[Federal Register Volume 64, Number 221 (Wednesday, November 17, 1999)]
[Rules and Regulations]
[Pages 62588-62594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30025]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300938; FRL-6388-5]
RIN 2070-AB78
Clopyralid; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of 3,6-dichloro-2-pyridinecarboxylic acid (clopyralid) in or
on flax seed. This action is in connection with a crisis exemption
issued under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizing use of the pesticide on flax. This
regulation establishes a maximum permissible level for residues of
clopyralid in this food commodity. The tolerance will expire and is
revoked on December 31, 2001.
DATES: This regulation is effective November 17, 1999. Objections and
requests for hearings, identified by docket control number OPP-300938,
must be received by EPA on or before January 18, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300938 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 308-9364; and e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300938. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2 (CM #2), 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday
[[Page 62589]]
through Friday, excluding legal holidays. The PIRIB telephone number is
(703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing a tolerance for residues of the herbicide 3,6-dichloro-2-
pyridinecarboxylic acid, in or on flax seed at 0.5 part per million
(ppm). This tolerance will expire and is revoked on December 31, 2001.
EPA will publish a document in the Federal Register to remove the
revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by the Food Quality Protection Act (FQPA). EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for clopyralid on flax and FFDCA
Tolerances
On June 25, 1999, the North Dakota Department of Agriculture
declared a crisis exemption for use of clopyralid on flax. There are no
adequate alternatives available to control Canada thistle and perennial
sowthistle. The populations of these two pests have been increasing due
to recent changes in weather. Under high weed pressure, yield in an
infested field could easily be reduced by 25%. Beyond yield loss from
weed competition, additional impacts from an infestation of Canada
thistle could include total loss of the crop because State law may
require destruction of thistle-infested areas in flax fields to prevent
spread of these weeds. After having reviewed the related specific
exemption, EPA concurs that emergency conditions existed for control of
Canada thistle and perennial sowthistle in North Dakota.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of clopyralid in or on flax
seed. In doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerance under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address an urgent non-routine situation
and to ensure that the resulting food is safe and lawful, EPA is
issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on December 31, 2001, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerance remaining in or on flax seed after that date
will not be unlawful, provided the pesticide is applied in a manner
that was lawful under FIFRA, and the residues do not exceed a level
that was authorized by this tolerance at the time of that application.
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.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether clopyralid
meets EPA's registration requirements for use on flax or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of clopyralid by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for any State other than North Dakota to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
clopyralid, contact the Agency's Registration Division at the address
provided under ``FOR FURTHER INFORMATION CONTACT.''
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
clopyralid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of 3,6-dichloro-2-pyridinecarboxylic acid on flax seed at 0.5
ppm. EPA's assessment of the dietary exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by clopyralid are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. For acute dietary risk assessment, EPA
determined that no appropriate endpoint attributable to a single dose
(exposure) was identified in oral toxicity studies. Therefore, an acute
RfD was not established for either females 13+ years or the general
population, including infants and children.
[[Page 62590]]
2. Short-term and intermediate-term toxicity. EPA determined that
endpoints for both dermal and inhalation risk assessments for short,
intermediate, and chronic occupational and residential exposure
scenarios were not required due to the low toxicity in rats by the
dermal and inhalation routes.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for clopyralid at 0.5 milligrams/kilograms/day (mg/kg/day). This RfD is
based on a 2-year feeding study in rats. The no observable adverse
effect level (NOAEL) of 50 mg/kg/day and an uncertainty factor of 100
is based on decreased body weight gain at the lowest observable adverse
effect level (LOAEL) of 150 mg/kg/day.
