[Federal Register Volume 63, Number 115 (Tuesday, June 16, 1998)]
[Rules and Regulations]
[Pages 32753-32760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15746]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185 and 186

[OPP-300663; FRL-5793-5]
RIN 2070-AB78


Quizalofop-p ethyl ester; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxyl] propanoate), and its acid metabolite quizalofop-p 
[(R)-(2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxyl]propionate) and the S 
enantiomers of the ester and the acid, all expressed as quizalofop-p 
ethyl ester in or on canola seed, canola meal, peppermint tops and 
spearmint tops. DuPont Agricultural Products requested the tolerances 
for canola and the Interregional Research Project Number 4 (IR-4) 
requested the tolerances for peppermint and spearmint. These tolerances 
were requested under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996 (Pub. L. 104-170).

DATES: This regulation is effective June 16, 1998. Objections and 
requests for hearings must be received by EPA on or before August 17, 
1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300663], 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-300663], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [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 5.1/6.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300663]. 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: Sidney Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 305-7610; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register published on October 
29, 1997 (62 FR 56176 (mint)) (FRL-5749-7) and December 17, 1997, 62 FR 
66080 (canola)) (FRL-5758-3), EPA, issued notices pursuant to section 
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(e) announcing the filing of pesticide petitions (PP) 6E4652 and 
5F4545 for tolerances by the IR-4 and DuPont Agricultural Products, 
Wilmington, Delaware. These notices included a summary of the petitions 
prepared by DuPont Agricultural Products, Wilmington, Delaware, the 
registrant. There were no comments received in response to these 
notices of filing.
    The petitions requested that 40 CFR 180.441 be amended by 
establishing tolerances for combined residues of the herbicide 
quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxyl] propanoate), and its acid metabolite quizalofop-p 
[(R)-(2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxyl] propionate) and the 
S enantiomers of the ester and the acid, all expressed as quizalofop-p 
ethyl ester, in or on canola seed at 1.0 part per million (ppm), canola 
meal at 1.5 ppm, and peppermint tops and spearmint tops at 2.0 ppm. .

I. Risk Assessment and Statutory Findings

    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and

[[Page 32754]]

children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 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 
three 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

[[Page 32755]]

pesticides that have established tolerances. If the TMRC exceeds the 
RfD or poses a lifetime cancer risk that is greater than approximately 
one in a million, EPA attempts to derive a more accurate exposure 
estimate for the pesticide by evaluating additional types of 
information (anticipated residue data and/or percent of crop treated 
data) which show, generally, that pesticide residues in most foods when 
they are eaten are well below established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup was not 
regionally based.

