[Federal Register Volume 62, Number 143 (Friday, July 25, 1997)]
[Rules and Regulations]
[Pages 39967-39974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19668]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300516; FRL-5732-3]
RIN 2070-AB78
Sodium Salt of Acifluorfen; Pesticide Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for the
combined residues of the sodium salt of acifluorfen and its metabolites
in or on lima beans, cowpeas, and southern peas . This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on lima beans, cowpeas, and southern peas. This
regulation establishes a maximum permissible level for residues of the
sodium salt of acifluorfen in these food commodities 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 tolerances will
expire and are revoked on December 31, 1998.
DATES: This regulation is effective July 25, 1997. Objections and
requests for hearings must be received by EPA on or before September
23, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300516], 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
[[Page 39968]]
by the docket control number, [OPP-300516], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 1132,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300516]. 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: Olga Odiott, 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) 308-9363, e-mail:
odiott.olga@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 tolerances for
the combined residues of the herbicide sodium salt of acifluorfen and
its metabolites (the corresponding acid, methyl ester and amino
analogues), in or on lima beans, cowpeas, and southern peas at 0.1 part
per million (ppm). These tolerances will expire and are revoked on
December 31, 1998. EPA will publish a document in the Federal Register
to remove the revoked tolerances 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 tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for the Sodium Salt of Acifluorfen on Lima
Beans, Cowpeas, and Southern Peas and FFDCA Tolerances
According to the Tennessee Extension Service the Hophornbeam
copperleaf (Acalypha ostryaefolia) has become such an overwhelming pest
that entire fields were abandoned in 1995. The fields in question
constitute some of the most fertile agricultural land in West
Tennessee, an area where farming and agriculturally related businesses
are the primary sources of income. The Applicant stated that registered
herbicides and/ or cultivation practices do not provide effective
control of this weed. The State is concerned that uncontrolled
Hophornbeam copperleaf could have a devastating effect for growers and
the local economy. EPA has authorized under FIFRA section 18 the use of
acifluorfen on lima beans, cowpeas, and southern peas for control of
Hophornbeam copperleaf in Tennessee. After having reviewed the
submission, EPA concurs that emergency conditions exist for this state.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of the acifluorfen in or on
lima beans, cowpeas, and southern peas. In doing so, EPA considered the
new safety standard in FFDCA section 408(b)(2), and EPA decided that
the necessary tolerance under FFDCA section 408(l)(6) would be
consistent with the new safety standard and with FIFRA section 18.
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 December 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 lima beans, cowpeas, and southern peas
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 acifluorfen meets EPA's
registration requirements for use on
[[Page 39969]]
lima beans, cowpeas, and southern peas or whether a permanent tolerance
for this use would be appropriate. Under these circumstances, EPA does
not believe that this tolerance serves as a basis for registration of
acifluorfen 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 Tennessee 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 acifluorfen, contact the Agency's Registration Division
at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute'', ``short-term'',
``intermediate term'', and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High-end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level.
[[Page 39970]]
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 (children 1 -6
years 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
acifluorfen and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for the
combined residues of the sodium salt of acifluorfen and its metabolites
( the corresponding acid, methyl ester, and amino analogues) in or on
lima beans, cowpeas, and southern peas at 0.1 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 acifluorfen are
discussed below.
1. Acute toxicity. An acute dietary endpoint was not identified
from the toxicity studies available to the Agency; therefore, this risk
assessment was not conducted.
2. Short - and intermediate - term toxicity. Based on the
available data, the Office of Pesticide Programs (OPP) has determined
that the NOEL of 300 mg/kg/day from a 21-day dermal toxicity study in
rabbits should be used to assess risks from short- and intermediate-
term dermal exposures. The Lowest Effect Level (LEL) of 1,000 mg/kg/day
was based on increased mortality (95%) by Day 8. For short- and
intermediate-term inhalation toxicity, the OPP has determined that the
NOEL of 20 mg/kg/day from a developmental toxicity study in rabbits
should be used to assess risks for residential exposure scenarios. The
LEL of 90 mg/kg/day was based on reduced mean fetal weights.
3. Chronic toxicity. EPA has established the RfD for acifluorfen at
0.013 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 2-
generation reproductive toxicity study in rats. The NOEL (parental and
reproductive) of 1.25 mg/kg/day was based on decreased survival and an
increased incidence of kidney lesions at the LEL of 25.0 mg/kg/day. A
100-fold uncertainty factor (UF) was added to account for inter-species
extrapolation and intra-species variability .
