[Federal Register Volume 63, Number 87 (Wednesday, May 6, 1998)]
[Rules and Regulations]
[Pages 24949-24955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12036]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300654; FRL-5789-3]
RIN 2070-AB78
Peroxyacetic Acid; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document establishes an exemption from the requirement of
a tolerance for residues of the antimicrobial pesticide peroxyacetic
acid up to 100 ppm, in or on raw agricultural commodities, in processed
commodities, when such residues result from the use of peroxyacetic
acid as an antimicrobial agent on fruits, tree nuts, cereal grains,
herbs, and spices. Ecolab, Inc. requested this exemption under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996 (Pub. L. 104-170).
DATES: This regulation is effective May 6, 1998. Objections and
requests for hearings must be received by EPA on or before July 6,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300654], 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-300654], 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: 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-300654]. 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: Marshall Swindell, Product
Manager 33, Antimicrobials Division (7510W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: 2800
Crystal Drive, 6th Floor, Arlington, VA, 22202, 703-308-6341, e-mail:
swindell.marshall@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 1998
(63 FR 2232) (FRL-5759-6), 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) 7F4808 for tolerance
by Ecolab, Inc., 370 Wabasha Street, St. Paul, MN 55102. This notice
included a summary of the petition prepared by Ecolab, Inc., the
registrant. There were no comments received in response to the notice
of filing.
Subsequently, the proposed tolerance exemption was amended to
delete meat, meat by-products, poultry, milk, and eggs. This was done
because at the low proposed use concentrations, no residues of
toxicological concern are expected on any animal feeds that may be
exposed to peroxyacetic acid. Therefore, no residues of toxicological
concern are anticipated either in animals that may consume these feeds,
or in associated animal by-products.
In addition, the proposed tolerance exemption was amended to
include a maximum residue limit of 100 ppm for peroxyacetic acid. This
limitation was added because of Agency concerns that a high use
concentration could result in measurable residues of peroxyacetic acid.
Residue data will be needed to increase or remove this limitation.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance or an exemption from the requirement of a tolerance (the
legal limit for a pesticide chemical residue in or on a food) only if
EPA determines that the tolerance or exemption from the requirement of
a 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
[[Page 24950]]
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'').
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.
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 of 1996 (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
[[Page 24951]]
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 sub-population group.
Further, regional consumption information is taken into account
through EPA's computer-based model for evaluating the exposure of
significant sub-populations including several regional groups, to
pesticide residues. For peroxyacetic acid, based on the lack of any
residues of toxicological concern, it is unlikely that significant
exposure through the proposed use would occur to any sub-population
although sensitive sub-populations may exist (eg.,catalase deficient
individuals).
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
peroxyacetic acid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for an exemption of a requirement
for a tolerance for residues of peroxyacetic acid up to 100 pm, in or
on raw agricultural commodities, in processed commodities, when such
residues result from the use of peroxyacetic acid as an antimicrobial
agent on fruits, tree nuts, cereal grains, herbs, and spices. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by peroxyacetic acid
(C2H4O3) are discussed below.
Ecolab, Inc. has requested a waiver of all toxicology testing
requirements for peroxyacetic acid. This includes waivers for all
acute, 90-day sub-chronic, chronic, carcinogenicity, developmental,
reproductive, mutagenicity, neurotoxicity and metabolism requirements.
Ecolab's rationale for waivers in each of these areas is similar, and
are summarized by the following four arguments:
1. Available data at the Agency are sufficient to estimate the
potential human health hazard of the end use product.
2. Peroxyacetic acid reacts rapidly on contact with material such
as food and is degraded to moieties which present no toxicological
concern. The primary degradation products of peroxyacetic acid are
acetic acid, which is generally regarded as safe (GRAS) according to
the Food and Drug Administration (21 CFR 184.1005), water, and oxygen.
Based on the chemical reactivity of this compound and the unstable
nature of the peroxide bond, conduct of long term residue or metabolism
studies would be extremely difficult and unreliable. This peroxyacetic
acid petition is also the companion to a similar tolerance petition
being ruled on for hydrogen peroxide. Peroxyacetic acid and hydrogen
peroxide are classified as peroxy compounds and have similar
characteristics for degradation, residue chemistry, dose-relationship
toxicology, and risk of exposure with the proposed food contact uses.