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action, EPA has sufficient data to assess the hazards of 
quizalofop-p ethyl ester and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for a tolerance for 
combined residues of quizalofop-p-ethyl ester on canola seed at 1.0 
ppm, canola meal at 1.5 ppm, and peppermint tops and spearmint tops at 
2.0 ppm. EPA's assessment of the dietary exposures and risks associated 
with establishing the tolerances 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 quizalofop-p ethyl 
ester are discussed below.
    1. Acute toxicity. Acute toxicology studies include: acute oral 
toxicity (lethal dose) (LD50s) at 1,480 and 1,670 milligrams 
(mg)/kilogram (kg) for female and male rats, respectively); eye 
irritation (not an eye irritant); dermal toxicity (LD50 > 
5,000 mg/kg in rats); inhalation toxicity (lethal concentration) 
(LC50 = 5.8 mg/liter(L)in rats); and dermal irritation (not 
a dermal sensitizer).
    2. Genotoxicity. Quizalofop ethyl was negative in the following 
genotoxicity tests: bacterial gene mutation assays (Ames assay); 
chromosomal aberration assays in Chinese hamster ovary (CHO) cells; 
unscheduled DNA synthesis; and combinant assays and reversion assay in 
Salmonella.
    3. Reproductive and developmental toxicity. A developmental 
toxicity study in rats administered dosage levels of 0, 30, 100, and 
300 mg/kg/day. The maternal toxicity NOEL was 30 mg/kg/day and a 
developmental toxicity NOEL was greater than 300 mg/kg/day, highest 
dose tested (HDT). The maternal NOEL was based on reduced food 
consumption and body weight, and increased liver weights. There were no 
developmental effects observed.
    A developmental toxicity study in rabbits administered dosage 
levels of 0, 7, 20, and 60 mg/kg/day with no developmental effects 
noted at 60 mg/kg/day (HDT). The maternal toxicity NOEL was established 
at 20 mg/kg/day based on decreased food consumption and body weight at 
60/mg/kg/day (HDT).
    In a two-generation reproductive toxicity study, Sprague-Dawley 
rats were fed diets containing quizalofop-p-ethyl at 0, 25, 100, or 400 
ppm (0, 1.25, 5.0, or 20 mg/kg/day respectively). The parental NOEL was 
100 ppm (5.0 mg/kg/day) and the lowest-observed effect level (LOEL) was 
400 ppm (20 mg/kg/day), based on decreased body weights in males of 
both generations. The developmental NOEL for effects on the offspring 
was 25 ppm (1.25 mg/kg/day) and the offspring developmental LOEL was 
100 ppm (5.0 mg/kg/day), based on increased incidence of eosinophilic 
changes in the livers of F2 weanling. In addition, at 400 ppm (20 mg/
kg/day), reductions in litter size, survival, body weights, and spleen 
weight were seen in offspring.
    4. Subchronic toxicity. A 90-day study was conducted in rats fed 
diets containing 0, 40, 128, 1,280 ppm (or approximately 0, 2, 6.4 and 
64 mg/kg/day, respectively). The NOEL was 2 mg/kg/day. This was based 
on increased liver weights at 6.4 mg/kg.
    A 90-day feeding study in mice was conducted with diets that 
contained 0, 100, 316 or 1,000 ppm (or approximately 0, 15, 47.4, and 
150 mg/kg/day, respectively). The NOEL was < 15 mg/kg/day (lowest dose 
tested) based on increased liver weights and reversible 
histopathological effects in the liver at the lowest dose tested.
    5. Chronic toxicity. An 18-month carcinogenicity study was 
conducted in CD-1 mice fed diets containing 0, 2, 10, 80 or 320 ppm (or 
approximately 0, 0.3, 1.5, 12, and 48 mg/kg/day, respectively). There 
were no carcinogenic effects observed under the conditions of the study 
at levels up to and including 12 mg/kg/day. A marginal increase in the 
incidence of hepatocellular tumors was observed at 48 mg/kg/day, the 
highest dose tested (HDT) which exceeded the maximum tolerated dose 
(MTD).
    A 2-year chronic toxicity/carcinogenicity study was conducted in 
rats fed diets containing 0, 25, 100 or 400 ppm (or 0, 0.9, 3.7, and 
15.5 mg/kg/day for males and 0, 1.1, 4.6, and 18.6 mg/kg/day for 
females, respectively). There were no carcinogenic effects observed 
under the conditions of the study at levels up to and including 18.6 g/
kg/day (HDT). The systemic NOEL was 0.9 mg/kg/day based on altered red 
cell parameters and slight/minimal centrilobuler enlargement of the 
liver at 3.7 mg/kg/day.
    A 1-year feeding study was conducted in dogs fed diets containing 
0, 25, 100 or 400 ppm (or approximately 0, 0.625, 2.5, or 10 mg/kg/day, 
respectively). The NOEL was greater than 10 mg/kg/day, the lowest dose 
tested (LDT).

