[Federal Register Volume 61, Number 220 (Wednesday, November 13, 1996)]
[Rules and Regulations]
[Pages 58135-58140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29020]
[[Page 58135]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300441; FRL-5572-9]
RIN 2070-AB78
Propiconazole; 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 the fungicide propiconazole in or on the raw
agricultural commodity sorghum in connection with EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of propiconazole on
sorghum in Texas. This regulation establishes maximum permissible
levels for residues of propiconazole in this food 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 automatically without further action by EPA on October 31,
1998.
DATES: This regulation becomes effective November 13, 1996. This
regulation expires and is revoked automatically without further action
by EPA on October 31, 1998. Objections and requests for hearings must
be received by EPA on or before January 13, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300441], 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-300441], 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: 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 number
[OPP-300441]. 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: Stephen Schaible,
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 22202, (703) 308-8337, e-mail:
schaible.stephen@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of the fungicide propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-
propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole, in or on grain
sorghum at 0.1 part per million (ppm) and grain sorghum stover at 1.5
ppm. These tolerances will expire and be revoked automatically without
further action by EPA on October 31, 1998.
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.
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 408(b)(2)(D) specifies factors EPA is to
consider in establishing a tolerance. Section 408(b)(3) requires EPA to
determine that there is a practical method for detecting and measuring
levels of the pesticide chemical residue in or on food and that the
tolerance be set at a level at or above the limit of detection of the
designated method. Section 408(b)(4) requires EPA to determine whether
a maximum residue level has been established for the pesticide chemical
by the Codex Alimentarius Commission. If so, and EPA does not propose
to adopt that level, EPA must publish for public comment a notice
explaining the reasons for departing from the Codex level. Section
408(c) governs EPA's establishment of exemptions from the requirement
for a tolerance using the same safety standard as section 408(B)(2)(A)
and incorporating the provisions of section 408(b)(2)(C) and (D).
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. Generally, these regulations
allow a State or Federal agency to apply for an exemption to allow use
of a pesticide for which that pesticide is not registered to alleviate
an emergency condition. The regulations set forth information
requirements, procedures, and standards for EPA's approval or denial of
such exemptions.
Prior to FQPA, when EPA granted an emergency exemption under
section 18 in connection with use of a pesticide that could result in
residues of the pesticide chemical in or on food, EPA did not establish
a tolerance or exemption from the requirement for a tolerance under
FFDCA. Rather, EPA advised the Food and Drug Administration (FDA) of
the emergency exemption and of the level of residues that EPA concluded
would be present in or on affected foods as a result of the
[[Page 58136]]
emergency use. However, new section 408(l)(6) 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(e) gives EPA general authority to establish tolerances
and exemptions from the requirement for a tolerance through notice and
comment rulemaking procedures upon EPA's initiative. 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. The other procedures set
out in section 408(e) and (g) are applicable to these tolerances and
exemptions. Tolerances and exemptions issued under section 408(l)(6)
must be consistent with the safety standards in section 408(b)(2) and
(c)(2), respectively, that are applicable to all tolerances and
exemptions under section 408, and with FIFRA section 18. Section
408(l)(6) specifies that such tolerances and exemptions must have an
expiration date but does not specify how EPA is to set such an
expiration date.
In light of FQPA, EPA is engaged in an intensive process, including
consultation with registrants, States, and other interested
stakeholders, to make decisions on the new policies and procedures that
will be appropriate as a result of enactment of FQPA. This process will
generally delay the review of food use applications, particularly those
involving exposure to children. However, recognizing the importance of
FIFRA section 18 emergency exemptions and their time sensitive nature,
EPA will continue to process section 18 applications for food uses
which clearly are emergencies and which clearly are consistent with the
new FFDCA section 408 safety standard and with FIFRA section 18. EPA
will issue a notice in the Federal Register soon summarizing the
requirements of FQPA, indicating how EPA intends to meet those
requirements, and describing actions necessary to assure that EPA
complies with the law. EPA intends to promulgate the procedural rule
required under section 408(l)(6) by August 3, 1997, but EPA also
intends to continue to grant appropriate section 18 emergency
exemptions and issue the associated tolerances and exemptions in the
interim pending promulgation of that rule. EPA also intends to issue
interim guidance to States and others on how EPA will implement section
18 of FIFRA and section 408(l)(6) in the near future.
