[Federal Register Volume 62, Number 232 (Wednesday, December 3, 1997)]
[Rules and Regulations]
[Pages 63858-63863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31547]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300574; FRL-5754-1]
RIN 2070-AB78
Sodium Chlorate; Exemption From Pesticide Tolerance for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited exemption from the
requirement of a tolerance for residues of sodium chlorate in or on
wheat. This action is in connection with crisis exemptions declared by
the states of Arkansas and Mississippi under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on wheat in Arkansas and Mississippi. This regulation
establishes an exemption from the requirement of a tolerance for
residues of sodium chlorate in this food commodity pursuant to section
408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996. The exemption will expire and
is revoked on July 31, 1998.
DATES: This regulation is effective December 3, 1997. Objections and
requests for hearings must be received by EPA on or before February 2,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300574], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300574], must also be submitted 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,
bring a copy of objections and hearing requests to Rm. 1132, Crystal
Mall #2, 1921 Jefferson Davis Hwy., 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 5.1/6.1
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-300574]. 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 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: CM #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 308-9364, 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 an exemption
from the requirement of a tolerance for residues of the defoliant/
desiccant sodium chlorate, in or on wheat. This exemption will expire
and is revoked on July 31, 1998. EPA will publish a document in the
Federal Register to remove the revoked exemption from the Code of
Federal Regulations.
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 Federal Food,
Drug, and Cosmetic Act (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 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
[[Page 63859]]
exemption from tolerance (the legal limit for a pesticide chemical
residue in or on a food) only if EPA determines that the exemption from
tolerance is ``safe.'' Section 408(c)(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. New section 408(c)(2)(B) requires EPA to take
into account, among other relevant conditions, the considerations set
forth in 408(c)(2)(C) and (D). 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) 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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Sodium Chlorate on Wheat and FFDCA
Tolerances
On May 27 and June 6, 1997, the states of Mississippi and Arkansas,
respectively, availed themselves of the authority to declare the
existence of a crisis situation within each state, thereby authorizing
use under FIFRA section 18 of sodium chlorate on wheat as a defoliant
or desiccant to aid in the harvest of wheat. A cool, wet spring delayed
the wheat harvest in these states. Continued heavy rains resulted in
the need for a harvest aid to desiccate winter weeds which developed in
the thin stands of an already diminished wheat crop.
As part of its assessment of these crisis exemptions, EPA assessed
the potential risks presented by residues of sodium chlorate in or on
wheat. In doing so, EPA considered the new safety standard in FFDCA
section 408(c)(2), and EPA decided that an exemption from the
requirement for a tolerance under FFDCA section 408(l)(6) would be
consistent with the new 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 exemption from
the requirement of a tolerance without notice and opportunity for
public comment under section 408(e), as provided in section 408(l)(6).
Although this exemption from the requirement of a tolerance will expire
and is revoked on July 31, 1998, under FFDCA section 408(l)(5),
residues of the pesticide remaining in or on wheat after that date will
not be unlawful, provided the pesticide is applied in a manner that was
lawful under FIFRA. EPA will take action to revoke this exemption
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because this exemption from the requirement of a tolerance is being
approved under emergency conditions EPA has not made any decisions
about whether sodium chlorate meets EPA's registration requirements for
use on wheat or whether a permanent exemption from the requirement of a
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this exemption serves as a basis for
registration of sodium chlorate by a State for special local needs
under FIFRA section 24(c). Nor does this exemption serve as the basis
for any State other than Arkansas and Mississippi to use this pesticide
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 exemption for sodium chlorate,
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. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal 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% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
[[Page 63860]]
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 MOE 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.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.,
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
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, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). 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. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
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% 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.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (children 1-6
years old) was not regionally based.
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, EPA has sufficient data to assess the hazards of sodium
chlorate and to make a determination on aggregate exposure, consistent
with section 408(b)(2), for a time-limited exemption from the
requirement of a tolerance for residues of sodium chlorate on wheat.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance exemption 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 sodium chlorate are
discussed below.
1. Acute toxicity. No acute dietary endpoint was identified. This
conclusion was based on a developmental toxicity study in which rats
were dosed at the limit dose of 1,000 mg/kg/day without any ill effects
to the dams or their fetuses.