B. Toxicological Endpoints

    1. Acute toxicity. There were no effects observed in oral toxicity 
studies that could be attributable to a single dose (exposure). 
Therefore, a dose and an endpoint have not been identified for this 
risk assessment. This risk assessment is not required. .
     2. Short - and intermediate - term toxicity. In a 21-day dermal 
toxicity study, New Zealand White rabbits (5/sex/dose) received 15 
repeated dermal applications (aqueous paste) of quizalofop-p-ethyl 
ester at doses of 0, 125, 600 or 2,000 mg/kg/day, 6 hours/day, 5 days/
week over a 21-day period. There was no dermal or systemic toxicity. 
The NOEL was 2,000 mg/kg/day. In addition, no maternal or developmental 
toxicity was observed following in utero exposures in rats and rabbits. 
These risk assessments are not required.
     3. Chronic toxicity. EPA has established the RfD for quizalofop-p 
ethyl ester at 0.009 mg/kg/day. This RfD is based on the 2-year feeding 
study in rats. Groups of male and female Sprague-Dawley rats (50/sex/
dose) were fed diets containing quizalofop-p-ethyl ester at 0, 25, 100 
or 400 ppm for 104 weeks. For chronic toxicity, the NOEL

[[Page 32756]]

was 25 ppm (0.9 mg/kg/day) and the LOEL was 100 ppm based on the 
occurrence of generalized hepatocyte enlargement in female rats and red 
blood cell destruction in males. In addition, there was generalized 
hepatocyte enlargement and red blood cell destruction in both sexes at 
400 ppm.
    RfD = 0.9 mg/kg/day (NOEL) = 0.009 mg/kg/day 100 (UF).
    4. Carcinogenicity. OPP's Health Effects Division, Carcinogenicity 
Peer Review Committee (CPRC) has evaluated the rat and mouse cancer 
studies for quizalofop-p ethyl ester along with other relevant short-
term toxicity, mutagenicity studies, and structure-activity 
relationships. The CPRC has classified quizalofop-p ethyl as a Group D 
carcinogen (not classifiable as to human cancer potential). The Group D 
classification is based on an approximate doubling in the incidence of 
mice liver tumors between controls and the high dose. This finding was 
not considered strong enough to warrant the classification of a 
Category C (possible human carcinogen): the increase was of marginal 
statistical significance, occurred at high dose which exceeded the MTD, 
and occurred in a study in which the concurrent control for liver 
tumors was somewhat low as compared to the historical controls, while 
the high dose control group was at the upper end of previous historical 
control groups. No new cancer studies are required for quizalofop-p 
ethyl ester at this time.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.441) for the combined residues of quizalofop-p ethyl ester and 
its acid metabolite quizalofop-p and the S enantiomers of the ester and 
the acid, all expressed as quizalofop-p ethyl ester in or on a variety 
of raw agricultural commodities. Tolerances are established for 
cottonseed at 0.1 ppm, lentils at 0.05 ppm. Time-limited tolerances are 
established for sugarbeet roots at 0.1 ppm, sugarbeet tops at 0.5 ppm, 
legume vegetables crop group at 0.25 ppm, and foliage of legume 
vegetables (except soybeans) at 3.0 ppm. Risk assessments were 
conducted by EPA to assess dietary exposures and risks from quizalofop-
p ethyl ester 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. There are no acute toxicological 
concerns for quizalofop-p ethyl ester.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment, EPA has made very conservative assumptions -- 100% of 
mint, canola, and all other commodities having quizalofop-p-ethyl ester 
tolerances will contain the regulable residues and those residues will 
be at the level of the tolerance. Thus, in making a safety 
determination for these tolerances, EPA is taking into account this 
conservative exposure assessment. The Dietary Risk Evaluation System 
(DRES) was used for the chronic dietary exposure analysis. The analysis 
evaluates individual food consumption as reported by respondents in the 
USDA 1977-78 Nationwide Food Consumption Survey (NFCS) and accumulates 
exposure to the chemical for each commodity. Regional consumption 
information is taken into account through EPA's computer-based model 
for evaluating the exposure of significant subpopulations including 
several regional groups. Review of these regional data allows the 
Agency to be reasonably certain that no regional population is exposed 
to residue levels higher than those estimated by the Agency.
    Existing tolerances and this rule for canola and mint result in a 
TMRC of 5.40 x 10-4 mg/kg/day for the U.S. general 
population (48 States), which represents 6.0% of the RfD. The use on 
canola will add a TMRC of 7.7 x 10-5 mg/kg/day, which 
represents 0.9% of the RfD for the U.S. population. The use on mint 
will add a TMRC of 2 x 10-6 mg/kg/day, which represents 
0.016% of the RfD. Existing tolerances and this rule result in a TMRC 
of 1.7 x 10-3 mg/kg/day for the highest exposed population 
subgroup (non-nursing infants <1 year old), which represents 19%. These 
tolerances for canola and mint will not contribute to the dietary 
burden of this population subgroup. Based on the risk estimates 
calculated, chronic dietary exposure does not exceed EPA's level of 
concern.
    2. From drinking water-- i. Acute exposure and risk. There are no 
acute toxicological concerns for quizalofop-p ethyl ester.
    ii. Chronic exposure and risk. Drinking water levels of concern 
(DWLOC) were calculated for chronic dietary exposure. To calculate the 
DWLOC, chronic dietary food exposure (from DRES analysis) was 
subtracted from the RfD. DWLOC were then calculated using default 
bodyweights and drinking water consumption figures. For adults, the 
estimate was based on a body weight of 60 kg (female)/70 kg(female) and 
consumption of 2 liters of water per day. For children, a body weight 
of 10 kg and a consumption of 1 liter of water per day were used. The 
DWLOC are calculated at 296 parts per billion (ppb) for the U.S. 
population, 256 ppb for females (13+ years old, not pregnant or 
nursing) and 73 ppb for infants and children. Agency estimates for 
quizalofop-p ethyl ester contamination is 8 ppb for surface water and 
0.15 ppb for groundwater. These levels are significantly less than 
levels of concern to EPA.
    3. From non-dietary exposure. Quizalofop-p ethyl ester is not 
registered for residential use sites.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Quizalofop-p ethyl is a member of the oxyphenoxy acid ester 
class of pesticides. Other members of this class include fluazifop-
butyl, diclofop-methyl, fenoxaprop-ethyl, and haloxyfop-methyl.
    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