4. Carcinogenicity. Acifluorfen has been classified as a Group B2
(probable human carcinogen) chemical by the OPP Cancer Peer Review
Committee (CPRC), based on an increased number of liver tumors in both
sexes of mice and a high incidence of uncommonly occurring stomach
papillomas in male mice. The Committee recommended using the
Q1* approach for quantification of human risk. The
Q1* is 0.11 (mg/kg/day)-1.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.383) for the combined residues of the sodium salt of
acifluorfen and its metabolites (the acid, methyl ester, and amino
analogues), in or on peanuts, rice, and soybeans at 0.1 ppm;
strawberries at 0.05 ppm; and, animal commodities at 0.02 ppm. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from acifluorfen as follows:
Chronic exposure and risk. This chronic dietary risk assessment was
partially refined using percent crop-treated estimates and anticipated
residue values for selected commodities. Expansion of these refinements
to the remaining commodities would result in a lower chronic dietary
exposure estimate. The risk assessment took into account the published
tolerances (none are currently pending) for the regulable residues of
the sodium salt of acifluorfen, plus this Section 18 tolerance. The
population subgroup with the largest percentage of the RfD occupied is
children 1 to 6 year old, at 0.4% of the RfD.
2. From drinking water. Based on available data used in EPA's
assessment of environmental risk, acifluorfen (acid) is persistent,
readily leaches, and is highly mobile. No Maximum Contaminant Level is
established for acifluorfen residues in drinking water. Health Advisory
Levels for acifluorfen residues in drinking water are established as
follows: for a 10-kg child, a range of 2 mg/L from 1-day exposure to
0.1 mg/L for longer-term exposure up to 7 years; for a 70-kg adult, 0.4
mg/L for longer-term exposure.
Information in the EPA Pesticides in Groundwater Database indicates
that a total of 1,185 discrete wells in 8 states (AR, CA, GA, IA, LA,
MS, VA, WA) were sampled for residues of acifluorfen during the period
1984-1991. Detectable residues were reported (0.003-0.025 g/L)
in only 0.3% of the sampled wells.
Chronic exposure and risk. The EPA has calculated chronic exposure
levels to acifluorfen residues in drinking water for the U.S.
population and children. The Agency estimated adult exposure to be 0.7
x 10-6 mg/kg/day and child exposure to be 2.5 x
10-6 mg/kg/day. The Agency used very conservative
assumptions for the exposure assessments. EPA used the highest
acifluorfen residue level (0.025 ug/L) found from the monitoring of
1,185 wells over an 8-year period in the 8 states mentioned above to
estimate exposure. In addition, all the drinking water consumed in the
US was assumed to contain this high end level of acifluorfen residues
(even though only 0.3% of all the wells monitored from 1984-91
contained detectable residues of acifluorfen). The Agency estimated
that the chronic dietary risks from drinking water will utilize <0.01% of="" [[page="" 39971]]="" the="" rfd="" for="" adults="" and=""><0.02% of="" the="" rfd="" for="" children.="" 3.="" from="" non-dietary="" exposure.="" acifluorfen="" is="" currently="" registered="" for="" use="" on="" the="" following="" outdoor="" residential="" sites:="" ornamentals="" (flowering="" plants,="" plants,="" lawns,="" woody="" shrubs);="" mulch;="" and,="" walkways,="" paths,="" trails,="" lanes,="" and="" private="" roads.="" based="" on="" the="" nature="" of="" the="" outdoor="" uses,="" the="" epa="" concludes="" that="" acute="" and="" chronic="" exposure="" scenarios="" do="" not="" exist="" for="" acifluorfen.="" a="" short-="" and/or="" intermediate-="" term="" exposure="" scenario="" may="" exist.="" short-="" and="" intermediate-term="" exposure="" and="" risk.="" the="" outdoor="" residential="" uses="" of="" acifluorfen="" may="" constitute="" a="" short-="" and/or="" intermediate-term="" exposure="" scenario,="" but="" the="" agency="" currently="" lacks="" residential-related="" exposure="" data="" to="" complete="" a="" comprehensive="" residential="" risk="" assessment="" of="" acifluorfen.="" 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).="" acifluorfen="" is="" a="" member="" of="" the="" diphenyl="" ether="" group="" of="" herbicides.="" other="" members="" include="" bifenox,="" diclofop="" methyl,="" fomesafen,="" lactofen,="" nitrofen,="" and="" oxyfluorfen.