[Federal Register Volume 62, Number 48 (Wednesday, March 12, 1997)]
[Rules and Regulations]
[Pages 11360-11364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5875]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300458; FRL-5593-1]
RIN 2070-AB78


Clopyralid; Pesticide Tolerance for Emergency Exemption

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 raw agricultural 
commodity cranberries in connection with EPA's granting of emergency 
exemptions under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of clopyralid on cranberries in the 
states of Massachusetts, Oregon, and Washington. This regulation 
establishes maximum permissible levels for residues of clopyralid in 
this food. The tolerance will expire July 31, 1998.
DATES: This regulation becomes effective March 12, 1997. This 
regulation expire on July 31, 1998. Objections and requests for 
hearings must be received by EPA on or before May 12, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300458], must be submitted to: Hearing 
Clerk (1900), Environmental Protection

[[Page 11361]]

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-300458], must also be 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 a copy of objections and hearing 
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Highway, 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: <a href="/cdn-cgi/l/email-protection#107f60603d747f737b7564507560717d71797c3e7560713e777f66"><span class="__cf_email__" data-cfemail="6c031c1c4108030f0709182c091c0d010d050042091c0d420b031a">[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 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300458]. 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: Sixth Floor, Crystal Station 
#1, 2800 Jefferson Davis Highway, Arlington, VA 22202. (703) 308-8326, 
e-mail: <a href="/cdn-cgi/l/email-protection#1d6d78707f786f6972733371747f7f645d786d7c707c747133786d7c337a726b"><span class="__cf_email__" data-cfemail="d1a1b4bcb3b4a3a5bebfffbdb8b3b3a891b4a1b0bcb0b8bdffb4a1b0ffb6bea7">[email protected]</span></a>.
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 clopyralid on cranberries at 2 parts per million (ppm). 
This tolerance will expire on July 31, 1998.

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. The FQPA amendments went 
into effect immediately. Among other things, FQPA amends FFDCA to bring 
all EPA pesticide tolerance-setting activities under a new section 408 
with a new safety standard and new procedures. These activities are 
described below and discussed in greater detail in the final rule 
establishing the time-limited tolerance associated with the emergency 
exemption for use of propiconazole on sorghum (61 CFR 58135, November 
13, 1996)(FRL-5572-9).
    New section 408(b)(2)(A)(i) 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, 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) 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. Section 408(l)(6) also requires EPA to promulgate regulations 
by August 3, 1997, governing the establishment of tolerances and 
exemptions under section 408(l)(6) and requires that the regulations be 
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18. 
Section 408(l)(6) allows EPA to establish tolerances or exemptions from 
the requirement for a tolerance, in connection with EPA's granting of 
FIFRA section 18 emergency exemptions, without providing notice or a 
period for public comment. Thus, consistent with the need to act 
expeditiously on requests for emergency exemptions under FIFRA, EPA can 
establish such tolerances or exemptions under the authority of section 
408(e) and (l)(6) without notice and comment rulemaking.
    In establishing section 18-related tolerances and exemptions during 
this interim period before EPA issues the section 408(l)(6) procedural 
regulation and before EPA makes its broad policy decisions concerning 
the interpretation and implementation of the new section 408, EPA does 
not intend to set precedents for the application of section 408 and the 
new safety standard to other tolerances and exemptions. Rather, these 
early section 18 tolerance and exemption decisions will be made on a 
case-by-case basis and will not bind EPA as it proceeds with further 
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new 
law.

II. Emergency Exemptions for Clopyralid on Cranberries and FFDCA 
Tolerances

    EPA has authorized use under FIFRA section 18 of clopyralid on 
cranberries for control of various weeds. Cancellations of the most 
effective registered alternatives have left growers with few tools to 
control weeds in a crop which cannot be cultivated. Over time, since 
control has been less than adequate, the problems have gotten steadily 
worse, resulting in near-epidemic levels of herbaceous perennial weeds 
over the past few years on many cranberry farms. The projected yield 
loss on the affected acres would cause those growers to suffer a 
significant economic loss.
    As part of its assessment of these specific exemptions, EPA 
assessed the potential risks presented by residues of clopyralid on 
cranberries. 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 clearly be consistent with the new 
safety standard and with FIFRA section 18. This tolerance for residues 
of clopyralid will permit the marketing of cranberries treated in 
accordance with the provisions of the section 18 emergency exemptions. 
Consistent with the need to move quickly on these emergency exemptions 
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

