82 FR 30993 - Titanium Dioxide; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 127 (July 5, 2017)
Federal Register Volume 82, Issue 127 (July 5, 2017)
| Page Range | 30993-30997 | |
| FR Document | 2017-14099 |
[Federal Register Volume 82, Number 127 (Wednesday, July 5, 2017)] [Rules and Regulations] [Pages 30993-30997] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-14099] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0252; FRL-9961-82] 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 honey when used as an inert ingredient (colorant) at a concentration of not more than 0.1% by weight in pesticide formulations intended for varroa mite control around bee hives. Bayer Healthcare, 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 July 5, 2017. Objections and requests for hearings must be received on or before September 5, 2017, 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-2016-0252, 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-2016-0252 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 [[Page 30994]] before September 5, 2017. 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-2016-0252, 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 July 20, 2016 (81 FR 47150) (FRL-9948- 45), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10888) by Technology Sciences Group Inc., on behalf of Bayer HealthCare, LLC, P.O. Box 390, Shawnee Mission, KS 66201. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of titanium dioxide (CAS Reg. No. 13463-67-7) in honey when used as an inert ingredient (colorant) at a concentration not more than 0.1% by weight in pesticide formulations intended for varroa mite control around bee hives. That document referenced a summary of the petition prepared by Technology Sciences Group Inc., 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 180.910 as requested. Exemptions under section 180.910 cover residues applied to growing crops and raw agricultural crops after harvest. Because the petitioner requested an exemption to cover residues only in honey resulting specifically from the use in hives, the Agency has determined that the broader exemption in section 180.910 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. 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 [[Page 30995]] 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 carcinogenicity is not a concern 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-size titanium dioxide. Even assuming the 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 TiO2 [titanium dioxide] were the basis for the original NIOSH designation of TiO2 [titanium dioxide] 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 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- 2016-0252. 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 (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); and when used as a UV stabilizer in pesticide formulations of napropamide at no more than 5% of the product formulation (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), [[Page 30996]] 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, an 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 in honey of titanium dioxide, when used as an inert ingredient (colorant) in pesticide formulations intended for varroa mite control around bee hives at a maximum concentration of 0.1% by weight, 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 beehives with concentrations of titanium dioxide exceeding 0.1% by weight of the formulation. 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) in pesticide formulations intended for varroa mite control around bee hives at a maximum concentration of 0.1% by weight in the pesticide formulation. 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: May 8, 2017. 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. [[Page 30997]] 0 2. Section 180.1195 is revised to read as follows: Sec. 180.1195 Titanium dioxide. (a) 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 (UV protectant) in microencapsulated formulations of the insecticide lambda cyhalothrin at no more than 3.0% by weight of the formulation and as an inert ingredient (UV stabilizer) at no more than 5% in pesticide formulations containing the active ingredient napropamide. (b) Residues of titanium dioxide (CAS Reg. No. 13463-67-7) in honey are exempted from the requirement of a tolerance, when used as an inert ingredient (colorant) in pesticide formulations intended for varroa mite control around bee hives at no more than 0.1% by weight in the pesticide formulation. [FR Doc. 2017-14099 Filed 7-3-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations 30993
consensus standards pursuant to section List of Subjects in 40 CFR Part 180 Authority: 21 U.S.C. 321(q), 346a and 371.
12(d) of the National Technology Environmental protection, ■ 2. In § 180.960, add alphabetically the
Transfer and Advancement Act Administrative practice and procedure, polymers ‘‘Oxirane, 2-methyl, polymer
(NTTAA) (15 U.S.C. 272 note). Agricultural commodities, Pesticides with oxirane, hydrogen sulfate,
XI. Congressional Review Act and pests, Reporting and recordkeeping ammonium salt; average molecular
requirements.
weight (in amu), 1800’’ and ‘‘Oxirane, 2-
Pursuant to the Congressional Review Dated: May 18, 2017. methyl, polymer with oxirane, hydrogen
Act (5 U.S.C. 801 et seq.), EPA will Donna Davis, sulfate, potassium salt; average
submit a report containing this rule and Acting Associate Director, Registration molecular weight (in amu), 2100’’ to the
other required information to the U.S. Division, Office of Pesticide Programs. table to read as follows:
Senate, the U.S. House of
Therefore, 40 CFR chapter I is
Representatives, and the Comptroller § 180.960 Polymers; exemptions from the
amended as follows:
General of the United States prior to requirement of a tolerance.
publication of the rule in the Federal PART 180—[AMENDED] * * * * *
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2). ■ 1. The authority citation for part 180
continues to read as follows:
Polymer CAS No.
