and intermediate-term non-occupational exposure scenarios. The EPA has 
identified a toxicity endpoint for short and intermediate term non-
occupational risks. However, no acceptable reliable exposure data to 
assess the potential risks are available at this time. Based on the 
level of the short and intermediate-term endpoints, the Agency does not 
expect the short and intermediate-term aggregate risk to exceed the 
level of concern.
    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

[[Page 49922]]

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 activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether maneb 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 does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
maneb has a common mechanism of toxicity with other substances.

C. 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 
above, EPA has concluded that aggregate exposure to maneb 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 in drinking water, 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 maneb 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.
    The MOE for the U.S. population exceeds the desired MOE, therefore, 
EPA has no short- and intermediate-term aggregate risk concerns.

D. Aggregate Cancer Risk for U.S. Population

    The aggregate dietary cancer risk for ETU was calculated to be 1.2 
x 10-6 for all the published and pending uses for maneb 
including this section 18 use and for all commodities which contain ETU 
as a result of the use of EDBC compounds. In EPA's best scientific 
judgement, additional potential exposure from residues in water would 
not increase cancer risk estimates above the Agency'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 maneb, EPA considered data from developmental 
toxicity studies in the rat and a two-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 100-
fold safety factor (usually 100 for combined inter- and intra-species 
variability)) and not the additional tenfold safety 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 safety factor.
    ii. Developmental toxicity studies. From the rat developmental 
study for ETU, the oral developmental NOEL is 5 mg/kg/day, based on a 
threshold finding of delayed ossification in the fetal skeletal 
structures at the NOEL.
    iii. Reproductive toxicity study. There is no reproduction study 
with ETU available. In the rat reproduction study for maneb, the 
parental (systemic) NOEL was 6.0 mg/kg/day, based on decreased body 
weight and food consumption at the LOEL of 25 mg/kg/day. The 
developmental (pup) NOEL was 6.0 mg/kg/day, based on increased startle 
response at the LOEL 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 NOEL and LOEL 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 NOEL 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 NOEL

[[Page 49923]]

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 conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to maneb 
from food will utilize 78.4% of the RfD for non-nursing 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 in 
drinking water, 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 maneb residues.
    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.

V. 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 ethylenethiourea. 
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. Prior to publication 
in PAM II, additional enforcement methodology is available in the 
interim to anyone who is interested in pesticide enforcement when 
requested from: Calvin Furlow, Public Response and Program Resource 
Branch, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm 1128, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, 703-305-5805.

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.

VI. 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.

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 November 24, 1997, 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 
Confidential Business Information (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

    EPA has established a record for this rulemaking under docket 
control number [OPP-300545] (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 Room 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., 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

    This final rule establishes a time-limited tolerance under FFDCA 
section

[[Page 49924]]

408(l)(6). 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 actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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: August 29, 1997.

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

PART 180--[AMENDED]

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

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

    2. Section 180.110 is revised to read as follows:


Sec. 180.110  Maneb; tolerances for residues.

    (a) General . Tolerances for residues of the fungicide maneb 
(manganous ethylenebisdithiocarbamate), calculated as zinc 
ethylenebisdithiocarbamate, are established in or on raw agricultural 
commodities in the following table:

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Almonds.........................  0.1                 None              
Apples..........................  2                   None              
Apricots........................  10                  None              
Bananas (not more than 0.5 part   4                   None              
 per million) shall be in the                                           
 pulp after peel is removed and                                         
 discarded (preharvest                                                  
 application only).                                                     
Beans (dry form)................  7                   None              
Beans (succulent form)..........  10                  None              
Broccoli........................  10                  None              
Brussels sprouts................  10                  None              
Cabbage.........................  10                  None              
Carrots.........................  7                   None              
Cauliflower.....................  10                  None              
Celery..........................  5                   None              
Chinese cabbage.................  10                  None              
Collards........................  10                  None              
Cranberries.....................  7                   None              
Cucumbers.......................  4                   None              
Eggplants.......................  7                   None              
Endive (escarole)...............  10                  None              
Figs............................  7                   None              
Grapes..........................  7                   None              
Kale............................  10                  None              
Kohlrabi........................  10                  None              
Lettuce.........................  10                  None              
Melons..........................  4                   None              
Mustard greens..................  10                  None              
Nectarines......................  10                  None              
Onions..........................  7                   None              
Papayas.........................  10                  None              
Peaches.........................  10                  None              
Peppers.........................  7                   None              
Potatoes........................  0.1                 None              
Pumpkins........................  7                   None              
Rhubarb.........................  10                  None              
Spinach.........................  10                  None              
Sugar beet tops.................  45                  None              

[[Page 49925]]

                                                                        
Summer squash...................  4                   None              
Sweet corn (kernels plus cob      5                   None              
 with husk removed).                                                    
Tomatoes........................  4                   None              
Turnip roots....................  7                   None              
Turnip tops.....................  10                  None              
Winter squash...................  4                   None              
------------------------------------------------------------------------

    (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                6/15/98           
------------------------------------------------------------------------

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

[FR Doc. 97-25097 Filed 9-23-97; 8:45 am]
BILLING CODE 6560-50-F