### 12011 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations

**§ 1275.58 Requests for declassification.**

Challenges to the classification and requests for the declassification of national security classified materials are governed by the provisions of 36 CFR part 1256, subpart E, as that may be amended from time to time.

**§ 1275.60 Freedom of Information Act (FOIA) requests.** 

(a) The Archivist will process Freedom of Information Act (FOIA) requests for access to only those materials within the Presidential historical materials that are identifiable by an archivist as records of an agency as defined in § 1275.16(f). The Archivist will process these requests in accordance with the FOIA regulations set forth in 36 CFR part 1250, NARA Records Subject to FOIA.

(b) In order to allow NARA archivists to devote as much time and effort as possible to the processing of materials for general public access, the Archivist will not process those FOIA requests where the requester can reasonably obtain the same materials through a request directed to an agency (as defined in § 1275.16(f)), unless the requester demonstrates that he or she has unsuccessfully sought access from that agency or its successor in law or function.

Dated: March 2, 2016. David S. Ferriero, Archivist of the United States.
[FR Doc. 2016–05149 Filed 3–7–16; 8:45 am]

**BILLING CODE 7515–01–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 180**

**[EPA–HQ–OPP–2014–0194; FRL–9942–24]**

**Amitraz, Carfentrazone-ethyl, Ethephon, Malathion, Mancozeb, et al.;**  **Tolerance Actions; Correction**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule; correction.

**SUMMARY :**  EPA issued a document in the Federal Register of November 20, 2015, concerning the removal of the entry ‘‘Rice, straw’’ from the table in 40 CFR 180.361(a). EPA subsequently issued a document in the Federal Register of December 21, 2015, which redesignated 40 CFR 180.361(a) as 40 CFR 180.361(a)(1). This document corrects the document published on November 20, 2015, to remove the entry ‘‘Rice, straw’’ from the table in paragraph (a)(1). **DATES :**  This final rule correction is effective May 18, 2016.

**FOR FURTHER INFORMATION CONTACT :**  Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov.

**SUPPLEMENTARY INFORMATION :** 

I. General Information
A. Does this action apply to me?

The Agency included in the November 20, 2015 document a list of those who may be potentially affected by this action.
B. How can I get copies of this document and other related information?

The dockets for this action, identified by docket identification (ID) number EPA–HQ–OPP–2014–0194 are 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 dockets available
at http://www.epa.gov/dockets.

II. What does this correction do?

The final rule in the Federal Register of November 20, 2015, amended 40 CFR 180.361 to remove the entry ‘‘Rice, straw’’ from the table in paragraph (a). In the final rule in the Federal Register of December 21, 2015 (80 FR 79267) (FRL–9937–18), paragraph (a) was redesignated as paragraph (a)(1) so we are amending 40 CFR 180.361 to remove the entry ‘‘Rice, straw’’ from the table in paragraph (a)(1).

FR Doc. 2015–28491 published in the Federal Register of November 20, 2015 (80 FR 72593) (FRL–9935–01) is corrected as follows:

**§ 180.361 [Amended]**

■ 1. On page 72598, second column, under the heading § 180.361 [Amended], instruction 16, line 3, correct paragraph (a) to read paragraph (a)(1). 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 25, 2016. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2016–04765 Filed 3–7–16; 8:45 am]

**BILLING CODE 6560–50–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 180**

**[EPA–HQ–OPP–2014–0922; FRL–9942–18]**

**Zoxamide; Pesticide Tolerances**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  This regulation establishes tolerances for residues of zoxamide in or on the tomato subgroup 8–10A, the small, vine climbing fruit, except fuzzy kiwifruit, subgroup 13–07F, the tuberous and corm vegetable subgroup 1C and ginseng. Interregional Research Project Number 4 (IR–4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

**DATES :**  This regulation is effective March 8, 2016. Objections and requests for hearings must be received on or before May 9, 2016, 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–2014–0922, 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 :**  Susan Lewis, Registration Division (7505P), Office of Pesticide Programs,


### 12012 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations

Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; main telephone number: (703) 305–7090; email address: RDFRNotices@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. 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 EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://www.ecfr.gov/cgi-bin/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–2014–0922 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 May 9, 2016. 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– 2014–0922, 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. Summary of Petitioned-For Tolerance

