[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Rules and Regulations]
[Pages 33563-33569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16215]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[OPP-300496; FRL-5720-4]
RIN 2070-AB78
Bentazon; Pesticide Tolerance for Emergency Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of the herbicide bentazon and its metabolite(s) in or on the
raw agricultural commodity succulent peas in connection with EPA's
granting an emergency exemption under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on succulent peas in Minnesota and Wisconsin. The tolerance
will expire and is revoked on June 30, 1998.
DATES: This regulation becomes effective June 20, 1997. Objections and
requests for hearings must be received by EPA on or before August 19,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300496], 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-300496], must 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 number
[OPP-300496]. 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: Virginia Dietrich,
Registration Division (7505W), Office of Pesticide Programs,
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 Hwy., Arlington, VA (703) 308-
8347, e-mail: dietrich.virginia@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 a tolerance for
residues of the herbicide bentazon and its 6- and 8-hydroxy metabolites
in or on succulent peas at 3 part per million (ppm). This tolerance
will expire and is revoked on June 30, 1998. After June 30, 1998, EPA
will publish a document in the Federal Register to remove the revoked
tolerance from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the 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 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
[[Page 33564]]
providing notice or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Bentazon on Succulent Peas and FFDCA
Tolerances
In February and March of 1997, the Departments of Agriculture from
Minnesota and Wisconsin each applied for emergency exemptions for the
use of bentazon on succulent peas. Bentazon is currently registered for
use on succulent peas for the control of Canada thistle. However, to
effectively control Canada thistle with bentazon, two applications are
needed. The current 30-day preharvest interval (PHI) does not allow for
a second application of bentazon. If Canada thistle is not adequately
controlled, its buds can be harvested along with the peas because they
are similar in size and shape. Growers face docking or rejection of
their crop if contaminated with Canada thistle buds. This could result
in significant economic loss. Minnesota and Wisconsin therefore have
requested an exemption from the 30-day PHI currently required for the
use of bentazon in succulent peas to control Canada thistle; requesting
a 10-day PHI instead. This exemption was granted on May 9, 1997. They
also requested that a time-limited tolerance be established that would
accommodate residues greater than those allowed under the current
tolerance for succulent peas.
EPA has authorized the use of bentazon on succulent peas for
control of Canada thistle under FIFRA section 18. After having reviewed
the submission, EPA concurs that emergency conditions exist for these
states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of bentazon in or on
succulent peas. In doing so, EPA considered the new safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance
under FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. This tolerance will permit the
marketing of succulent peas treated in accordance with the provisions
of the section 18 emergency exemption. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment under section 408(e), as provided in section
408(l)(6). Although this tolerance will expire and is revoked on June
30, 1998, under FFDCA section 408(l)(5), residues of the pesticide not
in excess of the amounts specified in the tolerance remaining in or on
succulent peas after that date will not be unlawful, provided the
pesticide is applied in a manner that is lawful under FIFRA. EPA will
take action to revoke this tolerance earlier if any experience with,
scientific data on, or other relevant information on this pesticide
indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether bentazon meets
EPA's registration requirements for use on succulent peas or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of bentazon by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for any State other than Minnesota and Wisconsin to use this pesticide
on this crop under section 18 of FIFRA without following all provisions
of section 18 as identified in 40 CFR part 166. For additional
information regarding the emergency exemption for bentazon, 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 hundreddfold 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 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, 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
[[Page 33565]]
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 bentazon are
discussed below.
1. Acute toxicity. For acute dietary risk assessment, the Agency
selected the NOEL of 100 milligrams per kilogram per day (mg/kg/day),
based on developmental effects of increased post-implantation loss and
decreased fetal body weight at the lowest effect level (LEL) of 250 mg/
kg/day, from the developmental toxicity study in rats. Since there were
no maternal findings, but there were developmental findings, at the
highest dose tested of 250 mg/kg/day, an MOE of at least 300 is
considered appropriate for females 13+ years of age exposed to dietary
residues of bentazon.
