[Federal Register Volume 63, Number 87 (Wednesday, May 6, 1998)]
[Rules and Regulations]
[Pages 24955-24963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12037]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300655; FRL-5789-4]
RIN 2070-AB78


Hydrogen Peroxide; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a

[[Page 24956]]

tolerance for residues of the antimicrobial pesticide hydrogen peroxide 
up to 120 ppm, in or on raw agricultural commodities, in processed 
commodities, when such residues result from the use of hydrogen 
peroxide 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-300655], 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-300655], 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#137c63633e777c70787667537663727e727a7f3d7663723d747c65"><span class="__cf_email__" data-cfemail="721d02025f161d11191706321702131f131b1e5c1702135c151d04">[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-300655]. 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, 401M 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: 
<a href="/cdn-cgi/l/email-protection#e794908e8983828b8bc98a8695948f868b8ba78297868a868e8bc9829786c9808891"><span class="__cf_email__" data-cfemail="780b0f11161c1d14145615190a0b10191414381d081915191114561d0819561f170e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 14, 1998 
(63 FR 2235) (FRL-5759-7), 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) 7F4834 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 hydrogen peroxide. 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 120 ppm for hydrogen peroxide. This 
limitation was added because of Agency concerns that a high use 
concentration could result in measurable residues of hydrogen peroxide. 
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 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

[[Page 24957]]

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 
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 hydrogen 
peroxide, 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 hydrogen 
peroxide 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 hydrogen peroxide up to 120 ppm, in or on raw 
agricultural commodities, in processed commodities, when such residues 
result from the use of hydrogen peroxide 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

[[Page 24958]]

sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
hydrogen peroxide (H<INF>2</INF>O<INF>2</INF>) are discussed below.
    Ecolab, Inc. has requested a waiver of all toxicology testing 
requirements for hydrogen peroxide. This includes waivers for all 
acute, 90-day sub-chronic, chronic, oncogenicity, developmental, 
reproductive, mutagenicity, neurotoxicity and metabolism requirements 
for hydrogen peroxide. 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. Hydrogen peroxide is generally recognized as safe (GRAS) 
according to the Food and Drug Administration (21 CFR part 178) when 
used on food-processing equipment, utensils, and food contact articles.
    3. Based on the chemical reactivity of this compound and its 
unstable nature, conduct of long term or metabolism studies would be 
extremely difficult and unreliable.
    4. The published Reregistration Eligibility Document for Peroxy 
Compounds (Case 4072, December, 1993), has waived all further 
toxicology testing requirements for peroxy compounds.
    The Agency has reviewed the data waivers requested and concurs that 
no generic toxicology testing will be needed for hydrogen peroxide for 
the following reasons.
    1. Hydrogen peroxide 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 
accelerates decomposition. The instability of hydrogen peroxide to 
exist as itself, along with detoxifying enzymes found in cells (eg., 
catalase, glutathione peroxidase), makes it very difficult to find any 
residues of hydrogen peroxide in or on foods (at proposed use levels), 
by conventional analytical methods.
    The proposed food contact applications also utilize very low 
concentrations of hydrogen peroxide. Therefore, food residues are 
expected to be short-lived, based on half-lives for hydrogen peroxide 
as short as about 4 minutes under certain conditions. Residues are not 
of toxicological concern because hydrogen peroxide decomposes rapidly 
into oxygen and water. The Agency has no toxicological concern with 
oxygen and water.
    2. There are acceptable acute generic data referenced in the 
Reregistration Eligibility Document for Peroxy Compounds (December 
1993, Case 4072). Hydrogen peroxide was found to be corrosive and 
severely irritating to the eyes, skin, and mucous membranes but only 
when high concentrations were used. The proposed use patterns are 
expected to result in a lack of any residues of toxicological concern.
    3. A waiver was granted for all the remaining toxicology testing 
requirements because of the reasons given above, and because there is 
an extensive data base assembled by the Agency's Office of Water. 
Although the Office of Water's data does show toxicological effects in 
experimental animals only at high concentrations, the Agency is not 
concerned because of the rapid decomposition of hydrogen peroxide into 
oxygen and water.
    Therefore, the lack of any residues of toxicological concern and 
the existence of toxicological effects only at high dose levels in 
experimental animals minimizes any concern for exposure to the very low 
doses that may be present as a result of the proposed uses.
    The Agency also recognizes that commercially available 3% hydrogen 
peroxide solutions have been used for many years for personal and 
medical uses. The use directions for some of these products state that 
these 3% solutions can be used as a sanitizing mouthwash. Other food 
contact and medicinal uses for hydrogen peroxide include applications 
for wines and liquors (artificial aging), dentrifices, sanitary 
lotions, and pharmaceutical preparations.
    The long use history of hydrogen peroxide and weight of empirical 
evidence and experimental data has led the FDA to put hydrogen peroxide 
on the GRAS list when used on food processing equipment, utensils, and 
food contact articles (21 CFR 178). Potential symptoms of acute 
overexposure to medium or high concentrations of hydrogen peroxide 
include irritation of eyes, nose and throat, corneal ulceration, 
erythema, vesicles on skin, and bleaching of hair.
    The following is a summary of the existing generic data base for 
acute, subchronic, chronic, mutagenic, developmental, reproductive, and 
carcinogenic effects of hydrogen peroxide in mammalian test animals. 
These data show that significant toxicological effects of hydrogen 
peroxide in mammalian test systems are measurable only at high doses. 
The proposed food contact use patterns are not expected to result in 
residues of toxicological concern due to the rapid decomposition of 
hydrogen peroxide into oxygen and water. The following generic acute 
toxicology data for hydrogen peroxide were cited in the 1993 RED for 
hydrogen peroxide. The subchronic, chronic, carcinogenicity, 
developmental, and reproductive toxicology, along with the mutagenicity 
data are summarized from the Office of Water data base.
    1. Acute studies-- i. A study on mice showed an acute oral 
LD<INF>50</INF> of 2,000 milligrams/kilogram (mg/kg).
    ii. A study on rats showed an acute dermal LD<INF>50</INF> of 4,060 
mg/kg.
    iii. A study on mice showed an acute inhalation LC<INF>50</INF> of 
227 ul/L.
    iv. An eye irritation study on rabbits produced severe irritation.
    v. A dermal irritation study on rabbits showed hydrogen peroxide 
was corrosive.
    2. Subchronic exposure-- i. Weanling Osborne-Mendel rats were 
exposed to a 0.45% (560 mg/kg/day) aqueous solution of hydrogen 
peroxide in drinking water for 3 weeks. When corrected for differences 
observed in water intake between control and treated rats, there were 
no significant differences observed in absolute and relative organ 
weights of the kidney, spleen, heart, or testes. A NOEL of 560 mg/kg/
day was determined, although a lowest-observed-effect level (LOEL) was 
not.
    ii. Young male Holtzman rats were administered doses of 0, 500, 
1,000, or 1,500 mg/kg/day hydrogen peroxide in water for 8 weeks. 
Increased mortality was noted at the high dose. Increased incidence of 
dental caries and pathological changes in the periodontium were also 
noted at the mid and high dose. A LOEL of 500 mg/kg/day was determined, 
but a NOEL was not established.
    iii. Male and female C57BL/6N, DBA/2N, and BALB/cAnN mice were 
given hydrogen peroxide at 0, 0.1, or 0.4% in drinking water for 30 or 
60 days. Equivalent doses (assuming water intake of 150 ml/kg/day) were 
0, 150, or 600 mg/kg/day. The high dose resulted in erosion of the 
glandular stomach in 29% of mice treated for 30 days and in 40% of mice 
treated for 60 days. Duodenal lesions, but no frank nodules, were also 
observed at the high dose. A LOEL of 600 mg/kg/day was determined, but 
due to the lack of data reported at the 150 mg/kg/day dose, a NOEL 
could not be definitively assigned.
    3. Chronic exposure-- i. Wistar rats were administered 30 or 60 mg/
kg/day hydrogen peroxide for 100 days by oral intubation. After 100 
days, decreases in plasma protein, hematocrit, and plasma catalase were 
observed. Administration

