[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Rules and Regulations]
[Pages 28253-28258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13603]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300658; FRL-5790-1]
RIN 2070-AB78
Hydroxyethylidine Diphosphonic Acid; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of hydroxyethylidine diphosphonic acid
(HEDP), when used as an inert ingredient (stabilizer/ chelator) in
antimicrobial pesticide formulations applied in or on raw agricultural
commodities. Ecolab, Inc. requested this tolerance under the Federal
Food, Drug and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective May 22, 1998. Objections and
requests for hearings must be received by EPA on or before July 21,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300658], 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-300658], 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. 119, CM #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: [email protected]. 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-300658]. 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: Amelia M. Acierto,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-8377, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of December 17, 1997
(62 FR 66091) (FRL-5760-5), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide petition (PP 7E4922) for a
tolerance exemption by Ecolab Inc., 370 N. Wabasha Street, St. Paul,
Minnesota 55102. This notice included a summary of the petition
prepared by Ecolab Inc., the petitioner. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR 180.1001(c) be amended by
establishing an exemption from the requirement of a tolerance for
residues of the inert ingredient hydroxyethylidine diphosphonic acid
(HEDP), when used as an inert ingredient (stabilizer and chelator) in
antimicrobial pesticide formulations used in or on raw agricultural
commodities.
I. Risk Assessment and Statutory Findings
New 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. . . .''
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'').
[[Page 28254]]
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. 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 hundredfold MOE is based on the same rationale as
the hundredfold uncertainty factor.
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 the Food
Quality Protection Act, 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 percent of the crop is treated by pesticides that
have established tolerances. If the TMRC exceeds the RfD or poses a
lifetime cancer risk that is greater than approximately one in a
million, EPA attempts to derive a more accurate exposure estimate for
the pesticide by evaluating additional types of information
(anticipated residue data and/or percent of crop treated data) which
show, generally, that pesticide residues in most foods when they are
eaten are well below established tolerances.
II. 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 HEDP and
to make a determination on aggregate exposure, consistent with section
408(b)(2), for an exemption from the requirement of a tolerance for
residues of HEDP when used as an inert ingredient in antimicrobial
pesticide formulations applied to raw agricultural commodities. EPA's
assessment of the dietary exposures and risks associated
[[Page 28255]]
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 HEDP are discussed
below.
1. Acute toxicity. A rat acute oral study with an LD50
of 2,400 mg/kg.
2. Genotoxicity. HEDP was reported to be non-mutagenic in a
Salmonella/Mammalian microsome test or in a L5178Y TK mouse lymphoma
cell point mutation assay, with and without mammalian microsomal
activation.
3. Subchronic toxicity-- i. Dogs. In a subchronic feeding study in
beagle dogs (4 dogs/sex/dose), HEDP was administered at doses of 0,
1,000, 3,000, or 10,000 ppm for 90 days. The NOEL was 3,000 ppm (75
milligrams/kilogram/day (mg/kg/day)) and the Lowest Observed Effect
Level (LOEL) was 10,000 ppm (250 mg/kg/day based on decreased weight
gain in females, and decreased testicular weight accompanied by
evidence of bilateral focal degeneration of the testicular germinal
epithelium in males.
ii. Rats. In a subchronic feeding study in rats, Sprague-Dawley
strain rats were fed HEDP at dietary concentrations of 0, 3,000, 10,000
and 30,000 ppm for 90 days. The NOEL was 10,000 ppm (approximately 500
mg/kg/day) and the LOEL was 30,000 ppm (approximately 1,500 mg/kg/day)
based on decreased body weight, decreased food consumption, slight
anemia, and decreased heart, liver, and kidney weights.
4. Developmental toxicity study. In a developmental toxicity study,
rabbits were administered HEDP at doses of 0, 25, 50 and 100 mg/kg/day,
either incorporated into feed or by intubation with water. The NOEL for
both systemic and developmental effects was 50 mg/kg/day and the LOEL
was 100 mg/kg/day gavage dose based on decreased maternal weight gain/
food consumption and decreased fetal body weights.
