Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 44151 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

B. Submission to Congress and the 

Comptroller General 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

C. Petitions for Judicial Review 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by September 25, 2012. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. Parties with 

objections to this direct final rule are 

encouraged to file a comment in 

response to the parallel notice of 

proposed rulemaking for this action 

published in the proposed rules section 

of today’s Federal Register, rather than 

file an immediate petition for judicial 

review of this direct final rule, so that 

EPA can withdraw this direct final rule 

and address the comment in the 

proposed rulemaking. 

This action to remove four internal 

administrative requirements from the 

regulation for the control of motor 

vehicle emissions in the Northern 

Virginia Area may not be challenged 

later in proceedings to enforce its 

requirements. (See section 307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference. 

Dated: July 10, 2012. 

W.C. Early, 

Acting Regional Administrator, Region III. 

Therefore, 40 CFR part 52 is amended 

as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for 40 CFR 

part 52 continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

§ 52.2420 [Amended] 

■ 2. In § 52.2420, the table in paragraph 

(c) is amended by removing the entries 

for Sections ‘‘5–91–40’’, ‘‘5–91–60’’, ‘‘5– 

91–80’’, and ‘‘5–91–110’’ from the table. 

[FR Doc. 2012–18104 Filed 7–26–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0829; FRL–9354–6] 

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) 

when used as an inert ingredient 

(Ultraviolet-stabilizer) (UV), at no more 

than 5% in pesticide formulations 

containing the active ingredient 

napropamide, used in or on growing 

crops. United Phosphorus, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an amendment to 

an existing requirement of a tolerance. 

This regulation eliminates the need to 

establish a maximum permissible level 

for residues of titanium dioxide. 

DATES: This regulation is effective July 

27, 2012. Objections and requests for 

hearings must be received on or before 

September 25, 2012, 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–2011–0829, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: 

David Lieu, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0079; email address: 

lieu.david@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 


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44152 Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I 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:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&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–2011–0829 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 September 25, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0829, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statue. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

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 November 

9, 2011 (76 FR 69692) (FRL–9325–1), 

EPA issued a notice pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

1E7918) by United Phosphorus, Inc., 

630 Freedom Business Center, Suite 

402, King of Prussia, PA 19406. The 

petition requested that 40 CFR 180.1195 

be amended by modifying an exemption 

from the requirement of a tolerance for 

residues of titanium dioxide (CAS Reg. 

No. 13463–67–7) when used as an inert 

ingredient, UV-stabilizer, at no more 

than 5% in pesticide formulations 

containing the active ingredient 

napropamide. That notice referenced a 

summary of the petition prepared by 

United Phosphorus, 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. 

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 


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Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 44153 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by titanium dioxide as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

A substantial proportion of the 

toxicity data provided in this unit has 

been taken from comprehensive reviews 

and publications from The International 

Agency for Research on Cancer (IARC), 

World Health Organization (WHO) and 

National Cancer Institute (NCI). The 

titanium dioxide acute toxicity studies 

show low toxicity near limit doses. 

Titanium dioxide is also not a skin 

sensitizer. A 28-day lung instillation 

studies demonstrated slight fibrogenic 

effects comparable to that of a nuisance 

dust. A 90-day lung instillation study 

showed statistically significant signs of 

inflammation immediately after 

exposure but they were absent after 1- 

month. Many subchronic and chronic 

oral toxicity studies were performed on 

different species including rats, mice, 

dogs, cats, rabbits and guinea pigs. The 

doses ranged up to 100,000 parts per 

million (ppm) (5,000 milligrams/ 

kilograms/day (mg/kg/day)) with study 

durations up to 2 years. None of these 

studies showed mortality or adverse 

toxicological effects caused by titanium 

dioxide. No reproductive or 

developmental studies were available 

for review in the toxicity database. 

Mutagenicity studies including sister 

chromatid exchange assays, in vitro 

micronucleus assays, comet assays, 

reverse mutation tests and chromosome 

aberration test produced mixed results 

but overall these tests showed that 

titanium dioxide is not mutagenic. 

Titanium dioxide is not carcinogenic via 

the oral, intraperitoneal or subcutaneous 

routes of exposure in rats or mice; 

however, there is concern via the 

inhalation route. In inhalation studies, 

tumors present in the lungs are thought 

to have been a localized fibrogenic effect 

caused by overloading of the lungs with 

high concentrations of titanium dioxide 

particles over a prolonged period of 

time. The concentrations used in these 

studies are near limit dose levels. Actual 

environmentally anticipated exposures 

of titanium dioxide based on the use 

patterns of products that would contain 

titanium dioxide are orders of 

magnitude less than that allowed by the 

Occupational Safety and Health 

Administration’s (OSHA) Permissible 

Exposure Limit (PEL). Specific 

information on the studies received and 

the nature of the adverse effects caused 

by titanium dioxide can be found at 

http://www.regulations.gov in the 

document ‘‘Titanium Dioxide (TiO2). 