* * * * * * *
Oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, ammonium salt; average molecular weight (in amu), 1800 ................. 57608–14–7
Oxirane, 2-methyl, polymer with oxirane, hydrogen sulfate, potassium salt; average molecular weight (in amu), 2100 .................. 1838191–48–2
* * * * * * *
[FR Doc. 2017–14111 Filed 7–3–17; 8:45 am] Unit I.C. of the SUPPLEMENTARY Classification System (NAICS) codes is
BILLING CODE 6560–50–P INFORMATION). not intended to be exhaustive, but rather
ADDRESSES: The docket for this action, provides a guide to help readers
identified by docket identification (ID) determine whether this document
ENVIRONMENTAL PROTECTION applies to them. Potentially affected
number EPA–HQ–OPP–2016–0252, is
AGENCY entities may include:
available at http://www.regulations.gov
• Crop production (NAICS code 111).
40 CFR Part 180 or at the Office of Pesticide Programs • Animal production (NAICS code
Regulatory Public Docket (OPP Docket) 112).
[EPA–HQ–OPP–2016–0252; FRL–9961–82] in the Environmental Protection Agency • Food manufacturing (NAICS code
Docket Center (EPA/DC), West William 311).
Titanium Dioxide; Exemption From the
Requirement of a Tolerance
Jefferson Clinton Bldg., Rm. 3334, 1301 • Pesticide manufacturing (NAICS
Constitution Ave. NW., Washington, DC code 32532).
AGENCY: Environmental Protection 20460–0001. The Public Reading Room
Agency (EPA). is open from 8:30 a.m. to 4:30 p.m., B. How can I get electronic access to
ACTION: Final rule. Monday through Friday, excluding legal other related information?
holidays. The telephone number for the You may access a frequently updated
SUMMARY: This regulation establishes an Public Reading Room is (202) 566–1744, electronic version of 40 CFR part 180
exemption from the requirement of a and the telephone number for the OPP through the Government Printing
tolerance for residues of titanium Docket is (703) 305–5805. Please review Office’s e-CFR site at http://
dioxide (CAS Reg. No. 13463–67–7) in the visitor instructions and additional www.ecfr.gov/cgi-bin/text-
honey when used as an inert ingredient information about the docket available idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
(colorant) at a concentration of not more at http://www.epa.gov/dockets. 40tab_02.tpl.
than 0.1% by weight in pesticide
FOR FURTHER INFORMATION CONTACT: C. How can I file an objection or hearing
formulations intended for varroa mite
Michael Goodis, Registration Division request?
control around bee hives. Bayer
(7505P), Office of Pesticide Programs,
Healthcare, LLC submitted a petition to Under FFDCA section 408(g), 21
Environmental Protection Agency, 1200
EPA under the Federal Food, Drug, and U.S.C. 346a, any person may file an
Pennsylvania Ave. NW., Washington,
Cosmetic Act (FFDCA), requesting objection to any aspect of this regulation
DC 20460–0001; main telephone
establishment of an exemption from the and may also request a hearing on those
number: (703) 305–7090; email address:
requirement of a tolerance. This objections. You must file your objection
RDFRNotices@epa.gov.
