[Federal Register Volume 66, Number 246 (Friday, December 21, 2001)]
[Rules and Regulations]
[Pages 65850-65856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-31496]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301196; FRL-6811-6]
RIN 2070-AB78


Sodium thiosulfate; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of sodium thiosulfate when used as an inert 
ingredient (dechlorinator) in or on growing crops, or when applied to 
raw agricultural commodities after harvest. Eden Bioscience submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996 requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of sodium thiosulfate.

DATES: This regulation is effective December 21, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301196, 
must be received by EPA on or before February 19, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301196 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Kathryn Boyle, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6304; and e-mail address: 
<a href="/cdn-cgi/l/email-protection#89ebe6f0e5eca7e2e8fde1fbf0e7c9ecf9e8a7eee6ff"><span class="__cf_email__" data-cfemail="7f1d1006131a51141e0b170d06113f1a0f1e51181009">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR

[[Page 65851]]

part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301196. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of September 6, 2000 (65 FR 54015) (FRL-
6738-4), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide petition (PP 0E6177) by Eden Bioscience, 11816 
Creek Parkway North, Bothell, Washington, 98011-8205. This notice 
included a summary prepared by the petitioner. There were no comments 
received in response to the notice of filing.
    The petition requested that 40 CFR 180.1001(c) be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of sodium thiosulfate penthydrate (CAS Reg. No. 10102-17-7). 
The petition requested only the use of sodium thiosulfate pentahydrate; 
however, sodium thiosulfate is also available in an anhydrous form. The 
two chemical substances differ only in the attachment of the water 
molecules. The petition specified that sodium thiosulfate should be 
used at a concentration of 1 to 6% of the formulated product.
    The sodium thiosulfate will be used as a pretreatment for the water 
in tank mixes to remove chlorine or other reactant species, thus 
functioning as a dechlorinator or reducing agent. When mixed with 
chlorine-containing water, sodium thiosulfate reacts with the chlorine 
according to the equation Na<INF>2</INF>S<INF>2</INF>O<INF>3</INF> + 
4Cl<INF>2</INF> + 5H<INF>2</INF>O <r-arrow> 2NaHSO<INF>4</INF> + 8HCl. 
Sodium thiosulfate also reacts with hydrochloric acid (produced in the 
previous reaction) to form breakdown products such as sulfur, salt and 
water: Na<INF>2</INF>S<INF>2</INF>O<INF>3</INF> + 2HCl <r-arrow> 2NaCl 
+ H<INF>2</INF>O + S + SO<INF>2</INF>.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by sodium 
thiosulfate are discussed in this unit. The information submitted in 
support of this petition included portions of the Food and Drug 
Administration (FDA) generally recognized as safe (GRAS) determination 
(``Evaluation of the Health Aspects of Sodium Thiosulfate as a Food 
Ingredient''), articles from open literature, and an acute oral 
toxicity study.

A. Medical Uses

    There are medical uses of sodium thiosulfate. It has been used as 
an antidote for acute cyanide poisoning (intravenous injection), and is 
an ingredient in various dermally-applied lotion formulations used to 
treat acne and ringworm.

B. GRAS Determination

    Sodium thiosulfate pentahydrate has been classified as GRAS by the 
FDA when used as a formulation aid or reducing agent in alcoholic 
beverages (not to exceed 0.00005%) and table salt (not to exceed 0.1%). 
A GRAS determination means general recognition of safety by experts 
qualified by scientific training and experience to evaluate the safety 
of the substance for the specified use pattern. As noted by the 
limitations stated above, sodium thiosulfate has a very limited use 
pattern. EPA will use the information evaluated as part of the FDA GRAS 
determination to inform the Agency's decision.
    In its 1975 Evaluation, FDA reported the following information on 
the sodium thiosulfate absorption and metabolism: Sodium thiosulfate is 
a normal constituent of human body fluids and is excreted in the urine 
of man and higher animals. Quantitative studies have demonstrated the 
consistent presence of 2 to 17 milligrams (mg) of thiosulfate sulfur in 
24-hour urine specimens of healthy young adults. Variations in 
excretion of thiosulfate are related to the extent of protein 
metabolism, activity of the intestinal flora, and the sulfur-amino

[[Page 65852]]

acid content of the diet. The sulfur-containing amino acids of dietary 
protein are the source of the endogenous thiosulfate pool. Orally 
administered thiosulfate that is absorbed from the gastrointestinal 
tract is excreted in the urine unchanged or after oxidation to sulfate. 
From 5 to 70% of an oral dose of sodium thiosulfate is considered to be 
absorbed from the gastrointestinal tract of man and the remainder to be 
excreted in the feces.
    According to the Evaluation, sodium thiosulfate was found to cause 
no mutagenic effects.
    The Evaluation also included a summary of the results of 
developmental studies on rats, mice, and hamsters. It was determined 
there was no effect on nidation, maternal or fetal survival, or fetal 
development.

