[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Rules and Regulations]
[Pages 58310-58314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-21933]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0289; FRL-7677-1]


Sodium Thiosulfate; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends an existing exemption from the 
requirement of a tolerance for residues of sodium thiosulfate on raw 
agricultural commodities when used in pesticide formulations as an 
inert ingredient on raw agricultural commodities after harvest. Eden 
Bioscience Corporation submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA), requesting an unlimited 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 September 30, 2004. Objections and 
requests for hearings must be received on or before November 29, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004-0289. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 South 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; e-mail address: 
[email protected].

[[Page 58311]]


SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111),
     Animal production (NAICS code 112),
     Food manufacturing (NAICS code 311),
     Pesticide manufacturing (NAICS code 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. Background and Statutory Findings

    In response to the original pesticide petition (PP OE6177) 
submitted in 2000 by Eden Bioscience, EPA established tolerance 
exemptions for sodium thiosulfate also known as thiosulfuric acid, 
disodium salt, anhydrous, (CAS Reg. No. 7772-98-7) or sodium 
thiosulfate pentahydrate also known as thiosulfuric acid disodium salt, 
pentahydrate, (CAS Reg. No. 10102-17-7). The exemptions as established 
specified that the percent of sodium thiosulfate was not to exceed 6% 
of the formulated product. For a discussion of the information 
submitted and the results of the Agency's review and evaluation, see 
the Federal Register of December 21, 2001 (66 FR 65850) (FRL-6811-6).
    In the Federal Register of November 26, 2003 (68 FR 66416) (FRL-
7333-8), EPA issued a notice pursuant to section 408(d)(3) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), 
announcing the filing of a pesticide tolerance petition (PP OE6177) by 
Eden Bioscience, 3830 Monte Villa Parkway, Bothell, Washington, 98021-
6942. This notice included a summary of the petition prepared by the 
petitioner Eden Bioscience.
    The petition requested that the existing exemption in 40 CFR 
180.1001, newly re-designated as 180.910, be amended by removing the 6% 
in the formulation limitation for residues of sodium thiosulfate (CAS 
Reg No.10102-17-7). There were no comments received in response to the 
notice of filing.
    The petition was amended by Eden Bioscience Corporation because 
recent research indicates that higher levels of sodium thiosulfate than 
the currently allowed 6% are needed in certain situations, such as the 
use of very high water volumes with products containing a low 
percentage of active ingredient. Therefore, Eden Bioscience proposed to 
amend the existing exemption to permit the use of sodium thiosulfate in 
a pesticide formulated product as an inert ingredient with no numerical 
limitation when used on growing crops or on raw agricultural 
commodities after harvest.
    Section 408(c)(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(c)(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. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which 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. 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.
    In support of the sodium thiosulfate petition submitted in 2000, 
the petitioner submitted mutagenicity information obtained from open 
literature, an acute oral toxicity study, and FDA's review and 
evaluation of the developmental studies conducted in the mouse, rat, 
hamster, and rabbit. There was no indication of any effect on maternal 
or fetal survival, or in incidences of visceral or skeletal 
abnormalities. There was no effect on genotoxicity, or mutagenicity for 
sodium thiosulfate. The Agency's review and evaluation of all submitted 
information was cited in the final rule published in the Federal 
Register of December 21, 2001, (66 FR 65850). No new or additional 
information was submitted to the Agency as a result of the amendment to 
the petition.

IV. 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 evaluated the use of sodium thiosulfate as an inert ingredient 
in addition to its use as a GRAS (Generally Recognized As Safe) 
substance as part of the previous action. A complete discussion on the 
possible dietary, and other non-occupational exposures is contained in 
the final rule published in the Federal Register of December 21, 2001, 
(66 FR 65850).

