83 FR 8616 - Titanium Dioxide; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 40 (February 28, 2018)
Federal Register Volume 83, Issue 40 (February 28, 2018)
| Page Range | 8616-8619 | |
| FR Document | 2018-04108 |
[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)] [Rules and Regulations] [Pages 8616-8619] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04108] [[Page 8616]] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0257; FRL-9972-63] Titanium Dioxide; 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 titanium dioxide (CAS Reg. No. 13463-67- 7) in pre-harvest crops when used as an inert ingredient (colorant) at a concentration of not more than 45% in foliar applications of pesticide formulations containing anthraquinone. Landis International, Inc., on behalf of Arkion Life Sciences, LLC 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 February 28, 2018. Objections and requests for hearings must be received on or before April 30, 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-2017-0257, 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-2017-0257 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 April 30, 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-2017-0257, 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 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 September 15, 2017 (82 FR 43352) (FRL- 9965-43), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN- 11010) by Landis International, Inc., on behalf of Arkion Life Sciences, LLC., 551 Mews Drive, Suite J, New Castle DE 19720. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of titanium dioxide (CAS Reg. No. 13463-67-7) in pre-harvest crops when used as an inert ingredient (colorant) at a concentration not more than 45% by weight in pesticide formulations containing anthraquinone. That document referenced a summary of the petition prepared by Landis International Inc., on behalf of Arkion Life Sciences, LLC, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA is establishing an exemption from the requirement of a tolerance in 40 CFR 180.1195, instead of 40 CFR 180.920 as requested. Exemptions under section 180.920 cover residues applied to growing crops. Because the petitioner requested an exemption to cover residues only in pre-harvest crops with foliar pesticide applications containing anthraquinone, the Agency has determined that the broader exemption in section 180.920 is not appropriate. For ease of reference, the Agency is establishing this exemption in section 180.1195, which contains other limited exemptions for residues of titanium dioxide. [[Page 8617]] 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 fine-particle-sized titanium dioxide. Even assuming this study indicates the potential for carcinogenicity, EPA does not expect any reasonably foreseeable uses of titanium dioxide in pesticide formulations that might result in residential exposures to 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 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, which means there will not be 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. [[Page 8618]] 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 pesticides. 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- 2017-0257. 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 Ultraviolet (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); and when used in pesticide placed at entrance to bee hives intended to control varroa mites in hive at a maximum of 0.1% weight/weight (wt/wt) (40 CFR 180.1195). Titanium dioxide is also approved for use as a colorant in food (21 CFR 73.575); in drugs (21 CFR 73.1575); and in cosmetics (21 CFR 73.2575 and 73.3126). 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. 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, a Food Quality Protection Act Safety Factor (FQPA SF) is not needed to protect the safety of infants and children. 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 establishment of an exemption from tolerance under 40 CFR 180.1195 for residues pre-harvest crops of titanium dioxide, when used as an inert ingredient (colorant) up to 45% in foliar pesticide formulations containing anthraquinone, is safe under FFDCA section 408. V. Analytical Enforcement Methodology Although EPA is establishing a limitation on the amount of titanium dioxide that may be used in pesticide formulations, an analytical enforcement methodology is not necessary for this exemption from the requirement of tolerance. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution for use in pre- harvest crops [[Page 8619]] with concentrations of titanium dioxide exceeding 45% by weight of the formulations containing anthraquinone. VI. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.1195 for titanium dioxide (CAS Reg. No. 13463-67-7) when used as an inert ingredient (colorant) up to 45% in foliar pesticide formulations containing anthraquinone. 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) or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). 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: February 15, 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. Section 180.1195 is amended by adding paragraph (c) to read as follows: Sec. 180.1195 Titanium dioxide. * * * * * (c) Titanium dioxide (CAS Reg. No. 13463-67-7) is exempted from the requirement of a tolerance for residues in or on growing crops, when used as an inert ingredient (colorant) in foliar applications at no more than 45% of the formulations containing anthraquinone. [FR Doc. 2018-04108 Filed 2-27-18; 8:45 am] BILLING CODE 6560-50-P
![8616 Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Rules and Regulations
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
AGENCY www.regulations.gov. Follow the online
I. General Information
instructions for submitting comments.
40 CFR Part 180 A. Does this action apply to me? Do not submit electronically any
[EPA–HQ–OPP–2017–0257; FRL–9972–63] You may be potentially affected by information you consider to be CBI or
this action if you are an agricultural other information whose disclosure is
Titanium Dioxide; Exemption From the producer, food manufacturer, or restricted by statute.
