[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Rules and Regulations]
[Pages 9430-9435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4651]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300603; FRL-5766-4]
RIN 2070-AB78
Bensulfuron Methyl (methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl)
amino] carbonyl] amino] sulfonyl] methyl] Benzoate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
bensulfuron methyl in or on crayfish. In addition, this regulation
raises the tolerance for residues of bensulfuron methyl on rice straw.
E.I. duPont de Nemours and Company, Inc. requested this tolerance under
the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective February 25, 1998. Objections and
requests for hearings must be received by EPA on or before April 27,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300603], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300603], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: 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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300603]. 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: Jim Tompkins, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 305-5697, e-mail:
tompkins.jim@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 16, 1997 (62
FR 27033) (FRL-5717-7), EPA, issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of pesticide petitions (PP) 4F4367 and 5F4490.
This notice included a summary of the petitions prepared by E.I. duPont
de Nemours and Company, Inc., the registrant. There were no comments
received in response to the notice of filing.
The petitions requested that 40 CFR 180.445 be amended by
establishing a tolerance for residues of the herbicide bensulfuron
methyl, in or on rice (grain) at 0.02 parts per million (ppm), rice
straw at 0.05 ppm, and crayfish at 0.05 ppm.
I. Risk Assessment and Statutory Findings
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. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of
[[Page 9431]]
100 is commonly used since it is assumed that people may be up to 10
times more sensitive to pesticides than the test animals, and that one
person or subgroup of the population (such as infants and children)
could be up to 10 times more sensitive to a pesticide than another. In
addition, EPA assesses the potential risks to infants and children
based on the weight of the evidence of the toxicology studies and
determines whether an additional uncertainty factor is warranted. Thus,
an aggregate daily exposure to a pesticide residue at or below the RfD
(expressed as 100% or less of the RfD) is generally considered
acceptable by EPA. EPA generally uses the RfD to evaluate the chronic
risks posed by pesticide exposure. For shorter term risks, EPA
calculates a margin of exposure (MOE) by dividing the estimated human
exposure into the NOEL from the appropriate animal study. Commonly, EPA
finds MOEs lower than 100 to be unacceptable. This 100-fold MOE is
based on the same rationale as the 100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100% of the crop is treated by pesticides that have
established tolerances. If the TMRC exceeds the RfD or poses a lifetime
cancer risk that is greater than approximately one in a million, EPA
attempts to derive a more accurate exposure estimate for the pesticide
by evaluating additional types of information (anticipated residue 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.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup was not
regionally based.
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of
bensulfuron methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl) amino]
carbonyl] amino] sulfonyl] methyl] benzoate and to make a determination
on aggregate exposure, consistent with
[[Page 9432]]
section 408(b)(2), for tolerances for residues of bensulfuron methyl on
rice straw at 0.3 ppm and crayfish at 0.05 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by bensulfuron methyl-
2[[[[[(4,6-dimethoxy-pyrimidin-2-yl) amino] carbonyl] amino] sulfonyl]
methyl] benzoate are discussed below.
1. An acute oral study with an LD50 greater than 5,000
milligrams/kilogram (mg/kg) (limit test).
2. A 90-day dog feeding study with a no-observed-effect level
(NOEL) of 32.1 milligrams/kilogram/day (mg/kg/day) in males and 36.3
mg/kg/day in females.
3. A 90-day mouse feeding study with a NOEL of 132 mg/kg/day in
males and 133 mg/kg/day in females.
4. A 90-day rat feeding study with a NOEL of 93 mg/kg/day in males
and 111 mg/kg/day in females.
5. A rat developmental study with a developmental NOEL of greater
than 1,320 mg/kg/day, the highest dose tested.
6. A rabbit developmental study with a developmental NOEL of 300
mg/kg/day.
7. A two-generation rat reproduction study with a reproductive NOEL
of 309 mg/kg/day in males and 405 mg/kg/day in females.
8. A Salmonella/Mammalian Activation Assay, negative with and
without metabolic activation.
9. An in vivo bone marrow chromosome study in rats with no evidence
of induced chromosome aberration in bone marrow.
10. An in vitro sister chromatid exchange assay in CHO cells with a
slight increase in SCE frequency in nonactivated system at maximum
concentration, but negative in the activated system at the same
concentration.
11. A 1-year dog feeding study with a NOEL of 21.4 mg/kg/day in
males and 19.9 mg/kg/day in females.
12. A 2-year mouse chronic feeding/carcinogenicity study with a
NOEL of 226 mg/kg/day in males and 227 mg/kg/day in females for
systemic effects and with no carcinogenic potential observed under
conditions of the study up to 455 mg/kg/day in males and 460 mg/kg/day
in females, the highest dose tested.