5. Reproductive toxicity study. In a combined two-generation
reproduction/developmental toxicity study, rats (22 rats/sex/dose) were
administered HEDP at doses of 0, 0.1, and 0.5 percent in the diet. The
NOEL for developmental and reproductive findings was 50 mg/kg/day (0.1
percent in the diet) and the LOEL was 250 mg/kg/day (0.5 percent in the
diet) based on reduced litter size in the first litter (F1a) and an
increase in stillborn pups in the second liter (F1b). These effects
occurred in the absence of maternal toxicity and were seen in both
reproductive litters of the first generation.
B. Toxicological Endpoints
1. Acute toxicity. An acute dietary risk assessment is not required
because no significant treatment-related effects attributable to a
single exposure (dose) were seen in the oral studies conducted with
HEDP.
2. Short - and intermediate - term toxicity. A short- and
intermediate-term risk assessment is not required for HEDP since
significant short- and intermediate- term exposures are not expected as
a result of the proposed use pattern.
3. Chronic toxicity. EPA has established the RfD for HEDP at 0.05
mg/kg/day. This RfD is based on a reproductive/developmental toxicity
study in rats with a NOEL of 50 mg/kg/day. An uncertainty factor of
1,000 was used in the calculation of the RfD to account for
intraspecies variability (tenfold uncertainty factor), interspecies
extrapolation (tenfold uncertainty factor), lack of chronic toxicity/
carcinogenicity data (threefold uncertainty factor), and the additional
sensitivity of infants and children (threefold uncertainty factor). The
product of these four individual uncertainty factors results in an
overall uncertainty factor of 1,000.
4. Carcinogenicity. A survey of the open literature has not
revealed any studies as to the carcinogenicity of HEDP. Since HEDP has
been determined to be nonmutagenic in genotoxicity testing and no
preneoplastic lesions have been noted in any of the available animal or
human test data, it is expected that the use of an additional threefold
uncertainty factor in the chronic risk assessment of HEDP to account
for the lack of carcinogenicity data should be protective of any
possible cancer risk.
C. Exposures and Risks
1. From food and feed uses. Risk assessments were conducted by EPA
to assess dietary exposures and risks from HEDP as follows:
i. Acute exposure and risk. Since there are no acute toxicological
concerns for HEDP, an acute dietary risk assessment was not required.
ii. Chronic exposure and risk. For the purpose of assessing chronic
dietary exposure from HEDP, EPA considered the proposed use of HEDP as
a component of an antimicrobial pesticide formulation at a
concentration not to exceed 1 percent of the formulation and a maximum
use rate of the antimicrobial formulation used in fruit and vegetable
wash water of 1 ounce/16.4 gallons of water. There are no established
U.S. tolerances for HEDP, and there are no other registered uses for
HEDP on food or feed crops in the United States. In conducting this
exposure assessment, EPA assumed that residues of 1 part per billion
(ppb) of HEDP would be present in all raw agricultural commodities,
resulting in a large overestimate of dietary exposure and protective of
any chronic dietary exposure scenario. (Limted data provided by the
petitioner and prior estimations of dietary intake made by the U.S Food
and Drug Administration (FDA) for the use of HEDP in antimicrobial
applications to processed foods indicate that residues of HEDP in the
treated commodities would be unlikely to exceed 1 ppb.) Based on the
assumption that residues would be present at 1 ppb in all items
consumed in the diet, it is estimated that the resultant dietary
exposure would be 0.00004 mg/kg/day for adults (U.S. population) and
0.0001 mg/kg/day for children.
2. From drinking water-- i. Acute exposure and risk. Since there
are no acute toxicological concerns for HEDP, an acute drinking water
risk assessment was not required.
ii. Chronic exposure and risk. For the purposes of assessing
chronic exposure in drinking water, EPA has considered the current use
of HEDP as an antiscalant in municipal drinking water treatment systems
at a maximum concentration of 25 ppb in consumed water. Based on a
typical average daily consumption of 2 liters of water/ day by adults
and 1 liter water/day by children. The exposure to HEDP from drinking
water exposure would not be expected to exceed 0.0007 mg/kg/day for
adults and 0.0025 mg/kg/day for children.
3. From non-dietary exposure. Since there are no acute
toxicological concerns for HEDP, an acute nondietary risk assessment
was not required.