The published Reregistration Eligibility Document for Peroxy
Compounds (Case 4072, December, 1993), has waived all further
toxicology testing requirements for peroxyacetic acid.
The Agency has reviewed the data waivers requested and concurs that
no additional acute short term or long term toxicology or mutagenicity
testing will be needed for peroxyacetic acid for the following reasons.
1. Peroxyacetic acid is highly reactive and short lived because of
the inherent instability of the peroxide bond (i.e., the O-O bond).
Agitation or contact with rough surfaces, sunlight, organics, and
metals can accelerate decomposition. The instability of peroxyacetic
acid to exist as itself, along with detoxifying enzymes found in cells
(eg., catalase, glutathione peroxidase), makes it very difficult to
find any residues of peroxyacetic acid in or on foods (at the proposed
use levels), by conventional analytical methods.
The proposed food contact applications utilize very low
concentrations of peroxyacetic acid. Therefore, food residues produced
by the proposed uses are expected to be short-lived, based on half-
lives for peroxyacetic acid which can be as short as a few minutes. The
primary degradates are acetic acid, oxygen, and water, and these
degradates are not of toxicological concern.
2. There are acceptable acute generic data referenced in the
Reregistration Eligibility Document for Peroxy Compounds (December
1993, Case 4072). Peroxyacetic acid was found to be corrosive and
severely irritating to the eyes, skin, and mucous membranes but only
when high concentrations were used. The proposed food contact use
patterns are not expected to result in any residue levels of
toxicological concern. The RED document waived all additional non-acute
toxicology data requirements for peroxyacetic acid.
3. No data exists for the subchronic, chronic, carcinogenicity,
mutagenicity, developmental and reproductive toxicity of peroxyacetic
acid. However, peroxyacetic acid shares similar chemical
characteristics with hydrogen peroxide which has a more extensive
toxicology data base. For example, peroxyacetic acid and hydrogen
peroxide both decompose into two identical degradates that do not pose
any toxicological concern. These two degradates are oxygen and water.
Acetic acid is the third additional residue degradate of peroxyacetic
acid which also does not pose any toxicological concern.
Peroxyacetic acid and hydrogen peroxide also show similar chemical
characteristics for corrosivity, pH, rapid peroxide bond dissociation,
and production of oxygen molecules. Because of these similar chemical
characteristics, and low expected exposures with the proposed uses, the
dose-response toxicology relationships (i.e., adverse effects
experienced only at very high doses) shown by the data for hydrogen
peroxide, can also be expected with peroxyacetic acid. The remaining
toxicology testing requirements for peroxyacetic acid were waived
because of the similar chemical characteristics, similar expected dose-
response relationships with hydrogen peroxide, low exposure levels
under the proposed uses, and for the reasons given above.
[[Page 24952]]
The following generic acute toxicology data for peroxyacetic acid
were cited in the 1993 RED document.
Acute studies for peroxyacetic acid-- i. A study on rats showed an
acute oral LD50 of 1,540 milligrams/kilogram (mg/kg).
ii. A study on rabbits showed an acute dermal LD50 of
1,410 mg/kg.
iii. A study on rats showed an acute inhalation LC50 of
0.450 mg/L.
iv. An eye irritation study on rabbits produced severe irritation.
v. A dermal irritation study on rabbits showed hydrogen peroxide
was corrosive.
B. Toxicological Endpoints
1. Acute toxicity. The Agency has concluded that with the proposed
food contact uses of peroxyacetic acid, no apparent toxicity endpoint
exists to suggest any evidence of significant toxicity from a one-day
or single-event exposure.
2. Short - and intermediate - term toxicity. The Agency has
concluded that for the proposed food contact uses of peroxyacetic acid,
based on the similarity and commonality in the peroxide bond chemistry,
residues, degradates, and also with the dose-response relationships
with hydrogen peroxide, no apparent toxicity endpoint would be expected
from short and intermediate term exposure.
3. Chronic toxicity. A RfD for peroxyacetic acid has not been
established because of its short half life and lack of any residues and
degradates of toxicological concern. As discussed in the December 1993
Reregistration Eligibility Document for Peroxy Compounds, and in this
final rule, under the proposed and existing dietary related use
patterns (i.e., raw and processed agricultural commodities, food
processing equipment in breweries, wineries, and beverage plants),
there is also expected to be a lack of any residues and degradates of
toxicological concern.
