[Federal Register Volume 62, Number 73 (Wednesday, April 16, 1997)]
[Rules and Regulations]
[Pages 18528-18532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9372]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185, and 186

[OPP-300473; FRL-5600-2]
RIN 2070-AB78


Clopyralid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes tolerances for residues of the 
herbicide clopyralid (3,6-dichloro-2-pyridine-carboxylic acid) in or on 
the raw agricultural commodities corn, field, fodder; corn, field, 
forage; corn, field, grain; and corn, field, milling fractions. It also 
removes time-limited tolerances for residues of clopyralid on the same 
commodities that expired on December 31, 1996. DowElanco requested 
these tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA) 
as amended by the Food Quality Protection Act of l996 (Pub. L. 104-
170).

DATES: This regulation becomes effective April 16, 1997. Written 
objections must be received on or before June 16, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300473; PP 8F3622, 0H 5597], may 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 should 
be identified by the docket control number and submitted to: Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring copy of 
objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson 
Davis Highway, Arlington, VA 22202.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically to the OPP by sending 
electronic mail (e-mail) to: <a href="/cdn-cgi/l/email-protection#59362929743d363a323c2d193c293834383035773c2938773e362f"><span class="__cf_email__" data-cfemail="adc2dddd80c9c2cec6c8d9edc8ddccc0ccc4c183c8ddcc83cac2db">[email protected]</span></a>. 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 in 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-300473; PP 8F3622, 0H5597]. 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. Additional 
information on electronic submissions can be found below in this 
document.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product 
Manager (PM) 23, Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 237, CM #2, 1921 Jefferson Davis 
Hwy., Arlington, VA 22202, (703)-305-6224; e-mail: 
<a href="/cdn-cgi/l/email-protection#95f8fcf9f9f0e7bbfffaf4fbfbf0d5f0e5f4f8f4fcf9bbf0e5f4bbf2fae3"><span class="__cf_email__" data-cfemail="5b363237373e297531343a35353e1b3e2b3a363a3237753e2b3a753c342d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: On April 25, l994 EPA established time-
limited tolerances under sections 408 and 409 of the Federal Food Drug, 
and Cosmetic Act (FFDCA), 2l U.S.C. 346a(d) and 348, for residues of 
clopyralid on corn, field, fodder; corn, field, forage; corn, field, 
grain; and corn, field, milling fractions (59 FR 19639)(FRL-4775-4). 
These tolerances expired on December 31, l996. DowElanco, on September 
27, l996, requested that the time-limited tolerances for residues of 
the herbicide clopyralid in the field corn commodities under the 
regulations mentioned above be made permanent tolerances based on 
residue data that they had submitted as required to change the 
tolerances from time-limited to permanent tolerances. DowElanco also 
submitted a summary of its petition as required under the Federal Food, 
Drug and Cosmetic Act (FFDCA) as amended by the Food Quality Protection 
Act of l996 (Pub. L. 104-170).
    A notice announcing the filing of DowElanco's petition was 
published in the Federal Register, (61 FR 65221-65223, December 11, 
l996)(FRL-5574-4). The proposed analytical method for determining 
residues is gas chromatography with electrolytic conductivity 
detection. The method for enforcement is available from the FDA; it is 
pending publication in the Pesticide Analytical Manual II.
    The basis for the conditional time-limited tolerances that expired 
December 31, l996 was given in the Federal Register notice of Final 
Rule (59 FR 19339). The required residue chemistry data have been 
received, reviewed and found adequate by EPA to support the proposed 
tolerances. Based on the review of the residue chemistry data, EPA 
finds the tolerances established by this Final Rule adequately 
supported.
    There were no comments received in response to the notices of 
filing.
    The data submitted in the petition and other relevant material have 
been evaluated. The toxicology data listed below were found acceptable 
by EPA in support of these tolerances.

