83 FR 37440 - Titanium dioxide; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 148 (August 1, 2018)
Federal Register Volume 83, Issue 148 (August 1, 2018)
| Page Range | 37440-37443 | |
| FR Document | 2018-16470 |
[Federal Register Volume 83, Number 148 (Wednesday, August 1, 2018)] [Rules and Regulations] [Pages 37440-37443] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16470] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2018-0150; FRL-9980-39] Titanium dioxide; Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation amends the exemption from the requirement of a tolerance for residues of titanium dioxide (CAS Reg. No. 13463-67-7) when used as an inert ingredient in pesticide formulations applied to growing crops to allow for use as a carrier. SciReg. Inc., on behalf of Bayer CropScience Biologics GmbH, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of titanium dioxide resulting from this use. DATES: This regulation is effective August 1, 2018. Objections and requests for hearings must be received on or before October 1, 2018, 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: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2018-0150, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. 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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 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-2018-0150 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 1, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). 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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2018-0150, by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or [[Page 37441]] delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Petition for Exemption In the Federal Register of May 18, 2018 (83 FR 23247) (FRL-9976- 87), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11085) by SciReg. Inc., on behalf of Bayer CropScience Biologics GmbH, Lukaswiese 4, 23970 Wismar, Germany. The petition requested that the 40 CFR 180.920 exemption from the requirement of a tolerance for residues of titanium dioxide (CAS Reg. No. 13463-67-7) be amended to allow for use as a carrier when used as an inert ingredient in pesticide formulations applied to growing crops only. That document referenced a summary of the petition prepared by SciReg. Inc., on behalf of Bayer CropScience Biologics GmbH, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. 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(c)(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 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. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for titanium dioxide including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with titanium dioxide follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered their 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 available toxicity studies on titanium dioxide via the oral route of exposure clearly demonstrate a lack of toxicity. The several studies in mice, rats, dogs, cats, rabbits and other species of varying durations do not indicate toxicity, even at very high doses (e.g., 50,000 ppm or 2,500 mg/kg/day dietary exposure for two years in rats). There are no studies on the dermal toxicity of titanium dioxide and there is no expected toxicity via the dermal route of exposure because as an insoluble solid material, titanium dioxide is not absorbed via the skin. The available inhalation studies indicate that the primary toxicity of titanium dioxide is due to deposition of the inhaled particles. Although these studies suggest equivocal evidence of carcinogenicity due to prolonged exposure to titanium dioxide particles, EPA has determined that these effects are not relevant for assessing risk from exposure to titanium dioxide when used as an inert ingredient in pesticide formulations based on the following. First, tumors were only observed in two of the available studies and only in one species. In one study, those tumors were only observed in rats continually exposed to ultrafine particles of titanium dioxide. In the second study, tumors were only observed from exposure to fine particles of titanium dioxide at extremely high concentrations (250 mg/m\3\), in which the animals experienced overloading of lung clearance, with chronic inflammation resulting in lung tumors. All but one of the tumors in the second study were subsequently reclassified as non-neoplastic or non-cancerous in nature. No tumors were observed in studies involving mice. The titanium dioxide used in pesticide formulations is considered pigmentary grade, not ultrafine or nanoscale. Consequently, the tumors observed from exposure to ultrafine particles of titanium dioxide are not relevant for assessing exposure to the type of titanium dioxide used in pesticide formulations. Following the reclassification of the tumors observed in the second inhalation study, EPA does not consider these effects to be strong evidence of