[[Page 32757]]

in its files concerning common mechanism issues to most risk 
assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether quizalofop-p ethyl ester has a common mechanism of toxicity 
with other substances or how to include this pesticide in a cumulative 
risk assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
quizalofop-p ethyl ester does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that quizalofop-p ethyl ester 
has a common mechanism of toxicity with other substances.
    5. Endocrine disruption. EPA is required to develop a screening 
program to determine whether certain substances (including all 
pesticides and inerts) ``may have an effect in humans that is similar 
to an effect produced by a naturally occurring estrogen, or such other 
endocrine effect....''
    The Agency is currently working with interested stakeholders, 
including other government agencies, public interest groups, industry 
and research scientists in developing a screening and testing program 
and a priority setting scheme to implement this program. Congress has 
allowed 3 years from the passage of FQPA (August 3, 1999) to implement 
this program. EPA may require further testing of this active ingredient 
and end use products for endocrine disrupter effects.

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. There are no acute toxicological concerns for 
quizalofop-p ethyl ester.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to quizalofop-p ethyl 
ester from food will utilize 6.0% of the RfD for the U.S. population. 
The major identifiable subgroup with the highest aggregate exposure is 
non-nursing infants <1 year old at 19% of the RfD. 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 quizalofop-p ethyl ester in drinking water 
and from non-dietary, non-occupational exposure, EPA does not expect 
the aggregate exposure to exceed 100% of the RfD. EPA concludes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to quizalofop-p ethyl ester residues.

E. Aggregate Cancer Risk for U.S. Population

    The Agency has classified quizlopfop-p ethyl as a Category D 
chemical (not classifiable as to human cancer potential) based on 
results of rat and mouse cancer studies along with other relevant 
short-term toxicity, mutagenicity studies, and structure-activity 
relationships. The Group D classification is based on an approximate 
doubling in the incidence of mice liver tumors between controls and the 
high dose. This finding was not considered strong enough to warrant the 
classification of a Category C (possible human carcinogen): the 
increase was of marginal statistical significance, occurred at high 
dose which exceeded the MTD, and occurred in a study in which the 
concurrent control for liver tumors was somewhat low as compared to the 
historical controls, while the high dose control group was at the upper 
end of previous historical control groups. Based on results of the 
above adequate studies and the Category D classification, the Agency 
believes that any cancer risk posed by quizalofop-p ethyl is negligible 
and there is reasonable certainty that no harm will result from 
exposure to residue of quizalofop-p ethyl.

F. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of quizalofop-p ethyl ester, 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 gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard 
uncertainty factor (usually 100 for combined inter- and intra-species 
variability)) and not the additional tenfold MOE/uncertainty factor 
when EPA has a complete data base under existing guidelines and when 
the severity of the effect in infants or children or the potency or 
unusual toxic properties of a compound do not raise concerns regarding 
the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies. Developmental toxicity studies 
showed no increased sensitivity in fetuses as compared to maternal 
animals following in utero exposures in rats and rabbits.
    iii. Reproductive toxicity study. In a two generation reproductive 
toxicity study, rats were fed diets of 0, 1.25, 5.0 or 20 mg/kg/day of 
quizalofop-p ethyl. The parental NOEL was 5.0 mg/kg/day and the LOEL 
was 20 mg/kg/day, based on decreased body weights in males of both 
generations. The developmental NOEL for effects on the offspring was 
1.25 mg/kg/day and the offspring developmental LOEL was 5.0 mg/kg/day, 
based on increased incidence of eosinophilic changes in the livers of 
F2 weanling. In addition, at 20 mg/kg/day, reductions in litter size, 
survival, body weights, and spleen weight were seen in the offspring.
    iv. Pre- and post-natal sensitivity. The histopathology data for F2 
weanlings in the two-generation reproductive toxicity study suggested 
an increased sensitivity to the offspring. In that study, an increase 
in the incidence of eosinophilic changes in the liver were noted in the 
F2 weanlings, and the offspring NOEL was less than the parental 
systemic NOEL. However, the significance of these observations in the 
two-generation reproductive toxicity study is rendered questionable due 
to: (a) The changes in the weanling livers were not well characterized; 
(b) the biological significance of this endpoint was not known; (c) the 
precise dose of test substance to 21-day old weanlings cannot be 
determined with any accuracy, but it is likely to exceed that of the 
adults; (d) this endpoint

[[Page 32758]]

(eosinophilic changes), in adults, would not be considered appropriate 
for use in regulation of a chemical because of the questionable 
biological significance of this effect; and, (e) previous toxicological 
studies show the liver as the target organ in rats. No particular 
significance to the offspring is attributed to the liver effects.
    v. Conclusion. The database is complete and the weight of the 
evidence reveals no special susceptibility to developmental toxicity. 
Therefore, EPA has determined that reliable data support use of the 
standard 100-fold safety factor. An additional ten-fold safety factor 
is not necessary to protect the safety of infants and children.
    2. Acute aggregate risk. There are no acute toxicological concerns 
for quizalofop-p ethyl ester.
    3. Chronic aggregate risk. Using the conservative exposure 
assumptions described above, EPA has concluded that aggregate exposure 
to quizalofop-p ethyl ester from food will utilize 19% of the RfD for 
the highest exposed population subgroup (non-nursing infants <1 year 
old). 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. Because there are no indoor or outdoor residential uses 
for quizalofop-p ethyl, and the estimates of quizalofop-p ethyl chronic 
residues in drinking water are much less (estimated at 8.08 ppb) than 
the 73 ppb concern level, aggregate (food, water, and residential) 
chronic exposure for infants, children, and adults will not exceed the 
Agency's level of concern. EPA concludes that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to quizalofop-p ethyl ester residues.
    4. Short- or intermediate-term risk. Because no toxicological 
endpoints have been identified for short-, intermediate-, and/or 
chronic-term dermal or inhalation exposures, the Agency believes there 
is reasonable certainty that no harm will result from exposure to 
quizalofop-p ethyl due to approved tolerances.

III. Other Considerations

A. Metabolism In Plants and Animals

    The Agency has previously concluded that the nature of the 
quizalofop-p ethyl residue in plants is adequately understood. The 
residues of concern are quizalofop-p ethyl ester and its acid 
metabolite, quizalofop-p, and the S enantiomers of both the ester and 
the acid, all expressed as quizalofop-p (40 CFR 180.441(c)). In 
animals, the residues of concern are slightly different and include 
quizalofop ethyl, quizalofop methyl, and quizalofop acid, all expressed 
as quizalofop-ethyl (40 CFR 180.441(b)).

