[Federal Register Volume 74, Number 154 (Wednesday, August 12, 2009)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19193]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Carbon Black; 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 carbon black (CAS Reg. No. 1333-86-4)
under 40 CFR 180.920 when used as an inert ingredient (colorant) in
pesticide formulations applied to seeds used to grow agricultural and
horticultural crops. Becker Underwood, Inc. submitted a petition 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 carbon black.
DATES: This regulation is effective August 12, 2009. Objections and
requests for hearings must be received on or before October 13, 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-2009-0129. 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: 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:
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
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 40 CFR part 180 through the
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.
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. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2009-0129 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 October 13, 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 your copies, identified by docket ID
number EPA-HQ-OPP-2009-0129, 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 and Statutory Findings
In the Federal Register of May 6, 2009 (74 FR 20947) (FRL-8412-7),
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a,
as amended by the Food Quality Protection Act (FQPA) (Public Law 104-
170), announcing the filing of a pesticide petition (PP 8E7484) by
Becker Underwood, Inc., 801 Dayton Ave., P.O. Box 667, Ames, IA 50010.
The petition requested that 40 CFR 180.920 be amended by establishing
an exemption from the requirement of a tolerance for residues of carbon
black when used as an inert ingredient (colorant) in pesticide
formulations applied to seeds used to grow agricultural and
horticultural crops. That notice included a summary of the petition
prepared by the petitioner. There were no comments received in response
to the notice of filing.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) 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
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has
exempted inert ingredients from the requirement of a tolerance based on
the low toxicity of the individual inert ingredients.
IV. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by carbon
black are discussed in this unit.
Based on the limited systemic toxicity, carbon black is not
expected to pose a hazard when used for its proposed use pattern as an
inert ingredient (colorant) in pesticide formulations applied to seeds
used to grow agricultural and horticultural crops. Six acute toxicity
studies were submitted by the petitioner to support this action. The
results indicate that carbon black is very low in toxicity. The acute
oral toxicity of carbon black to rats and the acute dermal toxicity to
rabbits are both low. The lethal dose (LD)50 for both was
determined to be greater than 5,050 milligrams/kilogram (mg/kg) and the
EPA Toxicity Category is IV. The acute inhalation toxicity to rats was
also low with a lethal concentration (LC)50 of greater than
2.54 mg/Liter (L) and the toxicity category is IV. Acute eye and dermal
irritation to rabbits were both rated as non-irritating with a Toxicity
category of IV. A skin sensitization study on guinea pigs determined
that carbon black is not a dermal sensitizer.
The toxicity of carbon black is summarized in a 2005 Tolerance
Reassessment Document (http://www.epa.gov/opprd001/inerts/carbonblack.pdf). No systemic toxicity was identified in a chronic
toxicity/carcinogenicity study in mice and rats fed carbon black at
doses up to 1,000 mg/kg/day for 2 years (Gandhi, 2005). No
developmental or reproductive studies were identified in this report
for carbon black. However, there was no evidence of effects on
reproductive organs observed in a 2 year, long term study in rats. The
lack of systemic toxicity identified at doses up to 1,000 mg/kg/day in
the 2 year chronic toxicity study also supports the lack of
developmental and reproductive effects. It has also been determined
that assays for mutagenicity are negative for carbon black. No
neurotoxicity information is available, however, no neurological
effects were observed in any of the available studies. There is no
evidence of carcinogenicity by oral route. However, there is some
evidence of lung tumors in occupational exposure scenarios via
V. 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).
Residential exposures (inhalation and dermal) are not expected
since there are no existing or proposed residential uses. Dietary
exposure (food and drinking water) to carbon black is not expected
since it is a solid, insoluble particle that adsorbs to the seed
surface only. It is not likely that it will be absorbed into the seed
and translocated to the plant and harvested plant parts. In addition,
carbon black has limited toxicity, therefore no harm is expected.
As stated above, no hazard was identified for dietary and
residential exposures to carbon black. Therefore, no aggregate risk
assessments were performed. For carbon black, a qualitative assessment
for all pathways of human exposure (food, drinking water, and
residential) is appropriate given the lack of human health concerns,
associated with the exposure to carbon black when used as an inert
ingredient (colorant) in pesticide formulations applied to seed used to
grow agricultural and horticultural crops.
VI. Cumulative Effects
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.''
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 carbon black and any other
substances and carbon black does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance exemption, therefore, EPA has not assumed that carbon black
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/.