Requirement of a Tolerance pesticide manufacturer. The following • Mail: OPP Docket, Environmental
list of North American Industrial Protection Agency Docket Center (EPA/
AGENCY: Environmental Protection DC), (28221T), 1200 Pennsylvania Ave.
Agency (EPA). Classification System (NAICS) codes is
not intended to be exhaustive, but rather NW, Washington, DC 20460–0001.
ACTION: Final rule.
provides a guide to help readers • Hand Delivery: To make special
determine whether this document arrangements for hand delivery or
SUMMARY: This regulation establishes an
applies to them. Potentially affected delivery of boxed information, please
exemption from the requirement of a
entities may include: follow the instructions at http://
tolerance for residues of titanium
• Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
dioxide (CAS Reg. No. 13463–67–7) in
pre-harvest crops when used as an inert • Animal production (NAICS code Additional instructions on
112). commenting or visiting the docket,
ingredient (colorant) at a concentration
of not more than 45% in foliar • Food manufacturing (NAICS code along with more information about
311). dockets generally, is available at http://
applications of pesticide formulations
containing anthraquinone. Landis • Pesticide manufacturing (NAICS www.epa.gov/dockets.
International, Inc., on behalf of Arkion code 32532). II. Petition for Exemption
Life Sciences, LLC submitted a petition B. How can I get electronic access to In the Federal Register of September
to EPA under the Federal Food, Drug, other related information? 15, 2017 (82 FR 43352) (FRL–9965–43),
and Cosmetic Act (FFDCA), requesting
You may access a frequently updated EPA issued a document pursuant to
establishment of an exemption from the
electronic version of 40 CFR part 180 FFDCA section 408, 21 U.S.C. 346a,
requirement of a tolerance. This
through the Government Printing announcing the filing of a pesticide
regulation eliminates the need to
Office’s e-CFR site at http:// petition (PP IN–11010) by Landis
establish a maximum permissible level
www.ecfr.gov/cgi-bin/text-idx?&c= International, Inc., on behalf of Arkion
for residues of titanium dioxide
ecfr&tpl=/ecfrbrowse/Title40/40tab_ Life Sciences, LLC., 551 Mews Drive,
resulting from this use.
02.tpl. Suite J, New Castle DE 19720. The
DATES: This regulation is effective petition requested that 40 CFR 180.920
February 28, 2018. Objections and C. How can I file an objection or hearing be amended by establishing an
requests for hearings must be received request? exemption from the requirement of a
on or before April 30, 2018, and must Under FFDCA section 408(g), 21 tolerance for residues of titanium
be filed in accordance with the U.S.C. 346a, any person may file an dioxide (CAS Reg. No. 13463–67–7) in
instructions provided in 40 CFR part objection to any aspect of this regulation pre-harvest crops when used as an inert
178 (see also Unit I.C. of the and may also request a hearing on those ingredient (colorant) at a concentration
SUPPLEMENTARY INFORMATION). not more than 45% by weight in
objections. You must file your objection
ADDRESSES: The docket for this action, or request a hearing on this regulation pesticide formulations containing
identified by docket identification (ID) in accordance with the instructions anthraquinone. That document
number EPA–HQ–OPP–2017–0257, is provided in 40 CFR part 178. To ensure referenced a summary of the petition
available at http://www.regulations.gov proper receipt by EPA, you must prepared by Landis International Inc.,
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– on behalf of Arkion Life Sciences, LLC,
Regulatory Public Docket (OPP Docket) OPP–2017–0257 in the subject line on the petitioner, which is available in the
in the Environmental Protection Agency the first page of your submission. All docket, http://www.regulations.gov.
Docket Center (EPA/DC), West William objections and requests for a hearing There were no comments received in
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be response to the notice of filing.
