[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Rules and Regulations]
[Pages 26960-26966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12908]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300489; FRL-5717-5]
RIN 2070-AB78
Propamocarb Hydrochloride; Pesticide Tolerance 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 the fungicide propamocarb hydrochloride in or on the food
commodities tomatoes, tomato puree, and tomato paste in connection with
EPA's granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of
propamocarb hydrochloride on
[[Page 26961]]
tomatoes in the states of California, Florida, Maryland, New Jersey,
New York, Pennsylvania, and Virginia. The tolerances will expire and
are revoked by EPA on May 15, 1999.
DATES: This regulation becomes effective May 16, 1997. Objections and
requests for hearings must be received by EPA on or before July 15,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300489], 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
document control number, [OPP-300489], 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-300489]. 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 (7505W), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
Arlington, VA (703) 308-8326, 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 propamocarb hydrochloride on tomatoes at 0.5 parts per
million (ppm), in tomato puree at 1.0 ppm, and in tomato paste at 3.0
ppm. These tolerances will expire and be revoked by EPA on May 15,
1999. After May 15, 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 FFDCA, 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. 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 CFR
58135, November 13, 1996)(FRL-5572-9).
New Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA
requires EPA to establish a time-limited tolerance or exemption from
the requirement for a tolerance for pesticide chemical residues in food
that will result from the use of a pesticide under an emergency
exemption granted by EPA under section 18 of FIFRA. Such tolerances can
be established without providing notice or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemptions for Propamocarb hydrochloride on Tomatoes
and FFDCA Tolerances
Recent failures to control late blight in tomatoes and potatoes
with the registered fungicides, have been caused almost exclusively by
immigrant strains of late blight (Phytophthora infestans), which are
resistant to the control of choice, metalaxyl. Before the immigrant
strains of late blight arrived, all of the strains in the United States
were previously controlled by treatment with metalaxyl. Presently,
there are no fungicides registered in the United States that will
provide adequate control of the immigrant strains of late blight. After
having reviewed their submissions, EPA concurs that emergency
conditions exist for the states previously listed.
As part of its assessment of these specific exemptions, EPA
assessed the potential risks presented by residues of propamocarb
hydrochloride on tomatoes, in tomato puree, and in tomato paste. 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 clearly be consistent with the new safety
standard and with FIFRA section 18. These tolerances will permit the
marketing of tomatoes treated in accordance with the provisions of the
section 18 emergency exemptions and the marketing of tomato puree and
tomato paste containing residues resulting from the processing of
treated tomatoes. Consistent with the need to move quickly on these
emergency exemptions 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
[[Page 26962]]
these tolerances will expire and are revoked by EPA on May 15, 1999,
under FFDCA section 408(l)(5), residues of propamocarb hydrochloride
not in excess of the amount specified in these tolerances remaining in
or on tomatoes, tomato puree and tomato paste after that date will not
be unlawful, provided the pesticide is applied during the term of, and
in accordance with all the conditions of, section 18 of FIFRA. 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.
EPA has not made any decisions about whether propamocarb
hydrochloride meets EPA's registration requirements for use on tomatoes
or whether permanent tolerances for this use would be appropriate.
These tolerances do not serve as a basis for registration of
propamocarb hydrochloride by a State for special local needs under
FIFRA section 24(c). Nor do these tolerances serve as the basis for any
states other than California, Florida, Maryland, New Jersey, New York,
Pennsylvania and Virginia 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 exemptions for propamocarb hydrochloride, 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. For many
of these 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 hundredfold margin of exposure is based on the same
rationale as the hundredfold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments, e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL, will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
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. 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 percent
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.
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.
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 propamocarb
hydrochloride are discussed below.
1. Acute toxicity. Agency toxicologists have recommended that the
developmental NOEL of 150 milligrams per kilogram per day (mg/kg/day)
from the rabbit developmental toxicity study be used for acute dietary
risk calculations. The developmental lowest observable effect level
(LOEL) of 300 mg/kg/day is based on increased post-implantation loss
(developmental) and decreased body weight gain (maternal). The
population of concern for this risk assessment is females 13+ years
old.
2. Short- and intermediate-term toxicity. OPP recommends use of the
developmental toxicity study in rabbits for short- and intermediate
term MOE calculations. The maternal NOEL was 150 mg/kg/day and the LOEL
of 300 mg/kg/day was based on decreased body weight gain during
gestation days 6 to 18. The developmental NOEL was 150 mg/kg/day. The
developmental LOEL of 300 mg/kg/day was based on increased post-
implantation loss.