EPA intends to address how it will provide an expiration date for
section 408(l)(6) tolerances and exemptions in the general procedural
rule to be promulgated by August 3, 1997. In the interim, EPA has
decided to proceed as follows. Section 408(l)(5) specifies that, if a
tolerance or exemption from the requirement for a tolerance for a
pesticide chemical residue in or on a food has been revoked under
section 408, food containing the residue is not unsafe (and thus
subject to action by FDA as ``adulterated'') if ``the residue is
present as the result of an application or use of a pesticide at a time
and in a manner that was lawful'' under FIFRA and ``the residue does
not exceed a level that was authorized at the time of that application
or use to be present on the food under a tolerance. . . .'' Taking
section 408(l)(5) and (6) together, EPA has concluded that the best way
to effect an ``expiration date'' during this interim period for a
tolerance or exemption established in connection with EPA's grant of a
FIFRA section 18 emergency exemption is to specify that the tolerance
or exemption will expire and be revoked automatically, without further
action by EPA, as of a specified date. That date will generally be
approximately 1 year from the date of issuance of the emergency
exemption. Under section 408(l)(5), food that contains residues of the
pesticide chemical as a result of lawful use under the terms of the
section 18 emergency exemption, and at levels that are authorized at
the time of that application or use under the tolerance or exemption
that was established under section 408(l)(6) in connection with the
section 18 action, would remain lawful after the tolerance or exemption
is automatically revoked. EPA believes that handling the section 18-
related tolerances and exemptions in this manner will allow EPA to
respond promptly to emergency conditions during this interim period and
will ensure that food containing pesticide residues as a result of use
under an emergency exemption will not be considered ``adulterated.''
In deciding to continue to act on section 18 emergency exemptions
and to issue the associated tolerances and exemptions early in the
process of FQPA implementation, EPA recognizes that it will be
necessary to make decisions about the new FFDCA section 408, including
the new safety standard. 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 Exemption for Propiconazole on Sorghum and FFDCA
Tolerances
On September 4, 1996, the Texas Department of Agriculture availed
of itself the authority to declare the existence of a crisis situation
within the state, thereby authorizing use under FIFRA section 18 of
propiconazole on sorghum for control of northern leaf blight. Texas
stated that unusually wet weather conditions this summer have resulted
in an increase of this disease above normally occurring levels. It is
estimated that as much as 90% of all the world's grain sorghum grown
for seed production is grown in the requested site of this section 18
application. Due to the high market prices for grain sorghum, acreage
has increased this last year and reserves of certified seed for
planting have been exhausted. If northern leaf blight significantly
reduces yield and seed quality of the sorghum grown for seed in this
area, there may not be enough available seed for planting in the 1997
season. This could result in an economic disaster affecting grain
sorghum producers everywhere.
As part of its assessment of this crisis declaration, EPA assessed
the potential risks presented by residues of propiconazole in or on
sorghum. In doing so, EPA considered the new safety standard in FFDCA
section 408(b)(2), and EPA decided to grant the section 18
[[Page 58137]]
exemptions only after concluding 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 propiconazole
will permit the marketing of sorghum treated in accordance with the
provisions of the section 18 emergency exemptions. Consistent with the
need to move quickly on the emergency exemptions 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 automatically without further action by EPA on October
31, 1998, under FFDCA section 408(l)(5), residues of propiconazole not
in excess of the amounts specified in the tolerances remaining in or on
sorghum 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 indicate that the residues are
not safe.
EPA has not made any decisions about whether propiconazole meets
the requirements for registration under FIFRA section 3 for use on
sorghum, or whether a permanent tolerance for propiconazole for sorghum
would be appropriate. This action by EPA does not serve as a basis for
registration of propiconazole by a State for special local needs under
FIFRA section 24(c). Nor does this action serve as the basis for any
State other than Texas 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 propiconazole, 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 by EPA to pose a reasonable certainty of
no harm.