Risk Assessment to Support Proposed 

Amendment to Exemption from the 

Requirement of a Tolerance When used 

as an Inert Ingredient in Pesticide 

Formulations under 40 CFR 180.1195,’’ 

in docket ID number EPA–HQ–OPP– 

2011–0829. 

B. Toxicological Points of Departure/ 

Levels of Concern 

The available toxicity studies on 

titanium dioxide via oral route of 

exposure clearly demonstrate lack of 

toxicity. The several studies in mice, 

rats, dogs, cats, rabbits and other species 

of varying durations do not indicate 

toxicity at very high doses (e.g., 50,000 

ppm or 2,500 mg/kg/day dietary 

exposure for 2 years in rats). No end 

point of concern via oral route of 

exposure has been identified in the 

available database. Therefore, dietary 

exposure was not estimated. This 

conclusion is in agreement with the 

conclusion of the 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. The available inhalation 

studies indicate that the primary 

toxicity of titanium dioxide is due to 

deposition of the inhaled particles and 

also suggest equivocal evidence of 

carcinogenicity due to prolonged 

exposure to titanium dioxide particles. 

No direct exposure to titanium dioxide 

particles is expected in pesticide 

napropamide formulations (less than 

5% in formulations). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses and drinking water. In 

evaluating dietary exposure to titanium 

dioxide, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

titanium dioxide in food as follows: 

An exposure assessment for titanium 

dioxide was not conducted because no 

endpoint of concern was identified in 

the database. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). Based on the use pattern 

provided by the registrant and use 

limitations/restrictions there are no 

residential uses and thus no residential 

exposures are expected. 

3. 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.’’ 

EPA has not found titanium dioxide 

to share a common mechanism of 

toxicity with any other substances, and 

titanium dioxide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that titanium dioxide does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (FQPA) 

Safety Factor (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

There were no significant hazards 

identified in the available data at levels 

at or below the limit dose of 1,000 mg/ 

kg/day. Thus, due to its 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 


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44154 Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 

needed to protect the safety of infants 

and children. 

E. Aggregate Risks and Determination of 

Safety 

Titanium dioxide has two exemptions 

from the requirement of a tolerance: 

pesticide formulations applied to 

growing crops, 40 CFR 180.920; and 

pesticide formulations applied to 

animals, 40 CFR 180.930. 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; 21 CFR 

73.3126). There has also been a previous 

exemption from 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 lambdacyhalothrin at no more than 3.0% by 

weight or the formulations (40 CFR 

180.1195). There was also no aggregate 

risk assessments performed since there 

was no single exposure, dietary or 

drinking water endpoints of concern. 

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, including infants 

and children, 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 of titanium 

dioxide when used as an inert 

ingredient (UV stabilizer) in pesticide 

formulations of napropamide at no more 

than 5% of the product formulation is 

considered safe under FFDCA section 

408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nation Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for titanium dioxide. 

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 (UVstabilizer) at no more than 5% in 

pesticide formulations containing the 

active ingredient napropamide in 

pesticide formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 18, 2012. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 


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Federal Register / Vol. 77, No. 145 / Friday, July 27, 2012 / Rules and Regulations 44155 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.1195 is revised to read 

as follows: 

§ 180.1195 Titanium dioxide. 

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. 

[FR Doc. 2012–18374 Filed 7–26–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

43 CFR Part 3830 

[WO–620–1990–00–24 1A] 

RIN 1004–AE27 

Administration of Mining Claims and 

Sites 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Interim final rule. 

SUMMARY: The Bureau of Land 

Management (BLM) is issuing this rule 

to amend regulations on locating, 

recording, and maintaining mining 

claims or sites. In this rule, the BLM 

amends its regulations to respond to a 

recent law that changes the way the 

maintenance fee is calculated for 

unpatented placer mining claims. The 

law specifies that the holder of an 

unpatented placer mining claim must 

pay the initial and annual maintenance 

fee for each 20 acres or portion thereof 

contained in the claim; and reiterates 

that an initial maintenance fee payment 

is due at the time of recording the claim 

with the BLM and that the annual 

maintenance fee is due on or before 

September 1 of each year. 

DATES: The interim final rule is effective 

July 27, 2012. If you wish to comment 

on the interim final rule, you should 

submit your comments by September 

25, 2012. 

