[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Rules and Regulations]
[Pages 26949-26954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12913]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300491; FRL-5718-2]
RIN 2070-AB78


Clopyralid; Pesticide Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of the herbicide clopyralid in or on the food commodity canola 
in connection with EPA's granting emergency exemptions under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on canola in Idaho, Montana, Minnesota, North 
Dakota and Washington. The tolerance will expire and is revoked on July 
31, 1998.
DATES: This regulation becomes effective May 16, 1997. Objections and 
requests for hearings must be received by EPA on or before July 15, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300491],

[[Page 26950]]

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-300491], must 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: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[OPP-300491]. 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: Libby Pemberton, Registration 
Division (7505W), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Sixth Floor, Crystal 
Station #1, 2800 Jefferson Davis Highway, Arlington, VA (703) 308-8326, 
e-mail:[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the herbicide clopyralid, in or on canola at 3 parts per 
million (ppm). This tolerance will expire and be revoked by EPA on July 
31, 1998. After July 31, 1998, EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA 
amends FFDCA to bring all EPA pesticide tolerance-setting activities 
under section 408 with a new safety standard and new procedures. These 
activities are described below and discussed in greater detail in the 
final rule establishing the time-limited tolerance associated with the 
emergency exemption for use of propiconazole on sorghum (61 FR 58135, 
November 13, 1996) (FRL-5572-9).
    New Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under section 18 of FIFRA. Such tolerances can 
be established without providing notice or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerance to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Clopyralid on Canola and FFDCA 
Tolerances

    EPA has authorized under FIFRA section 18 the use of clopyralid on 
canola for control of perennial sowthistle and/or Canada thistle. 
Biological and economic assessments indicate that an urgent, non-
routine situation exists for the canola crop in the states of North 
Dakota, Minnesota, Montana, Idaho and Washington, and that losses near 
100% will occur where thistle stands are thick. Perennial sowthistle 
and Canadian thistle are particularly severe in cool, moist weather. 
After having reviewed the submissions, EPA concurs that emergency 
conditions exist for these states.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of clopyralid in or 
on canola. 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. This tolerance will permit the 
marketing of canola treated in accordance with the provisions of the 
section 18 emergency exemption. 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 July 
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 
canola after that date will not be unlawful, provided the pesticide is 
applied during the term of, and in accordance with all the conditions 
of, section 18 of 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.
    EPA has not made any decisions about whether clopyralid meets EPA's 
registration requirements for use on canola or whether a permanent 
tolerance for this use would be appropriate. This tolerance does not

[[Page 26951]]

serve as a basis for registration of clopyralid 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 Idaho, Montana, Minnesota, North 
Dakota, and Washington 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 clopyralid, 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. For many 
of these 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.
    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 margin of exposure 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.
    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. 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 to 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 
clopyralid and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for the time-limited tolerances for 
residues of clopyralid in or on canola at 3 ppm. EPA's assessment of 
the dietary exposures and risks associated with establishing this 
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 clopyralid are 
discussed below.
    1. Acute toxicity. No toxicology studies were identified by the 
Office of Pesticide Programs (OPP) which demonstrated the need for an 
acute dietary risk assessment.
    2. Short-term non-dietary inhalation and dermal toxicity. Based on 
available data indicating that there was no evidence of toxicity by the 
dermal or inhalation routes, non-dietary exposure risks were not 
calculated.
    3. Chronic toxicity. Based on the available chronic toxicity data, 
OPP has established the RfD for clopyralid at 0.5 milligrams(mg)/ 
kilogram(kg)/day. The RfD was established based on an NOEL of 50 mg/kg/
day from a 2-year rat feeding study. Effects observed at the lowest 
effect level (LEL) were decreased mean body weights in females. An 
uncertainty factor of 100 was used.
    4. Carcinogenicity. No evidence of carcinogenicity was seen in mice 
or in rats fed clopyralid for 24 months.