Constitution Ave. NW, Washington, DC received by the Hearing Clerk on or Based upon review of the data
20460–0001. The Public Reading Room before April 30, 2018. Addresses for supporting the petition, EPA is
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections establishing an exemption from the
Monday through Friday, excluding legal and hearing requests are provided in 40 requirement of a tolerance in 40 CFR
holidays. The telephone number for the CFR 178.25(b). 180.1195, instead of 40 CFR 180.920 as
Public Reading Room is (202) 566–1744, In addition to filing an objection or requested. Exemptions under section
and the telephone number for the OPP hearing request with the Hearing Clerk 180.920 cover residues applied to
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please growing crops. Because the petitioner
the visitor instructions and additional submit a copy of the filing (excluding requested an exemption to cover
information about the docket available any Confidential Business Information residues only in pre-harvest crops with
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. foliar pesticide applications containing
FOR FURTHER INFORMATION CONTACT: Information not marked confidential anthraquinone, the Agency has
sradovich on DSK3GMQ082PROD with RULES
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be determined that the broader exemption
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior in section 180.920 is not appropriate.
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your For ease of reference, the Agency is
Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified establishing this exemption in section
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP– 180.1195, which contains other limited
(703) 305–7090; email address: 2017–0257, by one of the following exemptions for residues of titanium
RDFRNotices@epa.gov. methods: dioxide.
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![Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Rules and Regulations 8617
III. Inert Ingredient Definition occur as a result of pesticide use in exposure to fine particles of titanium
Inert ingredients are all ingredients residential settings. If EPA is able to dioxide at extremely high
that are not active ingredients as defined determine that a finite tolerance is not concentrations (250 mg/m3), in which
in 40 CFR 153.125 and include, but are necessary to ensure that there is a the animals experienced overloading of
not limited to, the following types of reasonable certainty that no harm will lung clearance, with chronic
ingredients (except when they have a result from aggregate exposure to the inflammation resulting in lung tumors.
pesticidal efficacy of their own): inert ingredient, an exemption from the All but one of the tumors in the second
Solvents such as alcohols and requirement of a tolerance may be study were subsequently reclassified as
hydrocarbons; surfactants such as established. non-neoplastic or non-cancerous in
Consistent with FFDCA section nature. No tumors were observed in
polyoxyethylene polymers and fatty
408(c)(2)(A), and the factors specified in studies involving mice.
acids; carriers such as clay and
FFDCA section 408(c)(2)(B), EPA has The titanium dioxide used in
diatomaceous earth; thickeners such as reviewed the available scientific data
carrageenan and modified cellulose; pesticide formulations is considered
and other relevant information in pigmentary grade, not ultrafine or
wetting, spreading, and dispersing support of this action. EPA has
agents; propellants in aerosol nanoscale. Consequently, the tumors
sufficient data to assess the hazards of observed from exposure to ultrafine
dispensers; microencapsulating agents; and to make a determination on
and emulsifiers. The term ‘‘inert’’ is not particles of titanium dioxide are not
aggregate exposure for titanium dioxide relevant for assessing exposure to the
intended to imply nontoxicity; the including exposure resulting from the
ingredient may or may not be type of titanium dioxide used in
exemption established by this action. pesticide formulations. Following the
chemically active. Generally, EPA has EPA’s assessment of exposures and risks
exempted inert ingredients from the reclassification of the tumors observed
associated with titanium dioxide in the second inhalation study, EPA
requirement of a tolerance based on the follows.
low toxicity of the individual inert does not consider these effects to be
ingredients. A. Toxicological Profile strong evidence of carcinogenicity from
EPA has evaluated the available exposure to fine-particle-sized titanium
IV. Aggregate Risk Assessment and dioxide. Even assuming this study
Determination of Safety toxicity data and considered their
validity, completeness, and reliability as indicates the potential for
Section 408(c)(2)(A)(i) of FFDCA well as the relationship of the results of carcinogenicity, EPA does not expect
allows EPA to establish an exemption the studies to human risk. EPA has also any reasonably foreseeable uses of
from the requirement for a tolerance (the considered available information titanium dioxide in pesticide
legal limit for a pesticide chemical concerning the variability of the formulations that might result in
residue in or on a food) only if EPA sensitivities of major identifiable residential exposures to approach the
determines that the tolerance is ‘‘safe.’’ subgroups of consumers, including levels of exposure necessary to elicit the
Section 408(b)(2)(A)(ii) of FFDCA infants and children. effects seen in the available inhalation
defines ‘‘safe’’ to mean that ‘‘there is a The available toxicity studies on study. The levels at which effects were
reasonable certainty that no harm will titanium dioxide via the oral route of observed in that study greatly exceed
result from aggregate exposure to the exposure clearly demonstrate a lack of any reasonable dose for toxicity testing
pesticide chemical residue, including toxicity. The several studies in mice, and any likely residential exposure
all anticipated dietary exposures and all rats, dogs, cats, rabbits and other species levels. Moreover, when used as an inert
other exposures for which there is of varying durations do not indicate in pesticide formulations, titanium
reliable information.’’ This includes toxicity, even at very high doses (e.g. dioxide will be bound to other
exposure through drinking water and in 50,000 ppm or 2,500 mg/kg/day dietary materials, which means there will not
residential settings, but does not include exposure for two years in rats). There be significant inhalation exposure to
occupational exposure. Section are no studies on the dermal toxicity of titanium dioxide particles themselves.