4. Carcinogenicity. Clopyralid has not been classified by EPA, but
there is no evidence of tumorigenic potential in Sprague Dawley rats up
to 1,500 mg/kg/day for 2-years and CD-1 mice up to 2,000 mg/kg/day for
18 months.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.431) for residues of 3,6-dichloro-2-pyridinecarboxylic acid, in
or on a variety of raw agricultural commodities, including meat, fat,
and meat byproducts of cattle, goats, hogs, horses, poultry, and sheep;
and milk. Risk assessments were conducted by EPA to assess dietary
exposures and risks from clopyralid as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. For acute dietary risk assessment, EPA
determined that no appropriate endpoint attributable to a single dose
(exposure) was identified in oral toxicity studies. Therefore, an acute
RfD was not established for either females 13+ years or the general
population, including infants and children. An acute dietary risk
assessment is therefore not required.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made very conservative assumptions: 100% crop
treated is assumed for all crops and residues will be at the level of
the tolerance. The existing clopyralid tolerances (published and
pending) result in a theoretical maximum residue contribution (TMRC)
that is equivalent to the following percentages of the chronic RfD. As
the 10x safety factor was removed, the chronic RfD is equal to the PAD
(population-adjusted dose). As a result, the exposure given as a
percentage of the total allowable exposure is reported as %PAD.
------------------------------------------------------------------------
Percent Reference
Population Subgroup Exposure (mg/kg/ Dose\1\ (% Chronic
day) PAD/RfD)
------------------------------------------------------------------------
U.S. Population (total)......... 0.009030 1.8%
All Infants (<1 year old)....... 0.008191 1.6%
Nursing Infants (<1 year old)... 0.003915 0.8%
Non-Nursing Infants (<1 year 0.009991 2.0%
old).
Children (1-6 years old)........ 0.020987 4.2%
Children (7-12 years old)....... 0.014009 2.8%
Non-Hispanic Whites............. 0.009121 1.8%
Non-Hispanic/non-white/non-black 0.009199 1.8%
Males 13-19 years............... 0.009860 2.0%
------------------------------------------------------------------------
\1\ Percentage reference dose (% Chronic PAD) = Exposure x 100% (as
RfD=PAD in this case)/Chronic PAD
The subgroups listed above are: (1) The U.S. Population (total);
(2) those for infants and children; and, (3) the other subgroups
(except regions and seasons) for which the percentage of the chronic
PAD occupied is greater than that occupied by the subgroup U.S.
Population (total).
2. From drinking water. Clopyralid is persistent and mobile. There
is no established Maximum Contaminant Level for residues of clopyralid
in drinking water. No health advisory levels for clopyralid in drinking
water have been established. Estimates for the concentration of
clopyralid in surface water are based on GENEEC (Generic Estimated
Environmental Concentration) modeling and in ground water on SCI-GROW
modeling.
i. Acute exposure and risk. EPA determined that no appropriate
endpoint attributable to a single dose (exposure) was identified in
oral toxicity studies. Therefore, an acute RfD was not established for
either females 13+ years or the general population, including infants
and children. An acute risk assessment is therefore not required.
ii. Chronic exposure and risk. The highest EEC for clopyralid in
surface water (27 g/L) is from the non-cropland uses of
clopyralid. The EEC for ground water is 9.7 g/L which also
results from non-cropland uses. For purposes of risk assessment, the
maximum EEC for clopyralid in drinking water (27 g/L) should
be used for comparison to the back-calculated human health drinking
water levels of comparison (DWLOC) for the chronic (non-cancer)
endpoint. These DWLOCs for various population categories are summarized
in the following table.
Drinking Water Levels of Comparison for Chronic Exposure\1\
----------------------------------------------------------------------------------------------------------------
Max. Water
Population Category\2\ Chronic RfD (mg/kg/ Food Exposure (mg/ Exposure\3\ (mg/kg/ DWLOC \4\,\5\,\6\
day) kg/day) day) (g/L)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)......... 0.5 0.009030 0.4910 17,000
Females (13+ years, nursing).... 0.5 0.008776 0.4912 15,000
Children 1-6 years.............. 0.5 0.020987 0.4790 4,800
----------------------------------------------------------------------------------------------------------------
\1\ Values are expressed to 2 significant figures.
\2\ Within each of these categories, the subgroup with the highest food exposure was selected.
\3\ Maximum Water Exposure (Chronic) (mg/kg/day) = Chronic RfD (mg/kg/day) - Food Exposure (mg/kg/day).
\4\ DWLOC(g/L) = Max. water exposure (mg/kg/day) x body wt (kg) [(10-3 mg/g) * water
consumed daily (L/day)].