B. Analytical Enforcement Methodology

    An adequate enforcement method for determination of quizalofop-p-
ethyl and related regulated residues is available in PAM II.

C. Magnitude of Residues

    The maximum residues detected on fresh mint foliage at the proposed 
labeled level of DuPont's product, Assure, of 0.2 pounds(lbs) active 
ingredient(ai) per acre (1x) applied 30 days before harvest were 0.22, 
0.46, and 1.0 ppm for Indiana, Oregon and Washington, respectively. The 
largest residue found on fresh mint foliage, 2.6 ppm, was detected in a 
Washington sample treated with 0.4 lbs. per acre (2x) 29 days before 
harvest, twice the maximum yearly rate allowed. At the Level of 
Quantitation (LOQ) of 0.05 ppm, there were no detectable residues in 
the mint oil, either at the proposed label rate of 0.2 lbs. ai/acre(A), 
or at the exaggerated rate of 0.4 lbs. ai/A, indicating that 
quizalofop-p ethyl and its acid metabolite are not concentrated during 
the oil distillation process. Adequate residue data were provided to 
support a tolerance of 2.0 ppm for mint. There are no livestock 
feedstuffs associated with mint.
    Adequate residue data were provided to support proposed tolerances 
canola seed and canola meal. Processing data provided for canola seed 
indicated concentration in canola meal. Based on the concentration 
factor of 2.3x and the highest average field trial (HAFT) residue level 
of 0.65 ppm for canola seed, a tolerance at 1.5 ppm for canola meal is 
considered adequate.
    Results of a ruminant feeding study lead to the conclusion that the 
established quizalofop and quizalofop-p ethyl tolerance in milk, and in 
fat, meat, and meat by-products of cattle, goats, hogs, horse, and 
sheep are adequate and need not be increased from the additional use on 
canola. Additionally, the established tolerances of quizalofop and 
quizalofop-p ethyl in eggs, and in fat, meat, and meat by-products of 
poultry are adequate and need not be changed from the additional use on 
canola.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican Maximum Residue Limits 
(MRLs) for quizalofop-p ethyl residues in/on mint. Since there are no 
Mexican or Codex MRLs/tolerances for quizalofop-p-ethyl in/on canola 
seed, compatibility is not a problem at this time. Compatibility cannot 
be achieved with the Canadian negligible residue types limit at 0.1 ppm 
as the U.S. use pattern had findings of real residues above 0.1 ppm. 
Additionally, the Canadian MRL is in terms of parent only, thus the 
tolerance expressions are not compatible.

E. Rotational Crop Restrictions

    Available data support a 120 day plant back interval.

IV. Conclusion

    Therefore, tolerances are established for combined residues of 
quizalofop-p ethyl ester [ethyl (R)-(2[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxyl]-propanoate), and its acid metabolite quizalofop-p [R-
(2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxyl)propionate and the S 
enantiomers of the ester and the acid, all expressed as quizalofop-p 
ethyl ester in or on canola seed at 1.0 ppm, canola meal at 1.5 ppm, 
and peppermint tops and spearmint tops at 2.0 ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by August 17, 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

[[Page 32759]]

statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the information that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice.

VI. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300663] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [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 address in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since these tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950) and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

40 CFR Part 185

    Environmental protection, Food additives, Pesticides and pests.

40 CFR Part 186

    Environmental protection, Animal feeds, Pesticides and pests.

