[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: <a href="/cdn-cgi/l/email-protection#f7988787da9398949c9283b79287969a969e9bd9928796d9909881"><span class="__cf_email__" data-cfemail="422d32326f262d21292736022732232f232b2e6c2732236c252d34">[email protected]</span></a>. 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: 
<a href="/cdn-cgi/l/email-protection#6302000a0611170c4d020e060f0a02230613020e020a0f4d0613024d040c15"><span class="__cf_email__" data-cfemail="f594969c9087819adb949890999c94b590859498949c99db908594db929a83">[email protected]</span></a>.

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 LD<INF>50</INF> 
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:
    <a href="/cdn-cgi/l/email-protection#92fde2e2bff6fdf1f9f7e6d2f7e2f3fff3fbfebcf7e2f3bcf5fde4"><span class="__cf_email__" data-cfemail="c0afb0b0eda4afa3aba5b480a5b0a1ada1a9aceea5b0a1eea7afb6">[email protected]</span></a>.

    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


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