[[Page 11362]]

provided in section 408(l)(6). Although this tolerance will expire on 
July 31, 1998, under FFDCA section 408(l)(5), residues of clopyralid 
not in excess of the amount specified in this tolerance remaining in or 
on cranberries after that date will not be unlawful, provided the 
pesticide is applied during the term of, and in accordance with all the 
conditions of, the emergency exemptions. 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 the 
requirements for registration under FIFRA section 3 for use on 
cranberries or whether a permanent tolerance for clopyralid for 
cranberries would be appropriate. This action by EPA does not serve as 
a basis for registration of clopyralid by a State for special local 
needs under FIFRA section 24(c). Nor does this action serve as the 
basis for any States other than Massachusetts, Oregon, and Washington 
to use this product 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 exemptions 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 percent 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, and other non-
occupational exposures, such as where residues leach into groundwater 
or surface water that is consumed as drinking water. 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 percent 
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.

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. Clopyralid is already registered by EPA for outdoor 
Christmas tree plantations, grasses grown for seed, fallow cropland, 
non-cropland and other non-food uses, as well as several food use 
registrations. EPA believes it 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 cranberries at 2 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing this tolerance follows.

A. Toxicological Profile

    1. Chronic toxicity. Based on the available chronic toxicity data, 
the EPA's Office of Pesticide Programs (OPP) has established the RfD 
for clopyralid at 0.5 milligrams/kilogram/day (mg/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.
    2. Acute toxicity. No toxicology studies were identified by OPP 
which demonstrated the need for an acute dietary risk assessment.
    3. 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, worker exposure risks were not calculated.
    4. Carcinogenicity. No evidence of carcinogenicity was seen in mice 
or in rats fed clopyralid for 24 months.

B. Aggregate Exposure

    Tolerances are established for residues of clopyralid (3,6-
dichloro-2-pyridinecarboxylic acid) in or on several raw agricultural 
commodities (40 CFR 180.431(a) and (b)).
    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.

[[Page 11363]]

These conservative assumptions result in overestimation of human 
dietary exposures.
    Other potential sources of exposure of the general population to 
residues of pesticides are residues in drinking water and exposure from 
non-occupational sources. 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.
    The Agency does not have available data to perform a quantitative 
drinking water risk assessment for clopyralid at this time. Previous 
experience with persistent and mobile pesticides for which there have 
been available data to perform quantitative risk assessments have 
demonstrated that drinking water exposure is typically a small 
percentage of the total exposure. This observation holds even for 
pesticides detected in wells and drinking water at levels nearing or 
exceeding established MCLs. Based on this experience and the OPP's best 
scientific judgement, EPA concludes that it is not likely that the 
potential exposure from residues of clopyralid in drinking water added 
to the current dietary exposure will result in an exposure which 
exceeds the RfD.
    Clopyralid is registered for uses, such as lawns, that could result 
in non-occupational exposure and EPA acknowledges that there may be 
short-, intermediate-, and long-term non-occupational, non-dietary 
exposure scenarios. At this time, the Agency has insufficient 
information to assess the potential risks from such exposure. However, 
available data for clopyralid indicate no evidence of toxicity by the 
dermal or inhalation routes. Given the time-limited nature of this 
request, the need to make emergency exemption decisions quickly, and 
the significant scientific uncertainty at this time about how to 
aggregate non-occupational exposure with dietary exposure, the Agency 
will make its safety determination for this tolerance based on those 
factors which it can reasonably integrate into a risk assessment.
    At this time, the Agency has not made a determination that 
clopyralid and other substances that may have a common mode of toxicity 
would have cumulative effects. Clopyralid is a member of the pyridinoxy 
class of herbicides. Other members of this class include fluroxypyr, 
tricolpyr, and picloram. Given the time limited nature of this request, 
the need to make emergency exemption decisions quickly, and the 
significant scientific uncertainty at this time about how to define 
common mode of toxicity EPA will make its safety determination for 
these tolerances based on those factors which can reasonably integrate 
into a risk assessment. For purposes of this tolerance only, the Agency 
is considering only the potential risks of clopyralid in its aggregate 
exposure.

C. Safety Determinations For U.S. Population

    Taking into account the completeness and reliability of the 
toxicity data, EPA has concluded that dietary exposure to clopyralid 
from published tolerances will utilize 1.65 percent of the RfD for the 
U.S. population. EPA does not anticipate that the potential exposure 
from residues of clopyralid in drinking water added to the current 
dietary exposure will result in a chronic exposure which would exceed 
100% of the RfD. EPA concludes that there is a reasonable certainty 
that no harm will result from aggregate exposure to clopyralid 
residues.