2. Short - and intermediate - term non-dietary toxicity. The
available acute
[[Page 63861]]
dermal and inhalation studies are of dilute mixtures with other active
ingredients. The Toxicity Categories were III for the dermal studies,
and IV for the inhalation studies. Aqueous sodium chlorate has been
used as an antiseptic wash for the skin and mucous membranes.
Considering the low toxicity of sodium chlorate, non-dietary exposure
is not a concern.
3. Chronic toxicity. EPA has not established an RfD for sodium
chlorate. For purposes of this exemption, based upon available toxicity
data, an RfD for sodium chlorate of 0.1 milligrams/kilogram/day (mg/kg/
day) was used. This RfD is based on a 90-day oral toxicity study in
rats with a NOEL of 100 mg/kg/day and an uncertainty factor of 1,000
(10-fold each for inter and intra-species extrapolation, and use of a
less-than-chronic endpoint) based on anemia, reticulocytosis, and
depressed adrenal weights at the LOEL of 1,000 mg/kg/day.
4. Carcinogenicity. Sodium chlorate is used as a desiccant. Because
it is chemically similar to chlorine dioxide and chlorite which are not
carcinogenic, and dietary exposure is virtually eliminated by
hydrolysis during cooking, carcinogenicity is not a concern.
B. Exposures and Risks
1. From food and feed uses. Exemptions from the requirement of
tolerances have been established (40 CFR 180.1020) for the residues of
sodium chlorate, in or on a variety of raw agricultural commodities,
including corn, rice, safflower, and sorghum. Risk assessments were
conducted by EPA to assess dietary exposures and risks from sodium
chlorate 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 one day or single exposure.
ii. Chronic exposure and risk. Field trial residue values were non-
detectable at the limit of detection of 2 ppm, even at the 2 x rate.
The risk assessment assumed that 100% of all wheat commodities will
contain sodium chlorate residues and those residues would all be at 2
ppm, which results in an overestimate of human dietary exposure.
Additionally, residues of sodium chlorate would likely be substantially
reduced through hydrolysis during cooking, although this reduction was
not taken into account for this conservative risk assessment.
2. From drinking water. There is no established Maximum
Concentration Level for residues of sodium chlorate in drinking water.
No drinking water health advisory levels have been established for
sodium chlorate.
Chronic exposure and risk. Because the Agency lacks sufficient
water-related exposure data to complete a comprehensive drinking water
risk assessment for many pesticides, EPA has commenced and nearly
completed a process to identify a reasonable yet conservative bounding
figure for the potential contribution of water-related exposure to the
aggregate risk posed by a pesticide. In developing the bounding figure,
EPA estimated residue levels in water for a number of specific
pesticides using various data sources. The Agency then applied the
estimated residue levels, in conjunction with appropriate toxicological
endpoints (RfDs or acute dietary NOELs) and assumptions about body
weight and consumption, to calculate, for each pesticide, the increment
of aggregate risk contributed by consumption of contaminated water.
While EPA has not yet pinpointed the appropriate bounding figure for
exposure from contaminated water, the ranges the Agency is continuing
to examine are all below the level that would cause sodium chlorate to
exceed the RfD if the exemption being considered in this document were
granted. The Agency has therefore concluded that the potential
exposures associated with sodium chlorate in water, even at the higher
levels the Agency is considering as a conservative upper bound, would
not prevent the Agency from determining that there is a reasonable
certainty of no harm if the exemption is granted.
3. From non-dietary exposure. Sodium chlorate is currently
registered for use on the following residential non-food sites: wood
treatment, outdoor turf, and ornamental perennials, shrubs, and trees.
The available acute dermal and inhalation studies are of dilute
mixtures with other active ingredients. The Toxicity Categories are III
for the dermal studies, and IV for the inhalation studies. Aqueous
sodium chlorate has been used as an antiseptic wash for the skin and
mucous membranes. Agricultural workers would be exposed to aqueous
solutions containing a low percentage of sodium chlorate. Considering
the low toxicity of sodium chlorate, non-dietary exposure is not a
concern.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether sodium chlorate 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,
sodium chlorate does not appear to produce a toxic metabolite produced
by other substances. For the purposes of this tolerance action,
therefore, EPA has not
[[Page 63862]]
assumed that sodium chlorate has a common mechanism of toxicity with
other substances.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Chronic risk. Using the very conservative TMRC exposure
assumptions described above, EPA has concluded that aggregate exposure
to sodium chlorate from food will utilize 3% of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure is children (1-6 years old) discussed below. 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 sodium chlorate in drinking water
and from non-dietary, non-occupational exposure, EPA does not expect
the aggregate exposure to exceed 100% of the RfD. EPA concludes that
there is a reasonable certainty that no harm will result from aggregate
exposure to sodium chlorate residues.