[[Page 26963]]
3. Chronic risk. Based on the available chronic toxicity data, the
Office of Pesticide Programs (OPP) has established the RfD for
propamocarb hydrochloride at 0.11 milligrams(mg)/kilogram(kg)/day. The
RfD was established based on a threshold LOEL of 33.31 mg/kg/day in
males and 33.27 mg/kg/day in females in a 1-year dog feeding study. The
LOEL was based on body weight gain depression, decreased food
efficiency and gastritis. An uncertainty factor (UF) of 100 was used to
account for both interspecies extrapolation and intraspecies
variability. An additional UF of 3 was used to account for the lack of
a NOEL.
4. Cancer risk. Propamocarb hydrochloride is classified as a
``Group D'', not classifiable as to human carcinogenicity due to
inadequacy of the data. Dietary rodent studies conducted in 1983 in
Germany showed no evidence of carcinogenicity. The registrant is
currently conducting studies in accordance with U.S. protocols.
B. Aggregate Exposure
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking water (whether
from groundwater or surface water), and exposure through pesticide use
in gardens, lawns, or buildings (residential and other indoor uses). In
evaluating food exposures, EPA takes into account varying consumption
patterns of major identifiable subgroups of consumers including infants
and children. There are no established U.S. tolerances for propamocarb
hydrochloride, and there are no registered uses for propamocarb
hydrochloride on food or feed crops in the United States.
1. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1 day or
single exposure. Drinking water is also considered a component of the
acute dietary exposure, however, 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 1 day exposure is a reasonably probable event. It is
highly unlikely that, in 1 day, an individual would have multiple high-
end exposures to the same pesticide by 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. In conjunction with this Section 18 use, the acute dietary
(food only) risk assessment used tolerance level residue values and
assumed 100% crop treated for all commodities requiring tolerances, as
did the time-limited tolerance established for the Section 18 exemption
for potatoes.
2. Chronic exposure-- i. Dietary - food exposures. For the purpose
of assessing chronic dietary exposure from propamocarb hydrochloride,
EPA assumed tolerance level residues and 100% of crop treated for the
proposed use of propamocarb hydrochloride on tomatoes. These
conservative assumptions result in overestimation of human dietary
exposures. Secondary residues of propamocarb hydrochloride are not
expected to transfer to animal commodities as a result of the proposed
use.
ii. Drinking water exposure. 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
consumption of contaminated water, the ranges the Agency is continuing
to examine are all below the level that would cause propamocarb
hydrochloride to exceed the RfD if the tolerances being considered in
this document were granted. The Agency has therefore concluded that the
potential exposures associated with propamocarb hydrochloride 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 tolerances are granted.
Based on the available studies used in EPA's assessment of
environmental risk, propamocarb hydrochloride is relatively non-
persistent and mobility varies as a function of soil texture and soil
reaction. There is no entry for propamocarb hydrochloride in the
``Pesticides in Groundwater Data Base'' (EPA 734-12-92-001, September
1992). There is no established Maximum Concentration Level (MCL) for
residues of propamocarb hydrochloride in drinking water. No drinking
water health advisory levels have been established for propamocarb
hydrochloride.
iii. Non-dietary, non-occupational exposure--short and intermediate
term exposure. Short- and intermediate-term aggregate exposure takes
into account chronic dietary food and water (considered to be
background exposure level) plus indoor and outdoor residential
exposure. Propamocarb hydrochloride is registered for uses, such as
lawn and ornamentals, that could result in non-occupational exposure
and EPA acknowledges that there may be short-, intermediate-, and long-
term non-occupational, non-dietary exposure scenarios. At this time,
the Agency has insufficient information to assess the potential risks
from such exposure.
C. Cumulative Exposure to Substances with Common Mechanisms of Toxicity
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other
[[Page 26964]]
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 propamocarb hydrochloride 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,
propamocarb hydrochloride 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 propamocarb hydrochloride
has a common mechanism of toxicity with other substances.