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 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. Propiconazole is already registered by EPA for use on
apricots, bananas, barley, celery, corn, grass, nectarines, peaches,
peanuts, pecans, pineapple, plums, rice, rye, wheat, and wild rice (see
40 CFR 180.434 for specific tolerances). Tolerances exist for meat,
milk, poultry and eggs to address the potential for secondary residues
resulting from the use of treated commodities as feed. Secondary
residues in animal commodities from this section 18 use, resulting from
the use of grain sorghum stover as feed, are not expected to exceed
existing tolerances. At this time, EPA is not in possession of a
registration application for propiconazole on sorghum. However, based
on information submitted to the Agency, EPA has sufficient data to
assess the hazards of propiconazole and to make a determination on
aggregate exposure, consistent with section 408(b)(2), for a time-
limited tolerance for residues of propiconazole on grain sorghum at 0.1
ppm and grain sorghum stover at 1.5 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 has established the RfD for propiconazole at 0.013 milligrams(mg)/
kilogram(kg)/day. This RfD is based on a 1 year dog
[[Page 58138]]
feeding study with a NOEL of 1.25 mg/kg/day and an uncertainty factor
of 100. The uncertainty factor of 100 was applied to account for inter-
species extrapolation (10) and intra-species variability (10). Mild
irritation of the gastric mucosa was the effect observed at the lowest
effect level (LEL) of 6.2 mg/kg/day.
2. Acute toxicity. Agency toxicologists have recommended that the
developmental NOEL of 30 mg/kg/day from the rat developmental toxicity
study be used for acute dietary risk calculations. The LEL of 90 mg/kg/
day is based on the increased incidence of unossified sternebrae,
rudimentary ribs, and shortened or absent renal papillae. The
population of concern for this risk assessment is females 13+ years
old.
3. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), EPA has
classified propiconazole as Group ``C'' for carcinogenicity (possible
human carcinogen). The Cancer Peer Review Committee recommended the RfD
approach for quantitation of human risk. Therefore, the RfD is deemed
protective of all chronic human health effects, including cancer.
B. Aggregate Exposure
Tolerances have been established (40 CFR 180.434) for the residues
of propiconazole and its metabolites determined as 2,4-dichlorobenzoic
acid (expressed as parent compound) in or on various raw agricultural
commodities ranging from 0.05 ppm in milk to 60.0 ppm in grass seed
screenings.
1. Chronic exposure. For the purpose of assessing chronic dietary
exposure from propiconazole, EPA assumed anticipated residue and
percent of crop treated refinements to estimate the Anticipated Residue
Contribution (ARC) from the proposed and existing food uses of
propiconazole. The use of anticipated residues and/or percent of crop
treated data for several of the existing food uses in this analysis
results in a more refined estimate of exposure than the TMRC.
Other potential sources of exposure of the general population to
residues of pesticides are residues in drinking water and exposure from
non-occupational sources. Review of terrestrial field dissipation data
by the Environmental Fate and Effects Division indicates that
propiconazole is persistent and leaches into groundwater (Pesticides in
Groundwater Database (EPA 734-12-92-001, September 1992). There is no
established Maximum Concentration Level for residues of propiconazole
in drinking water. No drinking water health advisory levels have been
established for propiconazole.
The Agency does not have available data to perform a quantitative
drinking water risk assessment for propiconazole at this time. Previous
experience with more persistent and mobile pesticides for which there
have been available data to perform quantitative risk assessments have
demonstrated that drinking water exposure is typically a small
percentage of the total exposure when compared to the total dietary
exposure. This observation holds even for pesticides detected in wells
and drinking water at levels nearing or exceeding established MCLs.
Based on this experience and the OPP's best scientific judgement, EPA
concludes that it is not likely that the potential exposure from
residues of propiconazole in drinking water added to the current
dietary exposure will result in an exposure which exceeds the RfD.
Propiconazole is currently registered for residential use as a
preservative treatment for wood and for lawn and ornamental uses. At
this time, the Agency does not have reliable data which would allow
quantitative incorporation of risk from these uses into a human health
risk assessment.