carcinogenicity from exposure to fineparticle-sized titanium dioxide. Further, EPA does not expect any reasonably foreseeable uses of titanium dioxide in pesticide formulations that might result in residential exposures that would approach the levels of exposure necessary to elicit the effects seen in the available inhalation study. The levels at which effects were observed in that study greatly exceed any reasonable [[Page 37442]] dose for toxicity testing and any likely residential exposure levels. Moreover, when used as an inert in pesticide formulations, titanium dioxide will be bound to other materials, with no significant inhalation exposure to titanium dioxide particles themselves. This position is consistent with the National Institute of Occupational Health and Safety's (NIOSH) recent assessment that ultrafine but not fine titanium dioxide would be considered a ``potential occupational carcinogen.'' The NIOSH Current Intelligence Bulletin ``Occupational Exposure to Titanium Dioxide'' concludes that ``[t]he lung tumors observed in rats after exposure to 250 mg/m\3\ of fine TiO 2 [titanium dioxide] were the basis for the original NIOSH designation of TiO2 as a ``potential occupational carcinogen.'' However, because this dose is considered to be significantly higher than currently accepted inhalation toxicology practice, NIOSH concluded that the response at such a high dose should not be used in making its hazard identification.'' NIOSH concluded that the data is insufficient to classify fine titanium dioxide as a potential occupational carcinogen. Because the predominant form of titanium dioxide used commercially, and the form used as an inert ingredient in pesticide formulations, is pigment grade, which is not in the ultrafine or nanoscale particle size range but rather in the fine particle size range, EPA concludes that carcinogenicity is not a concern from exposure to titanium dioxide resulting from its use as an inert ingredient in pesticide formulations. Specific information on the studies received and the nature of the adverse effects caused by titanium dioxide as well as the no-observed- adverse-effect level (NOAEL) and the lowest-observed-adverse-effect level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of July 27, 2012 (77 FR 44151) (FRL- 9354-6) and in the Agency's risk assessment which can be found at http://www.regulations.gov in document ``Titanium Dioxide; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When used as an Inert Ingredient in Pesticide Formulations'' in docket ID number EPA-HQ-OPP- 2018-0150. B. Toxicological Points of Departure/Levels of Concern Because the available data indicate no toxicity via the oral route of exposure, no endpoint of concern for that route of exposure has been identified in the available database. This conclusion is in agreement with the conclusion of the World Health Organization (WHO) Committee on Food Coloring Materials that no Acceptable Daily Intake (ADI) need be set for the use of titanium dioxide based on the range of acute, sub- acute, and chronic toxicity assays, all showing low mammalian toxicity. Similarly, no significant toxicity of titanium dioxide is expected via the dermal route of exposure, so no endpoint was identified. Because the effects seen in inhalation studies occurred at doses above the levels at which pesticide exposure is expected and for particle sizes that are different from the size of titanium dioxide used in pesticide formulations, the Agency has concluded that those risks are not relevant for assessing risk from pesticide exposure and therefore, did not identify an endpoint for assessing inhalation exposure risk. C. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to titanium dioxide, EPA considered exposure under the proposed exemption from the requirement of a tolerance and all other existing exemptions from the requirement of a tolerance for residues of titanium dioxide. EPA assessed dietary exposures from titanium dioxide in food as follows: Residues of titanium dioxide are exempt from the requirement of a tolerance when used as an inert ingredient in many different circumstances: When used in pesticide formulations applied to growing crops as a pigment/coloring agent in plastic bags used to wrap growing bananas or colorant on seeds for planting (40 CFR 180.920); when used in pesticide formulations applied to animals (40 CFR 180.930); when used as a UV protectant in microencapsulated formulations of the insecticide lambda-cyhalothrin at no more than 3.0% by weight (40 CFR 180.1195); when used as a UV stabilizer in pesticide formulations of napropamide at no more than 5% of the product formulation (40 CFR 180.1195); when used in pesticide placed at entrance to bee hives intended to control varroa mites in hive at a maximum of 0.1% wt/wt (40 CFR 180.1195); and when used in anthraquinone pesticide formulations at a maximum of 45% wt/wt (40 CFR 180.1195). Titanium dioxide is also approved for use as a colorant in food (21 CFR 73.575). Although dietary exposure may be expected from use of titanium dioxide in pesticide formulations applied to bee hives and on other crops (as well as from other non-pesticidal sources), a quantitative exposure assessment for titanium dioxide was not conducted because no endpoint of concern was identified in the database. 