4. Carcinogenicity. The Agency believes that based on the known
chemistry of peroxy compounds, toxic effects occur as a result of
species formed either during spontaneous decomposition or enzymatic
conversion of the peroxy bond (i.e., O-O bond). These effects occur
only after long term administration of high dose levels, where the
parent compound is continually present. Available data show that
peroxyacetic acid rapidly breaks down into oxygen, water, and acetic
acid. Because of this rapid decomposition, the Agency does not expect
residues of the parent compound on the treated comodities.
Based on the proposed use concentrations for peroxyacetic acid, and
data indicating a lack of residues of concern on food, exposure to
peroxyacetic acid under the proposed food contact use concentrations is
not likely to result in any adverse clinical effects, including
promotion of carcinogenisis. This conclusion is supported by the rapid
decomposition of peroxyacetic acid into oxygen, water, and acetic acid,
which are not of toxicological concern, and the existence of specific
enzymes in the human body (i.e., catalase and glutathione peroxidase)
which also can break down peroxyacetic acid.
C. Exposures and Risks
1. From food and feed uses. An exemption from the requirement of a
tolerance is being established (40 CFR 180.1196) for the residues of
peroxyacetic acid) up to 100 ppm, in or on a variety of (raw
agricultural commodities, in processed commodities, when such residues
result from the use of peroxyacetic acid as an antimicrobial agent on
fruits, tree nuts, cereal grains, herbs, and spices.
There are no existing tolerances or exemptions from tolerances in
title 40 of the CFR for peroxyacetic acid for direct food and feed
contact uses. The following 21 CFR tolerances and/or exemptions from
tolerances are noted:
Under 21 CFR 184.1005, the acetic acid degradate of peroxyacetic
acid is GRAS as a direct food additive substance when used in baked
goods, cheeses, dairy product analogs, chewing gum, condiments,
relishes, fats, oils, gravies, sauces, and meat products. Under 21 CFR
178.1010, peroxyacetic acid is approved for use as a sanitizing
solution for use on food processing equipment and utensils, and on
dairy processing equipment. It is also approved for use in sterilizing
polymeric food-contact surfaces. Under 21 CFR 173.315, peroxyacetic
acid is approved for use in washing or to assist in the lye peeling of
fruits and vegetables.
Risk assessments were conducted by EPA to assess dietary exposures
and risks from peroxyacetic acid 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. No acute exposure and risk assessment
is applicable for peroxyacetic acid because no acute toxicological
effects of concern are anticipated with the proposed food contact uses
for peroxyacetic acid. This is due to the lack of any residues of
toxicological concern as a result of the rapid decomposition of
peroxyacetic acid into acetic acid, oxygen, and water.
ii. Chronic exposure and risk. Residues of peroxyacetic acid are
not expected to remain on the surface of materials which it contacts.
Therefore, the risk from dietary exposure is expected to be negligible.
No chronic exposure and risk assessment is applicable because no
chronic toxicological effects are anticipated with the proposed food
contact uses for peroxyacetic acid. This is due to the lack of any
residues of toxicological concern as a result of the rapid
decomposition of peroxyacetic acid into acetic acid, oxygen, and water.
2. From drinking water. Although the proposed food contact uses for
peroxyacetic acid may result in transfer of peroxyacetic acid to
potential drinking water sources, no risk assessment is applicable
because of: (a) the rapid degradation of peroxyacetic acid into acetic
acid, oxygen, and water, and (b) there are not expected to be any
residues of toxicological concern. Information from the EPA Office of
Water also indicates that when used for potable water disinfection, no
measurable residues of peroxyacetic acid were present by the time the
water is pumped through the distribution system and arrived at the tap.
3. From non-dietary exposure. Peroxyacetic acid is currently
registered by EPA for a wide variety of uses including: agricultural
premises and equipment; food handling/storage establishments premises
and equipment; commercial, institutional and industrial premises and
equipment; residential and public access premises; medical premises and
equipment; materials preservation; and industrial processes and water
systems. The Agency does not know of all approved or actual uses for
peroxyacetic acid. However, non-dietary exposures are not expected to
pose any quantifiable added risk because of the lack of any expected
residues and degradates of toxicological concern. Minimal residues and
degradates are expected due to previously discussed unique chemistry
associated with peroxide bond chemistry.
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.''