In the Federal Register of April 6, 2015 (80 FR 18327) (FRL–9924–00), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E8335) by IR–4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of residues of the sum of zoxamide (3, 5-dichloro-N-(3-chloro-1- ethyl-1-methyl-2-oxopropyl)-4- methylbenzamide) and its metabolites 3,5-dichloro-1,4-benzenedicarboxylic acid (RH–1455 and RH–141455) and 3,5-dichloro-4-hydroxymethylbenzoic acid (RH–1452 and RH–141452) calculated as the stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 parts per million (ppm) and vegetable, tuberous and corm, subgroup 1C at 0.060 ppm. In addition, IR–4 requested to establish tolerances for residues, determined by measuring only zoxamide (3,5-dichloro-N-(3-chloro-1- ethyl-1-methyl-2-oxypropyl)-4- methylbenzamide, in or on the raw agricultural commodity tomato subgroup 8–10A at 2.0 ppm and fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13–07F at 5.0 ppm. IR–4 also proposed, upon the approval of the aforementioned tolerances, to remove established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm. That document referenced a summary of the petition prepared by Gowan Company, the registrant, which is available in the docket, http://www.regulations.gov

. There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 . . . .’’

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 zoxamide including exposure resulting from the tolerances established by this action. EPA’s assessment of exposures and risks associated with zoxamide follows. A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its 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.

In repeat dose oral and dermal toxicity studies in rats, there were no indications of systemic toxicity up to the highest dose tested (HDT); most of the highest doses were at or above the limit dose (1,000 milligrams/kilogram/ day (mg/kg/day)). In the repeat dose oral toxicity studies in dogs, effects included increased liver and thyroid weights, liver histopathology (i.e., hepatocellular hypertrophy), and increased alkaline phosphatase.


### 12013 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations

In the rat and rabbit prenatal developmental toxicity studies, there were no indications of susceptibility, as there was neither maternal nor developmental toxicity up to the HDT. In the rat reproduction study, there were no indications of susceptibility, since parental effects (i.e., decreased maternal body weight) occurred in the absence of reproductive or offspring toxicity.

Zoxamide has been classified as ‘‘not likely to be carcinogenic in humans’’ based on the results of carcinogenicity studies in rats and mice. In the acute and subchronic neurotoxicity studies, there were no indications of neurotoxicity up to the HDT.

Specific information on the studies received and the nature of the adverse effects caused by zoxamide as well as the no-observed-adverse-effect-level(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in the document titled ‘‘ Zoxamide. Human Health Aggregate Risk Assessment for the Proposed New Uses on Ginseng, Tomato Subgroup 8–10A; Small Fruit, Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13–07F; and Tuberous and Corm Vegetable Subgroup 1C’’ on page 25 in docket ID number EPA–HQ–OPP–
2014–0922. B. Toxicological Points of Departure/ Levels of Concern

Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides

.

A summary of the toxicological endpoints for zoxamide used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 18, 2014 (79 FR 41911) (FRL–9913–35).
C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to zoxamide, EPA considered exposure under the petitioned-for tolerances as well as all existing zoxamide tolerances in 40 CFR 180.567. EPA assessed dietary exposures from zoxamide in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single
exposure.

No such effects were identified in the toxicological studies for zoxamide; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture’s (USDA’s) 2003–2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) database. As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all established and proposed commodities. The assessment also utilized default processing factors from the Dietary Exposure Evaluation Model—Food Commodity Intake Database (DEEM– FCID) version 7.81 except for raisin and potato granules/flakes, where the processing factor was set at 1.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that zoxamide does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is
unnecessary.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for zoxamide. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking
water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for zoxamide and its major metabolites in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of zoxamide and its metabolites. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide

.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW) model, the estimated drinking water concentrations (EDWCs) of zoxamide and its major metabolites for chronic exposures are estimated to be 22.84 parts per billion (ppb) for surface water and 65.8 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 65.8 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term ‘‘residential exposure’’ is used inthis document to refer to nonoccupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Zoxamide is not registered for any specific use patterns that would result in residential
exposure.

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.’’

EPA has not found zoxamide to share a common mechanism of toxicity with any other substances, and zoxamide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that zoxamide 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://www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides

.


### 12014 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations

D. Safety Factor for Infants and Children

1. 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 Safety Factor (FQPA 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.

