[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
* * * * *
------------------------------------------------------------------------
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)
* * * * *
------------------------------------------------------------------------
[[Page 38956]]
[FR Doc. E9-18725 Filed 8-4-09; 8:45 am]
BILLING CODE 6560-50-S