2. Chronic toxicity. An RfD of 0.03 mg/kg/day was established based
on the 1-year dog feeding study with a NOEL of 3.2 mg/kg/day and an
uncertainty factor of 100 based on body weight loss and anemia at the
LEL of 13.1 mg/kg/day. Due to the extra sensitivity of pups in the rat
reproductive toxicity study, an additional modifying factor of 3 should
be added to the usual uncertainty factor of 100. The RfD should be,
therefore, changed from 0.03 mg/kg/day to 0.01 mg/kg/day for purposes
of these section 18's only, resulting in a total uncertainty factor of
300.
3. Carcinogenicity. Bentazon has been classified as a Group ``E''
chemical (evidence of non-carcinogenicity in two acceptable animal
studies) by the Office of Pesticide Program's Cancer Peer Review
Committee.
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.
Bentazon is currently registered for use on food and feed crops and
for outdoor residential uses on ornamentals and ornamental turf.
Permanent tolerances (see 40 CFR 180.355) for combined residues of
bentazon and its 6- and 8- hydroxy metabolites, have been established
for over 2 dozen food or feed commodities. Permanent tolerances are
also established in animal raw agricultural commodities for bentazon
and its metabolite, 2-amino-N-isopropyl benzamide.
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 one day exposure is a reasonably probable event.
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.
The acute dietary (food only) risk assessment used tolerance level
residues and assumed 100% crop-treated. The resulting high-end exposure
estimate of 0.01125 mg/kg/day, results in a dietary (food only) MOE of
8,888 for females 13+ years old which is considered acceptable.
Using the available monitoring data for groundwater, an exposure
estimate of 3 x 10-3 mg/kg/day for adults was calculated.
Adding this water exposure to the food exposure resulted in a MOE of
7,000 for females 13+ years.
It should be noted that the acute drinking water component of the
risk calculations presented in this document are relevant to sub-
populations with high-end exposure within the United States (FL and
CA). Because the calculated risk, based on high-end exposure is
acceptable, we believe that the overall risk assessment is protective
of the whole U.S. population.
In the best scientific judgment of the Office of Pesticide
Programs, the aggregate acute risk (food and water) from the currently
registered uses and this section 18 use of bentazon does not exceed our
level of concern.
2. Chronic exposure-- i. Dietary-food exposure. The chronic dietary
(food only) risk assessment used tolerance level residues and assumed
100% crop treated. Therefore, the resulting exposure estimates should
be viewed as conservative; further refinement using anticipated
residues and percent of crop-treated would result in lower dietary
exposure estimates. The existing bentazon tolerances plus the proposed
Section 18 use resulted in a Theoretical Maximum Residue Contribution
(TMRC) that is equivalent to the following percentages of the RfD:
------------------------------------------------------------------------
TMRC(mg/kg/
Subpopulation day) Percent RfD
------------------------------------------------------------------------
U.S. Population................................ 0.001079 12
Nursing Infants................................ 0.001755 18
Non-Nursing Infants (< 1="" year="" old).............="" 0.003755="" 39="" children="" (1-6="" years="" old).......................="" 0.002411="" 24="" children="" (7-12="" years="" old)......................="" 0.001633="" 15="" hispanics......................................="" 0.001074="" 12="" ------------------------------------------------------------------------="" [[page="" 33566]]="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" ii.="" dietary="" and="" drinking="" water="" exposure.="" to="" account="" for="" the="" exposure="" from="" drinking="" water,="" the="" agency="" decided="" to="" use="" the="" health="" advisory="" level="" of="" 20="" ppb.="" this="" level="" is="" a="" conservative="" estimate="" of="" exposure="" since="" it="" is="" unlikely="" that="" a="" person="" would="" be="" exposed="" to="" this="" level="" daily="" for="" a="" life-time.="" the="" following="" assumptions="" were="" made="" during="" the="" calculations:="" an="" adult="" weighs="" 70="" kg="" and="" consumes="" 2="" liters="" of="" water="" a="" day,="" a="" child="" weighs="" 10="" kg="" and="" consumes="" 1="" liter="" of="" water="" a="" day.