="" acifluorfen="" is="" a="" major="" metabolite="" of="" lactofen="" in="" plants,="" and="" is="" assumed="" to="" share="" a="" common="" mechanism="" of="" toxicity="" with="" lactofen.="" at="" present,="" there="" is="" not="" sufficient="" information="" to="" determine="" if="" any="" other="" pesticides="" may="" also="" share="" this="" common="" mechanism="" of="" toxicity.="" for="" purposes="" of="" this="" section="" 18="" time-limited="" tolerance="" action,="" the="" agency="" has="" not="" assumed="" that="" acifluorfen="" and="" lactofen="" have="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances.="" to="" estimate="" the="" cumulative="" (acifluorfen="" +="" lactofen)="" aggregate="" (food="" +="" water)="" dietary="" and="" cancer="" exposures,="" estimates="" for="" lactofen="" on="" its="" regulated="" commodities="" (snap="" beans,="" soybeans,="" and="" cottonseed)="" were="" added="" to="" estimates="" for="" acifluorfen="" (encompassing="" all="" its="" established="" plant="" and="" animal="" commodity="" tolerances="" and="" the="" tolerance="" proposed="" for="" this="" section="" 18="" use).="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" chronic="" risk.="" using="" the="" arc="" exposure="" assumptions="" described="" above,="" and="" taking="" into="" account="" the="" completeness="" and="" reliabilty="" of="" the="" toxicity="" data,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" acifluorfen="" from="" food="" and="" water="" will="" utilize="">0.2% (0.2% from
food + 0.01% from water) of the RfD for the U.S. population.
The chronic dietary (food only) risk assessment for lactofen was
based on percent crop-treated values for soybeans and anticipated
residue estimates for soybeans, snap beans, and cottonseed. Using these
partially refined exposure assumptions, the Agency determined that
chronic dietary (food only) exposure will utilize <1% of="" the="" rfd="" for="" lactofen="" (established="" at="" 0.02="" mg/kg/day)="" for="" the="" u.s.="" population.="" the="" agency="" determined="" that="" exposure="" to="" lactofen="" from="" drinking="" water="" will="" utilize=""><1% of="" the="" rfd.="" this="" assessment="" was="" based="" on="" acifluorfen="" monitoring="" data.="" the="" aggregate="" chronic="" (food="" +="" water)="" dietary="" exposure="" contributed="" by="" lactofen="" residues="" will="" utilize=""><2%><0.0004 mg/kg/day)="" of="" the="" lactofen="" rfd="" (and="" corresponds="" to="" 3%="" of="" the="" acifluorfen="" rfd).="" the="" cumulative="" (acifluorfen="" +="" lactofen)="" aggregate="" chronic="" dietary="" (food="" +="" water)="" exposure="" was="" estimated="" to="" be="" on="" the="" order="" of="" 3="" -="" 4%="" of="" the="" rfd="" for="" acifluorfen.="" 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.="" there="" are="" no="" registered="" indoor="" residential="" uses="" of="" acifluorfen="" and="" the="" agency="" has="" determined="" that="" chronic="" exposure="" scenarios="" do="" not="" exist="" for="" the="" the="" outdoor="" residential="" uses="" of="" acifluorfen.="" lactofen="" is="" not="" registered="" for="" residential="" uses.therefore,="" residential="" exposure="" is="" not="" considered="" to="" be="" a="" contributing="" factor="" to="" cumulative="" aggregate="" chronic="" exposure.="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" cumulative="" chronic="" aggregate="" exposure="" to="" lactofen="" and="" the="" sodium="" salt="" of="" acifluorfen="" residues.="" 2.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" there="" are="" no="" registered="" residential="" uses="" of="" lactofen.="" there="" are="" no="" registered="" indoor="" uses="" of="" acifluorfen.="" although="" the="" outdoor="" residential="" uses="" of="" acifluorfen="" may="" constitute="" a="" short-="" and/or="" intermediate-term="" exposure="" scenario,="" the="" agency="" currently="" lacks="" sufficient="" residential-="" related="" exposure="" data="" to="" complete="" a="" comprehensive="" residential="" risk="" assessment="" for="" many="" pesticides,="" including="" acifluorfen.="" based="" on="" the="" low="" percentage="">3 - 4%) of the RfD occupied
by the cumulative (lactofen + acifluorfen) aggregate dietary exposure,
and in the best scientific judgment of the EPA, the short- and
intermediate-term aggregate exposure to residues of lactofen and the
sodium salt of acifluorfen will not exceed the Agency's level of
concern.
