Document ID: EPA-HQ-OPP-2009-0490-0004
Agency: epa
Document Type: Rule
Title: Sodium and Ammonium Naphthalenesulfonate Formaldehyde Condensates; Exemption from the Requirement of a Tolerance
Posted Date: 2009-10-07T04:00Z

[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Rules and Regulations]               
[Page 51470-51474]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc09-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0490; FRL-8439-1]

 
Sodium and Ammonium Naphthalenesulfonate Formaldehyde 
Condensates; 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 the sodium and ammonium 
napthalenesulfonate formaldehyde condensates, herein referred to in 
this document as the SANFCs, when used as inert ingredients in 
pesticide formulations applied pre-harvest and post-harvest. The Joint 
Inerts Task Force (JITF), Cluster Support Team Number 11 and Akzo Nobel 
Surface Chemistry, LLC, submitted petitions to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of the SANFCs.

DATES: This regulation is effective October 7, 2009. Objections and 
requests for hearings must be received on or before December 7, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0490. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at http://www.regulations.gov, or, if only

[[Page 51471]]

available in hard copy, at the OPP Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Elizabeth Fertich, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 347-8560; e-mail address: 
fertich.elizabeth@epa.gov.

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 those 
engaged in the following activities:
     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 to 
provide 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?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0490 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 as required by 40 CFR part 178 
on or before December 7, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0490, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background

    In the Federal Register of August 19, 2009 (74 FR 41898) (FRL-8426-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7572) by The JITF, CST 11, c/o CropLife America, 1156 15th Street, 
NW., Suite 400, Washington, DC 20005. The petition requested that 40 
CFR 180.910 be amended by establishing exemptions from the requirement 
of a tolerance for residues of SANFCs. That notice referenced a summary 
of the petition prepared by the JITF, CST 11, the petitioner, which is 
available to the public in the docket, http://www.regulations.gov. 
Docket ID number EPA-HQ-OPP-2009-0043 was established for this 
petition. There were no comments received in response to the notice of 
filing.
    In the Federal Register of August 19, 2009 (74 FR 41895]) (FRL-
8429-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7562) by Akzo Nobel Surface Chemistry, LLC, 525 West Van Buren 
Street, Chicago, IL 60607-3823. The petition requested that 40 CFR 
180.910 be amended by establishing exemptions from the requirement of a 
tolerance for residues of mono-, di-, and trimethylnapthalenesulfonic 
acids and napthalenesulfonic acids formaldehyde condensates, ammonium 
and sodium salts. That notice referenced a summary of the petition 
prepared by Akzo Nobel Surface Chemistry, LLC, the petitioner, which is 
available to the public in the docket, http://www.regulations.gov. 
Docket ID number EPA-HQ-OPP-2008-0822 was established for this 
petition. There were no comments received in response to the notice of 
filing.
    These two petitions are grouped because they fall under the same 
general chemical description criteria.

 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. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the

[[Page 51472]]

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) 
of FFDCA 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) of 
FFDCA 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.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
exemption from the requirement of a tolerance for residues of the 
SANFCs when used as inert ingredients in pesticide formulations applied 
pre-harvest and post-harvest. EPA's assessment of exposures and risks 
associated with establishing tolerances follows.

 A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The toxicology database for the SANFC inerts is adequate to support 
their use as inert ingredients in pesticide formulations. The existing 
toxicology database for the SANFC consists of two OPPTS Harmonized 
Guidelines 870.3650 (combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test in rats), and 
several studies from the scientific literature on acute toxicity and 
mutagenicity.
    The available toxicity data indicates that SANFC has low acute oral 
and inhalation toxicity. SANFC was not mutagenic in an Ames test. In a 
repeated 28 to 42 day OPPTS Harmonized Guideline 870.3650 combined 
repeated dose toxicity study with the reproduction/developmental 
toxicity screening with the representative test compound, 
naphthalenesulfonic acid, sodium salt polymer with formaldehyde (CAS 
9084-06-4), there was no evidence of increased susceptibility. Parental 
toxicity manifested as decrements in body-weight gain in both sexes at 
the limit dose (1,000 milligrams/kilogram/ day (mg/kg/day). No 
developmental or reproductive effects were observed at doses of 100, 
300, and 1,000 mg/kg/day. In an OPPTS Harmonized Guideline 870.3650 
study submitted by Akzo Nobel Chemistry, LLC, no systemic toxicity was 
observed at doses up to and including 456 mg/kg/day. The highest dose 
tested (HDT). There was no evidence of potential neurotoxicity or 
immunotoxicity in the adult animal in the OPPTS Harmonized Guideline 
870.3650 study at the limit dose of 1,000 mg/kg/day. There is no 
evidence that the SANFCs are carcinogenic. There are no chronic data 
available on the SANFC surfactants; however, no structural alerts for 
cancer were identified in a qualitative structure activity relationship 
(SAR) database, DEREK Version 11. In addition, there was little concern 
about any of the postulated metabolites having greater toxicity than 
the parent compounds. The higher molecular weight (MW) polymeric SANFC 
surfactants (MW >1,000) are not expected to be readily absorbed or 
metabolized, and should thus be rapidly excreted (likely in the feces) 
unchanged. Additionally, lower molecular microsome cytochrome P-450 
oxygenases may hydroxylate the naphthalene ring and/or methylene bridge 
to produce alternative metabolites that should also be readily 
conjugated and excreted. Furthermore, these compounds are formaldehyde 
condensates and do not contain free formaldehyde. Therefore, 
formaldehyde is not a residue of concern. In summary, all available 
data indicate that SANFCs have a low hazard potential.
    Specific information on the studies received are included in the 
Agency's Human Health Risk Assessment which can be found at http://
www.regulations.gov in document Sodium and Ammonium 
Naphthalenesulfonate Formaldehyde Condensates (SANFCs) - JITF CST 11 
Inert Ingredients), Human Health Risk Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations, pages 6-8 and 11-14 in docket ID 
number EPA-HQ-OPP-2009-0043 and also in document Mono-, Di-, and 
Trimethylnapthalensulfonic Acids and Naphthalenesulfonic Acids 
Formaldehyde Condensates, Ammonium and Sodium Salts: Review of 
Toxicological Studies in Support of an Exemption from the Requirement 
of a Tolerance (40 CFR 180.920 and 40 CFR 180.910) When Used as Inert 
Ingredients in Pesticide Formulations in docket ID number EPA-HQ-OPP-
2008-0822.