="" using="" the="" health="" advisory="" level="" of="" 20="" ppb="" for="" bentazon="" in="" groundwater,="" and="" adding="" the="" calculated="" percentage="" of="" the="" rfd="" based="" on="" consumption="" by="" adults="" and="" children,="" to="" the="" existing="" percent="" of="" the="" rfd="" for="" food="" consumption,="" the="" total="" percentage="" of="" the="" rfd="" taken="" up="" by="" food="" and="" water="" consumption="" is:="" ------------------------------------------------------------------------="" percent="" rfd="" subpopulation="" ----------------------="" total="" percent="" rfd="" food="" water="" ------------------------------------------------------------------------="" u.s.="" population................="" 12="" 6="" 18="" nursing="" infants................="" 18="" 21="" 39="" non-nursing="" infants=""><1 year="" 39="" 21="" 60="" old).="" children="" (1-6="" years="" old).......="" 24="" 21="" 45="" children="" (7-12="" years="" old)......="" 15="" 21="" 36="" hispanics......................="" 12="" 6="" 18="" ------------------------------------------------------------------------="" using="" these="" conservative="" estimates,="" the="" sum="" total="" of="" the="" aggregate="" chronic="" risk="" estimates="" (food="" +="" water)="" for="" bentazon="" for="" the="" population="" subgroup="" with="" the="" largest="" percentage="" of="" the="" rfd="" occupied="" (non-nursing="" infants="" less="" than="" 1="" year="" old)="" is="" 60%.="" in="" the="" best="" scientific="" judgement="" of="" hed,="" the="" bentazon="" aggregate="" chronic="" risk="" does="" not="" exceed="" our="" level="" of="" concern.="" 3.="" short-="" and="" intermediate-term="" exposure.="" short-="" and="" intermediate-="" term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" although="" residential="" exposure="" data="" are="" not="" available="" for="" ornamentals="" and="" ornamental="" turf="" uses="" of="" bentazon,="" the="" agency="" notes="" that="" large="" moes="" were="" calculated="" for="" acute="" aggregate="" risk=""> 7,000) and occupational exposure (> 6,000 for the most
highly exposed group, aerial mixer loader). Therefore the Agency
believes short- and intermediate-term aggregate risk is likely to be
below the Agency's level of concern.
C. Cumulative Exposure to Substances With Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
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 bentazon 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,
bentazon 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 bentazon has a common mechanism of toxicity
with other substances.
D. Determination of Safety for U.S. Population
1. Acute risk. The acute dietary (food only) risk assessment used
tolerance level residues and assumed 100% crop-treated. The resulting
high-end exposure estimate of 0.01125 mg/kg/day, results in a dietary
(food only) MOE of 8,888 for females 13+ years old, which is considered
acceptable.
Using the available monitoring data for groundwater, an exposure
estimate of 3 x 10-3 mg/kg/day for adults was calculated.
Adding this water exposure to the food exposure resulted in a MOE of
7,000 for females 13+ years.
It should be noted that the acute drinking water component of the
risk calculations presented in this document are relevant to sub-
populations with high-end exposure within the United States (FL and
CA). Because the calculated risk, based on high-end exposure is
acceptable, we believe that the overall risk assessment is protective
of the whole U.S. population.
The Agency believes that the aggregate acute risk (food and water)
from the currently registered uses and this Section 18 use of bentazon
does not exceed our level of concern.
2. Short- and intermediate-term risk. Although residential exposure
data are not available for ornamental lawn uses of bentazon, the Agency
notes that large MOEs were calculated for acute aggregate risk
( 7,000) and occupational exposure (> 6,000 for the most
highly exposed group, aerial mixer loader). In the best scientific
judgement of the Agency, short- and intermediate-term aggregate risk
will be below the Agncy's level of concern.
3. Chronic risk. Using the conservative TMRC exposure assumptions
described above, EPA has concluded that aggregate exposure to bentazon
from food will utilize 18% of the RfD for the U.S. population. The
major identifiable subgroup with the
[[Page 33567]]
highest aggregate exposure is non-nursing infants which is discussed
below. 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 0appreciable
risks to human health. Despite the potential for exposure to bentazon
and from non-dietary, non-occupational exposure, EPA does not expect
the aggregate exposure to exceed 100% of the RfD. EPA concludes that
there is a reasonable certainty that no harm will result from aggregate
exposure to bentazon residues.
