[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: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-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: pemberton.libby@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing 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:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above, 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
