[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.

-----------------------------------------------------------------------

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