regulation eliminates the need to or request a hearing on this regulation
establish a maximum permissible level SUPPLEMENTARY INFORMATION:
in accordance with the instructions
for residues of titanium dioxide I. General Information provided in 40 CFR part 178. To ensure
sradovich on DSK3GMQ082PROD with RULES
resulting from this use. proper receipt by EPA, you must
DATES: This regulation is effective July
A. Does this action apply to me? identify docket ID number EPA–HQ–
5, 2017. Objections and requests for You may be potentially affected by OPP–2016–0252 in the subject line on
hearings must be received on or before this action if you are an agricultural the first page of your submission. All
September 5, 2017, and must be filed in producer, food manufacturer, or objections and requests for a hearing
accordance with the instructions pesticide manufacturer. The following must be in writing, and must be
provided in 40 CFR part 178 (see also list of North American Industrial received by the Hearing Clerk on or
VerDate Sep<11>2014 16:11 Jul 03, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\FR\FM\05JYR1.SGM 05JYR1](https://thefederalregister.org/doc/82_FR_31120/page/1.svg)
![Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations 30995
titanium dioxide is due to deposition of Titanium Dioxide’’ concludes that ‘‘[t]he Because the effects seen in inhalation
the inhaled particles. Although these lung tumors observed in rats after studies occurred at doses above the
studies suggest equivocal evidence of exposure to 250 mg/m3 of fine TiO2 levels at which pesticide exposure is
carcinogenicity due to prolonged [titanium dioxide] were the basis for the expected and for particle sizes that are
exposure to titanium dioxide particles, original NIOSH designation of TiO2 different from the size of titanium
EPA has determined that [titanium dioxide] as a ‘‘potential dioxide used in pesticide formulations,
carcinogenicity is not a concern from occupational carcinogen.’’ However, the Agency has concluded that those
exposure to titanium dioxide when used because this dose is considered to be risks are not relevant for assessing risk
as an inert ingredient in pesticide significantly higher than currently from pesticide exposure and therefore,
formulations based on the following: accepted inhalation toxicology practice, did not identify an endpoint for
First, tumors were only observed in two NIOSH concluded that the response at assessing inhalation exposure risk.
of the available studies and only in one such a high dose should not be used in C. Exposure Assessment
species. In one study, those tumors were making its hazard identification.’’
only observed in rats continually NIOSH concluded that the data is 1. Dietary exposure from food and
exposed to ultrafine particles of insufficient to classify fine titanium feed uses. In evaluating dietary
titanium dioxide. In the second study, dioxide as a potential occupational exposure to titanium dioxide, EPA
tumors were only observed from carcinogen. considered exposure under the
exposure to fine particles of titanium Because the predominant form of proposed exemption from the
dioxide at extremely high requirement of a tolerance and all other
titanium dioxide used commercially,
concentrations (250 mg/m3), in which existing exemptions from the
and the form used as an inert ingredient
the animals experienced overloading of requirement of a tolerance for residues
in pesticide formulations is pigment
lung clearance, with chronic of titanium dioxide. EPA assessed
grade, which is not in the ultrafine or
inflammation resulting in lung tumors. dietary exposures from titanium dioxide
nanoscale particle size range but rather
All but one of the tumors in the second in food as follows:
in the fine particle size range, EPA Residues of titanium dioxide are
study were subsequently reclassified as concludes that carcinogenicity is not a
non-neoplastic or non-cancerous in exempt from the requirement of a
concern from exposure to titanium tolerance when used as an inert
nature. No tumors were observed in dioxide resulting from its use as an inert
studies involving mice. ingredient in many different
ingredient in pesticides. circumstances: When used in pesticide
The titanium dioxide used in
pesticide formulations is considered Specific information on the studies formulations applied to growing crops
pigmentary grade, not ultrafine or received and the nature of the adverse (40 CFR 180.920); when used in
nanoscale. Consequently, the tumors effects caused by titanium dioxide as pesticide formulations applied to
observed from exposure to ultrafine well as the no-observed-adverse-effect animals (40 CFR 180.930); when used as
particles of titanium dioxide are not level (NOAEL) and the lowest-observed- a ultraviolet (UV) protectant in
relevant for assessing exposure to the adverse-effect level (LOAEL) from the microencapsulated formulations of the
type of titanium dioxide used in toxicity studies are discussed in the insecticide lambda-cyhalothrin at no
pesticide formulations. Following the final rule published in the Federal more than 3.0% by weight (40 CFR
reclassification of the tumors observed Register of July 27, 2012 (77 FR 44151) 180.1195); and when used as a UV
in the second inhalation study, EPA (FRL–9354–6) and in the Agency’s risk stabilizer in pesticide formulations of
does not consider these effects to be assessment which can be found at napropamide at no more than 5% of the
strong evidence of carcinogenicity from http://www.regulations.gov in document product formulation (40 CFR 180.1195).
