[Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
[Rules and Regulations]
[Pages 15615-15620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8387]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300464; FRL-5597-2]
RIN 2070-AC78
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 raw
agricultural commodities potatoes, milk; and meat, meat by-products,
and fat of cattle, goat, horse, sheep, and hogs 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 potatoes in the states of California, and
Texas. This regulation establishes maximum permissible levels for
residues of propamocarb hydrochloride in these foods 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 be revoked by EPA on March 15, 1999.
DATES: This regulation becomes effective April 2, 1997. Objections and
requests for hearings must be received by EPA on or before June 2,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300464], 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-300464], must also be submitted to:
Public Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm.
1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA. A copy of
objections and hearing requests filed with the Hearing Clerk may also
be submitted electronically by sending electronic mail (e-mail) to:
[email protected]. Copies of objections and hearing requests
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Copies of objections and hearing
requests will also be accepted on disks in WordPerfect 5.1 file format
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300464]. 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:
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
Arlington, VA 22202. (703) 308-8326, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of propamocarb hydrochloride on potatoes at 0.5 parts per
million (ppm) and in milk; and meat, meat by-products, and fat of
cattle, goat, horse, sheep, and hogs at 0.1
[[Page 15616]]
ppm. These tolerances will expire on March 15, 1999.
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) 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, 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. Section 408(l)(6)
also requires EPA to promulgate regulations by August 3, 1997,
governing the establishment of tolerances and exemptions under section
408(l)(6) and requires that the regulations be consistent with section
408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Propamocarb Hydrochloride on Potatoes
and FFDCA Tolerances
EPA has authorized use under FIFRA section 18 of propamocarb
hydrochloride on potatoes for control of late blight. Recent failures
to control late blight in potatoes as well as tomatoes 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 U.S. were previously
controlled by treatment with metalaxyl. Presently, there are no
fungicides registered in the U.S. that will provide adequate control of
the immigrant strains of late blight. After having reviewed their
submission, EPA concurs that an emergency condition exists.
As part of its assessment of these specific exemptions, EPA
assessed the potential risks presented by residues of propamocarb
hydrochloride on potatoes and milk; and meat, meat by-products, and fat
of cattle, goat, horse, sheep, and hogs. 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 for residues of propamocarb hydrochloride
will permit the marketing of potatoes treated in accordance with the
provisions of the section 18 emergency exemptions and the marketing of
milk; and meat, meat by-products, and fat of cattle, goat, horse,
sheep, and hogs with secondary residues resulting from the feeding of
the feedstuffs of treated potatoes. 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 these tolerances will expire and be revoked by EPA
on March 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 potatoes and milk; and meat, meat
by-products, and fat of cattle, goat, horse, sheep, and hogs after that
date will not be unlawful, provided the pesticide is applied during the
term of, and in accordance with all the conditions of, the emergency
exemptions. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicates that the residues are not safe.
EPA has not made any decisions about whether propamocarb
hydrochloride meets the requirements for registration under FIFRA
section 3 for use on potatoes or whether a permanent tolerance for
propamocarb hydrochloride for potatoes and milk; and meat, meat by-
products, and fat of cattle, goat, horse, sheep, and hogs would be
appropriate. This action by EPA does not serve as a basis for
registration of propamocarb hydrochloride by a State for special local
needs under FIFRA section 24(c). Nor does this action serve as the
basis for any States other than California, Texas and States which are
subsequently granted specific exemptions for this use to use this
product 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
[[Page 15617]]
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% or less of the RfD) is
generally considered acceptable by EPA.
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 margin of exposure 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, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. 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% 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
these actions. Propamocarb hydrochloride is registered by EPA for turf
and ornamental use. EPA believes it has sufficient data to assess the
hazards of propamocarb hydrochloride and to make a determination on
aggregate exposure, consistent with section 408(b)(2), for the time-
limited tolerances for residues of propamocarb hydrochloride on
potatoes at 0.5 parts per million (ppm) and in milk; and meat, meat by-
products, and fat of cattle, goat, horse, sheep, and hogs at 0.1 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing these tolerances follows.
A. Toxicological Profile
1. Chronic toxicity. Based on the available chronic toxicity data,
EPA's Office of Pesticide Programs (OPP) has established the RfD for
propamocarb hydrochloride at 0.11 milligrams (mg)/kilograms (kg)/day.
The RfD was established based on a threshold LOEL (lowest observable
effect level) of 33.31 mg/kg/day in males and 33.27 mg/kg in females in
a 11-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 inter-species
extrapolation and intra-species variability. An additional UF of 3 was
used to account for the lack of a NOEL.
2. Acute toxicity. Agency toxicologists have recommended that the
developmental NOEL of 150 mg/kg/day from the rabbit developmental
toxicity study be used for acute dietary risk calculations. The
developmental 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.
3. Short-term non-dietary inhalation and dermal 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 6-18. The developmental NOEL was 150
mg/kg/day. The developmental LOEL of 300 mg/kg/day was based on
increased post-implantation loss.