2. Dietary exposure from drinking water. Since a hazard endpoint of concern was not identified for the acute and chronic dietary assessment, a quantitative dietary exposure risk assessment for drinking water was not conducted, although exposures from drinking water may be expected from use on food crops. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). Titanium dioxide may be used in non-pesticide products such as paints, printing inks, paper and plastic products around the home. It has also been approved for use in drugs (21 CFR 73.1575) and in cosmetics (21 CFR 73.2575 and 73.3126). Additionally, titanium dioxide may be used as an inert ingredient in pesticides that include residential uses; however based on the discussion in Unit IV.B., a quantitative residential exposure assessment for titanium dioxide was not conducted. 4. 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.'' Because titanium dioxide does not have a toxic mode of action or a mechanism of toxicity, this provision does not apply. D. Safety Factor for Infants and Children Due to titanium dioxide's 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 titanium dioxide. For the same reasons that a quantitative risk assessment based on a safety factor approach is not appropriate for titanium dioxide, an FQPA SF is not needed to protect the safety of infants and children. [[Page 37443]] E. Aggregate Risks and Determination of Safety Taking into consideration all available information on titanium dioxide, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to titanium dioxide under reasonable foreseeable circumstances. Therefore, the exemption from tolerance under 40 CFR 180.920 for residues of titanium dioxide, when used as an inert ingredient in pesticide formulations is safe under FFDCA section 408. V. 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. VI. Conclusions Therefore, EPA is amending the exemption from the requirement of a tolerance in 40 CFR 180.920 for residues of titanium dioxide (CAS Reg. No. 13463-67-7) when used as an inert ingredient (carrier) in pesticide formulations. VII. Statutory and Executive Order Reviews This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) 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 action has been exempted from review under Executive Order 12866, this action 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This action 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 FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). 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 (NTTAA) (15 U.S.C. 272 note). VIII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action 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 11, 2018. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs. 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, revise the inert ingredient ``Titanium dioxide (CAS Reg. No. 13463-67-7)'' in the table to read as follows: Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance. * * * * * ---------------------------------------------------------------------------------------------------------------- Inert ingredients Limits Uses ---------------------------------------------------------------------------------------------------------------- . . . . . . . Titanium dioxide (CAS Reg. No. 13463- ......................... Pigment, colorant, carrier. 67-7). . . . . . . . ---------------------------------------------------------------------------------------------------------------- [FR Doc. 2018-16470 Filed 7-31-18; 8:45 a.m.] BILLING CODE 6560-50-P
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TABLE 52.385—EPA-APPROVED REGULATIONS—Continued
Dates Federal
Connecticut Section Comments/
Title/subject Register
state citation Date adopted Date approved 52.370 description
citation
by state by EPA
* * * * * * *
■ 5. Section 52.386 is amended by before October 1, 2018, and must be B. How can I get electronic access to
adding paragraph (c) to read as follows: filed in accordance with the instructions other related information?
provided in 40 CFR part 178 (see also You may access a frequently updated
§ 52.386 Section 110(a)(2) infrastructure
Unit I.C. of the SUPPLEMENTARY electronic version of 40 CFR part 180
requirements.
INFORMATION). through the Government Printing
* * * * *
(c) The Connecticut Department of ADDRESSES: The docket for this action, Office’s e-CFR site at http://
Energy and Environmental Protection identified by docket identification (ID) www.ecfr.gov/cgi-bin/text-
submitted the following infrastructure number EPA–HQ–OPP–2018–0150, is idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
SIPs on these dates: 2006 PM2.5 available at http://www.regulations.gov 40tab_02.tpl.