exposure to fine-particle-size titanium Titanium Dioxide; Human Health Risk Titanium dioxide is also approved for
dioxide. Even assuming the study Assessment and Ecological Effects use as a colorant in food (21 CFR
indicates the potential for Assessment to Support Proposed 73.575); in drugs (21 CFR 73.1575); and
carcinogenicity, EPA does not expect Exemption from the Requirement of a in cosmetics (21 CFR 73.2575 and
any reasonably foreseeable uses of Tolerance When used as an Inert 73.3126).
titanium dioxide in pesticide Ingredient in Pesticide Formulations in Although dietary exposure may be
formulations that might result in docket ID number EPA–HQ–OPP–2016– expected from use of titanium dioxide
residential exposures to approach the 0252. in pesticide formulations applied to bee
levels of exposure necessary to elicit the B. Toxicological Points of Departure/ hives and on other crops (as well as
effects seen in the available inhalation Levels of Concern from other non-pesticidal sources), a
study. The levels at which effects were quantitative exposure assessment for
observed in that study greatly exceed Because the available data indicate no titanium dioxide was not conducted
any reasonable dose for toxicity testing toxicity via the oral route of exposure, because no endpoint of concern was
and any likely residential exposure no endpoint of concern for that route of identified in the database.
levels. Moreover, when used as an inert exposure has been identified in the 2. Dietary exposure from drinking
in pesticide formulations, titanium available database. This conclusion is in water. Since a hazard endpoint of
dioxide will be bound to other agreement with the conclusion of the concern was not identified for the acute
materials, which means there will not World Health Organization (WHO) and chronic dietary assessment, a
be significant inhalation exposure to Committee on Food Coloring Materials quantitative dietary exposure risk
titanium dioxide particles themselves. that no Acceptable Daily Intake (ADI) assessment for drinking water was not
This position is consistent with the need be set for the use of titanium conducted, although exposures from
sradovich on DSK3GMQ082PROD with RULES
National Institute of Occupational dioxide based on the range of acute, drinking water may be expected from
Health and Safety’s (NIOSH) recent sub-acute, and chronic toxicity assays, use on food crops.
assessment that ultrafine but not fine all showing low mammalian toxicity. 3. From non-dietary exposure. The
titanium dioxide would be considered a Similarly, no significant toxicity of term ‘‘residential exposure’’ is used in
‘‘potential occupational carcinogen’’. titanium dioxide is expected via the this document to refer to non-
The NIOSH Current Intelligence dermal route of exposure, so no occupational, non-dietary exposure
Bulletin ‘‘Occupational Exposure to endpoint was identified. (e.g., textiles (clothing and diapers),
VerDate Sep<11>2014 16:11 Jul 03, 2017 Jkt 241001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\FR\FM\05JYR1.SGM 05JYR1](https://thefederalregister.org/doc/82_FR_31120/page/3.svg)
![30996 Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations
carpets, swimming pools, and hard dioxide that may be used in pesticide This action directly regulates growers,
surface disinfection on walls, floors, formulations, an analytical enforcement food processors, food handlers, and food
tables). methodology is not necessary for this retailers, not States or tribes, nor does
Titanium dioxide may be used in non- exemption from the requirement of this action alter the relationships or
pesticide products such as paints, tolerance. The limitation will be distribution of power and
printing inks, paper and plastic enforced through the pesticide responsibilities established by Congress
products around the home. Additionally registration process under the Federal in the preemption provisions of FFDCA
titanium dioxide may be used as an Insecticide, Fungicide, and Rodenticide section 408(n)(4). As such, the Agency
inert ingredient in pesticides that Act (FIFRA), 7 U.S.C. 136 et seq. EPA has determined that this action will not
include residential uses, however based will not register any pesticide for sale or have a substantial direct effect on States
on the discussion in Unit IV.B., a distribution for use in beehives with or tribal governments, on the