I. Toxicological Profile

    1. A rat oral lethal dose (LD<INF>50) of 4,300 milligrams/kilogram 
(mg/kg) of body weight.
    2. A 13-week mouse feeding study with a no-observed-effect level 
(NOEL) of 750 mg/kg/day.
    3. Two 180-day dog feeding studies with NOEL > 50 mg/kg/day.
    4. A rabbit teratology study with a developmental and a maternal 
NOEL > 250 mg/kg/day, highest dose tested (HDT).
    5. A rat teratology study with a developmental NOEL of > 250 mg/kg/

[[Page 18529]]

day (HDT) and a maternal toxicity NOEL of 75 mg/kg/day.
    6. A two-generation rat reproduction study with a reproductive NOEL 
of > 1,500 mg/kg/day and a systemic NOEL of 500 mg/kg/day.
    7. A 1-year dog feeding study with a NOEL of 100 mg/kg/day.
    8. A 2-year rat chronic feeding/oncogenicity study with a NOEL of 
50 mg/kg/day with no oncogenic potential observed under the conditions 
of the study at doses up to and including 150 mg/kg/day (HDT). A 
significant decrease in mean body weights of females occurred at 150 
mg/kg/day.
    9. A repeat 2-year rat chronic feeding/oncogenicity study with a 
systemic NOEL of 15 mg/kg/day and with no oncogenic potential observed 
under conditions of the study up to 1,500 mg/kg/day (HDT). Hyperplasia 
and thickening of the limiting ridge of the stomach occurred at 150 mg/
kg/day.
    10. Three 2-year mouse oncogenicity studies with no oncogenic 
potential observed under the conditions of the study up to and 
including 2,000 mg/kg/day (HDT) and a systemic NOEL of 500 mg/kg/day.
    11. A dominant lethal assay, negative.
    12. In vivo rat cytogenic study, negative.
    13. In vitro Salmonella and Saccharomyces assay, negative.
    14. An in vivo mouse host-mediated assay, negative.
    15. An unscheduled DNA synthesis assay in rats, negative.
    16. In an animal metabolism study At doses of 5 mg/kg (oral), 
radiolabeled clopyralid was excreted within 24 hours in all dosed rats. 
Fecal elimination was minor. Detectable levels of residual radio-
activity were observed in the carcass and stomach at 72 hours post-
dose. Analysis of urine and fecal extracts showed no apparent 
metabolism of clopyralid.

II. Aggregate Exposures

    1. From food and feed uses.  The primary source for human exposure 
to clopyralid will be from ingestion of both raw and processed 
agricultural commodities as proposed in the December 11, 1996 Notice 
for Filing cited above. Based on exposure from existing permanent 
tolerances listed in 40 CFR 180.431(a) of the Code of Federal 
Regulations and the subject proposed tolerances in field corn raw 
agricultural commodities, the Theoretical Maximum Residue Contributions 
(TMRC) for the U.S. (48 States) adult population is 0.008214 mg/kg body 
weight/day; for non-nursing infants, 0.015400; for children 1 to 6 
years old, 0.018454. These estimates are based on the assumption that 
100% of the field corn commodities are derived from field corn cultured 
with the aid of the herbicide clopyralid.
    2. From potable water. In examining aggregate exposure, FQPA 
directs EPA to consider available information concerning exposures from 
the pesticide residue in food and all other non-occupational exposures. 
The primary non-food sources of exposure the Agency looks at include 
drinking water (whether from groundwater or surface water), and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    There is presently no EPA Lifetime Health Advisory level for 
clopyralid and its degradates as drinking water contaminates. EPA does 
not have drinking water monitoring data available to perform a 
quantitative drinking water risk assessment. Available environmental 
fate data, conservative screening tools, GENEEC and Leaching Index have 
been used to estimate environmental concentrations of clopyralid in 
surface water and the leaching potential of clopyralid. The results of 
these screens indicate that clopyralid is moderately persistent, highly 
mobile in a soil and water environment, and may impact ground water and 
surface water.
    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 were 
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 uses. There is only one non-dietary use 
registered under the Federal Insecticide, Fungicide and Rodenticide 
Act, as amended. The use is for residential weed control in turf.
    i. Short-term or intermediate-term. A part of the hazard assessment 
process, the Agency reviews the available toxicological database to 
determine the endpoints of concern. For clopyralid, the Agency does not 
have a concern for a short-term or intermediate-term residential risk 
assessment because the available data does not indicate any evidence of 
significant toxicity by the dermal and inhalation routes. Therefore, a 
short-term or intermediate-term residential risk assessment was not 
required.
    ii. Chronic. As part of the hazard assessment process an endpoint 
of concern was determined for the chronic occupational or residential 
assessment. However, during the exposure assessment process, the 
exposures that would result from the use of clopyralid were determined 
to be of an intermittent nature. The frequency and duration of these 
exposures do not exhibit a chronic exposure pattern. The exposure does 
not occur often enough to be considered a chronic exposure; i.e, a 
continuous exposure that occurs for at least several months. Therefore, 
it was not deemed appropriate to aggregate exposure from the 
residential use with exposure from food and drinking water.
    iii. Acute. As part of the hazard assessment process, the Agency 
reviews the available toxicological database to determine the endpoints 
of concern. For clopyralid, the Agency does not have a concern for an 
acute dietary assessment because the available data do not indicate any 
evidence of significant toxicity from a 1 day or single event exposure 
by the oral route. Therefore, an acute dietary risk assessment was not 
required.
    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

[[Page 18530]]

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 clopralid 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 substances.