E. Determination of Safety for Infants and Children
In assessing the potential for additional sensitivity of infants
and children to residues of bentazon, 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 margin of exposure 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 margin of exposure and uncertainty factor (usually
100 for combined inter- and intra-species variability) and not the
additional tenfold margin of exposure/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 margin of exposure/safety factor.
1. Developmental toxicity studies--a. Rat study. From the rat
developmental toxicity study, the maternal (systemic) NOEL was 250 mg/
kg/day, the highest dose tested (HDT). The developmental (fetal) NOEL
was 100 mg/kg/day, based on increased post-implantation loss and
decreased fetal body weight at the lowest observed effect level (LOEL)
of 250 mg/kg/day.
b. Rabbit study. From the rabbit developmental toxicity study, the
maternal (systemic) NOEL was 150 mg/kg/day, based on abortion and
embryonic resorptions at the LOEL of 375 mg/kg/day. The developmental
(fetal) NOEL was 375 mg/kg/day, the HDT.
The presence of developmental effects in the absence of maternal
effects in the rat developmental toxicity study indicates that there is
extra pre-natal sensitivity for infants and children. The significant
developmental findings in the rat required an acute dietary risk
assessment for females 13+ years of age.
2. Reproductive toxicity study.--a. Rat study. From the rat
reproductive study, the parental (systemic) NOEL was 62 mg/kg/day,
based on increased incidences of kidney mineralization and liver
microgranules at the LOEL of 249 mg/kg/day. The reproductive (pup) NOEL
was 15 mg/kg/day, based on decreased pup body weight and weight gain at
the LEL of 62 mg/kg/day.
3. Pre- and post-natal sensitivity. Based on the results of the
reproductive toxicity study in rats, there were developmental (pup)
effects in the absence of parental effects. These results indicate
extra post-natal sensitivity for infants and children. This finding
requires a modifying factor of 3 to be added to the RfD. The RfD should
be, therefore, changed from 0.03 mg/kg/day to 0.01 mg/kg/day for
purposes of these section 18's only.
4. Acute risk. The acute dietary (food only) risk assessment used
tolerance level residues and assumed 100% crop-treated. The resulting
high-end exposure estimate of 0.01125 mg/kg/day, results in a dietary
(food only) MOE of 8,888 for females 13+ years old. If water is
considered in the acute exposure, the MOE is 7,000. Exposure estimates
(MOEs) for both scenarios are considered acceptable.
5. Short- or intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. Although residential exposure data are not
available for ornamental lawn uses of bentazon, the Agency notes that
large MOEs were calculated for acute aggregate risk ( 7,000)
and occupational exposure (> 6,000 for the most highly exposed group,
aerial mixer loader). Therefore the Agency believes short- and
intermediate-term aggregate risk is likely to be below the Agency's
level of concern.
6. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to bentazon
from food and water will utilize no more than 60% of the RfD for non-
nursing infants and children, the most highly exposed sub-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 bentazon from non-
dietary, non-occupational exposure, EPA does not expect the aggregate
exposure to exceed 100% of the RfD.) EPA concludes that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to bentazon residues.
V. Other Considerations
1. Metabolism in plants and animals. The qualitative nature of the
residue in plants is considered to be adequately understood.
Radiolabelled studies conducted at rates of up to 2.5 lb active
ingredient/acre on beans, corn, soybeans, rice and wheat indicate that
bentazon is readily absorbed from foliage, roots and seeds, and
translocates in some plant types. Bentazon is rapidly metabolized,
conjugated and incorporated into natural plant constituents. Metabolism
involves the hydroxylation of bentazon at the 6- and 8-position. The
terminal residues of regulatory concern are bentazon, 6-hydroxy
bentazon, and 8-hydroxy bentazon (as specified in 40 CFR 180.355 (a)).