B. Exposures and Risks

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking

[[Page 26952]]

water (whether from groundwater or surface water), and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses). In evaluating food exposures, EPA takes into account 
varying consumption patterns of major identifiable subgroups of 
consumers, including infants and children.
    1. From food and feed uses. Tolerances have been established (40 
CFR 180.431) for residues of clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid) in or on a variety of food commodities, 
including meat, fat, and meat byproducts of cattle, goats, hogs, 
horses, poultry, and sheep; and milk. Risk assessments were conducted 
by EPA to assess dietary exposures and risks from clopyralid as 
follows:
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. The Agency has determined that this 
risk assessment was not required.
    ii. Chronic exposure and risk. For the purpose of assessing chronic 
dietary exposure from clopyralid, EPA assumed tolerance level residues 
and 100% of crop treated for the proposed and existing food uses of 
clopyralid. These conservative assumptions result in overestimation of 
human dietary exposures.
    2. From drinking water. Studies indicate clopyralid is persistent 
in the field, very soluble in water, does not hydrolyze, and is very 
mobile in soil. Therefore, clopyralid has the potential to leach to 
ground water and/or contaminate surface water through dissolved 
residues in runoff. There is no entry for clopyralid in the 
``Pesticides in Groundwater Data Base'' (EPA 734-12-92-001, September 
1992). There is no established Maximum Concentration Level (MCL) for 
residues of clopyralid in drinking water. No drinking water health 
advisory levels have been established for clopyralid.
    i. Acute exposure and risk. The Agency has determined that this 
risk assessment was not required.
    ii. Chronic exposure and risk. Because the Agency lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
risk assessment for many pesticides, EPA has commenced and nearly 
completed a process to identify a reasonable yet conservative bounding 
figure for the potential contribution of water related exposure to the 
aggregate risk posed by a pesticide. In developing the bounding figure, 
EPA estimated residue levels in water for a number of specific 
pesticides using various data sources. The Agency then applied the 
estimated residue levels, in conjunction with appropriate toxicological 
endpoints (RfD's or acute dietary NOEL's) and assumptions about body 
weight and consumption, to calculate, for each pesticide, the increment 
of aggregate risk contributed by consumption of contaminated water. 
While EPA has not yet pinpointed the appropriate bounding figure for 
consumption of contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause clopyralid to 
exceed the RfD if the tolerance being considered in this document was 
granted. The Agency has therefore concluded that the potential 
exposures associated with clopyralid in water, even at the higher 
levels the Agency is considering as a conservative upper bound, would 
not prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerance is granted.
    3.  From non-dietary exposure. Clopyralid is registered by EPA for 
outdoor Christmas tree plantations, grasses grown for seed, fallow 
cropland, non-cropland and other non-food uses.
    i. Acute exposure and risk. The Agency has determined that this 
risk assessment was not required.
    ii. Chronic exposure and risk. The Agency has determined that a 
chronic non-dietary exposure does not exist for clopyralid.
    iii. Short- and intermediate term exposure and risk. The Agency has 
determined there are no short- and intermediate endpoints of concern. 
Therefore, this risk assessment is not required for clopyralid.
    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).
    EPA does not have, at this time, available data to determine 
whether clopyralid 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, 
clopyralid 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 clopyralid has a common mechanism of toxicity 
with other subtances.

C. Aggregate Risks and Determination of Safety For U.S. Population

    1. Acute risk. There are no acute dietary endpoints of concern; 
therefore an acute aggregate risk assessment is not required for 
clopyralid.
    2. Chronic risk. Using the conservative TMRC exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
clopyralid from food will utilize 12% of the RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is children (1 to 6 years old), discussed below. EPA

[[Page 26953]]

generally has no concern for exposures below 100% of the RfD because 
the RfD represents the level at or below which daily aggregate exposure 
over a lifetime will not pose appreciable risks to human health. 
Despite the potential for exposure to clopyralid in drinking water, EPA 
does not expect the aggregate exposure to exceed 100% of the RfD. EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to clopyralid residues.
    3. Short- and intermediate-term risk. EPA has determined there are 
no short- and intermediate-endpoints of concern; therefore, this 
aggregate risk assessment is not required for clopyralid.

D. Aggregate Cancer Risk for U.S. Population

    EPA has determined that there is no evidence of carcinogenicity in 
rats or mice for clopyralid; therefore, an aggregate cancer risk 
assessment is not required for clopyralid.