13. A 2-year rat chronic feeding/carcinogenicity study with a NOEL
of 30 mg/kg/day in males and 40 mg/kg/day in females for systemic
effects and with no carcinogenic potential observed under conditions of
the study up to 309 mg/kg/day in males and 405 mg/kg/day in females,
the highest dose tested.
Based on a NOEL of 19.9 mg/kg/day in the 1-year dog feeding study
and a safety factor of 100, the acceptable daily intake has been set at
0.2 mg/kg/day. These tolerances have a theoretical maximum residue
contribution of 0.000005 mg/kg/day and would utilize less than 1
percent of the reference dose (RfD) for the general US population.
There are no population subgroups for which the percentage of the RfD
utilized is greater than the general U.S. population.
B. Toxicological Endpoints
1. Acute toxicity. No toxicological effects attributable to a
single exposure (dose) were identified in any of the studies.
Therefore, this risk assessment is not required.
2. Short - and intermediate - term toxicity. EPA has concluded that
available evidence doe not indicate any evidence of significant
toxicity from short and intermediate term exposure.
3. Chronic toxicity. EPA has established the RfD for bensulfuron
methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl) amino] carbonyl] amino]
sulfonyl] methyl] benzoate at 0.20 mg/kg/day. This RfD is based on the
systemic NOEL of 19.9 mg/kg/day for females in a one year toxicity
study in beagle dogs.
4. Carcinogenicity. Although bensulfuron methyl has not received a
carcinogenicity classification, the Health Effects Division RfD
Committee found no evidence of carcinogenicity in the mouse or rat.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.445) for the residues of bensulfuron methyl, in or on rice
(grain) at 0.02 ppm, rice straw at 0.05 ppm. The petitioner has
proposed to increase the tolerance for rice straw to 0.3 ppm. A
tolerance of 0.05 ppm for bensulfuron methyl residues in crayfish is
proposed. Risk assessments were conducted by EPA to assess dietary
exposures and risks from bensulfuron methyl-2[[[[[(4,6-dimethoxy-
pyrimidin-2-yl) amino] carbonyl] amino] sulfonyl] methyl] benzoate as
follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. An acute risk assessment is not
required as an appropriate endpoint was not identified for bensulfuron
methyl.
ii. Chronic exposure and risk. The Agency's Dietary Risk Evaluation
System (DRES) does not contain the commodity crayfish. DRES does
contain the commodity fish, shellfish which includes crayfish as well
as other shellfish. For human dietary exposure calculations, The Agency
has substituted the commodity fish, shellfish for crayfish. In
conducting this chronic dietary risk assessment, The Agency has made
very conservative assumptions: (1) 100% of all commodities having
bensulfuron methyl tolerances will contain residues; (2) those residues
will be at the level of the tolerance; and (3) bensulfuron methyl
residues in fish, shellfish will be at the proposed tolerance level for
crayfish. These assumptions will result is an overestimate of dietary
exposure.
Thus, in making a safety determination for this tolerance, the
Agency is taking into account this conservative exposure assessment.
The existing tolerances (published and pending, and including the
proposed tolerance for crayfish) result in a Theoretical Maximum
Residue Contribution (TMRC) that is equivalent to less than 1% of the
RfD for the U.S. population (48 states). There are no population
subgroups for which the percentage of the RfD occupied is greater than
that occupied by the subgroup U.S. population (48 States).
2. From drinking water-- Chronic exposure and risk. Based on the
chronic dietary (food) exposure and using default body weights and
water consumption figures, chronic levels of concern (LOC) for
bensulfuron methyl in drinking water were calculated. For chronic
exposure, based on an adult body weight of 70 kg and 2 liters
consumption of water per day, the Agency's level of concern from
chronic exposure in drinking water is 7,000 parts per billion for
adults. For children (10 kg and consuming 1 liter water per day) our
level of concern for drinking water is 2,000 parts per billion.
Because all the Agency's estimates for the levels of bensulfuron
methyl in drinking water were less than 2 parts per billion, potential
residues in drinking water are not greater than the Agency's level of
concern.
3. From non-dietary exposure. There is no non-food use of
bensulfuron methyl currently registered under FIFRA, as amended. No
non-dietary
[[Page 9433]]
exposures are expected for the general population.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative 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 bensulfuron methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl) amino]
carbonyl] amino] sulfonyl] methyl] benzoate 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, bensulfuron methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl)
amino] carbonyl] amino] sulfonyl] methyl] benzoate 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
methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl) amino] carbonyl] amino]
sulfonyl] methyl] benzoate has a common mechanism of toxicity with
other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. An acute and intermediate-term risk assessment is
not required as an appropriate endpoints were not identified for
bensulfuron methyl.