[[Page 24953]]
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).
The Agency does not at this time have data specifically either to
support, or to refute a common mechanism of toxicity for peroxy
compounds (i.e., hydrogen peroxide, peroxyacetic acid). The Agency
believes that based on the known common chemistry of peroxy compounds,
toxic effects occur as a result of species formed either during
spontaneous decomposition or enzymatic conversion of the peroxy bond
(i.e., O-O bond). These effects occur only after long term
administration of high dose levels, where the parent compound is
continually present. Although a common mechanism of toxicity may or may
not be inferred, the Agency's concerns for cumulative risk is mitigated
by the lack of any measurable residues of the parent compound
(peroxyacetic acid) at proposed use levels, and by the rapid
decomposition of the parent compound into products which are not of
toxicological concern (i.e., oxygen and water). As data become
available, the Agency may require further studies on the peroxy
compounds to determine whether a cumulative risk assessment is
warranted.
The Agency does not have, at this time, available data to determine
whether peroxyacetic acid shares a common mechanism of toxicity with
other substances or how to include this pesticide in a cumulative risk
assessment. For the purposes of this tolerance action, EPA has not
assumed that peroxyacetic acid has a common mechanism of toxicity with
other substances.
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute, short term and intermediate risk. The Agency has
concluded that no toxicological endpoint exists for peroxyacetic acid
with the proposed food contact uses to suggest any evidence of
significant toxicity from acute, short term or intermediate term
exposures. 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.
The Agency concludes that there is a reasonable certainty of no
harm for acute, short term, and intermediate risk from aggregate
exposure to peroxyacetic acid under the proposed use concentrations.
2. Chronic risk. Low residues of peroxyacetic acid are expected
from the proposed food contact uses and these residues are expected to
convert rapidly into the harmless degradates of acetic acid, oxygen,
and water. Therefore, the chronic risk from dietary exposure is
expected to be negligible. No chronic exposure and risk assessment is
applicable because no chronic toxicological effects are anticipated
with the proposed food contact uses for peroxyacetic acid.
The Agency concludes that there is a reasonable certainty of no
harm for chronic risk from aggregate exposure to peroxyacetic acid
under the proposed use concentrations.
E. Aggregate Cancer Risk for U.S. Population
The Agency believes that based on the known chemistry of peroxy
compounds, toxic effects occur as a result of species formed either
during spontaneous decomposition or enzymatic conversion of the peroxy
bond (i.e., O-O bond). These effects occur only after long term
administration of high dose levels, where the parent compound is
continually present. Available data show that peroxyacetic acid rapidly
breaks down into oxygen, water, and acetic acid. Because of this rapid
decomposition, the Agency does not expect residues of the parent
compound on the treated commodities.
Based on the proposed use concentrations for peroxyacetic acid, and
data indicating a lack of residues of concern on food, exposure to
peroxyacetic acid under the proposed food contact use concentrations is
not likely to result in any adverse clinical effects, including
promotion of carcinogenisis. This conclusion is supported by the rapid
decomposition of peroxyacetic acid into oxygen, water, and acetic acid,
which are not of toxicological concern, and the existence of specific
enzymes in the human body (i.e., catalase and glutathione peroxidase)
which also can break down peroxyacetic acid.
The Agency concludes that cancer cancer risk for the U.S.
population from aggregate exposure to peroxyacetic acid is negligible
under the proposed food contact use concentrations.
F. 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
peroxyacetic acid, EPA considered data from developmental and
reproductive toxicity studies available on hydrogen peroxide from the
scientific literature and summarized by the Office of Water. 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
[[Page 24954]]
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
100-fold uncertainty factor/margin of exposure is designed to account
for inter-species extrapolation and intra-species variability.
In the case of the proposed food contact uses for peroxyacetic
acid, because of the lack of any significant residues of toxicological
concern, a NOEL was not identified for risk assessment purposes, and
the uncertainty (safety) factor approach was not used for assessing any
risk level by peroxyacetic acid. For the same reason, an additional
safety factor to protect infants and children is unnecessary.
Additionally, based on the following information, no increased
susceptibility to infants or children is expected to occur.
1. Three studies on the developmental and reproductive effects of
hydrogen peroxide (and by similarity, peroxyacetic acid) are available.