D. Determination of Safety for U.S. Population
1. Acute risk. The acute dietary MOE for females 13+ years old
(accounts for both maternal and fetal exposure) is 8,333. This MOE
calculation was based on the developmental NOEL of 150 mg/kg/day from
the developmental toxicity study in rabbits. This risk assessment also
assumed 100% crop treated with tolerance level residues on all treated
crops consumed, resulting in a significant over-estimate of dietary
exposure. The large acute dietary MOE calculated for females 13+ years
old provides assurance that there is a reasonable certainty of no harm
for both females 13+ and infants and children resulting from pre-natal
exposure to propamocarb hydrochloride, even if an additional tenfold
safety factor were applied.
2. Short- and intermediate-term risk. Propamocarb hydrochloride is
registered for use on turf and ornamentals and EPA acknowledges that
there may be short-, intermediate-, and long-term non-occupational
exposure scenarios. OPP has identified a toxicity endpoint for short-
and intermediate-term residential risk assessment. However, no
acceptable reliable exposure data to assess these potential risks are
available at this time. Given the time-limited nature of these
requests, the need to make emergency exemption decisions quickly, and
the significant scientific uncertainty at this time about how to
aggregate non-occupational exposure with dietary exposure, the Agency
will make its safety determination for this tolerance based on those
factors which it can reasonably integrate into a risk assessment.
3. Chronic risk. Using the conservative TMRC exposure assumptions
described above, EPA has concluded that aggregate exposure to
propamocarb hydrochloride from food will utilize 3 percent of the RfD
for the U.S. population. EPA generally has no concern for exposures
below 100 percent 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 propamocarb hydrochloride in drinking water from non-
dietary, non-occupational exposure, EPA does not expect the aggregate
exposure to exceed 100% of the RfD. EPA concludes that there is a
reasonable certainty that no harm will result from aggregate exposure
to propamocarb hydrochloride residues.
E. Determination of Safety for Infants and Children
In assessing the potential for additional sensitivity of infants
and children to residues of propamocarb hydrochloride, 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 pesticide exposure during prenatal development
to one or both parents. 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.
Based on current toxicological data requirements, the data base for
propamocarb hydrochloride relative to pre- and post-natal toxicity is
not complete. Although two acceptable prenatal developmental toxicity
studies (in rats and rabbits) have been submitted to the Agency, the
available rat reproductive toxicity study is not adequate. The RfD
Committee considered it to be supplementary and not upgradeable based
on the lack of systemic toxicity at dose levels, which did not achieve
the limit dose, indicating inadequacy of the high dose for reproductive
toxicity. Thus conclusions concerning post-natal sensitivity cannot be
made.
In the developmental toxicity study in rabbits, the developmental
and maternal NOELs were both 150 mg/kg/day. The developmental and
maternal LOELs of 300 mg/kg/day were based on increased post-
implantation loss (developmental) and decreased body weight gain
(maternal). The NOELs and LOELs occurred at the same doses for
developmental and maternal findings; there was no indication of pre-
natal sensitivity for infants and children.
In the developmental toxicity study in rats, the developmental NOEL
was 221 mg/kg/day and was below the maternal NOEL (740 mg/kg/day). The
[[Page 26965]]
developmental LOEL of 740 mg/kg/day was based on increased fetal death,
and an increased incidence of minor skeletal anomalies (incomplete
ossification of some vertebrae and sternebrae). The maternal NOEL was
740 mg/kg/day, based on increased maternal death, spastic gait and
decreased body weight at the LOEL of 2,210 mg/kg/day. These findings
indicate the possibility of increased prenatal sensitivity of fetuses
to in utero exposure to propamocarb.