2. Prenatal and postnatal sensitivity. There was no evidence for increased susceptibility following prenatal exposure in prenatal developmental toxicity studies in rats and rabbits. Additionally, there was no evidence forincreased susceptibility following preor postnatal exposure in the reproduction and fertility effects study in rats.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1 × . That decision is based on the following findings:

i. The toxicity database for zoxamide is complete.

ii. There is no indication that zoxamide is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that zoxamide results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to zoxamide in drinking water. These assessments will not underestimate the exposure and risks posed by zoxamide. E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, zoxamide is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to zoxamide from food and water will utilize 6.3% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. There are no residential uses for zoxamide.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

A short- and intermediate-term adverse effect was identified; however, zoxamide is not registered for any use patterns that would result in either short- or intermediate-term residential exposure. Short- and intermediate-term risk is assessed based on short- and intermediate-term residential exposure plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short- or intermediate-term risk), no furtherassessment of short- or intermediateterm risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risk for zoxamide.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, zoxamide is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to zoxamide residues. IV. Other Considerations A. Analytical Enforcement Methodology

Adequate enforcement methodology (Gas chromatography with electron capture detection (GC/ECD) and GC with mass selective detection (GC/ MSD)) is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@
epa.gov.
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 Nations 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 tolerances being established for the tomato subgroup 8–10A and the small vine climbing fruit, except fuzzy kiwifruit, subgroup 13–07F are harmonized with established Codex MRLs on tomato and grape, respectively. The tolerance being established for the tuberous and corm vegetable subgroup 1C at 0.06 ppm is not harmonized with a Codex MRL on potato at 0.02 ppm. The underlying residue data and residue definition used to support the Subgroup 1C tolerance supports a tolerance recommendation that is higher than the established Codex MRL on potato at 0.02 ppm. There is not a Codex MRL for ginseng.

V. Conclusion

Therefore, tolerances are establishedfor residues of zoxamide (3,5-dichloroN-(3-chloro-1-ethyl-1-methyl-2- oxopropyl)-4-methylbenzamide) and its metabolites 3,5-dichloro-1,4- benzenedicarboxylic acid (RH–1455 and RH–141455) and 3,5-dichloro-4- hydroxymethylbenzoic acid (RH–1452 and RH–141452) calculated as the


### 12015 Federal Register / Vol. 81, No. 45 / Tuesday, March 8, 2016 / Rules and Regulations

stoichiometric equivalent of zoxamide in or on the raw agricultural commodity ginseng at 0.30 ppm and vegetable, tuberous and corm, subgroup 1C at 0.06 ppm. In addition, tolerances are established for residues, determined bymeasuring only zoxamide (3,5-dichloroN-(3-chloro-1-ethyl-1-methyl-2- oxypropyl)-4-methylbenzamide, in or on raw agricultural commodity tomato subgroup 8–10A at 2.0 ppm and fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F at 5.0 ppm. Lastly, upon the establishment of the aforementioned tolerances, the established tolerances for grape at 3.0 ppm; tomato at 2.0 ppm; and potato at 0.060 ppm are removed as unnecessary. VI. Statutory and Executive Order Reviews

This action establishes tolerances 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 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 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). VII. 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 25, 2016. Susan Lewis, 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:

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

■ 2. In § 180.567:

■ a. In the table in paragraph (a)(1):

■ i. Add alphabetically entries for ‘‘Fruit, small vine climbing’’ and ‘‘Tomato subgroup 8–10A’’; and

■ ii. Remove the entries for ‘‘Grape’’ and ‘‘Tomato’’; and

■ b. In the table in paragraph (a)(2): ■ i. Add alphabetically entries for ‘‘Ginseng’’ and ‘‘Vegetable, tuberous and corm’’; and

■ ii. Remove the entry ‘‘Potato’’.

The additions read as follows:

**§ 180.567 Zoxamide; tolerances for residues.** 

(a) * * * (1) * * *

Commodity Parts per million

Fruit, small vine climbing, except

fuzzy kiwifruit, subgroup 13– 07F .......................................... 5.0

*****

Tomato subgroup 8–10A ............ 2.0

*****

(2) * * *

Commodity Parts per million

Ginseng ...................................... 0.30

*****

Vegetable, tuberous and corm,

subgroup 1C ........................... 0.06

* * * * * [FR Doc. 2016–04740 Filed 3–7–16; 8:45 am]

**BILLING CODE 6560–50–P**

**ENVIRONMENTAL PROTECTION AGENCY** 

**40 CFR Part 180**

**[EPA–HQ–OPP–2015–0443; FRL–9943–21]**

**Fluopyram; Pesticide Tolerances**

**AGENCY :**  Environmental Protection Agency (EPA).

**ACTION :**  Final rule.

**SUMMARY :**  This regulation establishes, amends, and deletes tolerances for residues of fluopyram in or on multiple commodities which are identified and discussed later in this document. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

**DATES :**  This regulation is effective March 8, 2016. Objections and requests for hearings must be received on or before May 9, 2016, 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)