The data from these studies indicates that no apparent developmental or
reproductive effects were observed from administration of hydrogen
peroxide at concentrations up to 1% (1,000 mg/kg).
2. Peroxyacetic acid is a highly reactive and short lived molecule
because of the inherent instability of the peroxide bond (i.e., the O-O
bond). Agitation or contact with rough surfaces, sunlight, organics,
and metals accelerates dissociation. The instability of peroxyacetic
acid to exist as itself, along with natural detoxifying enzymes found
in plant and animal cells (eg., catalase, glutathione peroxidase),
makes it very difficult to find any residues of peroxyacetic acid in or
on foods (at proposed use levels), by conventional analytical methods.
The proposed food contact applications utilize very low concentrations
of peroxyacetic acid ( ppm). Food residues are expected to be short-
lived and are not expected to accumulate. This is because peroxyacetic
acid dissociates rapidly into acetic acid, oxygen, and water. The
Agency has no toxicological concern with acetic acid, oxygen, and
water.
3. A waiver was granted for all the remaining toxicology testing
requirements because of the reasons given in items a and b above.
Therefore, because of the rapid decomposition of peroxyacetic acid
residues into degradates that are of no toxicological concern (i.e.,
oxygen, water, acetic acid), the Agency concludes that there is a
reasonable certainty of no harm for infants and children from exposure
to peroxyacetic acid under the proposed food contact use
concentrations.
III. Other Considerations
A. Endocrine Disruption
EPA is required to develop a screening program to determine whether
certain substances (including all pesticides and inerts) ``may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or such other endocrine effect...'' The Agency is
currently working with interested stakeholders, including other
government agencies, public interest groups, industry and research
scientists in developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed three
years from the passage of the FQPA (August, 1999) to implement this
program. At that time, the EPA may require further testing of this
active ingredient and end use products for endocrine disrupter effects.
There is no current evidence to suggest that peroxyacetic acid acts in
a manner similar to any known hormone or that it acts as an endocrine
disrupter.
B. Analytical Enforcement Methodology
Because an exemption from the requirement of a tolerance is being
granted for peroxyacetic acid, an enforcement analytical method is not
needed. However, an adequate analytical method (called QATM 202 by
Ecolab, Inc., a redox titration procedure), is available in the
interim. Because of the long lead time from establishing a tolerance or
exemption of the requirement of a tolerance to publication of the
enforcement methodology in the Pesticide Analytical Manual., Volume II,
the analytical method is being made available to anyone interested in
pesticide enforcement when requested from Norm Cook, Antimicrobials
Division (7510W), Office of Pesticide Programs, U.S. Environmental
Protection Agency, 401 M Street, SW., Washington, DC 20460. Office
location and telephone number: 2800 Crystal Drive, 6th Floor,
Arlington, VA 22202, 703-308-6411.
C. Magnitude of Residues
Residues of peroxyacetic acid are short lived on treated crops and
are not expected to bioaccumulate in livestock and/or poultry that
consume treated feedstuffs. Because of the lack of any residues of
toxicological concern, the Agency has waived this data requirement.
D. International Residue Limits
There are no Codex Alimentarius Commission (Codex) Maximum Residue
Levels (MRLs) for peroxyacetic acid.
IV. Conclusion
Therefore, the exemption from the requirement of a tolerance is
established for residues of peroxyacetic acid up to 100 ppm in or on
raw agricultural commodities, in processed commodities, when such
residues result from the use of peroxyacetic acid as an antimicrobial
agent on fruits, tree nuts, cereal grains, herbs, and spices.
It should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to
support the exemption from the requirement of a tolerance for
peroxyacetic acid, if new relevant adverse effects information comes to
the Agency's attention.
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 6, 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
[[Page 24955]]
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
EPA has established a record for this rulemaking under docket
control number [OPP-300654] (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 comment 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.
VII. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement 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.
Dated: April 30, 1998.
Frank Sanders,
Director, Antimicrobials 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. Section 180.1196 is added to read as follows:
Sec. 180.1196 Peroxyacetic acid; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of peroxyacetic acid up to 100 ppm in or on raw agricultural
commodities, in processed commodities, when such residues result from
the use of peroxyacetic acid as an antimicrobial agent on fruits, tree
nuts, cereal grains, herbs, and spices.
[FR Doc. 98-12036 Filed 5-5-98; 8:45 am]
BILLING CODE 6560-50-F