\5\ EPA Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+
years old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg.
\6\ EPA Default daily drinking rates are 2 L/day for adults and 1 L/day for children.
The estimated maximum concentrations of clopyralid in surface water
and ground water are less than EPA's levels of comparison for
clopyralid in drinking water as a contribution to chronic aggregate
exposure. Therefore, taking into account the present uses and uses
proposed and the fact that GENEEC can substantially overestimate (by up
to 3x) true pesticide concentrations in drinking water, EPA concludes
with reasonable certainty that
[[Page 62591]]
residues of clopyralid in drinking water (when considered along with
other sources of chronic exposure for which EPA has reliable data)
would not result in an unacceptable estimate of chronic (non-cancer)
aggregate human health risk at this time.
3. From non-dietary exposure. Clopyralid is currently not
registered for use on residential non-food sites.
4. Cumulative exposure to substances with a 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.''
EPA does not have, at this time, available data to determine
whether clopyralid has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
clopyralid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that clopyralid has a common mechanism of toxicity
with other substances. For more information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. EPA determined that no appropriate endpoint
attributable to a single dose (exposure) was identified in oral
toxicity studies. Therefore, an acute RfD was not established for
either females 13+ years or the general population, including infants
and children. An acute risk assessment is therefore not required.
2. Chronic risk. Using the conservative TMRC exposure assumptions
described in this unit, EPA has concluded that aggregate exposure to
clopyralid from food will utilize 1.8% of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure is children (1-6 years old). EPA generally has no concern for
exposures below 100% of the RfD because the RfD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. Despite the potential for
exposure to clopyralid in drinking water, EPA does not expect the
aggregate exposure to exceed 100% of the RfD.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account chronic dietary
food and water (considered to be a background exposure level) plus
indoor and outdoor residential exposure. EPA determined that endpoints
for both dermal and inhalation risk assessments for short,
intermediate, and chronic occupational and residential exposure
scenarios were not required because of the low toxicity in rats by the
dermal and inhalation routes.
4. Aggregate cancer risk for U.S. population. Clopyralid has not
been classified by EPA, but there is no evidence of tumorigenic
potential in Sprague Dawley rats up to 1,500 mg/kg/day for 2-years and
CD-1 mice up to 2,000 mg/kg/day for 18 months. Therefore, for the
purposes of this action only, a cancer risk assessment is not required.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to clopyralid residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children --i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of clopyralid, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. EPA believes that reliable data
support using the standard MOE and uncertainty factor (usually 100 for
combined interspecies and intraspecies variability) and not the
additional tenfold MOE/uncertainty factor when EPA has a complete data
base under existing guidelines and when the severity of the effect in
infants or children or the potency or unusual toxic properties of a
compound do not raise concerns regarding the adequacy of the standard
MOE/safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal (systemic) NOAEL of 75 mg/kg/day is based on
decreased body weight, decreased food consumption, and one death at the
LOAEL of 250 mg/kg/day. The developmental (fetal) NOAEL is >250 mg/kg/
day highest dose tested (HDT). In the developmental toxicity study in
rabbits, the maternal (systemic) NOAEL is >250 mg/kg/day (HDT). The
developmental (fetal) NOAEL is also >250 mg/kg/day (HDT).
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the parental (systemic) NOAEL is 500 mg/kg/day,
based on decreased body weight at the LOAEL of 1,500 mg/kg/day (HDT).
The reproductive (pup) NOAEL is >1,500 mg/kg/day (HDT).
iv. Prenatal and postnatal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity for clopyralid is
complete with respect to current data requirements. There are no
prenatal or postnatal toxicity concerns for infants and children, based
on the results of the rat and rabbit developmental toxicity studies as
well as the 2-generation rat reproductive toxicity study. Based on the
above, the the 10x safety factor was removed (1x) for purposes of this
action.
v. Conclusion. There is a complete toxicity data base for
clopyralid and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures.
