[Federal Register Volume 63, Number 179 (Wednesday, September 16, 1998)]
[Rules and Regulations]
[Pages 49479-49487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24846]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300699; FRL-6022-5]
RIN 2070-AB78
Propyzamide; 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
combined residues of propyzamide (pronamide) and its metabolites
containing the 3,5-dichlorobenzoyl moiety (calculated as 3,5-dichloro-
N-(1,1-dimethyl-2-propynyl)benzamide) in or on cranberries, grass hay,
and grass forage. This action is in response to EPA's granting of
emergency exemptions under section 18 of the Federal
[[Page 49480]]
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on cranberries, and on grass grown for seed. This regulation
establishes maximum permissible levels for residues of propyzamide in
these food and feed commodities 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 tolerances will expire and are revoked on
December 31, 1999.
DATES: This regulation is effective September 16, 1998. Objections and
requests for hearings must be received by EPA on or before November 16,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300699], 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-300699], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, 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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300699]. 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: Telephone numbers and e-mail
addresses: For propyzamide on cranberries: Andrew Ertman, (703) 308-
9367, e-mail: [email protected]; for propyzamide on grass
grown for seed: Andrea Beard (703) 308-9356, e-mail:
[email protected]. Office location (both): Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. By mail (both): Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
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
combined residues of the herbicide propyzamide (pronamide) and its
metabolites, in or on cranberries at 0.05 part per million (ppm), and
in or on grass forage at 1 ppm and grass hay at 0.5 ppm. These
tolerances will expire and are revoked on December 31, 1999. EPA will
publish a document in the Federal Register to remove the revoked
tolerances 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).
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 Exemptions for Propyzamide (Pronamide) and FFDCA
Tolerances
Propyzamide on Cranberries: Dodder is a serious and devastating
pest in commercial cranberry production as well as many other
agricultural crops. It is an obligate shoot parasite that, in order to
survive, must make a successful attachment to a host plant. The body of
the organism consists of thin, yellow, twining stems that produce small
clusters of white flowers and can form a dense mat of ``spaghetti-
like'' stems on top of infected plants. Dodder is prolific in its seed
production, and produces seeds in capsules that are contained in large
air spaces and are thus very buoyant. With the widespread adoption of
water harvesting, dodder infestations have become practically
ubiquitous in the Massachusetts production area. The detrimental impact
of dodder infestations on cranberry yields have been reported widely in
scientific journals, extension publications and internal memorandum.
Yield losses can range from 12% in slight infestations up to 100% in
severe infestations. Currently registered herbicides have not been
totally effective, leading to a steady increase in dodder infestations.
[[Page 49481]]
Propyzamide on Grasses grown for seed: Because of cancellation of
several herbicide uses in recent years, a shift in weed populations and
the development of resistance, plus restrictions imposed on open field
burning, grass growers are no longer able to control weeds adequately
with registered materials and cultural methods. The Applicants claim
that if weeds are not adequately controlled, growers will incur
significant economic losses due to reduced yields, and from losses due
to contaminated seed, and replanting of fields that do not meet
certification requirements. The Applicant proposed use of propyzamide,
in conjunction with several other herbicides, to comprise a
comprehensive management system to solve the current weed control
problems in grass seed production.
EPA has authorized under FIFRA section 18 the use of propyzamide on
cranberries for control of dodder in Massachusetts, and on grasses
grown for seed to control grassy weeds in Oregon. After having reviewed
the submissions, EPA concurs that emergency conditions exist for these
states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of propyzamide in or on
cranberries and grass hay and forage. In doing so, EPA considered the
new safety standard in FFDCA section 408(b)(2), and EPA decided that
the necessary tolerances 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 these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although these tolerances will expire
and are revoked on December 31, 1999, under FFDC a section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on cranberries or grass hay or grass forage
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether propyzamide
meets EPA's registration requirements for use on cranberries or grasses
grown for seed or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of propyzamide by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than Massachusetts or
Oregon to use this pesticide on the specified crops under section 18 of
FIFRA without following all provisions of section 18 as identified in
40 CFR part 166. For additional information regarding these emergency
exemptions for propyzamide, 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 percent 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.
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
[[Page 49482]]
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 dat
a 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
propyzamide and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
combined residues of propyzamide (pronamide) and its metabolites
containing the 3,5-dichlorobenzoyl moiety (calculated as 3,5-dichloro-
N-(1,1-dimethyl-2-propynyl)benzamide) on cranberries at 0.05 ppm, on
grass forage at 1.0 ppm, and on grass hay at 0.5 ppm. EPA's assessment
of the dietary exposures and risks associated with establishing the
tolerances 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 propyzamide are
discussed below.