408(b)(2)(C) of FFDCA requires EPA to titanium dioxide and there is no This position is consistent with the
give special consideration to exposure expected toxicity via the dermal route of National Institute of Occupational
of infants and children to the pesticide exposure because as an insoluble solid Health and Safety’s (NIOSH) recent
chemical residue in establishing a material, titanium dioxide is not assessment that ultrafine but not fine
tolerance and to ‘‘ensure that there is a absorbed via the skin. titanium dioxide would be considered a
reasonable certainty that no harm will The available inhalation studies ‘‘potential occupational carcinogen.’’
result to infants and children from indicate that the primary toxicity of The NIOSH Current Intelligence
aggregate exposure to the pesticide titanium dioxide is due to deposition of Bulletin ‘‘Occupational Exposure to
chemical residue. . . .’’ the inhaled particles. Although these Titanium Dioxide’’ concludes that ‘‘[t]he
EPA establishes exemptions from the studies suggest equivocal evidence of lung tumors observed in rats after
requirement of a tolerance only in those carcinogenicity due to prolonged exposure to 250 mg/m3 of fine TiO2
cases where it can be clearly exposure to titanium dioxide particles, [titanium dioxide] were the basis for the
demonstrated that the risks from EPA has determined that these effects original NIOSH designation of TiO2 as a
aggregate exposure to pesticide are not relevant for assessing risk from ‘‘potential occupational carcinogen.’’
chemical residues under reasonably exposure to titanium dioxide when used However, because this dose is
foreseeable circumstances will pose no as an inert ingredient in pesticide considered to be significantly higher
appreciable risks to human health. In formulations based on the following. than currently accepted inhalation
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order to determine the risks from First, tumors were only observed in two toxicology practice, NIOSH concluded
aggregate exposure to pesticide inert of the available studies and only in one that the response at such a high dose
ingredients, the Agency considers the species. In one study, those tumors were should not be used in making its hazard
toxicity of the inert in conjunction with only observed in rats continually identification.’’ NIOSH concluded that
possible exposure to residues of the exposed to ultrafine particles of the data is insufficient to classify fine
inert ingredient through food, drinking titanium dioxide. In the second study, titanium dioxide as a potential
water, and through other exposures that tumors were only observed from occupational carcinogen.
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![Federal Register / Vol. 83, No. 40 / Wednesday, February 28, 2018 / Rules and Regulations 8619
with concentrations of titanium dioxide power and responsibilities among the FEDERAL COMMUNICATIONS
exceeding 45% by weight of the various levels of government or between COMMISSION
formulations containing anthraquinone. the Federal Government and Indian
tribes. Thus, the Agency has determined 47 CFR Part 10
VI. Conclusions
that Executive Order 13132, entitled [PS Docket Nos. 15–91, 15–94; FCC 18–
Therefore, an exemption from the ‘‘Federalism’’ (64 FR 43255, August 10, 4]
requirement of a tolerance is established 1999) and Executive Order 13175,
under 40 CFR 180.1195 for titanium entitled ‘‘Consultation and Coordination Wireless Emergency Alerts;
dioxide (CAS Reg. No. 13463–67–7) with Indian Tribal Governments’’ (65 FR Emergency Alert System
when used as an inert ingredient 67249, November 9, 2000) do not apply
(colorant) up to 45% in foliar pesticide AGENCY: Federal Communications
to this action. In addition, this action
formulations containing anthraquinone. Commission.
does not impose any enforceable duty or
ACTION: Final rule.