Of residential uses, EPA believes that the lawn use poses the
greatest potential for chronic exposure. According to lawn care usage
data, there is no reported usage by homeowners. Two sources report
usage by lawn care operators and landscapers. Based on acres treated
information, between 3,850 to 6,725 households are estimated to be
potentially treated with propiconazole. This would represent between
0.004% to 0.007% of all households nationally. This calculation does
not include propiconazole use on golf courses.
2. Acute exposure. In assessing acute dietary exposure for
propiconazole, EPA assumed tolerance level residues, 100 percent crop
treated, and individual, single-day consumption information for
``females, 13+ years old'', the population of concern.
EPA has not estimated non-occupational exposures other than dietary
for propiconazole. Though the Agency acknowledges that there may be
short-term residential or drinking water exposure scenarios, no
acceptable reliable data to assess these potential risks are available
at this time. Propiconazole is registered for residential uses. While
dietary and residential scenarios could possibly occur in a single day,
propiconazole would rarely be present on both the food eaten and the
lawn on that single day. Even assuming this were the case, it is yet
more unlikely that residues would be present at tolerance level on all
food eaten that day for which propiconazole tolerances exist, as is
assumed in the acute dietary risk analysis, and on the lawn that same
day. Because the acute dietary exposure estimate assumes tolerance
level residues and 100% crop treated for all crops evaluated it is a
large over-estimate of exposure and it is considered to be protective
of any acute exposure scenario.
At this time, the Agency has not made a determination that
propiconazole and other substances that may have a common mode of
toxicity would have cumulative effects. For purposes of this tolerance
only, the Agency is considering only the potential risks of
propiconazole in its aggregate exposure.
C. Determination of Safety for U.S. Population
1. Chronic risk. Based on the completeness and reliability of the
toxicity data, EPA has concluded that dietary exposure to propiconazole
will utilize 6% of the RfD for the U.S. population. EPA generally has
no concern for exposures below 100 percent of the RfD. Acceptable,
reliable data are not available to quantitatively assess risk from
drinking water. However, EPA concludes that there is a reasonable
certainty that no harm to the U.S. population will result from
aggregate exposure to propiconazole residues.
2. Acute risk. For the population subgroup of concern, females 13+
years old, the calculated Margin Of Exposure (MOE) value is 3000. This
MOE does not exceed the Agency's level of concern for acute dietary
exposure.
D. Determination of Safety for Infants and Children
In assessing the potential for additional sensitivity of infants
and children to residues of propiconazole, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-year
reproductive toxicity study in rats. The developmental toxicity studies
are designed to evaluate adverse effects on the developing organism
resulting from pesticide exposure during prenatal development.
Reproductive toxicity studies provide information relating to effects
from exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
Based on current toxicological data requirements, the data base for
propiconazole relative to pre- and post-natal toxicity is complete. EPA
notes developmental toxicity NOELs of 30 mg/kg/day in rats and 400 mg/
kg/day
[[Page 58139]]
(HDT) in rabbits. Developmental toxicity was observed in rats at 90 mg/
kg/day; these effects occurred in the presence of maternal toxicity. In
rabbits, no developmental delays or alterations were noted; increased
abortions were observed at the maternally toxic dose of 400 mg/kg/day.
The developmental NOELs are more than 24- and 320-fold higher in the
rats and rabbits, respectively, than the NOEL of 1.25 mg/kg/day from
the 1-year feeding study in dogs, which is the basis of the RfD.