NAAQS—August 19, 2011 (CAA section or at the Office of Pesticide Programs C. How can I file an objection or hearing
110(a)(2)(D)(i)(I) transport provisions), Regulatory Public Docket (OPP Docket) request?
and 2012 PM2.5 NAAQS—December 14, in the Environmental Protection Agency
2015. These infrastructure SIPs are Under FFDCA section 408(g), 21
Docket Center (EPA/DC), West William
approved. Also with respect to the 1997 U.S.C. 346a, any person may file an
Jefferson Clinton Bldg., Rm. 3334, 1301
and 2006 PM2.5, 1997 and 2008 ozone, objection to any aspect of this regulation
Constitution Ave. NW, Washington, DC
2008 lead, 2010 nitrogen dioxide, and and may also request a hearing on those
20460–0001. The Public Reading Room
2010 sulfur dioxide NAAQS, elements objections. You must file your objection
is open from 8:30 a.m. to 4:30 p.m.,
related to PSD, which are in CAA or request a hearing on this regulation
Monday through Friday, excluding legal
section 110(a)(2)(C), (D)(i)(II), and (J) in accordance with the instructions
holidays. The telephone number for the
and were previously conditionally provided in 40 CFR part 178. To ensure
Public Reading Room is (202) 566–1744,
approved, are now approved. proper receipt by EPA, you must
and the telephone number for the OPP
identify docket ID number EPA–HQ–
[FR Doc. 2018–16431 Filed 7–31–18; 8:45 am] Docket is (703) 305–5805. Please review
OPP–2018–0150 in the subject line on
BILLING CODE 6560–50–P the visitor instructions and additional
the first page of your submission. All
information about the docket available
objections and requests for a hearing
at http://www.epa.gov/dockets.
ENVIRONMENTAL PROTECTION must be in writing, and must be
FOR FURTHER INFORMATION CONTACT: received by the Hearing Clerk on or
AGENCY
Michael Goodis, Registration Division before October 1, 2018. Addresses for
40 CFR Part 180 (7505P), Office of Pesticide Programs, mail and hand delivery of objections
Environmental Protection Agency, 1200 and hearing requests are provided in 40
[EPA–HQ–OPP–2018–0150; FRL–9980–39] Pennsylvania Ave. NW, Washington, DC CFR 178.25(b).
20460–0001; main telephone number: In addition to filing an objection or
Titanium dioxide; Exemption From the
(703) 305–7090; email address: hearing request with the Hearing Clerk
Requirement of a Tolerance
RDFRNotices@epa.gov. as described in 40 CFR part 178, please
AGENCY: Environmental Protection SUPPLEMENTARY INFORMATION: submit a copy of the filing (excluding
Agency (EPA). any Confidential Business Information
ACTION: Final rule. I. General Information (CBI)) for inclusion in the public docket.
A. Does this action apply to me? Information not marked confidential
SUMMARY: This regulation amends the pursuant to 40 CFR part 2 may be
exemption from the requirement of a You may be potentially affected by disclosed publicly by EPA without prior
tolerance for residues of titanium this action if you are an agricultural notice. Submit the non-CBI copy of your
dioxide (CAS Reg. No. 13463–67–7) producer, food manufacturer, or objection or hearing request, identified
when used as an inert ingredient in pesticide manufacturer. The following by docket ID number EPA–HQ–OPP–
pesticide formulations applied to list of North American Industrial 2018–0150, by one of the following
growing crops to allow for use as a Classification System (NAICS) codes is methods:
carrier. SciReg. Inc., on behalf of Bayer not intended to be exhaustive, but rather • Federal eRulemaking Portal: http://
CropScience Biologics GmbH, submitted provides a guide to help readers www.regulations.gov. Follow the online
a petition to EPA under the Federal determine whether this document instructions for submitting comments.
Food, Drug, and Cosmetic Act (FFDCA), applies to them. Potentially affected Do not submit electronically any
requesting establishment of an entities may include: information you consider to be CBI or
exemption from the requirement of a
• Crop production (NAICS code 111). other information whose disclosure is
sradovich on DSK3GMQ082PROD with RULES
tolerance. This regulation eliminates the restricted by statute.
• Animal production (NAICS code
need to establish a maximum • Mail: OPP Docket, Environmental
permissible level for residues of 112).
Protection Agency Docket Center (EPA/
titanium dioxide resulting from this use. • Food manufacturing (NAICS code DC), (28221T), 1200 Pennsylvania Ave.
DATES: This regulation is effective 311). NW, Washington, DC 20460–0001.