An additional uncertainty factor of 10x for infants and children is
appropriate for propamocarb hydrochloride, based upon the lack of data
to evaluate postnatal exposure (due to the inadequate reproduction
study) and based upon the increased sensitivity to prenatal exposure
(indicated by the rat developmental study NOELs). EPA has concluded
that the percent of the RfD that will be utilized by chronic dietary
(food) exposure to residues of propamocarb hydrochloride ranges from 2%
for nursing infants (<1 year="" old)="" up="" to="" 8%="" for="" non-nursing="" infants=""><1 year="" old).="" the="" uncertainty="" factor="" will="" not="" raise="" the="" percent="" of="" the="" rfd="" utilized="" above="" the="" level="" of="" concern="" (100%).="" additionally,="" the="" rfd="" calculation="" assumes="" tolerance="" level="" residues="" for="" all="" commodities="" and="" is="" therefore="" an="" over-estimate="" of="" dietary="" risk.="" refinement="" of="" the="" dietary="" risk="" assessment="" by="" using="" anticipated="" residue="" data="" would="" reduce="" dietary="" exposure.="" the="" addition="" of="" potential="" exposure="" from="" propamocarb="" hydrochloride="" residues="" in="" drinking="" water="" is="" not="" expected="" to="" result="" in="" an="" exposure="" which="" would="" exceed="" the="" rfd.="" v.="" other="" considerations="" the="" metabolism="" of="" propamocarb="" hydrochloride="" in="" tomatoes="" is="" adequately="" understood="" for="" the="" purposes="" of="" this="" tolerance.="" a="" codex="" mrl="" of="" 1="" mg/kg="" has="" been="" established="" for="" residues="" of="" propamocarb="" per="" se="" in/="" on="" tomatoes.="" the="" use="" pattern="" used="" for="" determining="" the="" codex="" mrl="" differs="" from="" that="" in="" this="" section="" 18="" exemption="" (maximum="" use="" rate="" overseas="" is="" 3.2="" lbs="" active="" ingredient(ai)/acre="" per="" application,="" the="" maximum="" use="" rate="" in="" the="" united="" states="" is="" 0.9="" lbs="" ai/acre).="" no="" canadian="" or="" mexican="" residue="" limits="" have="" been="" established.="" the="" residue="" of="" concern="" for="" the="" purposes="" of="" these="" tolerances="" is="" propamocarb="" hydrochloride.="" the="" proposed="" enforcement="" method="" designated="" upsr="" 22/91="" (mrid="" no.="" 439840-04)="" submitted="" with="" petition="" 6f4707="" is="" adequate="" to="" support="" the="" proposed="" time-limited="" tolerances.="" the="" method="" has="" been="" adequately="" radiovalidated="" for="" recovery="" of="" parent="" compound.="" the="" method="" is="" available="" to="" anyone="" who="" is="" interested="" in="" pesticide="" residue="" enforcement="" from:="" by="" mail,="" calvin="" furlow,="" 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.="" office="" location="" and="" telephone="" number:="" crystal="" mall="" #2,="" rm="" 1128,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va="" 703-305-="" 5805.="" vi.="" conclusion="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" propamocarb="" hydrochloride="" in="" or="" on="" tomatoes="" at="" 0.5="" parts="" per="" million="" (ppm),="" tomato="" puree="" at="" 1.0="" ppm,="" and="" tomato="" paste="" at="" 3.0="" ppm.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" july="" 15,="" 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="" the="" official="" record="" for="" this="" rulemaking,="" as="" well="" as="" the="" public="" version,="" has="" been="" established="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300489]="" (including="" comments="" and="" data="" submitted="" electronically="" as="" described="" below).="" 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="" official="" rulemaking="" record="" is="" located="" at="" the="" address="" in="" ``addresses''="" at="" the="" beginning="" of="" this="" document.="" electronic="" comments="" can="" 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. Comment and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number [OPP-300489]. Electronic
comments on this proposed rule may be filed online at many Federal
Depository Libraries.
IX. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not ``a significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition,
[[Page 26966]]
this action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993) or
special consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Because FFDCA section 408(l)(6) permits establishment of this
regulation without a notice of proposed rulemaking, the regulatory
flexibility analysis requirements of the Regulatory Flexibility Act, 5
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously
assessed whether establishing tolerances or exemptions from tolerance,
raising tolerance levels, or expanding exemptions adversely impact
small entities and concluded, as a generic matter, that there is no
adverse impact. (46 FR 24950) (May 4, 1981).
Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110
Stat. 847), EPA 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 the rule in today's 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: May 8, 1997.
Peter Caulkins,
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 180.499 is amended as follows:
i. By redesignating the existing text as paragraph (b), revising
the introductory text of newly designated paragraph (b), in the third
column to the table by changing ``March 15, 1999'' to ``3/15/99'', and
alphabetically adding entries for tomatoes; tomato paste and tomato
puree.
ii. By correctly alphabetizing the entry for ``milk'' in the table.
iii. By adding and reserving paragraphs (a), (c), and (d).
Sec. 180.499 Propamocarb hydrochloride; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fungicide propamocarb hydrochloride in
connection with use of the pesticide under section 18 emergency
exemptions granted by EPA. The tolerances will expire and are revoked
on the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * *
Tomatoes........................ 0.5 May 15, 1999
Tomato, puree................... 1.0 May 15, 1999
Tomato, paste................... 3.0 May 15, 1999
------------------------------------------------------------------------
(c) Tolerance with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-12908 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F