2. Chronic risk. Using the TMRC exposure assumptions described
above, EPA has concluded that aggregate exposure to bensulfuron methyl-
2[[[[[(4,6-dimethoxy-pyrimidin-2-yl) amino] carbonyl] amino] sulfonyl]
methyl] benzoate from food will utilize <1% of="" the="" rfd="" for="" the="" u.s.="" population.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" bensulfuron="" methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl)="" amino]="" carbonyl]="" amino]="" sulfonyl]="" methyl]="" benzoate="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" aggregate="" exposure="" to="" bensulfuron="" methyl-2[[[[[(4,6-dimethoxy-="" pyrimidin-2-yl)="" amino]="" carbonyl]="" amino]="" sulfonyl]="" methyl]="" benzoate="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" an="" acute="" and="" intermediate-term="" risk="" assessment="" is="" not="" required="" as="" appropriate="" endpoints="" were="" not="" identified="" for="" bensulfuron="" methyl.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" a="" carcinogenic="" risk="" assessment="" is="" not="" required="" as="" there="" is="" no="" evidence="" of="" carcinogenicity="" for="" bensulfuron="" methyl="" in="" the="" mouse="" or="" rat="" or="" dog.="" f.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--="" i.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" bensulfuron="" methyl-2[[[[[(4,6-dimethoxy-="" pyrimidin-2-yl)="" amino]="" carbonyl]="" amino]="" sulfonyl]="" methyl]="" benzoate,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" maternal="" pesticide="" exposure="" gestation.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-species="" variability))="" and="" not="" the="" additional="" tenfold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" and="" reproductive="" toxicity="" studies.="" the="" prenatal="" developmental="" toxicity="" data="" demonstrated="" no="" indication="" of="" increased="" sensitivity="" of="" rabbits="" to="" in="" utero="" exposure="" to="" bensulfuron="" methyl.="" in="" addition,="" the="" multigeneration="" reproduction="" study="" data="" did="" not="" identify="" any="" increased="" sensitivity="" of="" rats="" to="" in="" utero="" or="" postnatal="" exposure.="" in="" both="" studies,="" the="" maternal="" loel="" was="" less="" than="" or="" equivalent="" to="" the="" noel="" for="" effects="" in="" the="" offspring.="" minor="" [[page="" 9434]]="" ossification="" variations="" were="" observed="" in="" a="" developmental="" study="" in="" rats,="" but="" only="" at="" a="" dose="" of="" 1,320="" mg/kg/day="" which="" exceeds="" the="" limit="" dose="" of="" 1,000="" mg/kg/day="" as="" specified="" in="" guideline="" sec.="" 93-3a.="" for="" chronic="" dietary="" risk="" assessment,="" the="" agency="" determined="" that="" based="" on="" a="" complete="" database="" the="" 10x="" factor="" to="" account="" for="" enhanced="" sensitivity="" of="" infants="" and="" children="" (as="" required="" by="" fqpa)="" should="" be="" removed.="" removal="" of="" the="" 10x="" is="" based="" on="" a="" complete="" database.="" the="" present="" uf="" of="" 100="" (10x="" each="" for="" inter-and="" intra-species="" variability)="" is="" adequate="" to="" ensure="" protection="" of="" these="" population="" subgroups="" from="" exposure="" to="" bensulfuron="" methyl="" for="" reasons="" stated="" below:="" (a)="" there="" is="" no="" indication="" of="" increased="" sensitivity="" to="" young="" animals="" following="" pre-="" and/or="" post-natal="" exposure="" to="" bensulfuron="" methyl.="" (b)="" there="" is="" no="" increased="" sensitivity="" to="" fetuses="" as="" compared="" to="" maternal="" animals="" following="" in="" utero="" exposures="" in="" rats="" and="" rabbits.="" (c)="" there="" is="" no="" increased="" sensitivity="" to="" pups="" as="" compared="" to="" adults="" in="" a="" multi-generation="" reproduction="" toxicity="" study="" in="" rats.="" (d)="" considering="" the="" overall="" toxicity="" profile="" of="" bensulfuron="" methyl,="" it="" was="" noted="" that="" toxic="" effects="" were="" only="" observed="" at="" or="" near="" the="" limit="" dose="" with="" all="" short-="" and="" long-term="" studies.="" 2.="" acute="" risk.="" an="" acute="" risk="" assessment="" is="" not="" required="" as="" an="" appropriate="" endpoints="" were="" not="" identified="" for="" bensulfuron="" methyl.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" bensulfuron="" methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl)="" amino]="" carbonyl]="" amino]="" sulfonyl]="" methyl]="" benzoate="" from="" food="" will="" utilize=""><1% of="" the="" rfd="" for="" infants="" and="" children.