August 1, 2018. Objections and requests • Pesticide manufacturing (NAICS • Hand Delivery: To make special
for hearings must be received on or code 32532). arrangements for hand delivery or
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dose for toxicity testing and any likely available database. This conclusion is in hives and on other crops (as well as
residential exposure levels. Moreover, agreement with the conclusion of the from other non-pesticidal sources), a
when used as an inert in pesticide World Health Organization (WHO) quantitative exposure assessment for
formulations, titanium dioxide will be Committee on Food Coloring Materials titanium dioxide was not conducted
bound to other materials, with no that no Acceptable Daily Intake (ADI) because no endpoint of concern was
significant inhalation exposure to need be set for the use of titanium identified in the database.
titanium dioxide particles themselves. dioxide based on the range of acute, 2. Dietary exposure from drinking
This position is consistent with the sub-acute, and chronic toxicity assays, water. Since a hazard endpoint of
National Institute of Occupational all showing low mammalian toxicity. concern was not identified for the acute
Health and Safety’s (NIOSH) recent Similarly, no significant toxicity of and chronic dietary assessment, a
assessment that ultrafine but not fine titanium dioxide is expected via the quantitative dietary exposure risk
titanium dioxide would be considered a dermal route of exposure, so no assessment for drinking water was not
‘‘potential occupational carcinogen.’’ endpoint was identified. conducted, although exposures from
The NIOSH Current Intelligence Because the effects seen in inhalation drinking water may be expected from
Bulletin ‘‘Occupational Exposure to studies occurred at doses above the use on food crops.
Titanium Dioxide’’ concludes that ‘‘[t]he levels at which pesticide exposure is 3. From non-dietary exposure. The
lung tumors observed in rats after expected and for particle sizes that are term ‘‘residential exposure’’ is used in
exposure to 250 mg/m3 of fine TiO2 different from the size of titanium this document to refer to non-
[titanium dioxide] were the basis for the dioxide used in pesticide formulations, occupational, non-dietary exposure
original NIOSH designation of TiO2 as a the Agency has concluded that those (e.g., textiles (clothing and diapers),
‘‘potential occupational carcinogen.’’ risks are not relevant for assessing risk carpets, swimming pools, and hard
However, because this dose is from pesticide exposure and therefore, surface disinfection on walls, floors,
considered to be significantly higher did not identify an endpoint for tables).
than currently accepted inhalation assessing inhalation exposure risk. Titanium dioxide may be used in non-
toxicology practice, NIOSH concluded
C. Exposure Assessment pesticide products such as paints,
that the response at such a high dose
1. Dietary exposure from food and printing inks, paper and plastic
should not be used in making its hazard
feed uses. In evaluating dietary products around the home. It has also
identification.’’ NIOSH concluded that
exposure to titanium dioxide, EPA been approved for use in drugs (21 CFR
the data is insufficient to classify fine
considered exposure under the 73.1575) and in cosmetics (21 CFR
titanium dioxide as a potential
proposed exemption from the 73.2575 and 73.3126). Additionally,
occupational carcinogen.
Because the predominant form of requirement of a tolerance and all other titanium dioxide may be used as an
titanium dioxide used commercially, existing exemptions from the inert ingredient in pesticides that
and the form used as an inert ingredient requirement of a tolerance for residues include residential uses; however based
in pesticide formulations, is pigment of titanium dioxide. EPA assessed on the discussion in Unit IV.B., a
grade, which is not in the ultrafine or dietary exposures from titanium dioxide quantitative residential exposure
nanoscale particle size range but rather in food as follows: assessment for titanium dioxide was not
in the fine particle size range, EPA Residues of titanium dioxide are conducted.
concludes that carcinogenicity is not a exempt from the requirement of a 4. Cumulative effects from substances
concern from exposure to titanium tolerance when used as an inert with a common mechanism of toxicity.
