FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Fomesafen Index PageFomesafen. July 9, 1997. Pesticide Tolerances for Emergency Exemptions. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/July/Day-09/p17933.htm
[Federal Register: July 9, 1997 (Volume 62, Number 131)]
[Rules and Regulations]
[Page 36678-36684]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy97-12]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300512; FRL-5729-5]
RIN 2070-AB78
Fomesafen; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of fomesafen in or on snap beans . This action is in response
to EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on snap beans. This regulation establishes a maximum
permissible level for residues of fomesafen in this food commodity
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. The
tolerance will expire and is revoked on June 30, 1998.
DATES: This regulation is effective July 9, 1997. Objections and
requests for hearings must be received by EPA on or before September 8,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300512], 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-300512], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300512]. 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: Andrea Beard, 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) 308-9356, e-mail:
beard.andrea@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 fomesafen, in or on snap beans at 0.05 part
per million (ppm). This tolerance will expire and is revoked on 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 Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(i) 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
[[Page 36679]]
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such 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 Fomesafen on Snap Beans and FFDCA
Tolerances
Requests were received from a number of states for use of fomesafen
on snap beans for control of broadleaf weeds. The Applicants state that
since the loss of the herbicides dinoseb and chloramben, weed
contamination in U.S. bean fields has increased and significant crop
losses have occurred. The Applicants state that available alternative
pesticides and control techniques have produced unreliable results, and
that without this use of fomesafen, significant economic losses will
occur. EPA has authorized under FIFRA section 18 the use of fomesafen
on snap beans for control of broadleaf weeds in Arkansas, Maryland, New
York, Oklahoma, Pennsylvania, and Virginia. After having reviewed the
submission, EPA concurs that emergency conditions exist for this state.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fomesafen in or on snap
beans. 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. 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
snap beans after that date will not be unlawful, provided the pesticide
is applied in a manner that was 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 fomesafen meets EPA's
registration requirements for use on snap beans 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 fomesafen 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 Arkansas, Maryland, New York, Oklahoma, Pennsylvania,
and Virginia to use this pesticide on this crop under section 18 of
FIFRA without following all provisions of section 18 as identified in
40 CFR part 166. For additional information regarding the emergency
exemption for fomesafen, 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. 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 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
[[Page 36680]]
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 (non-nursing
infants <1 year old) was not regionally based.
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, EPA has sufficient data to assess the hazards of fomesafen
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of
fomesafen on snap beans 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 fomesafen are
discussed below.
1. Acute toxicity. EPA has selected the developmental NOEL of 7.5
mg/kg/day from the oral rat developmental toxicity study for the acute
dietary endpoint; at the lowest observed effect level (LOEL) of 50 mg/
kg/day, fetuses had delayed or partial ossification and extra ribs. The
population subgroup of concern is females 13+ years of age.
2. Short - and intermediate - term toxicity. EPA has selected the
NOEL of 10 mg/kg/day from the oral rabbit developmental toxicity study
for calculation of short-term MOE's. At the lowest effect level (LEL)
of 40 mg/kg/day, maternal toxicity included stomach mucosal erosion and
death.
3. Chronic toxicity. EPA has not established the RfD for fomesafen.
For the purposes of this tolerance, based upon available chronic
toxicity data, the RfD of 0.0025 mg/kg/day was used. This RfD is based
on the NOEL of 0.25 mg/kg/day from the rat carcinogenicity study. A
100-fold uncertainty factor was
[[Page 36681]]
used to calculate this RfD. At the LOEL of 5.0 mg/kg/day there was
liver toxicity and decreased body weight.
4. Carcinogenicity. Fomesafen is classified as a Group C carcinogen
with a Q* of 1.9 X 10<SUP>-1</SUP> (mg/kg/day)<SUP>-1</SUP> . This
classification was based on: (a)increases in both adenomas and
carcinomas at several dose levels in both sexes of mice; (b) some
evidence of reduced latency for the time of tumor appearance; (c)
limited evidence of mutagenic effects; and, (d) the structural
similarity of fomesafen to other biphenyl ether herbicides which have
been shown to be carcinogenic.
B. Exposures and Risks
1. From food and feed uses. A tolerance has been established (40
CFR 180.433) for the residues of fomesafen, in or on soybeans at 0.05
ppm. Risk assessments were conducted by EPA to assess dietary exposures
and risks from fomesafen 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. The acute dietary risk assessment used
tolerance level residue values and assumed 100% of crop treated. The
resulting high-end exposure estimate of 0.0002 mg/kg/day results in a
dietary MOE of 37,500 for the population subgroup of concern, females
13+ years old. This MOE is a conservative risk assessment; refinement
using anticipated residue values and percent crop treated data in
conjunction with Monte Carlo analysis would result in a lower acute
dietary exposure estimate.
ii. Chronic exposure and risk. The existing tolerance for soybeans
and this time-limited tolerance for snap beans result in an ARC that is
equivalent to the following percentages of the RfD: U.S. Population,
0.04%; Non-nursing Infants (<1 year old), 1.4%; Children (1-6 years
old), 0.7%; Nursing Infants, 0.5%; and Children (7-12 years old), 0.5%.
The dietary risk assessments used tolerance level residues, but
incorporated percent of crop treated information for soybeans and snap
beans. Additional refinement using anticipated residue values would
result in lower dietary exposure estimates.
iii. Cancer risk. A dietary (food only) cancer risk assessment
using anticipated residues and percent crop treated information was
performed for the U.S. population. The total calculated food cancer
risk is 9 X 10<SUP>-7</SUP>. This is an overestimate, as not all of the
snap bean crop in the eastern U.S. will be treated with fomesafen.
2. From drinking water. Fomesafen was not included in EPA's
National Survey of Pesticides in Drinking Water Wells. There are no
entries for fomesafen in the Pesticides in Ground Water Database. The
Agency has not extablished Maximum Contaminant Levels or Health
Advisory Levels for residues of fomesafen in drinking water.
Based on available data, EPA concludes that fomesafen could leach
to ground water and may reach levels of 1.0 microgram (ug)/Liter (L).
The level of 1.0 ug/L was based on a small scale prospective
groundwater monitoring study conducted on soybeans at a vulnerable site
in North Carolina. Fomesafen residues were detected in ground water (in
4 of 9 wells) sampled between 17 and 33 months after application.
Fomesafen concentrations measured 1.0 ug/L (equal to the limit of
determination of the analytical method).
Exposures and risks to residues of fomesafen in drinking water were
calculated, as follows:
Adult exposure = (chemical concentration in ug/L) X (10<SUP>-3</SUP>mg/
ug) X (2 L/day consumed) divided by (70 kg body weight).
Child exposure = (chemical concentration in ug/L) X (10<SUP>-3</SUP>
mg/ug) X (1 L/day consumed) divided by (10 kg body weight)
Adult exposure is thus calculated to be 2.9 X 10<SUP>-5</SUP> mg/kg/day
and exposure to children is calculated to be 1.0 X 10<SUP>-4</SUP> mg/
kg/day.
i. Acute exposure and risk. For the population subgroup of concern
for acute exposure (females 13+), the MOE is calculated at 260,000.
ii. Chronic exposure and risk. Exposure to residues of fomesafen in
water utilizes 1.2% of the RfD for adults and 4.0% of the RfD for
children.
iii. Cancer risk. Based on exposure levels for drinking water, as
given above, the estimate of cancer risk is 2.7 X 10<SUP>-6</SUP>. This
figure is an overestimate, as it was arrived at based on several very
conservative assumptions. Estimates used were calculated based on data
from only one small scale study conducted in NC, for use of fomesafen
on soybeans at a vulnerable site. This represents a worst case
scenario, so is not representative of the ``average'' conditions of
use. Additionally, there is language on the product label warning of
the potential of fomesafen to leach to ground water in vulnerable
areas. Vulnerable areas in this case refers to areas where soils are
permeable (sand and silt loams) and the water table is shallow. The
majority of areas of soybean production, and potential use of
fomesafen, will not likely be vulnerable sites, thus the data used from
the one small scale study greatly overestimates levels which could
actually occur. Further, it is assumed that this exaggerated level will
occur in all drinking water throughout the US, and that each individual
consumes 2 liters of drinking water per day.
3. From non-dietary exposure. Fomesafen is not currently registered
for use on sites that would be expected to result in non-
dietary(residential) exposure. A non-dietary risk assessment is thus
not appropriate for existing uses of fomesafen.
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
[[Page 36682]]
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).
When considering structural similarities with other chemicals,
fomesafen falls into the class of ``biphenyl ether'' chemical
compounds; this means that this group of chemicals have structural
similarities, including a biphenyl ether group in common. This is used
as a piece of supporting evidence for the classification of fomesafen
as a Group C carcinogen, since other chemicals of this group (with
similar structure) have been found to be carcinogens. However, other
indications of the carcinogenicity of fomesafen (i.e., increases of
adenomas and carcinomas in a mouse study, limited evidence of mutagenic
effects) were also used in deciding this cancer classification. At this
time, the Agency does not have sufficient understanding of the
structural relationship to the mechanism of toxicity of these chemicals
to conclude that they may be combined for the purposes of conducting a
risk assessment. Although fomesafen contains some chemical structures
in common with other chemicals that have been found to be carcinogens,
EPA does not yet fully understand the implications of such a
relationship, nor how, or if these structures relate to the
toxicological activity of the chemical.
For the purposes of this tolerance action, therefore, EPA has not
assumed that fomesafen has a common mechanism of toxicity with other
substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. For the population of concern (females 13+ years and
older), the calculated aggregate MOE value is 33,000. The aggregate MOE
is the reciprocal of the sum of the reciprocal MOE's for food (37,500)
and water (260,000). This aggregate MOE does not exceed EPA's level of
concern for acute dietary exposure.
2. Chronic risk. Using the conservative ARC exposure assumptions
described above, EPA has concluded that aggregate exposure to fomesafen
from food will utilize 1.6% (0.4% for food and 1.2% for water) of the
RfD for the U.S. population. The major identifiable subgroup with the
highest aggregate exposure is discussed below. 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 fomesafen 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 fomesafen residues.
D. Aggregate Cancer Risk for U.S. Population
Using the conservative exposure assumptions described above, the
total dietary (food only) cancer risk is estimated at 9 X
10<SUP>-7</SUP>. This is an overestimate, as not all of the snap bean
crop in the eastern U.S. will be treated with fomesafen. For drinking
water, the estimate of cancer risk is 2.7 X 10<SUP>-6</SUP>. As stated
above, this figure was based on extremely conservative assumptions, and
thus is an overestimate; taking this into consideration, EPA scientists
believe that the actual aggregate cancer risk will not exceed levels of
concern, and there is reasonable certainty of ho harm to the U.S.
population.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children.-- a. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of fomesafen, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from pesticide exposure during prenatal development to one or
both parents. Reproduction studies provide information relating to
effects from exposure to the pesticide on the reproductive capability
of mating animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
b. Developmental toxicity studies. In the rat developmental
toxicity study, the maternal (systemic) NOEL was established at 100 mg/
kg/day, based on stained fur at the LOEL of 200 mg/kg/day. The
developmental (fetal) NOEL was established at 7.5 mg/kg/day, based on
extra ribs and delayed ossification at the LOEL of 50 mg/kg/day.
In the rabbit developmental toxicity study, the maternal (systemic)
NOEL was established at 10 mg/kg/day, based on mortality and stomach
lesions at the LOEL of 40 mg/kg/day. The developmental (fetal) NOEL was
established at 40 mg/kg/day (highest dose tested).
c. Reproductive toxicity study. In the reproductive toxicity study
in rats, the parental (systemic) NOEL was 12.5 mg/kg/day, based on
decreased body weight and liver necrosis at the LOEL of 50 mg/kg/day.
The reproductive and developmental (pup) NOELs were 2.5 mg/kg/day,
based on decreased pup body weight and reduced litter size at the LOEL
of 12.5 mg/kg/day.
d. Pre- and post-natal sensitivity. There were no developmental
effects in rabbits at the highest dose tested, even in the presence of
maternal toxicity. However, based on the developmental toxicity study
in rats, developmental toxicity (alterations and delays in skeletal
ossification) occurred at a dose level which was not maternally toxic,
suggesting a special sensitivity to the fetus following in-utero
exposure. Based on the results of the rat developmental toxicity study,
an acute dietary risk assessment was conducted for females 13+ years of
age. The MOE of 33,000 obtained for this risk assessment demonstrates
that acute developmental (pre-natal) risks are low.
e. Conclusion. Based on the rat reproductive toxicity study
discussed above, the pup LOEL (decreased body weight and reduced litter
size) occurred at levels below the maternal NOEL and demonstrates post-
natal pup toxicity unrelated to maternal effects. These results are
suggestive of a special sensitivity for infants and children following
post-natal exposure. The low percentage of the RfD occupied by the most
highly exposed child subgroup (5.4% of the RfD) demonstrates that post-
natal risks to infants and children are low, and EPA concludes that
there
[[Page 36683]]
is reasonable certainty of no harm to infants and children.
2. Acute risk. The acute, aggregate dietary MOE of 33,000 which was
calculated for females 13+ years old, accounts for both maternal and
fetal exposure. The large agregate MOE calculated for females 13+ years
old provides assurance that there is a reasonable certainty of no harm
to infants and children.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to fomesafen
from food and water utilizes from 4.5% of the RfD for nursing infants
up to 5.4% of the RfD for non-nursing infants. As stated previously,
the results from the developmental rat study suggest a special
sensitivity to the fetus following in-utero exposure; and results from
the reproductive rat study suggest a special sensitivity for infants
and children following post-natal exposure. Therefore, EPA recommends
applying an extra 10-fold uncertainty (safety) factor, which would
bring the exposures given above to 45% and 54% of the RfD, for nursing
and non-nursing infants, respectively. 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. The low percentage of the
RfD occupied by estimates for the most highly exposed child population
subgroup demonstrates that risks to infants and children are below
EPA's level of concern. Despite the potential for exposure to fomesafen
in drinking water 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
to infants and children from aggregate exposure to fomesafen residues.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residues in plants and animals is adequately
understood. The residue of conern is fomesafen per se. Secondary
residues in meat, milk, poultry, and eggs are not expected, since snap
beans are not considered a livestock feed commodity.
B. Analytical Enforcement Methodology
An adequate enforcement method (Method GAM-RM-001/86) is available
to enforce fomesafen tolerances.
C. Magnitude of Residues
Residues of fomesafen are not likely to exceed 0.05 ppm in or on
snap beans as a result of this use. No animal feed items are associated
with this use, and therefore, no secondary residues in livestock
commodities are expected to result.
D. International Residue Limits
There are no CODEX or Canadian maximum residue levels established
for residues of fomesafen in or on snap beans. A Mexican tolerance of
0.01 ppm is established for fomesafen residues in or on ``beans''.
VI. Conclusion
Therefore, the tolerance is established for residues of fomesafen
in snap beans at 0.05 ppm.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by September 8, 1997 file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
Confidential Business Information (CBI). Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300512] (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 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
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.
[[Page 36684]]
IX. Regulatory Assessment Requirements
This final rule establishes a tolerance 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 tolerance 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 acations published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
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 Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 30, 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 180.433 is amended by designating the existing text as
paragraph (a) and adding a heading, by adding paragraph (b), and by
adding and reserving paragraphs (c) and (d) to read as follows:
Sec. 180.433 Sodium salt of fomesafen; tolerance for residues.
(a) General . * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of the herbicide fomesafen, in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. The tolerances will expire on the dates specified in the
following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Bean, snap...................... 0.05 June 30, 1998
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-17933 Filed 7-8-97; 8:45 am]
BILLING CODE 6560-50-F