2. Short- and intermediate-term risk. Short- 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.
D. 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 sodium chlorate, EPA considered data from
developmental toxicity studies 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 pre-and post-natal toxicity and the
completeness of the database 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 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 100-
fold safety factor (usually 100 for combined inter-and intra-species
variability)) and not the additional tenfold safety 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 safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal (systemic) NOEL was >1,000 mg/kg/day. The
developmental (fetal) NOEl was also >1,000 mg/kg/day.
iii. Pre- and post-natal sensitivity. Sodium chlorate is not a
developmental toxicant in rats. EPA has already applied an additional
10-fold uncertainty factor (resulting in a total 1,000-fold uncertainty
factor) to the NOEL used to set the RfD. This additional 10-fold
uncertainty factor should be adequate to protect infants and children.
2. Chronic risk. Using the very conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to sodium
chlorate from food will utilize from 1% of the RfD for nursing infants
up to 6% 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 exposure over a lifetime will
not pose appreciable risks to human health. Despite the potential for
exposure to sodium chlorate in drinking water and from non-dietary,
non-occupational exposure, EPA does not expect the aggregate exposure
to exceed 100% of the RfD. EPA concludes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to sodium chlorate residues.
V. Other Considerations
A. Metabolism In Plants and Animals
The metabolism of sodium chlorate in plants is adequately
understood. The residue of concern is sodium chlorate and sodium
chloride. The nature of the residue in animals is not applicable due to
no reasonable expectation of transfer of residues to meat/milk/poultry/
eggs.
B. Analytical Enforcement Methodology
Analytical methods for detecting and measuring the levels of the
pesticide residue are not needed. The Agency proposes to establish an
exemption from the requirement of a tolerance without any numerical
limitation; therefore, the Agency has concluded that analytical methods
are not required for enforcement purposes for sodium chlorate.
C. Magnitude of Residues
No detectable residues were found in wheat grain or straw from
wheat treated at the 2 x rate. Considering that no detectable residues
were found in wheat grain, it is unlikely that significant residues
will occur in the processed fractions of wheat. There is no likelihood
of transfer of residues to meat/milk/poultry/eggs. Therefore, magnitude
of the residue data in those commodities is not required.
D. International Residue Limits
No CODEX, Canadian, or Mexican maximum residue levels have been
established for residues of sodium chlorate.
E. Rotational Crop Restrictions
Considering the phytotoxic nature of sodium chlorate, which would
preclude the planting of a crop soon after treatment of a previous
crop, coupled with the fact that residues are below the limit of
quantitation shortly after application to target crops, EPA does not
believe measurable residues would be detected in rotational crops. For
the purposes of this section 18 use, rotational crop tolerances and/or
plant back restrictions will not be necessary.
VI. Conclusion
Therefore, the exemption from the requirement of a tolerance is
established for residues of sodium chlorate in wheat.
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 February 2, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given
[[Page 63863]]
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 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 Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300574] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., 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 will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ADDRESSES at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes a time-limited exemption from the
tolerance requirement under FFDCA section 408(l)(6). 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) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or 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 in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the exemption 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. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has 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 this rule in
today's Federal Register. This 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,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 21, 1997.
Linda A. Travers,
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. Section 180.1020 is amended by designating the existing text as
paragraph (a) and by adding paragraph (b) to read as follows:
Sec. 180.1020 Sodium chlorate; exemption from the requirement of a
tolerance.
* * * * *
(b) A time-limited exemption from the requirement of a tolerance is
established for residues of the defoliant/desiccant in connection with
use of the pesticide under section 18 emergency exemptions granted by
EPA. The exemption will expire and is revoked on the date specified in
the following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Wheat........................... NA 7/31/98
------------------------------------------------------------------------
[FR Doc. 97-31547 Filed 12-2-97; 8:45 am]
BILLING CODE 6560-50-F