4. Carcinogenicity. 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
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.
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.
These conservative assumptions result in overestimation of human
dietary exposures.
In examining aggregate exposure, FQPA directs EPA to consider
available
[[Page 15618]]
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).
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.
Propamocarb hydrochloride is registered for uses, such as lawn and
ornamental, 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. However, available data for propamocarb hydrochloride
indicate no evidence of toxicity by the dermal or inhalation routes.
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 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 subtances.
C. Safety Determinations For U.S. Population
Taking into account the completeness and reliability of the
toxicity data, EPA has concluded that dietary exposure to propamocarb
hydrochloride in food from published tolerances will utilize 2% of the
RfD for the U.S. population. A dietary (food only) MOE of greater than
118 would not be of Agency concern. A MOE of 30,000 was calculated.
EPA does not believe exposure to propamocarb hydrochloride in
drinking water or from residential uses would raise the percent of RfD
utilized or lower the MOE, to such extent that there was not an
adequate margin of exposure. 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
tolerance 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 tolerance is granted. An appropriate bounding figure for
residential exposure is expected to be lower than for drinking water.
Therefore, EPA concludes that there is a reasonable certainty that no
harm will result from aggregate exposure to propamocarb hydrochloride
residues.
D. Determination of Safety for Infants and Children.
FFDCA section 408 provides that EPA shall apply an additional ten-
fold
[[Page 15619]]
margin of exposure (safety) for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the data base unless EPA determines that a different
margin of exposure (safety) will be safe for infants and children.
Margins of exposure (safety) are often referred to as uncertainty
(safety) factors. EPA believes that reliable data support using the
standard margin of exposure (usually 100x for combined inter- and
intra-species variability)) and not the additional ten-fold margin of
exposure 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 margin of exposure. Based on
current toxicological data requirements, the data base for propamocarb
hydrochloride relative to pre- and post-natal toxicity is not complete.
The pre- and post-natal toxicology data base for propamocarb is not
complete with respect to current toxicological data requirements.
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
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 would be deemed appropriate for
propamocarb, 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). However, considering the large dietary MOE calculated for
females 13+ years (MOE = 30,000), even if an additional ten-fold
uncertainty factor were applied, aggregate acute risk estimates would
not exceed the margin of exposure. Therefore, EPA concludes that this
tolerance will pose reasonable certainty of no harm to infants and
children.
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 7%
for non-nursing infants (<1 year old). However, this 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 potatoes is
adequately understood for the purposes of this tolerance. There are no
Codex maximum residue levels established for residues of propamocarb
hydrochloride. The residue of concern, for the purposes of this
tolerance, 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; however, an independent laboratory validation has
not been submitted. Further the method has not undergone Agency method
validation. The method is available to anyone who is interested in
pesticide residue enforcement from: By mail, Calvin Furlow, Public
Response and Program Resources Branch, Field Operations 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 22202, 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 potatoes at 0.5 parts per million (ppm) and in
milk; and meat, meat by-products, and fat of cattle, goat, horse,
sheep, and hogs at 0.1 ppm. These tolerances will expire and be revoked
by EPA on March 15, 1999.
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 June 2, 1997, file written objections to any
aspect of this regulation (including the revocation provision) 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
[[Page 15620]]
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
A record has been established for this rulemaking under docket
number [OPP-300464]. A public version of this record, which does not
include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing requests, 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. The official rulemaking
record is the paper record maintained at the address in ``ADDRESSES''
at the beginning of this document.
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.
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),
entitled Enhancing the Intergovernmental Partnership, 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 tolerances,
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 Administrative Procedure Act
(APA) as amended by 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 this
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 17, 1997.
Stephen L. Johnson,
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. By adding Sec. 180.499 to read as follows:
Sec. 180.499 Propamocarb hydrochloride, tolerances for residues.
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 are specified in the following table. The tolerances expire
and will be revoked on the date specified in the table by EPA.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Potatoes 0.5 March 15, 1999
Cattle, fat 0.1 March 15, 1999
Cattle, meat 0.1 March 15, 1999
Cattle, mbyp (except kidney and 0.1 March 15, 1999
liver)
Goats, fat 0.1 March 15, 1999
Goats, meat 0.1 March 15, 1999
Goats, mbyp (except kidney and 0.1 March 15, 1999
liver)
Hogs, fat 0.1 March 15, 1999
Hogs, meat 0.1 March 15, 1999
Hogs, mbyp (except kidney and 0.1 March 15, 1999
liver)
Horse, fat 0.1 March 15, 1999
Horse, meat 0.1 March 15, 1999
Horse, mbyp (except kidney and 0.1 March 15, 1999
liver)
Sheep, fat 0.1 March 15, 1999
Sheep, meat 0.1 March 15, 1999
Sheep, mbyp (except kidney and 0.1 March 15, 1999
liver)
Milk 0.1 March 15, 1999
------------------------------------------------------------------------
[FR Doc. 97-8387 Filed 4-1-97; 8:45 am]
BILLING CODE 6560-50-F