VII. Safety Factor for Infants and Children
Section 408 of the FFDCA provides that EPA shall apply an
additional tenfold (10X) 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 database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. This additional margin of safety is commonly
referred to as the FQPA safety factor (SF). In applying this provision,
EPA either retains the default value of 10X or uses a different
additional safety factor when reliable data supports the choice of a
The toxicity database is sufficient for carbon black and potential
exposure is adequately characterized given the low toxicity of the
chemical. In terms of hazard, there are low concerns and no residual
uncertainties regarding prenatal and/or postnatal toxicity. ``Carbon
black has low subchronic and chronic toxicities. Although no
developmental or reproductive studies, per se, were identified, long-
term studies have not demonstrated any effects on the reproductive
organs of male or female rats. Additionally, the poor to nil absorption
of carbon black as demonstrated by the lack of significant adverse
effects by the oral route even at high doses would mitigate any
concerns'' (Gandhi, 2005). No acute or subchronic neurotoxicity studies
are available, but there were no signs of neurological effects observed
in the database at doses up to 1,000 mg/kg/day. Therefore, the Agency
concluded that these studies are not required. Based on this
information, there is no concern at this time for increased sensitivity
to infants and children to carbon black when used as an inert
ingredient in pesticide formulations as a colorant for pesticides
applied as seed treatment to seed used to grow agricultural and
horticultural crops and a safety factor analysis has not been used to
Further, given the limited exposure potential based on the proposed
use and limited systemic toxicity, a safety factor analysis has not
been used to assess the risks resulting from the inert pesticidal use
of carbon black. For the same reason, EPA has determined that an
additional safety factor is not needed to protect the safety of infants
VIII. Determination of Safety for U.S. Population
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Residues of concern are not anticipated for dietary exposure (food
and drinking water) or for residential exposure (dermal and inhalation)
from the use of carbon black for the proposed use pattern as an inert
ingredient in pesticide products. As discussed above, EPA expects
aggregate exposure to carbon black to pose no appreciable dietary risk
given that the data on carbon black shows a lack of systemic toxicity
at doses up to 1,000 mg/kg/day. In addition, dietary exposure is not
expected since carbon black is a solid, insoluble particle that adsorbs
to the seed surface only. It is not likely that it will be absorbed
into the seed and translocated to the plant and harvested plant parts.
Also, carbon black will be used in very small amounts as a colorant for
pesticides applied as a seed treatment to seed used to grow
agricultural and horticultural crops. Based on the available exposure
and toxicity information, a safety factor analysis has not been used to
assess the risks resulting from the inert pesticidal use of carbon
Taking into consideration all available information on carbon
black, 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 carbon black. Therefore, the establishment of an
exemption from tolerance under 40 CFR 180.920 for residues of carbon
black when used as an inert ingredient (colorant) in pesticide
formulations applied to seeds used to grow agricultural and
horticultural crops can be considered safe under section 408 of the
IX. Other Considerations
A. Endocrine Disruptors
EPA is required under FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including
all pesticide active and other ingredients) ``may have an effect in
humans that is similar to an effect produced by a naturally occurring
estrogen, or other such endocrine effects as the Administrator may
designate.'' Following recommendations of its Endocrine Disruptor and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen
and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program
include evaluations of potential effects in wildlife. For pesticide
chemicals, EPA will use the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may
help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops
and resources allow, screening of additional hormone systems may be
added to the Endocrine Disruptor Screening Program (EDSP).
When additional appropriate screening and/or testing protocols
being considered under the Agency's EDSP have been developed, carbon
black may be subjected to further screening and/or testing to better
characterize effects related to endocrine disruption.
B. Analytical Method(s)
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
C. Existing Exemptions
Currently, carbon black is exempted from tolerance requirements in
pesticide formulations applied to animals when used as a colorant/
pigment in animal tags (40 CFR 180.930).
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
carbon black nor have any CODEX Maximum Residue Levels been established
for any food crops at this time.
Therefore, an exemption from the requirement of a tolerance is
established for carbon black (CAS Reg. No. 1333-86-4) when used as an
inert ingredient (colorant) in pesticide formulations applied to seed
used to grow agricultural and horticultural crops.
XI. 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
XII. 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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: July 31, 2009.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.920, the table is amended by adding alphabetically the
following inert ingredient to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
Inert ingredients Limits Uses
* * * * * * *
Carbon Black (CAS Reg. No. 1333- For seed treatment Colorant.
86-4). use only
* * * * * * *
[FR Doc. E9-19193 Filed 8-11-09; 8:45 am]
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