[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Rules and Regulations]
[Pages 61639-61645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30383]


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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.

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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: [email protected]. 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: 
[email protected].

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* of 1.9  x  10-1 (mg/kg/
day)-1. 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  10-7. 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  
10-7. 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  10-7. 
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 (g)/
Liter (L). The level of 1.0 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 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 g/L)  x  
(10-3 mg/g)  x  (2 L/day consumed) divided by (70 
kg body weight).
    Child Exposure = (chemical concentration in g/L)  x  
(10-3 mg/g)  x  (1 L/day consumed) divided by (10 
kg body weight).
    Adult exposure is thus calculated to be 2.9  x  10-5 mg/
kg/day and exposure of children is calculated to be 1.0  x  
10-4 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  10-6. 
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  
10-7. 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  
10-6. 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-
[email protected].

    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