VII. Statutory and Executive Order contain any unfunded mandate as
Reviews described under Title II of the Unfunded SUMMARY: This document adopts
Mandates Reform Act (UMRA) (2 U.S.C. revisions to Wireless Emergency Alert
This action establishes an exemption
1501 et seq.). (WEA) rules to improve utility of WEA
from the requirement of a tolerance This action does not involve any
under FFDCA section 408(d) in as a life-saving tool. By this action, the
technical standards that would require Commission adopts rules that will
response to a petition submitted to the Agency consideration of voluntary
Agency. The Office of Management and improve the accuracy with which
consensus standards pursuant to section Participating CMS Providers transmit
Budget (OMB) has exempted these types
12(d) of the National Technology Alert Messages to the specified target
of actions from review under Executive
Transfer and Advancement Act area. This document also adopts rules to
Order 12866, entitled ‘‘Regulatory
(NTTAA) (15 U.S.C. 272 note). preserve Alert Messages on mobile
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action VIII. Congressional Review Act devices, inform consumers about WEA
has been exempted from review under capabilities at the point of sale, define
Pursuant to the Congressional Review participation in WEA, and extend the
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, compliance deadline for Spanish
submit a report containing this rule and language alerting. Through this action,
entitled ‘‘Actions Concerning other required information to the U.S.
Regulations That Significantly Affect the Commission hopes to empower state
Senate, the U.S. House of and local alert originators to utilize
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
FR 28355, May 22, 2001) or Executive WEA during emergencies.
General of the United States prior to
Order 13045, entitled ‘‘Protection of DATES: Effective dates: The amendments
publication of the rule in the Federal
Children from Environmental Health to §§ 10.10 and 10.210 are effective
Register. This action is not a ‘‘major
Risks and Safety Risks’’ (62 FR 19885, April 30, 2018. The amendments to
rule’’ as defined by 5 U.S.C. 804(2).
April 23, 1997). This action does not §§ 10.450 and 10.500 are effective
contain any information collections List of Subjects in 40 CFR Part 180 November 30, 2019. The amendment to
subject to OMB approval under the Environmental protection, § 10.240 contains new or modified
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, information collection requirements and
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides will not be effective until those
any special considerations under and pests, Reporting and recordkeeping information collection requirements are
Executive Order 12898, entitled requirements. approved by the Office of Management
‘‘Federal Actions to Address and Budget. The Federal
Dated: February 15, 2018. Communications Commission will
Environmental Justice in Minority
Populations and Low-Income Michael L. Goodis, publish a document in the Federal
Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of Register announcing the effective date
1994). Pesticide Programs. for the section.
Since tolerances and exemptions that Therefore, 40 CFR chapter I is Compliance dates: Participating CMS
are established on the basis of a petition amended as follows: Providers must comply with the new
under FFDCA section 408(d), such as point of sale disclosure rules by
PART 180—[AMENDED] November 30, 2019, or as specified by
the exemption in this final rule, do not
require the issuance of a proposed rule, ■ 1. The authority citation for part 180 publication in the Federal Register of a
the requirements of the Regulatory continues to read as follows: document announcing approval by the
Flexibility Act (RFA) (5 U.S.C. 601 et Office of Management and Budget
Authority: 21 U.S.C. 321(q), 346a and 371. (OMB) and the relevant effective date,
seq.), do not apply.
This action directly regulates growers, ■ 2. Section 180.1195 is amended by whichever is later. CMS Providers are
food processors, food handlers, and food adding paragraph (c) to read as follows: required to update their WEA election
retailers, not States or tribes, nor does status within June 28, 2018 of a
§ 180.1195 Titanium dioxide. document announcing approval by the
this action alter the relationships or
distribution of power and * * * * * Office of Management and Budget of the
responsibilities established by Congress (c) Titanium dioxide (CAS Reg. No. modified information collection
in the preemption provisions of FFDCA 13463–67–7) is exempted from the requirements.
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section 408(n)(4). As such, the Agency requirement of a tolerance for residues Applicability date: The requirement to
has determined that this action will not in or on growing crops, when used as an support Spanish language Alert
have a substantial direct effect on States inert ingredient (colorant) in foliar Messages in § 10.480 is applicable
or tribal governments, on the applications at no more than 45% of the beginning May 1, 2019.
relationship between the national formulations containing anthraquinone. FOR FURTHER INFORMATION CONTACT:
government and the States or tribal [FR Doc. 2018–04108 Filed 2–27–18; 8:45 am] James Wiley, Attorney Advisor,
governments, or on the distribution of BILLING CODE 6560–50–P Cybersecurity and Communications
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Document Created: 2018-02-28 03:19:39
Document Modified: 2018-02-28 03:19:39
| 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 February 28, 2018. Objections and requests for hearings must be received on or before April 30, 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 8616 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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