2023-25871. Tolpyralate; Pesticide Tolerances

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes tolerances for residues of tolpyralate in or on barley, wheat and livestock commodities. ISK Biosciences Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES:

This regulation is effective November 27, 2023. Objections and requests for hearings must be received on or before January 26, 2024, 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–2022–0198, is available at https://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 and for the OPP Docket is (202) 566–1744. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

Francisco Llarena-Arias, 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: [e-mail].

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 Office of the Federal Register's e-CFR site at https://www.ecfr.gov/​title-40.

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–2022–0198 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 January 26, 2024. 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–2022–0198, by one of the following methods:

• Federal eRulemaking Portal: https://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 https://www.epa.gov/​dockets/​contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

II. Summary of Petitioned-For Tolerance

In the Federal Register of May 20, 2022 (87 FR 30855) (FRL–9410–13–OCSPP), 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 1F8958) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio, 44077. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate including its metabolite MT–2153, in or on barley, grain at 0.015 parts per million (ppm); barley, hay at 0.2 ppm; barley, straw at 0.08 ppm; wheat, grain at 0.01 ppm; wheat, forage at 0.02 ppm; wheat, hay at 0.05 ppm; wheat, straw at 0.03 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket, https://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 tolerances for residues in livestock commodities. The reasons for these changes are explained in Unit IV.C.

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 tolpyralate including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with tolpyralate follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections of the rule that repeat what has been previously published in tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking and republishing the same sections is unnecessary and duplicative. EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published a number of tolerance rulemakings for tolpyralate, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to tolpyralate and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

A. Toxicological Profile

For a discussion of the Toxicological Profile of tolpyralate, see Unit III.A. of the July 27, 2017, rulemaking (82 FR 34877) (FRL–9964–15).

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. The PODs and levels of concern have not changed from the previous rulemaking and EPA incorporates the background information in the July 27, 2017, rulemaking. In addition, a summary of the toxicological endpoints for tolpyralate used for human risk assessment can be found in the document titled Tolpyralate: Human Health Risk Assessment for the Proposed Uses on Wheat and Barley and Addition of Aerial Application for Corn. (hereinafter “Tolpyralate Human Health Risk Assessment”) in docket ID number EPA–HQ–OPP–2022–0198 in regulations.gov.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to tolpyralate, EPA considered exposure under the petitioned-for tolerances as well as all existing tolpyralate tolerances in 40 CFR 180.696. EPA assessed dietary exposures from tolpyralate 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.

Such effects were identified for tolpyralate. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) under the Continuing Survey of Food Intake by Individuals (CSFII) and the Centers for Disease Control (CDC) under the National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WEIA) 2005–2010. As to residue levels in food, EPA assumed tolerance level residues for all commodities and 100% crop treated.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the United States Department of Agriculture (USDA) under the Continuing Survey of Food Intake by Individuals (CSFII) and the CDC under the National Health and Nutrition Examination Survey/What We Eat in America (NHANES/WEIA) 2005–2010. As to residue levels in food, EPA assumed tolerance level residues for all commodities and 100% crop treated.

iii. Cancer. The Agency has determined that quantification of risk using a non-linear approach ( i.e., reference dose or RfD), for tolpyralate will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to tolpyralate. As a result, the chronic dietary exposure assessment is protective for potential cancer risk, and a separate cancer exposure assessment was not conducted.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for tolpyralate. Tolerance level residues and/or 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. The estimates for drinking water exposure have not changed since the previous tolerance rulemaking; the additional uses do not impact the previous calculations for drinking water exposure estimates. For a discussion of the dietary exposure of drinking water of tolpyralate, see Unit III.C.2. of the July 27, 2017, rulemaking.

3. From non-dietary exposure. There are no residential (non-occupational) exposures associated with the new proposed uses and tolpyralate is not registered for any use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. The Agency is required to consider the cumulative risks of pesticides sharing a common mechanism of toxicity. The Agency has determined that the HPPD inhibitors, which include tolpyralate, share a common mechanism of toxicity as discussed in the HPPD Inhibiting Herbicides: State of the Science paper (K. Yozzo and M. Perron, 09/18/2020, TXR No. 0058084, D439367). As explained in that document, the members of this group share the ability to bind to and inhibit the HPPD enzyme, resulting in elevated systemic tyrosine levels and common apical outcomes that are mediated by tyrosine, including ocular and developmental effects. In 2021, after establishing a common mechanism grouping for the HPPD inhibitors, the Agency conducted the P-Hydroxyphenyl-Pyruvate Dioxygenase (HPPD) Inhibitors Cumulative Risk Assessment: Benzobicyclon, Bicyclopyrone, Isoxaflutole, Mesotrione, Pyrasulfotole, Tembotrione, Tolpyralate, and Topramezone (J. Godshall, 06/30/2021, D462487) and concluded that cumulative exposures to HPPD inhibitors (based on proposed and registered pesticidal uses at the time the assessment was conducted) did not present risks of concern.