III. Determination of Safety for U.S. Population and Non-nursing 
Infants

A. The U.S. Population

    Based on a NOEL of 50.80 mg/kg bwt/day from a 2-year, rat feeding 
study with a decreased mean body weight gain effect, and using an 
uncertainty factor of 100 to account for the interspecies extrapolation 
and intraspecies variability, the Agency has determined a Reference 
Dose (RfD) of 0.5 mg/kg bwt/day for this assessment of chronic risk. As 
indicated above, there is no endpoint of concern identified with acute 
and short- or intermediate-term exposures. Based on the available 
toxicity data and the available exposure data identified above, the 
proposed and existing tolerances will utilize 2% of the RfD for the 
U.S. population. As indicated above, whatever bounding figure EPA 
chooses for drinking water exposure, the exposure estimate for 
clopyralid would not exceed the RfD.

B. Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (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 exposure (safety) will be safe for infants and 
children. Margins of exposure (safety) are often referred to as 
uncertainty (safety) factors. EPA believes that reliable data support 
using the standard margin of exposure (usually 100x for combined inter- 
and intra-species variability)) and not the additional tenfold margin 
of exposure when EPA has a complete database 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.
    Based on current data requirements, the data base relative to pre- 
and post-natal toxicity is complete. Risk to infants and children was 
determined by use of two developmental toxicity studies and a two-
generation reproduction study. Both developmental studies had 
developmental NOELs of > 250 mg/kg/day, the highest dose tested. These 
studies also demonstrated that there was no developmental (prenatal) 
toxicity, at dosages at or below dosages that resulted in maternal 
toxicity. The maternal NOEL was > 250 mg/kg/day in the rabbit study and 
75 mg/kg/day in the rat study. The developmental NOELs are fivefold 
higher in both the rat and rabbit than the NOEL used for establishing 
the RfD. Based on current data requirements, the data base relative to 
pre- and post-natal toxicity is complete. There were no treatment-
related effects on any reproductive parameter in the adults or their 
offspring. The NOEL for reproductive effects was 1,500 mg/kg bwt/day, 
and there was no effect on reproductive parameters at > 1,500 mg/kg/day 
nor was there an adverse effect on the morphology, growth or viability 
of the offspring. The NOEL of the study was 30 times greater than the 
NOEL of 50.0 mg/kg/day used for establishing the RfD. These data taken 
together suggest minimal concern for developmental or reproductive 
toxicity and do not indicate any increased pre- or post-natal 
sensitivity. Therefore, EPA concludes that an additional uncertainty 
factor is not necessary to protect the safety of infants and children 
and that the RfD at 0.5 mg/kg/day is appropriate for assessing 
aggregate risk to infants and children.
    The percent of the RfD that will be utilized by the aggregate 
exposure from all tolerances to clopyralid will range from 3% for non-
nursing infants, up to 3.6% for children (1 to 6 years of age). 
Therefore, EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure. As 
indicated above, whatever bounding figure EPA chooses for drinking 
water exposure, the exposure estimate for clopyralid would not exceed 
the RfD. Non-dietary exposures were discussed above under ``Non-Dietary 
Exposure.''

IV. Other Considerations

    1. Endocrine effects. There was no reported endocrine effect in any 
of the toxicological studies reviewed in the toxicological profile of 
this final rule.
    2. Metabolism in plants and animals. The metabolism of clopyralid 
in plants and animals is adequately understood for the purposes of 
these tolerances. There are no metabolites of toxicological 
significance in plants. The residue of concern in plants and animals is 
the parent compound, clopyralid. In animal metabolism studies with C14 
labeled clopyralid, the residues found were clopyralid and its glycine 
conjugate.
    3. Analytical method. There is a practical analytical method for 
detecting and measuring levels of clopyralid in or on food with a limit 
of detection that allows monitoring of food with residues at or above 
the levels set in these tolerances. The analytical method for 
determining residues is gas chromatography with electrolytic 
conductivity detection, described in a method submitted by DowElanco.
    The quantitative limit of the method is 0.05 micrograms/gram in 
field corn fodder and forage and grain. EPA has provided information on 
this method to FDA. Because of the long lead time from establishing 
these tolerances to publication, the enforcement