C. Open Literature Articles

    Three of the articles from open literature were reviewed to 
determine if the articles could supply information to the Agency on the 
genotoxicity of sodium thiosulfate. There is no indication of any 
mutagenic activity associated with exposure to sodium thiosulfate.

D. Acute Oral Toxicity Study

    An acute oral toxicity study in the rat performed with sodium 
thiosulfate pentahydrate was submitted. The study was classified as 
acceptable, toxicity category IV. The LD<INF>50</INF> is greater than 
5,050 milligrams/kilograms (mg/kg) (males and females combined).

E. Developmental Toxicity

    As part of the information submitted in support of the petition, 
the petitioner submitted the final reports for the rat, mouse, and 
hamster developmental studies that were discussed in the FDA Evaluation 
(dated 1972), as well as the final report for a rabbit developmental 
toxicity study (dated 1974). These studies were performed using the 
anhydrous form of sodium thiosulfate. Due to the passage of almost 30 
years, as well as the changes in laboratory techniques that have 
occurred during this time, the data tables in the reports were reviewed 
to determine if any additional information were contained in the 
tables.
    1.Mouse. Animals were tested at the following dose levels: Negative 
control, positive control, 5.5, 25.5, 118 or 550 mg/kg/day over a 10-
day period from day 6 through day 15 of gestation. There was no 
indication of any effect on maternal or fetal survival, or in 
incidences of visceral or skeletal abnormalities. The male/female ratio 
of the fetuses were calculated to be, respectively, 1.08, 0.93, 0.74, 
0.90, 0.88, or 0.68. The ratios at the lowest and highest dose levels 
are lower than the other ratios.
    2. Rat. Animals were tested at the following dose levels: Negative 
control, positive control, 4.0, 19.0, 86.0, or 400 mg/kg/day over a 10-
day period from day 6 through day 15 of gestation. There was no 
indication of any effect on maternal or fetal survival, or in 
incidences of visceral or skeletal abnormalities. The male/female ratio 
of the fetuses were calculated to be, respectively, 0.84, 0.78, 0.84, 
0.98, 0.92, or 0.73. There is an indication of skewing (a lowering) in 
these ratios at the highest dose level and in the positive control.
    3.Hamster. Animals were tested at the following dose levels: 
negative control, positive control, 4.0, 19.0, 86.0, or 400 mg/kg/day 
over a 5-day period from day 6 through day 10 of gestation. There was 
no indication of any effect on maternal or fetal survival, or in 
incidences of visceral or skeletal abnormalities. The male/female ratio 
of the fetuses were calculated to be, respectively, 0.52, 0.54, 0.59, 
0.47, 0.40, or 0.53. These ratios (including those from the controls) 
are very unusual.
    4. Rabbit. The results of the rabbit developmental study were not 
considered in the FDA Evaluation. Animals were tested over a 13-day 
period from day 6 through day 18 of gestation. There was no indication 
of any effect on maternal or fetal survival, or in incidences of 
visceral or skeletal abnormalities at the highest dose level of 580 mg/
kg/day. There was no indication of any effect on the male/female ratio 
of the fetuses since the ratio ranged from 1.13 to 1.26.

F. Information from the Internet

    To ascertain whether additional information on sodium thiosulfate 
were available, the Agency also searched the Tox Net website at the 
National Library of Medicine (http://www.toxnet.nlm.nih.gov). This 
website contained only information on sodium thiosulfate anhydrous 
(CAS. Reg. No. 7772-98-7). The Tox Net website classified sodium 
thiosulfate as moderately toxic, and generally supported the 
information presented in the petition. The excerpts and summaries 
indicated that sodium thiosulfate is not mutagenic.No internet 
information indicated concerns for carcinogenicity or developmental/
reproductive toxicity. One study which investigated the ability of 
sodium thiosulfate to cross the placenta in sheep, concluded that 
maternally-administered sodium thiosulfate (50 mg/kg) does not increase 
fetal plasma thiosulfate concentrations. No information on sodium 
thiosulfate was available on the National Toxicology Program website, 
the Agency for Toxic Substances and Disease Registry website, or the 
Agency's Integrated Risk Information System website. The TSCATs 
database (http://esc.syrres.com/efdb/TSCATS.htm) did not contain any 
summaries of any developmental or reproductive studies conducted with 
sodium thiosulfate.

G. Toxicity of Sodium Thiosulfate

    Overall, sodium thiosulfate presents as a chemical with slight to 
moderate toxicity. It is Category IV for acute oral toxicity (the 
lowest classification), and there are no indications of mutagenicity. 
The available developmental data indicates no effect on maternal or 
fetal survival or increase in incidences of visceral or skeletal 
abnormalities. The sex ratios (the male/female ratio of the fetuses) 
should cluster close to 1, indicating equal numbers of males and 
females. This is evident in the range of ratios in the rabbit study. 
However, the Agency's re-evaluation of the summary data for the rat and 
mouse developmental data (two out of four species) suggest the 
possibility that various doses of sodium thiosulfate may be associated 
with an apparent skewing (a lowering) of the sex ratio. However, it was 
also most unusual that this skewing occurred not only for certain dose 
levels, but also for a positive control. The sex ratios for the hamster 
are very unusual. Therefore, there is an uncertainty as to what these 
ratios mean. But, there is the possibility of technician error in sex 
identification. In the three studies included in the FDA Evaluation 
(rat, mice, and hamster), the description of the studies included the 
following: All fetuses were examined grossly for the presence of 
external congenital abnormalities. One-third of the fetuses of each 
litter underwent detailed visceral examinations employing 10X 
magnification. ``The remaining two-thirds were cleared and examined for 
skeletal defects.'' Thus, there was no chance to correct any mis-
sexing. The rabbit study, in which there was no effect on the male/
female ratio of the fetuses, was performed in a different manner: ``All 
fetuses underwent a detailed gross examination for the presence of 
external congenital abnormalities.'' All were examined for visceral 
abnormalities. ``All fetuses were then cleared and examined for 
skeletal defects.'' Thus, the examination of all fetuses apparently 
allowed for greater accuracy in sexing.

[[Page 65853]]

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where the risks from aggregate exposure to pesticide 
chemical residues under reasonably foreseeable circumstances will pose 
no appreciable risks to human health. In order to determine the risks 
from aggregate exposure to pesticide inert ingredients, the Agency 
considers the toxicity of the inert in conjunction with possible 
exposure to residues of the inert ingredient through food, drinking 
water, and through other exposures that occur as a result of pesticide 
use in residential settings. If EPA is able to determine that a finite 
tolerance is not necessary to ensure that there is a reasonable 
certainty that no harm will result from aggregate exposure to the inert 
ingredient, an exemption from the requirement of a tolerance may be 
established.

A. Dietary Exposure

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that sodium thiosulfate could be present in 
all raw and processed agricultural commodities and drinking water, and 
that non-occupational non-dietary exposure was possible.
    1. Food. Protein, which is composed of various amino acids, is 
required for human survival. Sodium thiosulfate is produced in the 
human body during the metabolism of sulfur-containing amino acids. 
There is an effective self-regulating mechanism to rid the body of 
excess sodium thiosulfate through excretion in the urine. As previously 
stated, sodium thiosulfate is considered to be GRAS for a very specific 
use pattern. In the 1975 Evaluation, it was estimated that the per 
capita consumption of sodium thiosulfate was 12 micrograms (<greek-m>g) 
per day. Considering the use of sodium thiosulfate in pesticide 
products, as a dechlorinator when mixed with certain proteins such as 
harpin protein, and given the reactive nature (as a reducing agent) of 
sodium thiosulfate, this use pattern should not significantly increase 
the amount of sodium thiosulfate in the food supply above those amounts 
permitted by FDA.
    2. Drinking water exposure. Thiosulfate can be produced naturally 
by the reaction of elemental sulfur with sulfite ion in boiling water. 
Therefore, thiosulfate occurs naturally in such environments as hot 
springs, geysers, and marine hydrothermal vents. It can also occur in 
nature as the result of the biological or chemical oxidation of 
sulfide, and thus can be found in freshwater and marine sediments, and 
salt marshes.
    Considering that thiosulfate can be metabolized by sulfate-reducing 
bacteria, and given its ability to react with chlorine (to act as a 
reducing agent), sodium thiosulfate is unlikely to occur in drinking 
water.

B. Other Non-Occupational Exposure

    The medicinal uses of sodium thiosulfate are also regulated by FDA. 
There are other industrial uses of sodium thiosulfate which include use 
as a photographic fixing agent. Sodium thiosulfate is also used to 
remove chlorine from water used in aquariums.

C. Exposure Estimates

    As previously stated, it was estimated that the per capita 
consumption of sodium thiosulfate was 12 <greek-m>g per day. This was 
based on the amount of sodium thiosulfate used by the food industry and 
assuming a population of 210 million. (The Agency acknowledges that 
this exposure estimate is almost 30 years old.) If this were converted 
to mg/kg/day using a 60 kg (female) body weight, then the exposure 
could be estimated as 0.0002 mg/kg/day. The highest dose levels in each 
of the developmental toxicity studies (mouse, rat, hamster, and rabbit) 
were respectively 550, 400, 400, and 580 mg/kg/day. No effects were 
noted at these levels. The Agency has not attempted to use a safety 
factor analysis for sodium thiosulfate; however, the 0.0002 mg/kg/day 
is orders of magnitude lower than the highest dose levels from any of 
the developmental toxicity studies. Thus, the reported uses of sodium 
thiosulfate, its use as a GRAS substance and its use as an inert 
ingredient (a dechlorinator) should result in human exposure far below 
any dose level that could possibly produce an adverse effect.

VI. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify, or revoke a tolerance or tolerance 
exemption, the Agency consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.'' Sodium 
thiosulfate is produced in the human body during the metabolism of 
sulfur-containing amino acids. There is an effective self-regulating 
mechanism (excretion) to rid the body of excess sodium thiosulfate, so 
cumulative effects are unlikely as a result of exposure to sodium 
thiosulfate and a substance sharing a common mechanism of toxicity, 
assuming such a substance exists. The Agency has not made any 
conclusions as to whether or not sodium thiosulfate shares a common 
mechanism of toxicity with any other chemicals, since cumulative 
effects for sodium thiosulfate and other substances are unlikely.

VII. Determination of Safety for U.S. Population

    Based on the low-moderate toxicity of sodium thiosulfate and the 
low potential for exposure from the EPA regulated uses of sodium 
thiosulfate, as well as the FDA GRAS uses, the Agency has determined 
that aggregate exposure to sodium thiosulfate under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. Accordingly, EPA concludes that there is a reasonable certainty 
of no harm to the U.S. population from aggregate exposure to residues 
of sodium thiosulfate and that a tolerance is not necessary.

VIII. Determination of Safety for Infants and Children

    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 prenatal and postnatal toxicity and 
the completeness of the data base unless EPA concludes that a different 
margin of safety will be safe for infants and children. Due to the 
expected low toxicity of sodium thiosulfate, EPA has not used a safety 
factor analysis to assess the risk. For the same reasons the additional 
tenfold safety factor is unnecessary. The Agency has determined that 
there is a reasonable certainty of no harm to infants and children from 
aggregate exposure to residues of sodium thiosulfate and that a 
tolerance is not necessary.

IX. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect

[[Page 65854]]

produced by a naturally occurring estrogen, or such other endocrine 
effect.'' EPA has been working with interested stakeholders to develop 
a screening and testing program as well as a priority setting scheme. 
As the Agency proceeds with implementation of this program, further 
testing of products containing sodium thiosulfate for endocrine effects 
may be required.

B. Analytical Method(s)

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Exemptions

    There are no existing exemptions for sodium thiosulfate anhydrous 
or sodium thiosulfate pentahydrate.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
sodium thiosulfate anhydrous or sodium thiosulfate pentahydrate nor 
have any CODEX Maximum Residue Levels (MRLs) been established for any 
food crops at this time.

X. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of sodium thiosulfate anhydrous or sodium thiosulfate 
pentahydrate. Accordingly, EPA finds that exempting sodium thiosulfate 
anhydrous or sodium thiosulfate pentahydrate from the requirement of a 
tolerance will be safe.

XI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301196 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before February 
19, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at <a href="/cdn-cgi/l/email-protection#7d0912100d1614130e531714103d180d1c531a120b"><span class="__cf_email__" data-cfemail="f98d9694899290978ad7939094b99c8998d79e968f">[email protected]</span></a>, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-301196, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: <a href="/cdn-cgi/l/email-protection#3e514e4e135a515d555b4a7e5b4e5f10595148"><span class="__cf_email__" data-cfemail="dfb0afaff2bbb0bcb4baab9fbaafbef1b8b0a9">[email protected]</span></a>. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

XII. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance

[[Page 65855]]

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). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitledFederalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of this final rule in the Federal Register. This final 
rule 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: December 6, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:


    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. In Sec. 180.1001, the table in paragraph (c) is amended by 
adding alphabetically the following inert ingredient to read as 
follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (c) *  *  *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
     *        *        *        *        *        *        *
Sodium thiosulfate anhydrous      Not to exceed 6%    Dechlorinator,
 (CAS Reg. No.7772-98-7 or         of theformulated    reducing agent
 sodium thiosulfate                product
 pentahydrate,CAS Reg. No. 10102-
 17-7)
     *        *        *        *        *        *        *
------------------------------------------------------------------------


[[Page 65856]]

* * * * *

[FR Doc. 01-31496 Filed 12-20-01; 8:45 am]
BILLING CODE 6560-50-S


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