    Dated: May 28, 1998.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.
    2. Section 180.441 is revised to read as follows:


Sec. 180.441  Quizalofop ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for the combined 
residues of the herbicide quizalofop (2-[4-(6-chloroquinoxalin-2-yl 
oxy)phenoxy]propanoic acid) and quizalofop ethyl (ethyl-2-[4-(6-
chloroquinoxalin-2-yl oxy)phenoxy]propanoate), all expressed as 
quizalofop ethyl, in or on the following agricultural commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million 
------------------------------------------------------------------------
Soybean flour...............................................        0.5 
Soybean hulls...............................................        0.02
Soybean meal................................................        0.5 
Soybean soapstock...........................................        1.0 
Soybeans....................................................        0.05
------------------------------------------------------------------------


[[Page 32760]]

    (2) Tolerances are established for the combined residues of the 
herbicide quizalofop (2-[4-(6-chloroquinoxalin-2-yl 
oxy)phenoxy]propanoic acid), quizalop-ethyl (ethyl-2-[4-(6-
chloroquinoxalin-2-yl oxy)phenoxy]propanoate), and quizalofop-methyl 
(methyl 2-[4-(6-chloroquinoxalin-2-yl-oxy)phenoxy]propanoate, all 
expressed as quizalofop ethyl, as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million 
------------------------------------------------------------------------
Cattle, fat.................................................        0.05
Cattle, meat................................................        0.02
Cattle, mbyp................................................        0.05
Eggs........................................................        0.02
Goats, fat..................................................        0.05
Goats, meat.................................................        0.02
Goats, mbyp.................................................        0.05
Hogs, fat...................................................        0.05
Hogs, meat..................................................        0.02
Hogs, mbyp..................................................        0.05
Horses, fat.................................................        0.05
Horses, meat................................................        0.02
Horses, mbyp................................................        0.05
Milk........................................................        0.01
Milk, fat...................................................        0.05
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.02
Poultry, mbyp...............................................        0.05
Sheep, fat..................................................        0.05
Sheep, meat.................................................        0.02
Sheep, mbyp.................................................        0.05
------------------------------------------------------------------------

    (3) Tolerances are established for the combined residues of the 
herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-
chloroquinoxalin-2-yl)oxy)phenoxy)propanoate], and its acid metabolite 
quizalofop-p [R-(2-(4-((6-quinoxalin-2-yl)oxy)phenoxy)propanoic acid], 
and the S enantiomers of both the ester and the acid, all expressed as 
quizalofop-p-ethyl ester, in or on the following raw agricultural 
commodities;

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million 
------------------------------------------------------------------------
Canola, meal................................................        1.5 
Canola, seed................................................        1.0 
Cottonseed..................................................        0.1 
Lentils.....................................................        0.05
Peppermint, tops............................................        2.0 
Spearmint, tops.............................................        2.0 
------------------------------------------------------------------------

    (4) Time limited tolerances to expire on June 14, 1999 are 
established for the combined residues of the herbicide quizalofop-p 
ethyl ester (ethyl (R)-(2-(4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoate) and it acid metabolite quizalofop-p [R-(2-
(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid), and the S 
enantiomers of both the ester and the acid, all expressed as 
quizalofop-p-ethyl ester in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                         Commodities                            million 
------------------------------------------------------------------------
Foliage of legume vegetables (except soybeans)..............        3.0 
Legume vegetables (succulent or dried) group................        0.25
Sugarbeet molasses..........................................        0.2 
Sugarbeet, root.............................................        0.1 
Sugarbeet, top..............................................        0.5 
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec. 180.1(n), are established for 
the combined residues of the herbicide quizalofop-p ethyl ester [ethyl 
(R)-2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxy] propionate], its acid 
metabolite quizalofop-p [R-(2-[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy]) propanoic acid], and the S enantiomers of both the 
ester and the acid, all expressed as quizalofop-p ethyl ester, in or 
the raw agricultural commodities, as follows:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million 
------------------------------------------------------------------------
Pineapple...................................................        0.1 
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. [Reserved]

PART 185-- [AMENDED]

    3. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 348.


Sec. 185.5250  [Removed]

    b. Section Sec. 185.5250 is removed.

PART 186-- [AMENDED]

    4. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:
    Authority: 21 U.S.C. 342, 348, and 701.


Sec. 186.5250  [Removed]

    b. Section Sec. 186.5250 is removed.

[FR Doc. 98-15746 Filed 6-15-98; 8:45 am]
BILLING CODE 6560-50-F