[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: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 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:
pemberton.libby@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing 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="">-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="">-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:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
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