ADDRESSES: Mail: Director (630), Bureau 

of Land Management, U.S. Department 

of the Interior, 1849 C St. NW., 

Washington, DC 20240, Attention: 

1004–AE27. 

Personal or messenger delivery: U.S. 

Department of the Interior, Bureau of 

Land Management, 20 M St. SE., Room 

2134LM, Attention: Regulatory Affairs, 

Washington, DC 20003. 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions at this Web site. 

FOR FURTHER INFORMATION CONTACT: 

Sonia Santillan at 202–912–7123, in the 

Solid Minerals Group as to program 

matters or the substance of the interim 

final rule or Ian Senio in the Division of 

Regulatory Affairs at 202–912–7440 for 

information relating to the rulemaking 

process generally. Persons who use a 

telecommunications device for the deaf 

(TDD) may call the Federal Information 

Relay Service (FIRS) at 1–800–877– 

8339, 24 hours a day, 7 days a week to 

contact the above individuals. 

SUPPLEMENTARY INFORMATION: 

I. Public Comment Procedures 

II. Background 

III. Discussion of Interim Final Rule 

IV. Procedural Matters 

I. Public Comment Procedures 

If you wish to comment, you may 

submit your comments by one of several 

methods: 

You may mail comments to Director 

(630), Bureau of Land Management, U.S. 

Department of the Interior, 1849 C St. 

NW., Washington, DC 20240, Attention: 

1004–AE27; 

You may deliver comments to U.S. 

Department of the Interior, Bureau of 

Land Management, 20 M St. SE., Room 

2134LM, Attention: Regulatory Affairs, 

Washington, DC 20003; or 

You may access and comment on the 

interim final rule at the Federal 

eRulemaking Portal by following the 

instructions at that site (see ADDRESSES). 

Written comments on the interim 

final rule should be specific, should be 

confined to issues pertinent to the 

interim final rule, and should explain 

the reason for any recommended 

change. Where possible, comments 

should reference the specific section or 

paragraph of the proposal which the 

commenter is addressing. 

The BLM need not consider, or 

include in the administrative record for 

the final rule, comments that the BLM 

receives after September 25, 2012 or 

comments delivered to an address other 

than those listed above. 

Public Availability of Comments 

Comments, including names, street 

addresses, and other contact 

information of respondents, will be 

available for public review at BLM’s 

offices at the U.S. Department of the 

Interior, Bureau of Land Management, 

20 M St. SE., Room 2134LM, 

Washington, DC 20003, during regular 

business hours (7:45 a.m. to 4:15 p.m.), 

Monday through Friday, except Federal 

holidays. They will also be available at 

the Federal eRulemaking Portal http:// 

www.regulations.gov. Follow the 

instructions at this Web site. 

Before including your address, phone 

number, email address, or other 

personal identifying information in your 

comment, you should be aware that 

your entire comment, including your 

personal identifying information, may 

be made publicly available at any time. 

While you can ask us in your comment 

to withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

II. Background 

The BLM has responsibility for the 

collection of fees for placer and lode 

mining claims and mill and tunnel sites 

on Federal lands. During fiscal year (FY) 

2011, claimants recorded 58,775 new 

claims and sites with the BLM. In 

addition, the BLM processed 

maintenance fee payments for 375,958 

claims and sites. The BLM deposits the 

collected fees into a special fund, and 

Congress appropriates money to the 

BLM from the fund to pay for the 

administration of the Mining Law 

program, which includes mining claim 

recording and fee collection, processing 

grandfathered patent applications, 

processing applications for plans of 

operations, inspecting operations, and 

enforcing the regulations. 

Since 1992, Congress has passed 

several laws requiring claimants to pay 

various fees when locating, recording, 

and maintaining mining claims or sites 

on Federal lands. This rule implements 

Section 430 of the Consolidated 

Appropriations Act, 2012 (the FY2012 

Appropriations Act), Public Law 112– 

74, 125 Stat. 786, enacted on December 

23, 2011, which amended 30 U.S.C. 28f. 

III. Discussion of Interim Final Rule 

Why the Rule Is Being Published on an 

Interim Final Basis 

The BLM is adopting this interim 

final rule solely to implement the 

requirements of Section 430 of the 

FY2012 Appropriations Act, which 

amended 30 U.S.C. 28f. The BLM is not 

making any other changes to the 

regulations at 43 CFR part 3830. 

The Department of the Interior for 

good cause finds under 5 U.S.C. 

553(b)(3)(B) that notice and public 

procedure for this rule are unnecessary 

and that this rule may properly take 

effect upon publication. The reasons are 

as follows: 

• This rule merely codifies statutorily 

imposed procedural changes; 


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