1. Acute toxicity. None. For acute dietary risk assessment, EPA has
determined, based on the available data, that an acute dietary endpoint
was not necessary for purposes of risk assessment.
2. Short - and intermediate - term toxicity. EPA has not
identified any toxicity endpoints for short- or intermediate-term
toxicity, and has determined, based on the data, that these risk
assessments are not necessary.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for propyzamide at 0.08 milligrams/kilogram body weight/day (mg/kg bwt/
day). The RfD was established based on a 2-year feeding study in rats
with a NOEL of 8.46 mg/kg/day and using an uncertainty factor of 100.
The Lowest Observed Effect Level (LOEL) of 42.6 mg/kg/day was based on
decreased mean body weight and decreased mean body weight gain,
increased relative liver weight, increased incidences of hepatic
centrilobular hypertrophy, as well as eosinophilic cell alterations and
thyroid follicular cell hypertrophy in both males and females. In
females there was an increased incidence of ovarian hyperplasia.
4. Carcinogenicity. Propyzamide has been classified as a Group B2
(probable human carcinogen) chemical. The decision was based on the
finding of two types of tumors in the rat (benign testicular
interstitial cell tumors and thyroid follicular cell adenomas), and one
type in the mouse (liver carcinomas). The Agency recommended using the
Q1* approach (Q1* = 0.01540) for purposes of risk
assessment.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.317) for the residues of propyzamide, 3,5-dichloro-N-(1,1-
dimethyl-2-propynyl)benzamide and its metabolites (containing the 3,5-
dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-(1,1-dimethyl-
2-
[[Page 49483]]
propynyl)benzamide) in or on a variety of raw agricultural commodities
at levels ranging from 0.02 ppm in milk to 10 ppm in nongrass animal
feeds. Risk assessments were conducted by EPA to assess dietary
exposures and risks from propyzamide 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. As the Agency did not identify an
acute dietary endpoint, no acute risk assessment was conducted.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made partially refined assumptions. For
cranberries, the conservative assumptions of tolerance level residues
and 100% crop treated were used. Refinements to other commodities
included anticipated residues for lettuce, milk, eggs, and most poultry
commodities; additionally, percent of crop treated figures were
incorporated for small berries, grapes, cherries, stone fruits, pome
fruits, lettuce, and artichokes. All other commodities were assumed to
be 100% crop treated and to contain tolerance level residues.
The existing propyzamide tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in an
Anticipated Residue Contributions (ARCs) that are equivalent to <1% of
the RfD for all population subgroups, as shown below:
------------------------------------------------------------------------
Population Subgroup ARC (mg/kg/day) %RFD
------------------------------------------------------------------------
U.S. Population (48 States)..... 0.000151 0.19
Nursing Infants (<1 year old)... 0.000195 0.24
Non-Nursing Infants (<1 year 0.000601 0.75
old).
Children (1-6 years old)........ 0.000354 0.44
Children (7-12 years old)....... 0.000225 0.28
------------------------------------------------------------------------
iii. Cancer risk. Propyzamide has been classified as a Group B2
(probable human carcinogen) chemical by the Agency. The decision was
based on the finding of two types of tumors in the rat (benign
testicular interstitial cell tumors and thyroid follicular cell
adenomas), and one type in the mouse (liver carcinomas). The Agency
recommended using the Q1* approach
(Q1*=0.01540(mg/kg/day)-1) for purposes of risk
assessment. Using the partially refined exposure estimates described
above, the cancer risk estimate for the U.S.population is
2.3 x 10-6. The contribution of propyzamide exposure
resulting from this section 18 use has been amortized for 5 years for
the purposes of this section 18 only. Although the cancer risk estimate
exceeds 1 x 10-6, this risk analysis assumed all the beef,
goat, sheep, and pork commodities contain tolerance level residues.
Although the milk, turkey, poultry, and egg commodities were assumed to
contain anticipated residues, the percent treated values used were 100.
These commodities contribute significantly to the diet. Therefore, if
anticipated residues were used for all commodities, and actual percent
treated values were used for all these animal commodities, it is
expected that the cancer risk estimate from food would fall below
1 x 10-6.