[[Page 18531]]

methodology is being made available in the interim to anyone interested 
in pesticide enforcement when requested by mail from: Calvin Furlow, 
Public Response Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number; Rm. 1130A, 
CM #2, l921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-
5937.
    4.  International tolerances. There are no Codex Alimentarius 
Commission (Codex) Maximum Residue Levels (MRLs) for clopyralid.

V. Summary of Findings

    The analysis for clopyralid using tolerance level residues shows 
that the proposed use in the culture of field corn will not cause 
exposure to exceed the levels at which the Agency believes there is an 
appreciable risk. All population subgroups examined by EPA are exposed 
to clopyralid residues at levels below 100 percent of the RfD for 
chronic effects.
    Based on the information cited above, the Agency has determined 
that the establishment of these tolerances will be safe therefore, the 
tolerances are established as set forth below.
    In addition to the tolerances being amended, since for purposes of 
establishing tolerances FQPA has eliminated all distinctions between 
raw and processed food, EPA is combining the tolerances that now appear 
in Secs. 185.1100 and 186.1100 with the tolerances in Sec. 180.431 and 
is eliminating Secs. 185.1100 and 186.1100.

VI. 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 (1)(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 governs 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 June 16, 1997, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (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 a 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 issue(s) in the manner sought by the requestor would be 
adequate to justify the action requested (40 CFR 178.32). Information 
submitted in connection with an objection or hearing request may be 
claimed confidential by marking any part or all of that information as 
Confidential Business Information (CBI). Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VII. Public Docket

    EPA has established a record for this rulemaking under docket 
number [OPP-300473] (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 Response and Program 
Resources Branch, Field Operations 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:
    <a href="/cdn-cgi/l/email-protection#c9a6b9b9e4ada6aaa2acbd89acb9a8a4a8a0a5e7acb9a8e7aea6bf"><span class="__cf_email__" data-cfemail="87e8f7f7aae3e8e4ece2f3c7e2f7e6eae6eeeba9e2f7e6a9e0e8f1">[email protected]</span></a>.

    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 
address in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), this 
action is not a ``significant regulatory action'' and since this action 
does not impose any information collection requirements subject to 
approval under 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 mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, l993, special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, l994).
    Because tolerances established on the basis of a petition under 
section 408(d) of FFDCA do not require issuance of a proposed rule, the 
regulatory flexibility analysis requirements of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the 
recent amendment of the FFDCA, EPA had treated such rulemakings as 
subject to the RFA; however, the amendments to the FFDCA clarify that 
no proposal is required for such rulemakings and hence that the RFA is 
inapplicable. 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, l981).
    Pursuant to 5 U.S.C. 801(a)(1)(A), 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

[[Page 18532]]

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: April 4, 1997.

Stephen L. Johnson,

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

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.

    b. Section 180.431 is amended as follows:
    i. In paragraph (a) by revising the introductory text, and adding 
new entries to the table.
    ii. In paragraph (b) by removing the text, and adding a paragraph 
heading.
    iii. In paragraph (c) by the redesignating the text as paragraph 
(b), by adding a new paragraph heading, and by reserving it.
    iv. By adding paragraph (d) with a paragraph heading only and 
reserving it.


Sec. 180.431   Clopyralid; tolerances for residues.

    (a) General. Tolerances are established for combined residues of 
the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid) in or 
on the following commodities:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                      *      *      *      *      *                     
Corn, field, fodder........................................         10.0
Corn, field, forage........................................          3.0
Corn, field, grain.........................................          1.0
Corn, field, milling fractions.............................          1.5
                      *      *      *      *      *                     
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. *  *  *
    (c)  Tolerances with regional registrations. [Reserved]
    (d)  Indirect or inadvertent residues. [Reserved]

PART 185--[AMENDED]

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

Sec. 185.1100  [Removed]

    b. By removing Sec. 185.1100 Clopyralid.

PART 186--[AMENDED]

    3. 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. 186.1100  [Removed]

    b. By removing Sec. 186.1100 Clopyralid.

[FR Doc. 97-9372 Filed 4-15-97; 8:45 am]
BILLING CODE 6560-50-F


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