quantitative residential exposure concentrations of titanium dioxide relationship between the national
assessment for titanium dioxide was not exceeding 0.1% by weight of the government and the States or tribal
conducted. formulation. governments, or on the distribution of
4. Cumulative effects from substances power and responsibilities among the
VI. Conclusions
with a common mechanism of toxicity. various levels of government or between
Section 408(b)(2)(D)(v) of FFDCA Therefore, an exemption from the the Federal Government and Indian
requires that, when considering whether requirement of a tolerance is established tribes. Thus, the Agency has determined
to establish, modify, or revoke a under 40 CFR 180.1195 for titanium that Executive Order 13132, entitled
tolerance, the Agency consider dioxide (CAS Reg. No. 13463–67–7) ‘‘Federalism’’ (64 FR 43255, August 10,
‘‘available information’’ concerning the when used as an inert ingredient 1999) and Executive Order 13175,
cumulative effects of a particular (colorant) in pesticide formulations entitled ‘‘Consultation and Coordination
pesticide’s residues and ‘‘other intended for varroa mite control around with Indian Tribal Governments’’ (65 FR
substances that have a common bee hives at a maximum concentration 67249, November 9, 2000) do not apply
mechanism of toxicity.’’ of 0.1% by weight in the pesticide to this action. In addition, this action
Because titanium dioxide does not formulation. does not impose any enforceable duty or
have a toxic mode of action or a VII. Statutory and Executive Order contain any unfunded mandate as
mechanism of toxicity, this provision Reviews described under Title II of the Unfunded
does not apply. Mandates Reform Act (UMRA) (2 U.S.C.
This action establishes an exemption
D. Safety Factor for Infants and from the requirement of a tolerance 1501 et seq.).
Children under FFDCA section 408(d) in This action does not involve any
response to a petition submitted to the technical standards that would require
Due to titanium dioxide’s low Agency consideration of voluntary
potential hazard and the lack of a Agency. The Office of Management and
Budget (OMB) has exempted these types consensus standards pursuant to section
hazard endpoint, it was determined that 12(d) of the National Technology
a quantitative risk assessment using of actions from review under Executive
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
safety factors applied to a point of (NTTAA) (15 U.S.C. 272 note).
departure protective of an identified Planning and Review’’ (58 FR 51735,
hazard endpoint is not appropriate for October 4, 1993). Because this action VIII. Congressional Review Act
titanium dioxide. For the same reasons has been exempted from review under
Pursuant to the Congressional Review
that a quantitative risk assessment based Executive Order 12866, this action is
Act (5 U.S.C. 801 et seq.), EPA will
on a safety factor approach is not not subject to Executive Order 13211,
submit a report containing this rule and
appropriate for titanium dioxide, an entitled ‘‘Actions Concerning
other required information to the U.S.
FQPA SF is not needed to protect the Regulations That Significantly Affect
Senate, the U.S. House of
safety of infants and children. Energy Supply, Distribution, or Use’’ (66
Representatives, and the Comptroller
FR 28355, May 22, 2001) or Executive
E. Aggregate Risks and Determination of General of the United States prior to
Order 13045, entitled ‘‘Protection of
Safety publication of the rule in the Federal
Children from Environmental Health
Register. This action is not a ‘‘major
Taking into consideration all available Risks and Safety Risks’’ (62 FR 19885,
rule’’ as defined by 5 U.S.C. 804(2).
information on titanium dioxide, EPA April 23, 1997). This action does not
has determined that there is a contain any information collections List of Subjects in 40 CFR Part 180
reasonable certainty that no harm to any subject to OMB approval under the Environmental protection,
population subgroup will result from Paperwork Reduction Act (PRA) (44 Administrative practice and procedure,
aggregate exposure to titanium dioxide U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
under reasonable foreseeable any special considerations under and pests, Reporting and recordkeeping
circumstances. Therefore, the Executive Order 12898, entitled requirements.