[[Page 24959]]

of the same dose levels in feed had no effects. A NOEL of 30 mg/kg/day 
could be determined from this study.
    ii. Three-week old mice (strain not specified) were administered 
0.15% hydrogen peroxide in drinking water for 35 weeks, presumed 
equivalent to 150 mg/kg/day. Degenerative changes in the liver and 
kidney, as well as inflammation, irregularity and slight necrosis of 
the stomach wall were observed. The LOEL was determined to be 150 mg/
kg/day in this study, but a NOEL was not identified.
    iii. Male and female C57BL/6N mice were administered 0, 0.1, or 
0.4% hydrogen peroxide in drinking water for up to 700 days. Doses of 
0, 150, and 600 mg/kg/day were calculated based on assumed intake of 
150 mL/kg/day water. The gastrointestinal tract was examined over the 
course of the study through serial sacrifice at time points between 90-
700 days. Gastric lesions consisting of erosion and hyperplastic 
nodules were detected in the stomach and duodenum after 1-2 years 
exposure. The LOEL was determined to be 150 mg/kg/day from this study.
    4. Carcinogenicity-- i. Gastric carcinogenesis was investigated in 
male Wistar rats. Twenty-one rats received the initiator MNNG in 
drinking water for 8 weeks at 100 mg/L, while uninitiated rats (10 
animals) received plain drinking water. After 8 weeks, both groups 
received 1% hydrogen peroxide in drinking water from week 8 through 
week 40. Two other groups (30 and 10 rats, respectively) were chosen as 
initiated and uninitiated controls. Surviving rats were sacrificed and 
necropsied at 40 weeks. Erosion and ulceration along the limiting ridge 
of the fundic mucosa was observed. Initiated rats showed an increased 
incidence of adenomatous hyperplasia in this stomach area. There were 
no adenocarcinomas induced in the stomach or duodenum. Papillomas of 
the forestomach were induced by hydrogen peroxide alone.
    ii. Three month old Syrian hamsters were administered either: twice 
weekly applications of 30% hydrogen peroxide in the left buccal pouch, 
twice weekly buccal application of 0.25% 9,10 dimethyl-1,2-
benzanthracene with either 30% or 3% hydrogen peroxide (hydrogen 
peroxide applied on a different day than the DMBA), or DMBA only. 
Buccal pouches were examined for tumor development at 19 and 22 weeks 
after sacrifice. No epidermoid carcinomas were observed after 22 weeks 
of treatment with hydrogen peroxide alone. All three groups receiving 
DMBA treatment did develop tumors. The tumors in the group receiving 
the 30% hydrogen peroxide and DMBA were reported to be more anaplastic 
with deeper penetration of tissue. It was concluded that hydrogen 
peroxide may augment oral carcinogenesis induced by DMBA.
    iii. Male and female weanling C57Bl/6J mice were administered 0, 
0.1, or 0.4% hydrogen peroxide in drinking water for up to 108 weeks. 
Erosion of the glandular stomach was observed in 20% and 42% of dosed 
mice at the 0.1% and 0.4% dose levels, respectively, compared to 4% in 
controls. Duodenal nodules were observed in treated mice and were 
classified into hyperplasia, adenoma, and carcinoma. Hyperplasia was 
significantly increased at the 0.1% and 0.4% dose levels (40% and 62% 
of treated mice respectively), as was the incidence of duodenal 
carcinoma, observed in 5 of 99 high dose animals, 1 of 101 low dose 
animals, and absent in controls.
    iv. Various strains of mice (C57Bl/6N, DBA/2N, BALB/c) were exposed 
to 0.4% hydrogen peroxide in drinking water over their lifetime. 
Appearance of duodenal lesions (plaques and nodules) was noted in all 