D. Aggregate Cancer Risk for U.S. Population
Based on published tolerances (none are currently pending), and
this proposed Section 18 use, the dietary (food only) cancer risk from
/acifluorfen residues was calculated as 0.65 x 10-6 (upper
bound estimate). The calculation used the partially refined exposure
[[Page 39972]]
assumptions described above for generating ARCs, and amortized the
cancer risk over a 70-year lifetime. The drinking water cancer risk
from acifluorfen residues was estimated as 0.08 x 10-6.
The aggregate dietary (food + water) cancer risk from exposure to
acifluorfen residues is thus 0.73 x 10-6.
Based on the tolerances for lactofen (a B2 carcinogen with a
Q1* of 0.17 (mg/kg/day)-1) in/on snap beans,
soybeans, and cottonseed, the dietary (food only) cancer risk from
residues of lactofen was estimated as 0.45 x 10-6 (upper
bound) for the U.S. population. For this analysis the Agency used
percent crop-treated values for soybeans only and anticipated residue
estimates for all 3 crops. The drinking water cancer risk estimate for
lactofen was based on the acifluorfen monitoring data discussed above.
As previously indicated, the drinking water cancer risk from
acifluorfen residues was estimated as 0.08 x 10-6. The
cumulative (lactofen + acifluorfen) aggregate (food + water) upper
bound lifetime dietary cancer risk for the U.S. population from
exposure to acifluorfen and lactofen residues is thus the sum of:
Acifluorfen (food)--0.65 x 10-6
Lactofen (food)--0.45 x 10-6
Acifluorfen/Lactofen (water)--0.08 x 10-6
Cumulative Aggregate Total:--1.2 x 10-6
This cumulative aggregate dietary cancer risk of 1.2 x
10-6 for the U.S. population from exposure to acifluorfen
and lactofen is considered by EPA to be a very conservative estimate
because:
(1) The chronic/cancer analyses for acifluorfen and lactofen were
only partially refined by use of anticipated residue estimates and
percent crop-treated (%CT) values on selected commodities, and are thus
over-estimates of exposure.
(2) Lactofen use on snap beans is currently limited to Oregon and
Tennesse, which comprises only approximately 20% of the U.S. production
(for processing, in tons; approximately 12% based on acres planted; Ag.
Stat. 1992), so use of actual %CT values would be expected to
significantly reduce the estimate of exposure; snap beans represents
88% of the lactofen dietary (food) cancer risk contributions.
(3) Exposure estimates for lactofen/soybeans and acifluorfen/
soybeans were treated as additive for purposes of assessing cumulative
risk, and thus are likely an over-estimate of exposure,
(4) Tolerance levels for acifluorfen and lactofen are based on a
summing of the method sensitivity levels for each component of their
respective regulable residues, and do not reflect the presence of
detectable residues.
In fact, there is a consistent absence of quantifiable residues in
crops treated with either acifluorfen or lactofen.
For these reasons, the EPA considers that the cumulative (lactofen
+ acifluorfen) aggregate (food + water) upper bound dietary cancer risk
estimate of 1.2 x 10-6 for the U.S. population from
exposure to acifluorfen and lactofen represents a worst case scenario.
Further refinement would result in a lower risk estimate. In the best
scientific judgment of the Agency, this cumulative aggregate dietary
cancer risk estimate does not exceed the Agency's level of concern, and
EPA concludes that there is a reasonable certainty that no harm in the
form of cancer will result from cumulative aggregate exposure to
acifluorfen and lactofen residues.
The EPA notes that there are no registered indoor or outdoor
residential uses of lactofen, no registered indoor uses of acifluorfen,
and that the registered outdoor residential uses of acifluorfen are not
considered by the Agency to constitute a chronic exposure scenario.