dioxide resulting from its use as an inert ingredient in many different Section 408(b)(2)(D)(v) of FFDCA
ingredient in pesticide formulations. circumstances: When used in pesticide requires that, when considering whether
Specific information on the studies formulations applied to growing crops to establish, modify, or revoke a
received and the nature of the adverse as a pigment/coloring agent in plastic tolerance, the Agency consider
effects caused by titanium dioxide as bags used to wrap growing bananas or ‘‘available information’’ concerning the
well as the no-observed-adverse-effect colorant on seeds for planting (40 CFR cumulative effects of a particular
level (NOAEL) and the lowest-observed- 180.920); when used in pesticide pesticide’s residues and ‘‘other
adverse-effect level (LOAEL) from the formulations applied to animals (40 CFR substances that have a common
toxicity studies are discussed in the 180.930); when used as a UV protectant mechanism of toxicity.’’
final rule published in the Federal in microencapsulated formulations of Because titanium dioxide does not
Register of July 27, 2012 (77 FR 44151) the insecticide lambda-cyhalothrin at no have a toxic mode of action or a
(FRL–9354–6) and in the Agency’s risk more than 3.0% by weight (40 CFR mechanism of toxicity, this provision
assessment which can be found at 180.1195); when used as a UV stabilizer does not apply.
http://www.regulations.gov in document in pesticide formulations of
D. Safety Factor for Infants and
‘‘Titanium Dioxide; Human Health Risk napropamide at no more than 5% of the
Children
Assessment and Ecological Effects product formulation (40 CFR 180.1195);
Assessment to Support Proposed when used in pesticide placed at Due to titanium dioxide’s low
Exemption from the Requirement of a entrance to bee hives intended to potential hazard and the lack of a
Tolerance When used as an Inert control varroa mites in hive at a hazard endpoint, it was determined that
Ingredient in Pesticide Formulations’’ in maximum of 0.1% wt/wt (40 CFR a quantitative risk assessment using
docket ID number EPA–HQ–OPP–2018– 180.1195); and when used in safety factors applied to a point of
0150. anthraquinone pesticide formulations at departure protective of an identified
sradovich on DSK3GMQ082PROD with RULES
a maximum of 45% wt/wt (40 CFR hazard endpoint is not appropriate for
B. Toxicological Points of Departure/ 180.1195). Titanium dioxide is also titanium dioxide. For the same reasons
Levels of Concern approved for use as a colorant in food that a quantitative risk assessment based
Because the available data indicate no (21 CFR 73.575). on a safety factor approach is not
toxicity via the oral route of exposure, Although dietary exposure may be appropriate for titanium dioxide, an
no endpoint of concern for that route of expected from use of titanium dioxide FQPA SF is not needed to protect the
exposure has been identified in the in pesticide formulations applied to bee safety of infants and children.
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![Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Rules and Regulations 37443
E. Aggregate Risks and Determination of Children from Environmental Health described under Title II of the Unfunded
Safety Risks and Safety Risks’’ (62 FR 19885, Mandates Reform Act (UMRA) (2 U.S.C.
Taking into consideration all available April 23, 1997); or Executive Order 1501 et seq.).
information on titanium dioxide, EPA 13771, entitled ‘‘Reducing Regulations This action does not involve any
has determined that there is a and Controlling Regulatory Costs’’ (82 technical standards that would require
reasonable certainty that no harm to any FR 9339, February 3, 2017). This action Agency consideration of voluntary
population subgroup will result from does not contain any information consensus standards pursuant to section
aggregate exposure to titanium dioxide collections subject to OMB approval 12(d) of the National Technology
under reasonable foreseeable under the Paperwork Reduction Act Transfer and Advancement Act
circumstances. Therefore, the (PRA) (44 U.S.C. 3501 et seq.), nor does (NTTAA) (15 U.S.C. 272 note).
exemption from tolerance under 40 CFR it require any special considerations
under Executive Order 12898, entitled VIII. Congressional Review Act
180.920 for residues of titanium
dioxide, when used as an inert ‘‘Federal Actions to Address Pursuant to the Congressional Review
ingredient in pesticide formulations is Environmental Justice in Minority Act (5 U.S.C. 801 et seq.), EPA will
safe under FFDCA section 408. Populations and Low-Income submit a report containing this rule and
Populations’’ (59 FR 7629, February 16, other required information to the U.S.