2. From drinking water. Based on information in the Agency's files,
propyzamide is persistent and not mobile. There is no established
Maximum Contaminant Level for residues of propyzamide in drinking
water. A lifetime health advisory level of 0.05 mg/L for propyzamide in
drinking water has been established. The Agency utilized GENEEC and
SCIGROW computer modeling to estimate pesticide concentrations found in
surface and ground waters, respectively, thus providing a reasonable
and conservative upper-bound estimate for screening purposes, for use
in the human health risk assessment. For surface water, the chronic
(average 56-day) value is 8.3 parts per billion (ppb). The groundwater
screening concentration is 0.28 ppb.
i. Acute exposure and risk. Because no acute dietary endpoint was
identified, no acute risk assessment was conducted.
ii. Chronic exposure and risk. Chronic drinking water levels of
concern (DWLOC) for propyzamide were calculated based on the chronic
dietary (food) exposure estimates. A human health DWLOC is the
concentration in drinking water that would be acceptable as an upper
limit in light of total aggregate exposure to that chemical from food,
water, and non-occupational (residential) sources. It is current Agency
policy that the following subpopulations be addressed when calculating
drinking water levels of concern: US population (48 States), Males (13+
years), Females (13+ years), and all infants/children and if other
adult populations greater than the U.S. population, the highest of them
also. In conducting these calculations, default body weights are used
of 70 kg (adult male), 60 kg (adult females), and 10 kg (child);
default consumption values of water are used of 2 liters perday for
adults and 1 liter per day for children. Using these assumptions and
the levels provided by the computer models, given above, the resultant
DWLOCs were calculated to be 2,800 ppb for the Overall US population
and Males (13-19), 2,400 ppb for Females (13-19 yrs. old), and 790 ppb
for the most highly exposed infant/children subpopulation, Non-Nursing
Infants (<1 Year Old). These values are substantially higher than the
residue estimates calculated. Therefore, chronic exposure to
propyzamide residues in drinking water do not exceed the Agency's level
of concern.
iii. Cancer Risk. The cancer risk estimate (food only) is not
likely to exceed the Agency's level of concern. In addition, in the
Agency's best scientific judgment, considering the conservative nature
of the GENEEC surface water number of 8.3 ppb, EPA does not expect
significant additional contribution to cancer risk from exposure to
propyzamide in drinking water.
3. From non-dietary exposure. Propyzamide is currently registered
for use on numerous ornamental plants (including woody shrubs, shade
trees, and ornamental turf); there are no indoor uses registered.
However, all registered residential uses of propyzamide are currently
inactive, and therefore residential uses are not a contributing factor
to aggregate risk at this time.
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
[[Page 49484]]
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' The Agency believes that
``available information'' in this context might include not only
toxicity, chemistry, and exposure data, but also scientific policies
and methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
Propyzamide is a member of the substituted amides class of
pesticides. However, EPA does not have, at this time, available data to
determine whether propyzamide 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,
propyzamide 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 propyzamide has a common mechanism of toxicity
with other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. Because no acute dietary endpoint was identified, no
acute risk assessment was conducted.
2. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to propyzamide from
food will utilize 0.19% of the RfD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is Non-
Nursing Infants, with 0.75% of the RfD utilized, further 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 propyzamide 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 propyzamide
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. Because no endpoint was identified for this type
of exposure, EPA did not conduct a risk assessment for short- or
intermediate-term exposure.
D. Aggregate Cancer Risk for U.S. Population
As discussed in the previous section, EPA believes that if further
refinement of residue and percent crop treated estimates were
incorporated in to the risk assessment, the cancer risk from food would
fall below 1 x 10-6. Although the GENEEC drinking water
model indicates potential for low residues of propyzamide in water, it
is EPA's best scientific judgment that the total aggregate cancer risk
presented from propyzamide will not exceed 1 x 10-6, even if
drinking water exposures were to occur at the extremely conservative
screening levels estimated. Therefore, EPA concludes that there is a
reasonable certainty that no harm in the form of cancer will result
from aggregate exposure to propyzamide residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children --i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of propyzamide, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, there were no maternal (systemic) or developmental (fetal)
adverse effects observed at the highest dose tested (160 mg/kg/day).
In the developmental toxicity study in rabbits, the maternal
(systemic) NOEL was 5 mg/kg/day. The LOEL of 20 mg/kg/day was based on
anorexia, vacuolated hepatocytes, and soiled anal area. The
developmental (fetal) NOEL was 20 mg/kg/day. The developmental LOEL of
80 mg/kg/day was based on increased number of absorptions and
abortions.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the parental (systemic) NOEL was 10 mg/kg/day
(200 ppm), based on decreased body weight, and decreased feed
consumption at the
[[Page 49485]]
LOEL of 75 mg/kg/day (1,500 ppm). The reproductive (pup) NOEL was also
10 mg/kg/day (200 ppm) based on decreased pup weight at the LOEL of 75
mg/kg/day (1,500 ppm).
iv. Pre- and post-natal sensitivity. The toxicological database for
evaluating pre- and post-natal toxicity for propyzamide is complete
with respect to current data requirements. There are no pre- or post-
natal toxicity concerns for infants and children, based on the results
of the rat and rabbit developmental toxicity studies as well as the 2-
generation rat reproductive toxicity study.
v. Conclusion. Based upon the available data, outlined above, EPA
scientists concluded that reliable data support the conclusion that
using the standard 100-fold uncertainty factor will provide adequate
protection for infants and children, and that an additional 10-fold
uncertainty factor is not warranted. EPA concludes that there is
reasonable certainty of safety for infants and children exposed to
dietary residues of propyzamide.