strains after 90 days of treatment. Temporary withdraw of hydrogen 
peroxide produced apparent reversibility in C57BL/6N mice only after 30 
days of no treatment. After 150 days of treatment, C57BL/6N mice 
appeared to have an increased incidence of duodenal lesions relative to 
the other two strains. After 420-740 days of treatment, the incidence 
of duodenal carcinoma was 0, 1%, and 5% in control, low, and high dose, 
respectively. This study did not present concurrent control data, and 
used varying numbers of mice for examination at the various time 
points. Therefore, results from this study are considered equivocal.
    v. Strains of mice differing in catalase activities of the 
duodenum, blood, and liver (in order of decreasing activity: C3H/HeN, 
B6C3F1, C57BL/6N, C3H/C) were given a solution of 0.4% hydrogen 
peroxide in drinking water for approximately 6 months. The duodenum was 
examined for the incidence and total lesions in each strain. 
Approximately 18-22 mice per strain were examined. The data suggested 
that the number of duodenal lesions per mouse and total incidence was 
inversely correlated wi th catalase activity.
    vi. Recent experimental evidence (Upham, et al., Carcinogenesis 
18(1): 37-42, 1997) has implicated hydrogen peroxide in the inhibition 
of gap junctional intercellular communication in rat liver epithelial 
cells (a significant step in production of tumors). These recent data 
lend support to the above studies in the implication of high levels of 
hydrogen peroxide as a promotor of tumorigenesis. The International 
Agency for Research in Cancer (IARC) has designated hydrogen peroxide 
as not classifiable as to carcinogenicity, based on the data noted 
above.
    5. Developmental and reproductive toxicity. Three older studies on 
the developmental and reproductive effects of hydrogen peroxide are 
available. These data indicate no apparent developmental or 
reproductive effects observed from administration of hydrogen peroxide 
at concentrations up to 1% (1000 mg/kg).
    6. Mutagenicity-- i. In a standard plate incorporation assay, 
hydrogen peroxide (concentrations not stated) was weakly mutagenic to 
strains TA98, TA97, and TA1537 for frame shift mutations and to strain 
TA102 for oxidative mutations, but was not mutagenic to strains TA100 
and TA1538.
    ii. Using isolated hepatocytes from Female Fischer rats, hydrogen 
peroxide was incubated at concentrations from 0.01 to 1.0mM for 1 hour 
at 37 degrees Celsius. Overt cytotoxicity was observed at 1mM. A 
concentration dependent increase in single strand DNA breaks was 
observed at all other exposure levels. No double strand DNA breaks or 
DNA cross-links were observed.
    iii. In a human bronchial epithelial cell system, nucleic acid 
synthesis was observed to be significantly decreased after exposure to 
hydrogen peroxide at 1.2mM for six hours followed by a cell growth 
period of 7-9 days. At 100 m, single strand DNA breaks and DNA-protein 
cross links were observed, with single strand breaks predominating. DNA 
strand breakage has also been observed in other test systems (hamster 
V79 cells and bovine pulmonary artery and aortic endothelial cells).
    iv. Cell killing and DNA damage were examined in Chinese hamster 
fibroblast cells (V79-379A). After incubation of cells with 1-100 mM 
hydrogen peroxide at ice cold temperatures for 10 or 20 minutes, single 
strand breaks were observed at 1 mM hydrogen peroxide. Double strand 
breaks and cell killing were observed at higher (10mM) concentrations 
of hydrogen peroxide.

