Document ID: EPA-HQ-OPP-2009-0129-0003
Agency: epa
Document Type: Rule
Title: Carbon Black; Exemption from the Requirement of a Tolerance
Posted Date: 2009-08-12T04:00Z

[Federal Register: August 12, 2009 (Volume 74, Number 154)]
[Rules and Regulations]               
[Page 40509-40513]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au09-11]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0129; FRL-8426-3]

 
Carbon Black; 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 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

[[Page 40510]]

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: 
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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    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 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. 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

[[Page 40511]]

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 
inhalation route.

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 
different factor.
    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 
assess risk.

[[Page 40512]]

    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 
and children.

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 
black.
    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 
FFDCA.

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.

X. Conclusions

    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

[[Page 40513]]

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).

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 
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 31, 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 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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