2. Acute risk. Because no acute dietary endpoint was identified, no
acute risk assessment was conducted.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
propyzamide from food will utilize from 0.24% to 0.75% of the RfD for
infants and children. EPA generally has no concern for exposures below
100% of the RfD because the RfD represents the level at or below which
daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health. Despite the potential for exposure
to propyzamide in drinking water and from non-dietary, non-occupational
exposure, EPA does not expect the aggregate exposure to exceed 100% of
the RfD. EPA concludes that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to
propyzamide residues.
4. Short- or intermediate-term risk. Because no endpoint was
identified for short- or intermediate-term exposure, EPA did not
conduct a risk assessment for this type of exposure.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in plants and animals is adequately
understood. The residues of concern are the parent compound and its
metabolites containing the 3,5-dichlorobenzoyl moiety, calculated as
3,5-dichloro-N-(1,1-dimethyl-2-propynyl)benzamide(as specified in 40
CFR 180.317) .
B. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography using electron
capture detection) is available to enforce the tolerance expression.
This method is published in PAM II, as method I.
C. Magnitude of Residues
Residues of propyzamide and its regulated metabolites are not
expected to exceed 0.05 ppm in/on cranberries, 0.5 ppm in/on grass hay,
and 1 ppm in/on grass forage, as a result of these section 18 uses.
Secondary residues in animal commodities are not expected from
cranberries, and secondary residues resulting form the grass use are
not expected to exceed established tolerances.
D. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits for
propyzamide on cranberries or grass commodities, so harmonization is
not an issue for these section 18 uses.
E. Rotational Crop Restrictions
Cranberries are not a rotated crop, and thus rotational crop
restrictions are not applicable. Fields in which certified grass seed
is grown are not normally rotated to other crops, and rotational crop
restrictions are not required for this use.
VI. Conclusion
Therefore, the tolerances are established for combined residues of
propyzamide in/on cranberries at 0.05 ppm, grass hay at 0.5 ppm, and
grass forage at 1 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 16, 1998, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
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 Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300699] (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 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
[[Page 49486]]
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under FFDCA section
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 58-3, 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).
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a
regulation that is not required by statute and that creates a mandate
upon a State, local or tribal government, unless the Federal government
provides the funds necessary to pay the direct compliance costs
incurred by those governments. If the mandate is unfunded, EPA must
provide to the Office of Management and Budget (OMB) a description of
the extent of EPA's prior consultation with representatives of affected
State, local and tribal governments, the nature of their concerns,
copies of any written communications from the governments, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 12875 requires EPA to develop an effective process
permitting elected officials and other representatives of State, local
and tribal governments ``to provide meaningful and timely input in the
development of regulatory proposals containing significant unfunded
mandates.''
Today's rule does not create an unfunded federal mandate on State,
local or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian Tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
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 Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 26, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.317, by revising the heading; by adding a heading to
paragraph (a) and revising the introductory text; by designating the
current paragraph (b) as (c); by adding a new paragraph (b); by
revising the
[[Page 49487]]
introductory text of newly designated (c); and by adding and reserving
paragraph (d) to read as follows:
Sec. 180.317 Propyzamide; tolerances for residues.
(a) General. Tolerances are established for combined residues of
the herbicide propyzamide and its metabolites (containing the 3,5-
dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-(1,1-dimethyl-
2-propynyl)benzamide) in or on the following raw agricultural
commodities:
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of propyzamide, in connection with use of
the pesticide under section 18 emergency exemptions granted by EPA. The
tolerances will expire on the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Cranberries..................... 0.05 12/31/99
Grass, forage................... 1.0 12/31/99
Grass, hay...................... 0.5 12/31/99
------------------------------------------------------------------------
(c) Tolerances with regional registrations. Tolerances with
regional registration are established for the combined residues of the
herbicide propyzamide and its metabolites (containing the 3,5-
dichlorobenzoyl moiety and calculated as 3,5-dichloro-N-(1,1-dimethyl-
2-propynyl)benzamide) in or on the following raw agricultural
commodities:
* * * * *
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 98-24846 Filed 9-15-98; 8:45 am]
BILLING CODE 6560-50-F