[[Page 58312]]

    In that final rule, 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.
    Sodium thiosulfate is considered to be GRAS 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%), and the per capita 
consumption was estimated to be 12 micrograms per day based on a 
population of 210 million. This implies a dose of 0.0002 milligrams/
kilogram/day (mg/kg/day) for a 60 kg body weight female. This dose is 
orders of magnitude lower than the dose levels (550, 400, and 580 mg/
kg/day) used in the developmental toxicity studies which were evaluated 
by the Agency. No effects were noted at these levels. The use of sodium 
thiosulfate in pesticide products as a dechlorinator when mixed with 
certain proteins such as harpin protein (a limited use pattern), and 
especially given the reactive nature of sodium thiosulfate, should not 
significantly increase the amount of sodium thiosulfate in the food 
supply above the levels that currently exist as a result of uses that 
are regulated by the FDA. The final rule of December 21, 2001 (66 FR 
65850), established a tolerance exemption for the use of sodium 
thiosulfate as an inert ingredient when it constituted no more than 6% 
of the formulation. Thus, the Agency concludes that the reported uses 
of sodium thiosulfate, including its use as a GRAS substance, and its 
use as an inert ingredient, even without the 6% limitation, should 
result in human exposure far below any dose level that could possibly 
produce an adverse effect.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to the above chemical 
substances and any other substances. Sodium thiosulfate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
sodium thiosulfate has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

VI. Determination of Safety for U.S. Population, Infants and Children

    Due to the expected low toxicity of sodium thiosulfate, and the low 
potential for exposure, the Agency believes that aggregate exposures to 
thiosulfuric acid, disodium salt, anhydrous, and thiosulfuric acid, 
disodium salt, pentahydrate under reasonably forseeable circumstances 
will pose no appreciable risks to human health. 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 
unless EPA concludes that a different margin of safety will be safe for 
infants and children. EPA has not used a safety factor analysis to 
assess the risk. For the same reasons a tenfold safety factor is 
unnecessary. Based on the information in this preamble, EPA concludes 
that there is a reasonable certainty of no harm from aggregate exposure 
to residues of thiosulfuric acid, disodium salt, anhydrous (CAS Reg. 
No. 7772-98-7), and thiosulfuric acid, disodium salt, pentahydrate (CAS 
Reg. No. 10102-17-7), and that a tolerance is not necessary.

VII. 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 thiosulfuric acid, 
disodium salt, anhydrous, and thiosulfuric acid, disodium salt, 
pentahydrate, for endocrine effects may be required.

B. Analytical Method

    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 Tolerances

    There is an existing tolerance exemption in 40 CFR 180.910 for 
sodium thiosulfate anhydrous, (CAS Reg. No. 7772-98-7) or sodium 
thiosulfate pentahydrate, (CAS Reg. No. 10102-17-7). The Agency is 
amending this tolerance exemption to remove the 6% in the formulation 
limitation.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance or 
tolerance exemption for sodium thiosulfate.

VIII. Conclusions

    Based on this information in the record, summarized in this 
preamble, and in the final rule published on December 21, 2001 (66 FR 
65850), EPA concludes that there is reasonable certainty of no harm 
from aggregate exposure to residues of sodium thiosulfate. Accordingly, 
EPA finds that exempting thiosulfuric acid, disodium salt, anhydrous, 
(CAS Reg. No. 7772-98-7) or thiosulfuric acid, disodium salt, 
pentahydrate, (CAS Reg. No. 10102-17-7) from the requirement of a 
tolerance will be safe.

IX. 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

[[Page 58313]]

accordance with the instructions provided in this unit and in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number OPP-2004-0289 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 November 29, 2004.
    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 (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. 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) 564-6255.
    2. 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 ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2004-0289, 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 ADDRESSES. You may also send an electronic copy of your 
request via e-mail to: [email protected]. 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).

X. Statutory and Executive Order Reviews

    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, entitled 
Federalism(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

[[Page 58314]]

responsibilities between the Federal Government and Indian tribes, as 
specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

XI. Congressional Review Act

    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: September 24, 2004.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.910 the table is amended by revising the entry for 
``sodium thiosulfate'' to read as two separate entries and inserting 
them alphabetically as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest.; 
exemptions from the requirement of a tolerance.

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                 Inert Ingredients                       Limits                          Uses
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                                                  * * * * * * *
Thiosulfuric acid, disodium salt, anhydrous. (CAS    ..............  Dechlorinator, reducing agent
 Reg. No 7772-98-7).
Thiosulfuric acid, disodium salt, pentahydrate.      ..............  Dechlorinator, reducing agent
 (CAS Reg. No. 10102-17-7).
                                                  * * * * * * *
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[FR Doc. 04-21933 Filed 9-30-04; 8:45 am]
BILLING CODE 6560-50-S