establishment of an exemption from ‘‘Federal Actions to Address
tolerance under 40 CFR 180.1195 for Environmental Justice in Minority Dated: May 8, 2017.
residues in honey of titanium dioxide, Populations and Low-Income Michael L. Goodis,
when used as an inert ingredient Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
(colorant) in pesticide formulations 1994). Pesticide Programs.
intended for varroa mite control around Since tolerances and exemptions that Therefore, 40 CFR chapter I is
sradovich on DSK3GMQ082PROD with RULES
bee hives at a maximum concentration are established on the basis of a petition amended as follows:
of 0.1% by weight, is safe under FFDCA under FFDCA section 408(d), such as
section 408. the exemption in this final rule, do not PART 180—[AMENDED]
require the issuance of a proposed rule,
V. Analytical Enforcement Methodology the requirements of the Regulatory ■ 1. The authority citation for part 180
Although EPA is establishing a Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
limitation on the amount of titanium seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
VerDate Sep<11>2014 16:11 Jul 03, 2017 Jkt 241001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\FR\FM\05JYR1.SGM 05JYR1](https://thefederalregister.org/doc/82_FR_31120/page/4.svg)
![Federal Register / Vol. 82, No. 127 / Wednesday, July 5, 2017 / Rules and Regulations 30997
■ 2. Section 180.1195 is revised to read ACTION: Final rule. provide common carrier service over the
as follows: line for a minimum of two years and
SUMMARY: The Surface Transportation may not resell the line (except to the
§ 180.1195 Titanium dioxide. Board (Board or STB) adopts changes to carrier from which the line was
(a) Titanium dioxide (CAS Reg. No. its rules pertaining to Offers of Financial purchased) for five years after the
13463–67–7) is exempted from the Assistance to improve the process and purchase. 49 U.S.C. 10904(f)(4)(A); 49
requirement of a tolerance for residues protect it against abuse. CFR 1152.27(i)(2).
in or on growing crops, when used as an DATES: This rule is effective on July 29, On May 26, 2015, Norfolk Southern
inert ingredient (UV protectant) in 2017. Railway Company (NSR) filed a petition
microencapsulated formulations of the ADDRESSES: Information or questions to institute a rulemaking proceeding to
insecticide lambda cyhalothrin at no regarding this final rule should address abuses of Board processes. In
more than 3.0% by weight of the reference Docket No. EP 729 and be in particular, NSR sought to have the
formulation and as an inert ingredient writing addressed to: Chief, Section of Board establish new rules regarding the
(UV stabilizer) at no more than 5% in Administration, Office of Proceedings, OFA process. NSR proposed that the
pesticide formulations containing the Surface Transportation Board, 395 E Board establish new rules creating: A
active ingredient napropamide. Street SW., Washington, DC 20423– pre-approval process for filings
(b) Residues of titanium dioxide (CAS 0001. submitted by parties deemed abusive
Reg. No. 13463–67–7) in honey are filers; financial responsibility
exempted from the requirement of a FOR FURTHER INFORMATION CONTACT:
Jonathon Binet, (202) 245–0368. presumptions; and additional financial
tolerance, when used as an inert responsibility certifications. In a
ingredient (colorant) in pesticide Assistance for the hearing impaired is
available through the Federal decision served on September 23, 2015,
formulations intended for varroa mite the Board denied NSR’s petition, stating
control around bee hives at no more Information Relay Service (FIRS) at
that the Board would instead seek to
than 0.1% by weight in the pesticide (800) 877–8339.
address the concerns raised in the
formulation. SUPPLEMENTARY INFORMATION: In the ICC
petition through increased enforcement
[FR Doc. 2017–14099 Filed 7–3–17; 8:45 am]
Termination Act of 1995, Public Law of existing rules and by instituting an
104–88, 109 Stat. 803 (1995) (ICCTA), Advance Notice of Proposed
BILLING CODE 6560–50–P
Congress revised the process for filing Rulemaking (ANPRM) to consider
Offers of Financial Assistance (OFAs) possible changes to the OFA process.
