FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Fomesafen Index PageFomesafen. November 19, 1997. Pesticide Tolerances for Emergency Exemptions for residues in or on dry beans at 0.05 ppm. Final Rule. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-19/p30383.htm
[Federal Register: November 19, 1997 (Volume 62, Number 223)]
[Rules and Regulations]
[Page 61639-61645]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no97-15]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300571; FRL-5752-8]
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 dry beans. This action is in response to
EPA's granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on dry 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 October 31, 1998.
DATES: This regulation is effective November 19, 1997. Objections and
requests for hearings must be received by EPA on or before January 20,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300571], 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-300571], 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. 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-300571]. 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 dry beans at 0.05 part
per million (ppm). This tolerance will expire and is revoked on October
31, 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 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.
[[Page 61640]]
II. Emergency Exemption for Fomesafen on Dry Beans and FFDCA
Tolerances
Requests were received from a number of states for use of fomesafen
on dry 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 dry beans for control of broadleaf weeds in Maine, Michigan, and New
York. 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 fomesafen in or on dry
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
October 31, 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 dry 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 dry 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 Maine, Michigan, and New York 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 effectlevel'' 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 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 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
[[Page 61641]]
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 dry 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 developmental LOEL of 50 mg/kg/day, fetuses
had delayed or partial ossification and extra ribs. Since the effect of
concern is developmental, the risk assessment will evaluate acute
dietary risk to the population subgroup of concern, Females 13+ Years
Old.
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- and intermediate-term margins of exposure
(MOEs). At the LOEL 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 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<SUP>*</SUP> of 1.9 x 10<SUP>-1</SUP> (mg/kg/
day)<SUP>-1</SUP>. This classification was based on: (i) Increases in
both adenomas and carcinomas at several dose levels in both sexes of
mice; (ii) some evidence of reduced latency for the time of tumor
appearance; (iii) limited evidence of mutagenic effects; and, (iv) 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 permanent tolerance has been
established (40 CFR 180.433) for the residues of fomesafen, in or on
soybeans at 0.05 ppm. A time-limited tolerance was also established on
snap beans at 0.05 ppm recently, in connection with use under several
emergency exemptions. 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 percent of crop treated.
The resulting high-end exposure estimate of 0.0002 mg/kg/day translates
to a dietary MOE
[[Page 61642]]
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. For assessing chronic exposure and
risks, anticipated residue values for all commodities were used; and
percent of crop treated information for soybeans only; it was assumed
that 100 percent of the snap bean crop in the eastern United States
(the region where exemptions were issued, equivalent to 75 percent of
the domestic snap bean crop), and 100 percent of the dry bean crops
were treated. Based upon this, the existing uses on soybeans, snap
beans, and dry beans result in an ARC that is equivalent to the
following percentages of the RfD: U.S. population, 0.3%; Nursing
Infants, 0.3%; Non-nursing Infants (<1 year old), 0.8%; Children (1-6
years old), 0.7%; and Children (7-12 years old), 0.5%. Additional
refinement using percent of crop treated information for all
commodities 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, as
described above, was performed for the U.S. population. The calculated
food cancer risk from the established tolerances (excludes this action)
is 8.5 x 10<SUP>-7</SUP>. This is an overestimate, as not all of the
snap bean crop in the eastern United States will be treated with
fomesafen. The incremental contribution to the dietary cancer risk
posed by this use on dry beans, amortized over 5 years (the average
duration of a section 18 exemption, including repeat uses), is 0.5 x
10<SUP>-7</SUP>. Therefore, the total of the fomesafen dietary cancer
risk for the U.S. population from all commodity contributions,
including this new tolerance on dry beans, is 9.0 x 10<SUP>-7</SUP>.
It should be noted that this is an overestimation of risk, because not
all of the snap bean crops in the eastern United States, nor all of the
dry bean crops in the United States, 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 established 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 (<greek-m>g)/
Liter (L). The level of 1.0 <greek-m>g/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 <greek-m>g/L (equal
to the limit of determination of the analytical method).
Exposures and risks from residues of fomesafen in drinking water
were calculated, as follows:
Adult Exposure = (chemical concentration in <greek-m>g/L) x
(10<SUP>-3 </SUP>mg/<greek-m>g) x (2 L/day consumed) divided by (70
kg body weight).
Child Exposure = (chemical concentration in <greek-m>g/L) x
(10<SUP>-3</SUP> mg/<greek-m>g) 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 of 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+ Years Old), 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 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).
[[Page 61643]]
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
Old), the calculated aggregate MOE value is 23,000. The aggregate MOE
is the reciprocal of the sum of the reciprocal of the MOEs for food
(25,000) and water (260,000). This aggregate MOE does not exceed EPA's
level of concern for acute dietary exposure.
2. Chronic risk. Using the ARC exposure assumptions described
above, EPA has concluded that aggregate exposure to fomesafen from food
will utilize 1.5% (0.3% 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 Non-Nursing Infants, 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 and
dry bean crop in the eastern United States 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.
E. 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 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 maternal pesticide exposure during 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 100-
fold safety factor (usually 100 for combined inter- and intra-species
variability) and not the additional tenfold safety 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 safety factor.
ii. 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 fetal
(developmental) NOEL was 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 fetal (developmental) NOEL was
established at 40 mg/kg/day (highest dose tested, no effects seen).
iii. Reproductive toxicity study. In the 2-generation 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.
iv. 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
Old. The MOE of 23,000 obtained for this risk assessment demonstrates
that acute developmental (pre-natal) risks are low.
v. 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. Therefore, EPA recommends applying an extra 10-
fold uncertainty (safety) factor in the chronic risk analysis. The low
percentage of the RfD occupied by the most highly exposed child
subgroup (4.8% of the RfD; 48% using the extra 10-fold factor)
demonstrates that post-natal risks to infants and children are low.
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
[[Page 61644]]
exposure. The large aggregate 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 4.3% of the RfD for nursing infants
up to 4.8% 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 43% and 48% 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, Use the following paragraph or delete and
insert applicable text. and 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 concern is fomesafen per se. Secondary
residues in meat, milk, poultry, and eggs are not expected, since dry
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
dry 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 dry beans. A Mexican tolerance of
0.01 ppm is established for fomesafen residues in or on ``beans.''
E. Rotational Crop Restrictions
The federally registered label for the fomesafen product requested
under these exemptions carries the following rotational crop
restrictions: 4 months for small grains; 10 months for corn, cotton,
peanuts, and rice; and 18 months for all other crops, particularly
sunflowers, sugar beets, and sorghum. Part of the use restrictions for
these exemptions includes that all applicable restrictions on the
federal label must be followed; this includes these rotational crop
restrictions.
VI. Conclusion
Therefore, the tolerance is established for residues of fomesafen
in dry 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 January 20, 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
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 and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300571] (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 (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, 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
[[Page 61645]]
address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under FFDCA
section 408(l)(6). 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 under FFDCA section 408 (l)(6), 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 actions 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: October 22, 1997.
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. In Sec. 180.433, by alphabetically inserting the following item
into the table in paragraph (b) to read as follows:
Sec. 180.433 Sodium salt of fomesafen; tolerance for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * * * *
Beans, dry...................... 0.05 10/31/98
------------------------------------------------------------------------
* * * * *
[FR Doc. 97-30383 Filed 11-18-97; 8:45 am]
BILLING CODE 6560-50-F