Chronic exposure and risk. While non-dietary exposure to HEDP as a
result of its use in antimicrobial pesticide formulations applied to
raw agricultural commodites is unlikely other uses of HEPD for which
non-dietary exposure may result include its use in various personal
care and over-the-counter pharmaceutical products. It is expected that
the exposures associated with these uses would not exceed 0.0049 mg/kg/
day for adults and 0.0204 mg/kg/day for children.
[[Page 28256]]
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 HEDP 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, HEDP 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
HEDP has a common mechanism of toxicity with other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
Using the extremely conservative exposure assumptions described
above, EPA has concluded that aggregate exposure to HEDP from all
pesticide and nonpesticide uses will not exceed 0.006 mg/kg/day for
adults (12 percent of the RfD) and 0.023 mg/kg/day for children (46
percent of the RfD. EPA generally has no concern for exposures below
100 percent 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. EPA does not expect the aggregate
exposure to exceed 100 percent of the RfD. EPA therefore concludes that
there is a reasonable certainty that no harm will result from aggregate
exposure to HEDP residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
Safety factor for infants and children. In assessing the potential
for additional sensitivity of infants and children to residues of HEDP,
EPA considered data from developmental toxicity studies in the rat and
rabbit and a two-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
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. In either case, EPA generally defines the level of appreciable
risk as exposure that is greater than 1/100 of the NOEL in the animal
study appropriate to the particular risk assessment. This hundredfold
uncertainty (safety) factor/MOE (safety) is designed to account for
inter-species extraoplation and inter-species variability. EPA believes
that reliable data support using the hundredfold margin/factor, rather
than the thousandfold margin/factor, when EPA has a complete data base
under existing guidleines, and when the severity of the effect in
infants or children, the potency or unusual toxic properties of a
compound, or the quality of the exposure data do not raise concerns
regarding the adequacy of the standard margin/factor.
The following factors support retention of a tenfold uncertainly
factor: (i) The reproductive effects were observed at dose levels in
which there was no apparent maternal toxicity, (ii) the study was not
conducted in accordance with OPP's Subdivision F ( Hazard Evaluation:
Humans and Domestic Animals) Pesticide Assessment Guidelines, and (iii)
a prenatal developmental toxicity study of HEDP in rats conducted via
the gavage route of administration was not available (the dietary
developmental toxicity study in rats which was conducted as part of the
reproductive study did not completely meet Subdivision F Pesticide
Assessment Guideline requirements. However, the noted reproductive
effects (decreased average number of live fetuses and increases in
stillborn pups) were seen as separate, single litter events of the
first generation but not of the second generation which would render
less significance to a finding of a treatment-related effect. Taking
into account that in this case there are study deficiencies not absent
studies, the evidence of a reproductive effects in the absence of
maternal toxicity is equivocal, and developmental effects were observed
in rabbits at dose levels in which maternal toxicity was not observed,
EPA has concluded that the tenfold uncertainty factor for infants and
children should be reduced to a threefold uncertainty factor.
III. Other Considerations
A. Analytical Enforcement Methodology
The Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation; therefore, the Agency has
concluded that an analytical method is not required for enforcement
purposes for HEDP.
[[Page 28257]]
B. International Residue Limits
No Codex maximum residue levels have been established for HEDP.
IV. Conclusion
Therefore, an exemption from the requirement of a tolerance is
established for residues of HEDP when used as an inert ingredient
(stabilizer/ chelator) in antimicrobial pesticide formulations applied
to raw agricultural commodites at a level not to exceed 1 percent of
the antimicrobial pesticide formulation.
V. 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 July 21, 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 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.
VI. Public Docket and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300658] (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 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
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.
VII. Regulatory Assessment Requirements
This final rule establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. 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 on the basis of a petition under FFDCA section 408(d), 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.
VIII. 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.
[[Page 28258]]
Dated: May 8, 1998.
Peter Caulkins,
Acting 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. 346a and 371.
2. In Sec. 180.1001, in paragraph (c), the table is amended by
alphabetically adding the inert ingredient ``hydroxyethylidine
diphosphonic acid (HEDP)'' to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(c) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
* *
Hydroxyethylidine diphosphonic For use in Stabilizer,
acid (HEDP) (CAS Reg. No. antimicrobial chelator
2809-21-4). pesticide
formulations at not
more than 1 percent.
* * * * *
* *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-13603 Filed 5-21-98; 8:45 am]
BILLING CODE 6560-50-F