V. Analytical Enforcement Methodology 1994). Senate, the U.S. House of
An analytical method is not required Since tolerances and exemptions that
Representatives, and the Comptroller
for enforcement purposes since the are established on the basis of a petition
General of the United States prior to
Agency is establishing an exemption under FFDCA section 408(d), such as
publication of the rule in the Federal
from the requirement of a tolerance the exemption in this final rule, do not
Register. This action is not a ‘‘major
without any numerical limitation. require the issuance of a proposed rule,
rule’’ as defined by 5 U.S.C. 804(2).
the requirements of the Regulatory
VI. Conclusions Flexibility Act (RFA) (5 U.S.C. 601 et List of Subjects in 40 CFR Part 180
Therefore, EPA is amending the seq.), do not apply.
This action directly regulates growers, Environmental protection,
exemption from the requirement of a
food processors, food handlers, and food Administrative practice and procedure,
tolerance in 40 CFR 180.920 for residues
of titanium dioxide (CAS Reg. No. retailers, not States or tribes, nor does Agricultural commodities, Pesticides
13463–67–7) when used as an inert this action alter the relationships or and pests, Reporting and recordkeeping
ingredient (carrier) in pesticide distribution of power and requirements.
formulations. responsibilities established by Congress Dated: July 11, 2018.
in the preemption provisions of FFDCA Michael L. Goodis,
VII. Statutory and Executive Order section 408(n)(4). As such, the Agency
Reviews Director, Registration Division, Office of
has determined that this action will not Pesticide Programs.
This action establishes an exemption have a substantial direct effect on States
from the requirement of a tolerance or tribal governments, on the Therefore, 40 CFR chapter I is
under FFDCA section 408(d) in relationship between the national amended as follows:
response to a petition submitted to the government and the States or tribal
PART 180—[AMENDED]
Agency. The Office of Management and governments, or on the distribution of
Budget (OMB) has exempted these types power and responsibilities among the ■ 1. The authority citation for part 180
of actions from review under Executive various levels of government or between continues to read as follows:
Order 12866, entitled ‘‘Regulatory the Federal Government and Indian
Planning and Review’’ (58 FR 51735, tribes. Thus, the Agency has determined Authority: 21 U.S.C. 321(q), 346a and 371.
October 4, 1993). Because this action that Executive Order 13132, entitled ■ 2. In § 180.920, revise the inert
has been exempted from review under ‘‘Federalism’’ (64 FR 43255, August 10, ingredient ‘‘Titanium dioxide (CAS Reg.
Executive Order 12866, this action is 1999) and Executive Order 13175, No. 13463–67–7)’’ in the table to read as
not subject to Executive Order 13211, entitled ‘‘Consultation and Coordination follows:
entitled ‘‘Actions Concerning with Indian Tribal Governments’’ (65 FR
Regulations That Significantly Affect 67249, November 9, 2000) do not apply § 180.920 Inert ingredients used pre-
Energy Supply, Distribution, or Use’’ (66 to this action. In addition, this action harvest; exemptions from the requirement
FR 28355, May 22, 2001); Executive does not impose any enforceable duty or of a tolerance.
Order 13045, entitled ‘‘Protection of contain any unfunded mandate as * * * * *
Inert ingredients Limits Uses
. . . . . . .
Titanium dioxide (CAS Reg. No. 13463–67–7) ............. ........................................................................................ Pigment, colorant, carrier.
. . . . . . .
sradovich on DSK3GMQ082PROD with RULES
[FR Doc. 2018–16470 Filed 7–31–18; 8:45 a.m.]
BILLING CODE 6560–50–P
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Document Created: 2018-08-01 01:22:32
Document Modified: 2018-08-01 01:22:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective August 1, 2018. Objections and requests for hearings must be received on or before October 1, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone | |
| FR Citation | 83 FR 37440 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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