B. Toxicological Endpoints

    1. Acute toxicity. The Agency has concluded that for the proposed 
food contact uses, 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

[[Page 24960]]

for the proposed food contact uses, no apparent toxicity endpoint 
exists to suggest any evidence of significant toxicity from short and 
intermediate term exposure.
    3. Chronic toxicity. A RfD for hydrogen peroxide has not been 
established because of its short half life and lack of any residues 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 expected to be a 
lack of any residues 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 
hydrogen peroxide rapidly breaks down into oxygen and water. 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 hydrogen peroxide, and 
data indicating a lack of residues of concern on food, exposure to 
hydrogen peroxide 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 hydrogen peroxide into oxygen and water, 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 hydrogen peroxide.

C. Exposures and Risks

    1. From food and feed uses. An exemption from the requirement of a 
tolerance is being established (40 CFR 180.1197) for the residues of 
hydrogen peroxide) up to 120 ppm, in or on a variety of (raw 
agricultural commodities, in processed commodities, when such residues 
result from the use of hydrogen peroxide as an antimicrobial agent on 
fruits, tree nuts, cereal grains, herbs, and spices.
    There are no existing food or feed use tolerances or exemptions 
from the requirement of a tolerance in title 40 of the CFR for hydrogen 
peroxide. The following 21 CFR tolerances and/or exemptions from 
tolerances are noted:
    Under 21 CFR 184.1366, hydrogen peroxide is GRAS when used on milk 
intended for use in cheese making (maximum treatment level of 0.05%), 
whey, during preparation of modified whey by electrodialysis methods 
(maximum treatment level of 0.04%), dried eggs, dried egg whites, and 
dried egg yolks, tripe, beef feet, herring, wine, starch (maximum 
treatment level of 0.15%), instant tea, corn syrup (maximum treatment 
level of 0.15%), colored cheese whey (maximum treatment level of 
0.05%), wine vinegar, and emulsifiers containing fatty acid esters 
(maximum treatment level of 1.25%).
    Under 21 CFR 178.1010, hydrogen peroxide 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, hydrogen peroxide 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 hydrogen peroxide 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 because no acute toxicological effects of concern are 
anticipated with the proposed food contact uses for hydrogen peroxide. 
This is due to the lack of any residues of toxicological concern as a 
result of the automatic and rapid decomposition of hydrogen peroxide 
into oxygen and water.
    ii. Chronic exposure and risk. Residues of hydrogen peroxide 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 hydrogen peroxide. This is due to the lack of any 
residues of toxicological concern as a result of the automatic and 
rapid decomposition of hydrogen peroxide into oxygen and water.
    2. From drinking water. Although the proposed food contact uses for 
hydrogen peroxide acid may result in transfer of minor amounts of 
residues to potential drinking water sources, no risk assessment is 
warranted because of: (i) the rapid degradation of hydrogen peroxide 
into oxygen, and water, and (ii) these degradates are not of 
toxicological concern. Information from the EPA Office of Water also 
indicates that when used for potable water disinfection, no residues of 
hydrogen peroxyide acid are present by the time the water is pumped 
through a distribution system.
    3. From non-dietary exposure. Hydrogen peroxide 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.
    Hydrogen peroxide is also approved for a variety of medicinal uses 
including sanitization of scrapes, cuts, and burns to human and animal 
skin, and as a human oral sanitizing mouthwash. It is also used by 
medical doctors for general cleansing and sanitization of surgical 
areas of the body after operations. Hydrogen peroxide use in homes is 
medicinal and exposures are expected to be infrequent and at extremely 
short topical duration. The Agency does not know of all approved or 
actual uses for hydrogen peroxide. However, non-dietary exposures are 
not expected to pose any quantifiable added risk because of a lack of 
any significant residues of toxicological concern.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    The Agency believes that ``available information'' in this context 
might include not only toxicity, chemistry, and exposure data, but also 
scientific policies and methodologies for understanding common 
mechanisms of toxicity and conducting cumulative risk assessments. For 
most pesticides, although the Agency has some information in its files 
that may turn out to be helpful in eventually determining whether a 
pesticide shares a common mechanism of toxicity with any other 
substances, EPA does not at this time have the methodologies to resolve 
the complex scientific issues concerning

[[Page 24961]]

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 residues of the parent compound (hydrogen peroxide) 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.
    EPA does not have, at this time, available data to determine 
whether hydrogen peroxide 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, 
hydrogen peroxide does not appear to produce toxic metabolites. For the 
purposes of this exemption from the requirement of a tolerance, EPA has 
not assumed that hydrogen peroxide has a common mechanism of toxicity 
with other substances.

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute, short- and intermediate- term risk. The Agency has 
concluded that no endpoint exists to suggest any evidence of 
significant toxicity from acute, short term or intermediate term 
exposures from the proposed food contact uses of hydrogen peroxide. 
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 hydrogen peroxide under the proposed use concentrations.
    2. Chronic risk. Residues of hydrogen peroxide are expected to 
dissociate rapidly on the surface of materials which it contacts. 
Therefore, the chronic risk from dietary exposure is expected to be 
negligible. No chronic exposure and risk assessment is required because 
no chronic toxicological effects are anticipated with the proposed food 
contact uses for hydrogen peroxide. This is due to the lack of any 
residues of toxicological concern as a result of the automatic and 
rapid decomposition of hydrogen peroxide in air into oxygen and water.
    The Agency concludes that there is a reasonable certainty of no 
harm for chronic risk from aggregate exposure to hydrogen peroxide 
under the proposed use concentrations.