2. Acute risk. EPA determined that no appropriate endpoint
attributable to a single dose (exposure) was identified in oral
toxicity studies. Therefore, an acute RfD was not established for
either females 13+ years or the general population, including infants
and children. An acute risk assessment is therefore not required.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to clopyralid from food
will utilize 4.2% of the RfD for children (1-6 years old). EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
[[Page 62592]]
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to clopyralid in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
RfD.
4. Short-term or intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account chronic dietary
food and water (considered to be a background exposure level) plus
indoor and outdoor residential exposure. EPA determined that endpoints
for both dermal and inhalation risk assessments for short,
intermediate, and chronic occupational and residential exposure
scenarios were not required because of the low toxicity in rats by the
dermal and inhalation routes.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to clopyralid residues.
V. Other Considerations
A. Metabolism in Plants and Animals
The nature of the residue in plants and animals is adequately
understood.
B. Analytical Enforcement Methodology
An adequate analytical method is available for enforcement of the
proposed tolerances in flax seed. This method is a GC method using a
Hall electrolytic conductivity detector. This method has been submitted
to FDA for publication in PAM II. An enforcement method for animal
commodities is available in PAM II. This method is entitled ``Gas
Chromatographic Determination of Clopyralid Residues in Eggs, Bovine
Liver, and Milk.''
The method for flax seed may be requested from: Calvin Furlow,
PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 305-5229; e-mail address: [email protected].
C. Magnitude of Residues
A tolerance of 0.5 ppm for flax seed will cover residues in flax
meal. Flax meal is an animal feed item. It can comprise as much as 10%
of the diets of beef cattle, dairy cattle, and swine. It can also
comprise up to 30% of the diet of poultry. Clopyralid is registered for
use on grasses and several cereal grains (i.e., barley, corn, oats, and
wheat). Taking into account the tolerances and percent dry matter in
these crops as well as those in flax meal, this latter commodity will
not cause an increase in the dietary burden of animal commodities.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for clopyralid on flax.
E. Rotational Crop Restrictions
------------------------------------------------------------------------
Comments,
Crop Rotation Crop Conditions and
Interval Limitations
------------------------------------------------------------------------
Barley, grasses, field corn, 30 days Listed crops may be
oats, wheat. planted 30 days
following
application of
Curtail M.
Sugar beets.................... 5 months Do not plant in the
same growing
season following
application of
Curtail M.
Alfalfa, asparagus, canola 10.5 months Do not plant listed
(rapeseed), cole crops, dry crops for 10.5
beans\1\, grain sorghum, mint, months following
onions, popcorn, safflower, application of
soybeans\1\, sunflowers\1\, Curtail M.
sweet corn, strawberries.
Lentils, peas, potatoes, 18 months Do not plant listed
broadleaf crops grown for seed. crops for 18
months after
application unless
the risk of crop
injury is
acceptable. The
potential for
injury may be
reduced by
burning, removal,
or incorporation
of treated crop
residues followed
by a minimum of 2
supplemental fall
irrigations.
------------------------------------------------------------------------
\1\ If soils contain less than 2% organic matter and natural
precipitation is <15 inches during the 10.5 months following
application, these (footnoted) crops should not be planted until 18
months after application unless the risk of crop injury is acceptable.
The potential for injury may be reduced by burning, removal, or
incorporation of treated crop residues followed by a minimum of 2
supplemental fall irrigations.
VI. Conclusion
Therefore, the tolerance is established for residues of 3,6-
dichloro-2-pyridinecarboxylic acid in flax seed at 0.5 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300938 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before January
18, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
[[Page 62593]]
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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-300938, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person or
by courier, bring a copy to the location of the PIRIB described in Unit
I.B.2. You may also send an electronic copy of your request via e-mail
to: [email protected]. Please use an ASCII file format and avoid the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not
include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes a time-limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
This final rule does not contain any information collections subject to
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or require OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 petition under FFDCA section 408, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
IX. Submission to Congress and the General Accounting Office
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
[[Page 62594]]
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 27, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. In Sec. 180.431, in the table in paragraph (b), alphabetically
add the following commodity to read as follows:
Sec. 180.431 Clopyralid; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
* * * * *
Flax seed..................................... 0.5 12/31/01
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-30025 Filed 11-16-99; 8:45 am]
BILLING CODE 6560-50-F