Thus, no non-dietary, non-occupational chronic exposure to acifluorfen
or lactofen is expected, or is a factor in cumulative aggregate cancer
risk.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- a. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of acifluorfen, EPA considered data from
developmental toxicity studies in the rat and rabbit and a two-
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 for combined inter- and intra-species
variability) and not the additional 10-fold 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.
b. Developmental toxicity studies--Rats. The maternal (systemic)
NOEL was 90 mg/kg/day, based on decreased body weight at the Lowest
Observed Effect Level (LOEL) of 180 mg/kg/day, the highest dose tested
(HDT). The developmental (fetal) NOEL was 20 mg/kg/day, based on
decreased fetal weight at the LOEL of 90 mg/kg/day.
Rabbits. Both the maternal (systemic) and developmental NOEL were
36 mg/kg/day at the HDT.
c. Reproductive toxicity study. In a 2-generation reproductive
toxicity study in rats, both the parental (systemic) and reproductive
(pup) NOEL were 1.25 mg/kg/day, based on decreased survival and an
increased incidence of kidney lesions at the LOEL of 25.0 mg/kg/day.
d. Pre- and post-natal sensitivity. The toxicological data base for
evaluating pre- and post-natal toxicity for acifluorfen is complete
with respect to current data requirements. The available data indicate
that no developmental or maternal toxicity was observed in rabbits at
the highest dose tested (36 mg/kg/day).
In the developmental toxicity study in rats, an increased
sensitivity to acifluorfen was seen in developing fetuses as evidenced
by decreased fetal weights at the NOEL of 20 mg/kg/day (LOEL = 90 mg/
kg/day). Maternal toxicity was observed at the highest dose tested
(LOEL = 180 mg/kg/day) and was based on decreased body weight. Based on
these findings, an additional UF (3X or 10X) would be justified in
order to be protective of infants and children. However, a 100-fold UF
has already been applied to the RfD NOEL of 1.25 mg/kg/day, and the
developmental NOEL is more than 16-fold greater than the RfD NOEL.
Therefore, an additional UF does not appear to be necessary.
There was no parental or reproductive toxicity observed in a 2-
generation reproductive toxicity study in rats at doses up to 150 mg/
kg/day (HDT).
e. Conclusion. The cumulative data discussed above indicates
minimal concern for developmental or reproductive toxicity. Thus, these
data
[[Page 39973]]
support use of the standard uncertainty factor of 100 and an additional
safety factor is not needed to protect infants and children.
2. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate dietary (food +
water) exposure to acifluorfen will utilize 0.4% (up to
0.4% from food + 0.02% from water) of the RfD for
any of the infant and children subgroups of the U.S. population.
The Agency estimated that the dietary (food) exposure to lactofen
residues willl utilize <1% of="" the="" rfd="" (the="" rfd="" for="" lactofen="" is="" 0.02="" mg/="" kg/day)="" for="" any="" of="" the="" infant="" and="" children="" subgroups="" of="" the="" u.s.="" population="" (based="" on="" percent="" crop-treated="" values="" for="" soybeans="" and="" anticipated="" residue="" estimates="" for="" soybeans,="" snap="" beans,="" and="" cottonseed).="" the="" dietary="" (water)="" exposure="" of="" children="" to="" lactofen="" was="" based="" on="" acifluorfen="" monitoring="" data,="" and="" estimated="" as=""><1% of="" the="" rfd.="" the="" chronic="" aggregate="" (food="" +="" water)="" dietary="" exposure="" contributed="" by="" lactofen="" tolerances="" is="" thus=""><2%><0.0004 mg/kg/day)="" of="" the="" lactofen="" rfd="" (and="" corresponds="" to="" 3%="" of="" the="" acifluorfen="" rfd).="" cumulative="" (acifluorfen="" +="" lactofen)="" chronic="" aggregate="" (food="" +="" water)="" dietary="" exposure="" for="" infants="" and="" children="" is="" thus="" on="" the="" order="" of="" 3-4%="" of="" the="" rfd="" of="" acifluorfen.="" there="" are="" no="" registered="" indoor="" residential="" uses="" of="" acifluorfen.="" epa="" believes="" that="" the="" outdoor="" residential="" uses="" of="" acifluorfen="" do="" not="" constitute="" a="" chronic="" exposure="" scenario.="" lactofen="" is="" not="" registered="" for="" residential="" uses.="" therefore,="" residential="" exposure="" will="" not="" be="" a="" contributing="" factor="" to="" cumulative="" chronic="" aggregate="" exposure="" to="" infants="" and="" children.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" cumulative="" chronic="" aggregate="" exposure="" to="" lactofen="" and="" acifluorfen="" residues.="" 3.="" short-="" or="" intermediate-term="" risk.="" there="" are="" outdoor="" residential="" uses="" of="" acifluorfen,="" and="" these="" may="" constitute="" a="" short-="" and/or="" intermediate-term="" exposure="" scenario,="" but="" the="" agency="" currently="" lacks="" residential-related="" exposure="" data="" to="" complete="" a="" comprehensive="" residential="" risk="" assessment="" of="" acifluorfen.="" based="" on="" the="" lack="" of="" an="" identified="" acute="" toxicological="" endpoint="" for="" acifluorfen,="" and="" the="" low="">3-4%) percentage of the acifluorfen RfD occupied by
cumulative (lactofen + acifluorfen) aggregate (food + water) dietary
exposure for any of the infant and children subgroups of the U.S.