E. Aggregate Cancer Risk for U.S. Population

    Available data suggest that hydrogen peroxide acts as a promoter of 
carcinogenisis at relatively high doses (in excess of 600 mg/kg) after 
chronic administration in drinking water to experimental animals. 
Epidemiological reports indicate that the major effect from accidental 
ingestion of high doses of hydrogen peroxide in humans (i.e., 1,000 mg/
kg) is acute and severe clinical toxicity, which in a few cases 
resulted in death.
    Based on the proposed use concentrations for hydrogen peroxide, and 
data indicating negligible residues on food, exposure to hydrogen 
peroxide 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 further by the rapid 
decomposition of hydrogen peroxide into oxygen and water, which are not 
of toxicological concern, and the existence of specific enzymes (i.e., 
catalase and glutathione peroxidases) for breakdown of hydrogen 
peroxide.
    The Agency concludes that the cancer risk for the U.S. population 
from aggregate exposure to hydrogen peroxide 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 
hydrogen peroxide, EPA considered data from developmental and 
reproductive toxicity studies available 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 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

[[Page 24962]]

extrapolation and intra-species variability.
    In the case of the proposed food contact uses for hydrogen 
peroxide, because of the lack of any 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 hydrogen peroxide. For the same reason, an additional 
safety factor to protect infants and children is unnecessary. 
Additionally, based on the following conditions, no increased 
susceptibility to infants or children is expected to occur.
    1. Three older studies on the developmental and reproductive 
effects of hydrogen peroxide 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. Hydrogen peroxide 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 and metals accelerates 
dissociation. The proposed food contact applications utilize very low 
concentrations of hydrogen peroxide (i.e., ppm). Food residues are 
expected to be short-lived and are not expected to accumulate. This is 
because hydrogen peroxide dissociates rapidly in air into oxygen and 
water. The Agency has no toxicological concern with 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, and 
because there is an extensive data base assembled by the Agency's 
Office of Water showing toxicological effects in experimental animals 
only at high concentrations, which are not expected with the proposed 
use patterns.
    4. The Agency also recognizes that commercially available 3% 
hydrogen peroxide solutions have been used for many years for personal 
and medical uses. The use directions for some of these products state 
that these solutions can be used as a sanitizing mouthwash. The long 
use history of hydrogen peroxide and weight of empirical and 
experimental data has led the FDA to put it on the Generally Recognized 
As Safe (GRAS) list when used on food processing equipment, utensils, 
and food contact articles (21 CFR part 178).
    Therefore, because of the rapid decomposition of hydrogen peroxide 
residues into degradates that are of no toxicological concern (i.e., 
oxygen, water), the Agency concludes that there is a reasonable 
certainty of no harm for infants and children from exposure to hydrogen 
peroxide 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 hydrogen peroxide 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 hydrogen peroxide, an enforcement analytical method is not 
needed. However, an adequate analytical method (designated 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, US 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 hydrogen peroxide 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 hydrogen peroxide.

IV. Conclusion

    Therefore, the exemption from the requirement of a tolerance is 
established for residues of hydrogen peroxide up to 120 ppm in or on 
raw agricultural commodities, in processed commodities, when such 
residues result from the use of hydrogen peroxide 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 hydrogen 
peroxide, 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 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

[[Page 24963]]

 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-300655] (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#9df2ededb0f9f2fef6f8e9ddf8edfcf0fcf4f1b3f8edfcb3faf2eb"><span class="__cf_email__" data-cfemail="2d425d5d0049424e4648596d485d4c404c444103485d4c034a425b">[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.

    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 180.1197 is added to read as follows:


Sec. 180.1197  Hydrogen peroxide; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of hydrogen peroxide up to 120 ppm in or on raw agricultural 
commodities, in processed commodities, when such residues result from 
the use of hydrogen peroxide as an antimicrobial agent on fruits, tree 
nuts, cereal grains, herbs, and spices.

[FR Doc. 98-12037 Filed 5-5-98; 8:45 am]
BILLING CODE 6560-50-F


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