In the two-generation reproductive toxicity study in the rat, the
reproductive/developmental toxicity NOEL of 25 mg/kg/day was greater
than the parental (systemic) toxicity NOEL (<5 mg/kg/day;="" ldt).="" epa="" notes="" that="" the="" noel="" of="" 25="" mg/kg/day,="" for="" reproductive="" (pup)="" toxicity,="" was="" 20-fold="" higher="" than="" the="" noel="" of="" 1.25="" mg/kg/day="" from="" the="" 1-year="" feeding="" study="" in="" dogs,="" which="" is="" the="" basis="" of="" the="" rfd.="" the="" reproductive="" (pup)="" lel="" of="" 125="" mg/kg/day="" was="" based="" on="" decreased="" offspring="" survival="" of="" second="" generation="" (f2)="" pups,="" and="" on="" decreased="" body="" weight="" throughout="" lactation,="" and="" an="" increase="" in="" the="" incidence="" of="" hepatic="" cellular="" swelling="" for="" both="" generations="" of="" offspring="" (f1="" and="" f2="" pups).="" because="" these="" reproductive="" effects="" occurred="" in="" the="" presence="" of="" parental="" (systemic)="" toxicity,="" these="" data="" do="" not="" suggest="" an="" increased="" post-natal="" sensitivity="" to="" children="" and="" infants="" (that="" infants="" and="" children="" might="" be="" more="" sensitive="" than="" adults)="" to="" propiconazole="" exposure.="" 1.="" chronic="" risk.="" based="" on="" arc="" exposure="" estimates,="" epa="" has="" concluded="" that="" the="" percentage="" of="" the="" rfd="" that="" will="" be="" utilized="" by="" dietary="" exposure="" to="" residues="" of="" propiconazole="" ranges="" from="" 8%="" for="" children="" 7-12="" years="" old,="" up="" to="" 20%="" for="" non-nursing="" infants.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" safety="" factor="" 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="" concludes="" that="" a="" different="" margin="" of="" safety="" is="" appropriate.="" based="" on="" current="" toxicological="" data="" requirements,="" the="" data="" base="" for="" propiconazole="" relative="" to="" pre-="" and="" post-natal="" toxicity="" is="" complete.="" as="" mentioned="" above,="" because="" reproductive="" effects="" occurred="" in="" the="" presence="" of="" parental="" (systemic)="" toxicity,="" these="" data="" do="" not="" suggest="" an="" increased="" post-natal="" sensitivity="" of="" children="" and="" infants="" to="" propiconazole="" exposure,="" and="" therefore="" an="" additional="" safety="" factor="" was="" not="" applied.="" the="" arc="" value="" for="" the="" most="" highly="" exposed="" infant="" and="" children="" subgroup="" (non-nursing="" infants=""><1 year="" old)="" occupies="" 20="" percent="" of="" the="" rfd.="" this="" calculation="" assumes="" anticipated="" residue="" and="" percent="" of="" crop="" treated="" refinements="" for="" some="" commodities.="" acceptable,="" reliable="" data="" are="" not="" available="" to="" quantitatively="" assess="" risk="" to="" this="" subgroup="" from="" drinking="" water.="" however,="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" propiconazole="" residues.="" 2.="" acute="" risk.="" at="" present,="" the="" acute="" dietary="" moe="" for="" females="" 13+="" years="" old="" is="" 3000.="" this="" moe="" calculation="" was="" based="" on="" the="" developmental="" noel="" of="" 30="" mg/kg/day="" from="" the="" rat="" study.="" this="" risk="" assessment="" 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+="" years="" and="" the="" pre-natal="" development="" of="" infants.="" v.="" other="" considerations="" the="" nature="" of="" the="" residue="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" this="" tolerance.="" there="" are="" no="" codex="" maximum="" residue="" levels="" established="" for="" residues="" of="" propiconazole="" on="" sorghum.="" adequate="" enforcement="" methodology,="" gc/ecd,="" is="" available="" to="" enforce="" the="" tolerance="" expression.="" analytical="" methodologies="" for="" the="" determination="" of="" propiconazole="" and="" its="" metabolites="" in="" plant="" and="" animal="" commodities="" (ciba-geigy="" analytical="" methods="" ag-454="" and="" ag-517,="" respectively)="" have="" been="" successfully="" validated="" by="" the="" agency's="" analytical="" chemistry="" laboratory="" and="" have="" been="" approved="" for="" publication="" in="" pam="" ii="" for="" enforcement="" purposes.