D. Determination of Safety for Infants and Children

    Based on current toxicological data requirements, the data base for 
clopyralid relative to pre- and post-natal toxicity is complete. EPA 
notes that the developmental toxicity NOELs of >250 mg/kg/day, the 
highest dose tested (HDT) in both rats and rabbits demonstrate that 
there is no developmental (prenatal) toxicity present for clopyralid. 
EPA further notes that the developmental NOELs are 5-fold 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.
    In the two-generation reproductive toxicity study in rats, the pup 
toxicity NOEL of 1,500 mg/kg/day, the HDT, was greater than the 
parental (systemic) toxicity NOEL of 500 mg/kg/day. This finding 
suggests 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 30-fold higher than the RfD NOEL of 50 
mg/kg/day. This information, together with the uncertainty factor of 
100 utilized to calculate the RfD for clopyralid, is considered 
adequate protection for infants and children with respect to prenatal 
and postnatal development against dietary exposure to clopyralid 
residues. EPA believes that the data base of clopyralid is sufficiently 
complete regarding infants and children and that effects seen in that 
data are not such to suggest a 100-fold uncertainty factor will be 
inadequate. Therefore, EPA has determined that an additional 10-fold 
safety factor is not appropriate and that the 100-fold uncertainty 
factor will be safe for infants and children.
    EPA has concluded that the percent of the RfD that will be utilized 
by chronic dietary exposure to residues of clopyralid ranges from 1.07% 
for nursing infants (<1 year old) up to 3.72% 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.

V. Other Considerations

    The metabolism of clopyralid in plants and animals is adequately 
understood for the purposes of this tolerance. There are no Codex 
maximum residue levels established for residues of clopyralid on 
cranberries. The residue of concern is clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid). 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.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of clopyralid in 
cranberries at 2 ppm. This tolerance will expire on July 31, 1998.

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 May 12, 1997, file written objections to any 
aspect of this regulation (including the automatic revocation 
provision) and may also

[[Page 11364]]

request a hearing on those objections. Objections and hearing requests 
must be filed with the Hearing Clerk, at the address given above (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the Hearing Clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). If a hearing is requested, the objections must 
include a statement of the factual issues on which a hearing is 
requested, the requestor's contentions on such issues, and a summary of 
any evidence relied upon by the requestor (40 CFR 178.27). A request 
for a hearing will be granted if the Administrator determines that the 
material submitted shows the following: There is genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more of such issues in favor of the requestor, taking 
into account uncontested claims or facts to the contrary; and 
resolution of the factual issues in the manner sought by the requestor 
would be adequate to justify the action requested (40 CFR 178.32). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as Confidential Business Information (CBI). Information so 
marked will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2. A copy of the information that does not contain 
CBI must be submitted for inclusion in the public record. Information 
not marked confidential may be disclosed publicly by EPA without prior 
notice.

VIII. Public Docket

    A record has been established for this rulemaking under docket 
number [OPP-300458]. A public version of this record, 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#ee819e9ec38a818d858b9aae8b9e8f838f8782c08b9e8fc0898198"><span class="__cf_email__" data-cfemail="81eef1f1ace5eee2eae4f5c1e4f1e0ece0e8edafe4f1e0afe6eef7">[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, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, 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. The official rulemaking 
record is the paper record maintained at the 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.
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by 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) of the APA as amended.

List of Subjects in 40 CFR Part 180

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

    Dated: February 27, 1997.

Peter Caulkins,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR Chapter I is amended as follows:

PART 180--[AMENDED]

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

    2. In Sec. 180.431, by adding a new paragraph (c) to read as 
follows:


Sec. 180.431  Clopyralid; tolerances for residues.

*       *       *       *       *
    (c) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the herbicide clopyralid (3,6-dichloro-2-
pyridinecarboxylic acid) in connection with use of the pesticide under 
section 18 emergency exemptions granted by EPA. The tolerance is 
specified in the following table. The tolerance expires on the date 
specified in the table.

------------------------------------------------------------------------
            Commodity              Parts per million    Expiration Date 
------------------------------------------------------------------------
Cranberries.....................           2             July 31, 1998  
------------------------------------------------------------------------

[FR Doc. 97-5875 Filed 3-11-97; 8:45 am]
BILLING CODE 6560-50-F


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