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100%="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" despite="" the="" potential="" for="" exposure="" to="" bensulfuron="" methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl)="" amino]="" carbonyl]="" amino]="" sulfonyl]="" methyl]="" benzoate="" in="" drinking="" water,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" bensulfuron="" methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-yl)="" amino]="" carbonyl]="" amino]="" sulfonyl]="" methyl]="" benzoate="" residues.="" 4.="" short-="" or="" intermediate-term="" risk.="" epa="" has="" concluded="" that="" available="" evidence="" does="" not="" indicate="" any="" evidence="" of="" significant="" toxicity="" from="" short="" and="" intermediate="" term="" exposure.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" bensulfuron="" methyl="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" purposes="" of="" this="" tolerance.="" due="" to="" very="" low="" levels="" of="" residues="" with="" a="" small="" percentage="" of="" metabolites,="" these="" metabolites="" need="" not="" be="" regulated.="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" analytical="" method,="" high-pressure="" liquid="" chromatography="" using="" a="" photo="" conductivity="" detector,="" is="" available="" for="" enforcement="" purposes.="" the="" analytical="" method="" for="" enforcing="" these="" tolerances="" has="" been="" submitted="" for="" published="" in="" the="" pesticide="" analytical="" manual,="" vol="" ii="" (pam="" ii).="" because="" of="" the="" long="" lead="" time="" from="" establishing="" these="" tolerances="" to="" publication="" of="" the="" enforcement="" methodology="" in="" pam,="" the="" analytical="" methodology="" is="" being="" made="" available="" in="" the="" interim="" to="" anyone="" interested="" in="" pesticide="" enforcement="" when="" requested="" from:="" calvin="" furlow,="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460.="" office="" location="" and="" telephone="" number:="" rm.="" 119ff,="" cm="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va="" 22202,="" (703-305-5229).="" c.="" magnitude="" of="" residues="" the="" nature="" of="" the="" residue="" in="" plants="" is="" adequately="" understood="" for="" the="" purpose="" of="" this="" tolerance.="" based="" on="" the="" results="" of="" animal="" metabolism="" studies="" it="" is="" unlikely="" that="" significant="" residues="" would="" occur="" in="" secondary="" animal="" commodities="" from="" this="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" established="" codex,="" canadian="" or="" mexican="" residue="" limits="" for="" bensulfuron="" methyl="" in/on="" rice="" (grain="" and="" straw)="" and="" crayfish.="" thus,="" harmonization="" of="" the="" proposed="" tolerances="" with="" codex,="" canada="" and="" mexico="" are="" not="" an="" issue="" for="" these="" petitions.="" e.="" rotational="" crop="" restrictions="" no="" tolerances="" for="" inadvertent="" residues="" of="" bensulfuron="" methyl="" are="" required="" in="" rotational="" crops.="" the="" rotational="" crop="" restrictions="" contained="" on="" the="" current="" londax="" df="" label="" (epa="" 352-325)="" are="" adequate.="" iv.="" conclusion="" therefore,="" the="" tolerances="" are="" established="" for="" residues="" of="" bensulfuron="" methyl="" in/or="" on="" crayfish="" at="" 0.05="" ppm="" and="" increase="" tolerance="" on="" rice="" straw="" from="" 0.05="" to="" 0.3="" ppm.="" v.="" 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="" april="" 27,="" 1998,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" cbi.="" information="" so="" marked="" will="" not="" be="" [[page="" 9435]]="" 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.="" vi.="" public="" docket="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300603]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 119="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" hwy.,="" arlington,="" va.="" electronic="" comments="" may="" 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.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
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, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 9, 1998.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.445 is revised to read as follows:
Sec. 180.445 Bensulfuron methyl; tolerances for residues.
(a) General. Tolerances are established for residues of the
herbicide bensulfuron methyl (methyl-2[[[[[(4,6-dimethoxy-pyrimidin-2-
yl) amino] carbonyl] amino] sulfonyl] methyl] benzoate) in or on the
following raw agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Crayfish............................................. 0.05
Rice................................................. 0.02
Rice, straw.......................................... 0.3
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 98-4651 Filed 2-24-98; 8:45 am]
BILLING CODE 6560-50-F