="" these="" methods="" have="" not="" as="" of="" this="" time="" appeared="" in="" pam="" ii,="" but="" a="" copy="" of="" the="" methods="" may="" be="" obtained="" from="" the="" public="" response="" and="" program="" resources="" branch="" at="" the="" location="" listed="" under="" the="" addresses="" unit.="" vi.="" conclusion="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" propiconazole="" in="" grain="" sorghum="" at="" 0.1="" ppm="" and="" grain="" sorghum="" stover="" at="" 1.5="" ppm.="" these="" tolerances="" will="" expire="" and="" be="" automatically="" revoked="" without="" further="" action="" by="" epa="" on="" october="" 31,="" 1998.="" 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="" january="" 13,="" 1997="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" (including="" the="" automatic="" 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="" 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="" 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-300441].="" a="" public="" version="" of="" this="" record,="" which="" does="" not="" include="" any="" information="" [[page="" 58140]]="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8="" a.m.="" to="" 4:30="" 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),="" the="" agency="" must="" determine="" whether="" the="" regulatory="" action="" is="" ``significant''="" and="" therefore="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget="" (omb)="" and="" the="" requirements="" of="" the="" executive="" order.="" under="" section="" 3(f),="" the="" order="" defines="" ``a="" significant="" regulatory="" action''="" as="" an="" action="" that="" is="" likely="" to="" result="" in="" a="" rule:="" (1)="" having="" an="" annual="" effect="" on="" the="" economy="" of="" $100="" million="" or="" more,="" or="" adversely="" and="" materially="" affecting="" a="" sector="" of="" the="" economy,="" productivity,="" competition,="" jobs,="" the="" environment,="" public="" health="" or="" safety,="" or="" state,="" local="" or="" tribal="" governments="" or="" communities="" (also="" referred="" to="" as="" ``economically="" significant'');="" (2)="" creating="" serious="" inconsistency="" or="" otherwise="" interfering="" with="" an="" action="" taken="" or="" planned="" by="" another="" agency;="" (3)="" materially="" altering="" the="" budgetary="" impacts="" of="" entitlement,="" grants,="" user="" fees,="" or="" loan="" programs="" or="" the="" rights="" and="" obligations="" thereof;="" or="" (4)="" raising="" novel="" legal="" or="" policy="" issues="" arising="" out="" of="" legal="" mandates,="" the="" president's="" priorities,="" or="" the="" principles="" set="" forth="" in="" this="" executive="" order.="" pursuant="" to="" the="" terms="" of="" this="" executive="" order,="" epa="" has="" determined="" that="" this="" rule="" is="" not="" ``significant''="" and="" is="" therefore="" not="" subject="" to="" omb="" review.="" 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.="" 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="" the="" 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:="" october="" 31,="" 1996.="" daniel="" m.="" barolo,="" director,="" 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.="" 180.434,="" by="" adding="" a="" new="" paragraph="" (d)="" to="" read="" as="" follows:="" sec.="" 180.434="" 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-="" yl]methyl]-1h-1,2,4-triazole;="" tolerances="" for="" residues.="" *="" *="" *="" *="" *="" (d)="" time-limited="" tolerances="" are="" established="" for="" residues="" of="" the="" fungicide="" propiconazole,="" 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-="" dioxolan-2-yl]methyl]-1h-1,2,4-triazole,="" in="" connection="" with="" use="" of="" the="" pesticide="" under="" section="" 18="" emergency="" exemptions="" granted="" by="" epa.="" the="" tolerances="" are="" specified="" in="" the="" following="" table.="" each="" tolerance="" expires="" and="" is="" automatically="" revoked="" on="" the="" date="" specified="" in="" the="" table="" without="" further="" action="" by="" epa.="" ------------------------------------------------------------------------="" expiration/="" commodity="" parts="" per="" million="" revocation="" date="" ------------------------------------------------------------------------="" grain="" sorghum="" 0.1="" october="" 31,="" 1998="" grain="" sorghum="" stover="" 1.5="" october="" 31,="" 1998="" ------------------------------------------------------------------------="" [fr="" doc.="" 96-29020="" filed="" 11-12-96;="" 8:45="" am]="" billing="" code="" 6560-50-f="">