Document ID: EPA-HQ-OPP-2009-0490-0001
Agency: epa
Document Type: Rule
Title: Sodium and Ammonium Naphthalenesulfonate Formaldehyde Condensates; Exemption from the Requirement of a Tolerance
Posted Date: 2009-08-05T04:00Z

[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]               
[Page 38952-38956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au09-19]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0490; FRL-8428-5]

 
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 to growing corps under 40 CFR 180.920. 
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 August 5, 2009. Objections and 
requests for hearings must be received on or before October 5, 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 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: Kerry Leifer, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8811; e-mail address: leifer.kerry@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

[[Page 38953]]

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 October 5, 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 March 4, 2009 (74 FR 9397) (FRL-8401-8), 
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 9E7516) 
by The Joint Inerts Task Force (JITF), Cluster Support Team Number 11 
(CST 11), c/o CropLife America, 1156 15th Street, NW., Suite 400, 
Washington, DC 20005. The petition requested that 40 CFR 180.920 be 
amended by establishing exemptions from the requirement of a tolerance 
for residues of sodium and ammonium naphthalenesulfonate formaldehyde 
condensates. 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 the petition. There were no comments 
received in response to the notice of filing.
    In the Federal Register of March 25, 2009 (74 FR 12856) (FRL-8399-
4), 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 
8E7405) by Akzo Nobel Surface Chemistry, LLC, 525 West Van Buren 
Street, Chicago, IL 60607-3823. The petition requested that 40 CFR 
180.920 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 the 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.
    These petitions were submitted in response to a final rule 
published August 9, 2006 (71 FR 45415)(FRL-8084-1) in which the Agency 
revoked, under section 408(e)(1) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), the existing exemptions from the requirement of a 
tolerance for residues of certain inert ingredients because of 
insufficient data to make the determination of safety required by FFDCA 
section 408(b)(2). The expiration date for the tolerance exemptions 
subject to revocation was August 9, 2008, which was later extended to 
August 9, 2009, by a final rule published in the Federal Register of 
August 4, 2008 to allow for data to be submitted to support the 
establishment of tolerance exemptions for these inert ingredients prior 
to the effective date of the tolerance exemption revocation.

 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 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

[[Page 38954]]

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 to growing crops. 
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 
Guideline 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 28-42 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). 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 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, due to the low 
hazard potential for these inert compounds, a quantitative risk 
assessment is not required for the SANFC inerts.
    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 pages 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 to growing crops 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 dispersants, defoamers and emulsifiers 
in pesticide formulations. These surfactants have a wide range of 
industrial uses as well as serve as emulsifiers in personal care 
products and in food contact packaging.
    The residues of concern are for 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-, intermediate-, 
and long-term residential assessments, and therefore no quantitative 
aggregate risk 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

[[Page 38955]]

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 
to growing crops.

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. 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 sodium and ammonium 
naphthalenesulfonate formaldehyde condensates, 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 
to growing crops under 40 CFR 180.920.

VII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance 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 tolerance 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: July 29, 2009.
Lois Rossi,
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.  180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

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        Inert Ingredients               Limits               Uses
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                                * * * * *
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. E9-18725 Filed 8-4-09; 8:45 am]

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