B. Toxicity Endpoint Selection and FQPA Considerations

    There was no significant hazard identified in the OPPTS Harmonized 
Guideline 870.3650 study at the limit dose of 1,000 mg/kg/day to either 
parental animals or their offspring. Thus, due to their low potential 
hazard and the lack of a hazard endpoint, it was determined that a 
quantitative risk assessment using safety factors applied to a point of 
departure protective of an identified hazard endpoint is not 
appropriate for the SANFCs. The Agency notes that there was no evidence 
of neurotoxicity or increased susceptibility to the offspring of rats 
following prenatal or postnatal exposure in the OPPTS Harmonized 
Guideline 870.3650 studies. Based on this information, there is no 
concern, at this time, for increased sensitivity to infants and 
children to the SANFCs when used as inert ingredients in pesticide 
formulations applied pre-harvest and post-harvest and a safety factor 
analysis has not been used to assess risk. For the same reason, EPA has 
determined that an additional safety factor is not needed to protect 
the safety of infants and children.

C. Aggregate Exposures

     In examining aggregate exposure, section 408 of FFDCA 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).
    The SANFC inerts are used as disperants, defoamers and emulsifiers 
in pesticide formulations. These surfactants have a wide range of

[[Page 51473]]

industrial uses as well as serving as emulsifiers in personal care 
products and in food contact packaging.
    The residues of concern are the parent compound only. Considering 
the large size and polarity of the SANFC molecules, it is unlikely that 
they would be readily absorbed by livestock or taken up by plants for 
further metabolism.
    No hazard was identified for the acute and chronic dietary 
assessment (food and drinking water), or for the short-term, 
intermediate-term, and long-term residential assessments, and 
therefore, no quantitative aggregate exposure assessments were 
performed.

D. Cumulative Effects From Substances With a Common Mechanism of 
Toxicity

     Section 408(b)(2)(D)(v) of 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.''
    EPA has not found the SANFCs to share a common mechanism of 
toxicity with any other substances, and SANFCs do not appear to produce 
a toxic metabolite produced by other substances. For the purposes of 
this tolerance action, therefore, EPA has assumed that SANFCs do not 
have 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 EPA's website at http://www.epa.gov/pesticides/
cumulative.

E. Determination of safety

    Based on all available information, EPA concludes that there is a 
reasonable certainty that no harm will result to the general population 
or to infants and children from aggregate exposure to residues of the 
SANFCs when used as inert ingredients in pesticide formulations applied 
pre-harvest and post-harvest.

V. Other Considerations

A. Analytical Enforcement Methodology

     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.

B. Existing Exemptions

    The SANFCs have an existing exemption from the requirement of a 
tolerance under 40 CFR 180.920 for use as inert ingredients in 
pesticide formulations applied to growing crops.

C. International Residue Limits

    The Agency is not aware of any country requiring a tolerance for 
the SANFCs nor have any CODEX Maximum Residue Levels been established 
for any food crops at this time.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of the SANFCs, under the tolerance expression 
mono-, di-, and trimethylnapthalenesulfonic acids and 
napthalenesulfonic acids formaldehyde condensates, ammonium and sodium 
salts, when used as inert ingredients in pesticide formulations applied 
pre-harvest and post-harvest.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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 30, 2009.
G. Jeffrey Herndon,
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.

[[Page 51474]]

0
2. In Sec. 180.910, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

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

* * * * *

------------------------------------------------------------------------
        Inert Ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Mono-, di-, and                                       Surfactants,
 trimethylnapthalenesulfonic                           related adjuvants
 acids and napthalenesulfonic                          of surfactants
 acids formaldehyde condensates,
 ammonium and sodium salts (CAS
 Reg. Nos 9008-63-3, 9069-80-1,
 9084-06-4, 36290-04-7, 91078-68-
 1, 141959-43-5, 68425-94-5)
                              * * * * * * *
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[FR Doc. E9-24160 Filed 10-6-09; 8:45 am]

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