2. Analytical enforcement methodology. Adequate enforcement methods
are available for the determination of residues of bentazon and its 6-
and 8-hydroxy metabolites in/on plant commodities. The Pesticide
Analytical Manual (PAM) Vol. II lists Method II, a GLC method with
flame photometric detection for the determination of bentazon and its
hydroxy metabolites in/on corn, rice, and soybeans; the limit of
detection for each compound is 0.05 ppm. Method III, modified from
Method II, is available for the determination of bentazon and its
hydroxy metabolites in/on peanuts and seed and pod vegetables with a
limit of detection of 0.05 ppm for each compound.
3. Magnitude of residues. Regulable residues of bentazon and its
metabolites are not expected to exceed 3 ppm in/on succulent peas as a
result of this Section 18 use only.
[[Page 33568]]
4. Rotational crop restrictions. Confined rotational crop data
indicate that bentazon residues may be taken up by rotational crops (39
to 102 day plantback intervals), and that field rotational crop studies
are needed for the purposes of reregistration in order to determine if
plantback restrictions for bentazon end-use products are needed. The
petitioner will need to modify the proposed Basagran label once the
field rotational crop studies are submitted by the petitioner and
review by the Agency.
5. International residue limits. There is a Codex MRL of 0.2 ppm
for bentazon and its metabolites established in/on garden peas (young
pods), a Canadian MRL for parent only of 0.1 ppm (negligible)
established in/on peas, and a Mexican limit for parent (presumed) of
0.05 ppm established in/on green peas. Therefore, a compatibility issue
is relevant to the proposed tolerance. Harmonization of the U.S.
tolerance will not be possible as the use pattern proposed in this
petition will result in residues which greatly exceed the Codex MRL.
VI. Conclusion
Therefore, a tolerance in connection with the FIFRA section 18
emergency exemptions is established for residues of bentazon in
succulent peas at 3 ppm. In addition to the tolerance being established
for residues of bentazon in succulent peas, EPA is also, removing
Sec. 186.375 which contains a tolerance for residues of bentazon on
spent mint hay. That tolerance is being transferred to the table in
paragraph (a) of Sec. 180.355.
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 August 19, 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 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 number
[OPP-300499] (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 number [OPP-300499]. Electronic comments on
this proposed rule may be filed online at many Federal Depository
Libraries.
IX. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under section
408 of the FFDCA and is related to EPA's granting emergency exemptions
under section 18 of the FIFRA. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). In addition, this final rule does not contain any
information collections subject to additional OMB approval under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4). Nor does it require any prior consultation as specified by
Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993), or special considerations
as required by Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, because these tolerances are established without
notice and comment rulemaking, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. Nonetheless,
the Agency has previously assessed whether establishing tolerances,
exemptions from tolerances, raising tolerance levels or expanding
exemptions might adversely impact small entities and concluded, as a
generic matter, that there is no significant adverse economic impact
associated with these actions (46 FR 24950, May 4, 1981). In accordance
with Small Business Administration (SBA) policy, this determination
will be provided to the Chief Counsel for Advocacy of the SBA upon
request.
[[Page 33569]]
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Parts 180 and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Animal feeds, Pesticides and pests, Reporting
and recordkeeping requirements.
Dated: June 2, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.355 is amended as follows:
i. By adding a paragraph heading to paragraph (a), and revising the
phrase ``raw agricultural commodities'' to read ``food commodities''.
ii. By adding alphabetically an entry for ``Mint, spent hay'' to
the table in paragraph (a).
iii. In paragraph (b), by transferring and alphabetically adding
all of the entries currently in the table to the table in paragraph (a)
iv. By revising the remainder of paragraph (b).
v. By adding and reserving paragraphs (c) and (d).
Sec. 180.355 Bentazon; tolerances for residues.
(a) General. * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Mint, spent hay............................................ 4
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the herbicide bentazon and its
metabolites 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 Revocation
million Date
------------------------------------------------------------------------
Peas, succulent............................... 3 6/30/98
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
* * * * *
PART 186--[AMENDED]
2. In part 186:
a.The authority citation for part 186 continues to read as follows:
Authority: 21 U.S.C. 342, 348, and 701.
Sec. 186.375 [Removed]
b. Section 186.375 is removed.
[FR Doc. 97-16215 Filed 6-19-97; 8:45 am]
BILLING CODE 6560-50-F