ENVIRONMENTAL PROTECTION for continued rail service, codified at 49 Pet. of Norfolk S. Ry. to Institute a
AGENCY U.S.C. 10904. Under the OFA process, Rulemaking Proceeding to Address
as implemented in the Board’s Abuses of Board Processes (NSR
40 CFR Part 441 regulations at 49 CFR 1152.27, Petition), EP 727, slip op. at 4 (STB
financially responsible parties may offer served Sept. 23, 2015).
[EPA–HQ–OW–2014–0693; FRL–9957–10–
OW]
to temporarily subsidize continued rail The Board issued an ANPRM on
service over a line on which a carrier December 14, 2015. In that ANPRM, the
RIN 2040–AF26 seeks to abandon or discontinue service, Board explained that its experiences
or offer to purchase a line and provide have shown that there are areas where
Effluent Limitations Guidelines and continued rail service on a line that a
Standards for the Dental Category clarifications and revisions could
carrier seeks to abandon. enhance the OFA process and protect it
Correction Upon request, the abandoning or against abuse. Accordingly, the Board
discontinuing carrier must provide requested public comments on whether
In rule document C1–2017–12338, certain information required under 49
beginning on page 28777, in the issue of and how to improve any aspect of the
U.S.C. 10904(b) and 49 CFR 1152.27(a) OFA process, including enhancing its
Monday, June 26, 2017 make the to a party that is considering making an
following corrections: transparency and ensuring that it is
OFA. A party that decides to make an invoked only to further its statutory
§ 441.30 Pretreatment standards for OFA (the offeror) must submit the OFA purpose of preserving lines for
existing sources (PSES) [Corrected] to the Board, including the information continued rail service. The Board also
1. On page 28777, in the second specified in 49 CFR 1152.27(c)(1)(ii). If specifically requested comments on:
column, ‘‘§ 441.20 General definitions the Board determines that the OFA is Ensuring offerors are financially
[Corrected]’’ should read ‘‘§ 441.30 made by a ‘‘financially responsible’’ responsible; addressing issues related to
Pretreatment standards for existing person, the abandonment or the continuation of rail service; and
sources (PSES) [Corrected]’’. discontinuance authority is postponed clarifying the identities of potential
2. On page 28777, in the second to allow the parties to negotiate a sale offerors.
column, ‘‘the 18th line of paragraph or subsidy arrangement. 49 U.S.C. On September 30, 2016, the Board
(iii)’’ should read ‘‘in the 9th line of 10904(d)(2); 49 CFR 1152.27(e). If the issued a Notice of Proposed Rulemaking
paragraph (iii)’’. parties cannot agree to the terms of a (NPRM), addressing the comments on
[FR Doc. C2–2017–12338 Filed 7–3–17; 8:45 am] sale or subsidy, they may request that the ANPRM and proposing specific
BILLING CODE 1301–00–D
the Board set binding terms under 49 amendments to its regulations at 49 CFR
U.S.C. 10904(f)(1). After the Board has 1152.27 based on those comments. The
set the terms, the offeror can accept the Board proposed four amendments
terms or withdraw the OFA. When the intended to clarify the requirement that
SURFACE TRANSPORTATION BOARD
sradovich on DSK3GMQ082PROD with RULES
operation of a line is subsidized to OFA offerors be financially responsible
49 CFR Part 1152 prevent abandonment or discontinuance and to require offerors to provide
of service, it may only be subsidized for additional evidence of financial
[Docket No. EP 729] up to one year, unless the parties responsibility to the Board; one
mutually agree otherwise. 49 U.S.C. amendment intended to require that
Offers of Financial Assistance
10904(f)(4)(b). When a line is purchased potential offerors demonstrate the
AGENCY: Surface Transportation Board. pursuant to an OFA, the buyer must continued need for rail service over the
VerDate Sep<11>2014 16:11 Jul 03, 2017 Jkt 241001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\FR\FM\05JYR1.SGM 05JYR1](https://thefederalregister.org/doc/82_FR_31120/page/5.svg)
Document Created: 2017-07-04 02:00:58
Document Modified: 2017-07-04 02:00:58
| 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 July 5, 2017. Objections and requests for hearings must be received on or before September 5, 2017, 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 | 82 FR 30993 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR