sodium thiosulfate Exemption from the Requirement of a Tolerance 12/01
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:
boyle.kathryn@epa.gov.
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:
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Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
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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
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 Na2S2O3 +
4Cl2 + 5H2O 2NaHSO4 + 8HCl.
Sodium thiosulfate also reacts with hydrochloric acid (produced in the
previous reaction) to form breakdown products such as sulfur, salt and
water: Na2S2O3 + 2HCl 2NaCl
+ H2O + S + SO2.
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
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 LD50 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.
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 (µg)
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 µg 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 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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. Pleaseuse 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
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)
* * * * * * *
------------------------------------------------------------------------
* * * * *
Disclaimer: Please read
the pesticide label prior to use. The information contained at this web
site is not a substitute for a pesticide label. Trade names used herein
are for convenience only; no endorsement of products is intended, nor is
criticism of unnamed products implied. Most of this information is historical
in nature and may no longer be applicable.
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