population, in the best scientific judgment of EPA, short- and/or
intermediate-term cumulative aggregate exposure of acifluorfen and
lactofen to infants and children will not exceed the Agency's level of
concern.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in rice and goats is adequately
understood. Additional metabolism studies have been requested. At
present, the residue of concern in plants and animals is considered to
be as specified in 40 CFR 180.383 .
B. Analytical Enforcement Methodology
Adequate enforcement methodology (GLC/ECD and GLC/MS) is available
in the Pesticide Analytical Manual, Volume II, Methods 180.383 I and A,
to enforce the tolerance expression of 40 CFR 180.383.
C. Magnitude of Residues
Combined residues of the sodium salt of acifluorfen and its
regulated metabolites are not expected to exceed 0.1 ppm in/on lima
beans, southern peas, or cowpeas as a result of use under this Section
18 program. According to Table 1 of the OPPTS Test Guidelines, Series
860, Residue Chemistry, 8/96, there are no processed commodities
associated with lima beans, southern peas, or cowpeas. Cowpea seed,
forage, and hay are the only livestock feedstuffs associated with this
Section 18 action and, in the absence of residue data, their use for
feed or forage is being restricted under this Section 18 program. For
the purpose of this Section 18 program and its limited acreage, the EPA
will prohibit the use of treated plants for feed or forage. Thus,
secondary residues in animal commodities are not expected to exceed
existing tolerances as a result of this Section 18 use.
D. International Residue Limits
There are no Codex, Canadian, or Mexican maximum residue limits
established for acifluorfen.
E. Rotational Crop Restrictions
Under this Section 18 use, in case of crop failure, only peanuts,
soybeans, rice, lima beans, southern peas, or cowpeas may be
immediately replanted. Further plantback restrictions, applying to
crops without acifluorfen tolerances, are listed on the federal label,
and are also to be followed under this Section 18 program.
VI. Conclusion
Therefore, the tolerance is established for the combined residues
of the sodium salt of acifluorfen and its metabolites (the acid, methyl
ester, and amino analogues) in or on lima beans, cowpeas, and southern
peas at 0.1 ppm.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by September 23, 1997, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as
Confidential Business Information (CBI). Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for
[[Page 39974]]
inclusion in the public record. Information not marked confidential may
be disclosed publicly by EPA without prior notice.
VIII. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300516] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes time-limited tolerances under FFDCA
section 408(l)(6) response to a petition submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). This final rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance acations published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 10, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority : 21 U.S.C. 346a and 371.
2. Section 180.383 is amended as follows:
i. By designating the existing text as paragraph (a) and adding a
heading.
ii. By adding paragraph (b).
iii. By adding the headings and reserving paragraphs (c) and (d).
Section 180.383, as amended, reads as follows:
Sec. 180.383 Sodium salt of acifluorfen; tolerances for residues.
(a) General. * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues of the herbicide sodium salt of
acifluorfen and its metabolites (the corresponding acid, methyl ester,
and amino analogues) in connection with use of the pesticide under
section 18 emergency exemptions granted by EPA. The tolerances will
expire and are revoked on the dates specified in the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Cowpeas........................ 0.1 December 31, 1998
Lima beans...................... 0.1 December 31, 1998
Southern peas................... 0.1 December 31, 1998
------------------------------------------------------------------------
(c) Tolerances with regional restrictions. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-19668 Filed 7-24-97; 8:45 am]
BILLING CODE 6560-50-F