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

    In assessing the potential for additional sensitivity of infants 
and children to residues of clopyralid, 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 pesticide exposure during prenatal development 
to one or both parents. Reproduction studies provide information 
relating to effects from exposure to the pesticide on the reproductive 
capability of mating animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure 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 margin of exposure and uncertainty factor (usually 
100 for combined inter- and intra-species variability) and not the 
additional tenfold margin of exposure/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 margin of exposure/safety factor.
    1. Developmental toxicity studies. The developmental toxicity NOELs 
of > 250 mg/kg/day (HDT) in both rats and rabbits demonstrate that 
there is no developmental (pre-natal) toxicity present for clopyralid. 
EPA further notes that the developmental NOELs are fivefold higher in 
both rats and rabbits, respectively, than the NOEL of 50 mg/kg/day from 
the 2-year feeding study in rats, which is the basis for the RfD.
    2. Reproductive toxicity study. In the two-generation reproductive 
toxicity study in rats, the pup toxicity NOEL of 1,500 mg/kg/day (HDT) 
was greater than the parental (systemic) toxicity NOEL of 500 mg/kg/
day.
    3. Pre- and post-natal sensitivity. The above findings suggest that 
post-natal development in pups is not more sensitive and that infants 
and children may not be more sensitive to clopyralid than adult 
animals. The pup NOEL is thirtyfold higher than the RfD NOEL of 50 mg/
kg/day.
    4. Acute risk. The Agency has determined that this risk assessment 
was not required.
    5. Chronic risk. EPA has concluded that the percent of the RfD that 
will be utilized by chronic dietary exposure to residues of clopyralid 
ranges from 11% for nursing infants (<1 year old) up to 14% for 
children 1 to 6 years old. However, this calculation assumes tolerance 
level residues for all commodities and is therefore an over-estimate of 
dietary risk. Refinement of the dietary risk assessment by using 
anticipated residue data would reduce dietary exposure. The addition of 
potential exposure from clopyralid residues in drinking water is not 
expected to result in an exposure which would exceed the RfD.
    6. Short- or intermediate-term risk. The Agency has determined 
there are no short- and intermediate endpoints of concern. Therefore, 
this risk assessment is not required for clopyralid.

V. Other Considerations

A. Metabolism in Plants and Animals

    The metabolism of clopyralid in plants and animals is adequately 
understood for the purposes of this tolerance. The residue of concern 
is clopyralid (3,6-dichloro-2-pyridinecarboxylic acid).

B. Analytical Enforcement Methodology

    Adequate methods for purposes of data collection and enforcement of 
tolerances for clopyralid are available. A method for determining 
clopyralid residues is described in PAM, Vol. II.

C. Magnitude of residues

    Residues of clopyralid are not expected to exceed 3 ppm in canola 
as a result of this use. Clopyralid does not concentrate in canola 
processed by-products (refined oil and meal). Existing meat/milk/
poultry and egg tolerances should be adequate to cover secondary 
residues which result from feeding canola meal from treated canola.

D. International Residue Limits

    There are no Canadian, Mexican, or Codex maximum residue levels 
established for residues of clopyralid on canola.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of clopyralid in 
canola at 3 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 July 15, 1997, file written objections to any 
aspect of this regulation (including the revocation provision) 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

[[Page 26954]]

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.

VIII. Public Docket

    EPA has established a record for this rulemaking under docket 
number [OPP-300491] (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 Highway, 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.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950, May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 
Stat. 847), EPA 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 the rule in today's Federal Register. 
This rule 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: May 8, 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 180.431, paragraph (b) is amended by revising the 
introductory text, the column headings to the table, in the third 
column of the table by changing ``July 31, 1998'' to read ``7/31/98'' 
and by adding an entry for canola to the table.


Sec. 180.431  Clopyralid; tolerances for residues.

*     *     *    *    *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide clopyralid 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     Revocation  
                                               million         Date     
------------------------------------------------------------------------
Canola.....................................            3         7/31/98
                  *        *        *        *        *                 
------------------------------------------------------------------------

*     *     *     *      *
[FR Doc. 97-12913 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F