An updated cumulative risk assessment (CRA) was not performed for the proposed new uses of tolpyralate on barley and wheat. The tolerances for tolpyralate being established in this rulemaking for barley, wheat and livestock commoditiest, do not impact the screening-level CRA based on low recommended tolerance levels relative to other HPPD inhibitors in the Cumulative Assessment Group (CAG). Therefore, an updated CRA is not necessary for tolpyralate.

D. Safety Factor for Infants and Children

EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit III.D of July 27, 2017, rulemaking (82 FR 34877) (FRL–9964–15) for a discussion of the Agency's rationale for that determination.

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 population adjusted dose (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 margin of exposure (MOE) exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to tolpyralate will occupy 1.0% of the aPAD for females 13 to 49 years old, the only population relevant for assessing acute exposure to tolpyralate.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to tolpyralate from food and water will utilize 2.7% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. There are no residential uses for tolpyralate.

3. Short-term risk. A short-term adverse effect was identified; however, tolpyralate is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-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-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for tolpyralate.

4. Intermediate-term risk. An intermediate-term adverse effect was identified; however, tolpyralate is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no 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 intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for tolpyralate.

5. Aggregate cancer risk for U.S. population. Based on the discussion in Unit III.A., the chronic dietary exposure assessment is protective for potential cancer risk. Therefore, EPA does not expect exposure to tolpyralate to pose aggregate cancer risk.

6. 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 tolpyralate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (ISK Biosciences Method JSM0433) for plant commodities is a LC–MS/MS method that can be used to analyze for parent tolpyralate. It has been developed and independently validated and is adequate to enforce the established and proposed tolerances. For all matrices and analytes, the level of quantification (LOQ), defined as the lowest level of method validation (LLMV) or lowest spiking level where acceptable precision and accuracy data were obtained, was determined to be 0.01 ppm. The limit of detection (LOD) was 0.004 ppm.

Adequate enforcement methodology (ISK Biosciences Method D96518) for livestock commodities is a LC–MS/MS method that can be used to analyze for parent tolpyralate and the metabolite MT–2153 concurrently. It has been developed and independently validated and is adequate to enforce the established and proposed tolerances. For all matrices and analytes, the level of quantification (LOQ), defined as the lowest level of method validation (LLMV) or lowest spiking level where acceptable precision and accuracy data were obtained, was determined to be 0.01 ppm. The limit of detection (LOD) was 0.003 ppm.

The methods 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: [e-mail].

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 Codex has not established a MRL for tolpyralate.

C. Revisions to Petitioned-For Tolerances

The tolerances being established for the proposed new uses of tolpyralate are based on values obtained using the OECD MRL calculator and submitted residue data. The tolerances being established are consistent with the values in the petition, with the exception of barley, grain, which is established at 0.01 ppm instead of 0.015 ppm to correct a typo that was published in the Federal Register of May 20, 2022 (87 FR 30855) (FRL–9410–13–OCSPP). EPA is establishing tolerances for residues in livestock commodities due to an update in the dietary burden calculation.

As part of the review of the petition, a revised Maximum Reasonable Dietary Burden (MRDB), including the potential contributions of barley and wheat were evaluated. As indicated in EPA's regulation, 40 CFR 180.6, when finite pesticide chemical residues will be found in livestock commodities as a result of the use of a pesticide in or on animal feedstuffs, EPA will establish tolerances in livestock commodities to accommodate those residues. The additional uses of tolpyralate on barley and wheat will result in an increase in the MRDB for beef and dairy cattle and consequently necessitate increasing tolerances for tolpyralate residues in ruminant commodities. New tolerance levels in ruminant commodities were determined using the Langmuir model, and based on that analysis, EPA is establishing tolerances for residues in or on cattle, byproducts at 0.02 ppm; goat, byproducts at 0.02 ppm; horse, byproducts at 0.02 ppm and sheep, byproducts at 0.02 ppm.

V. Conclusion

Therefore, tolerances for plant commodities are established for residues of tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate in or on barley, grain at 0.01 ppm; barley, hay at 0.2 ppm; barley, straw at 0.08 ppm wheat, grain at 0.01 ppm; wheat, forage at 0.02 ppm; wheat, hay at 0.05 ppm and; wheat, straw at 0.03 ppm. Compliance with the tolerance levels specified below is to be determined by measuring only tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate, in or on the commodity.

In addition, tolerances for livestock commodities are established for residues of tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate and metabolite MT–2153 [1-ethyl-5-hydroxy-1H-pyrazol-4-yl-3-(2-methoxyethoxy)-4-mesyl-2-methylphenyl ketone], in or on cattle, byproducts at 0.02 ppm; goat, byproducts at 0.02 ppm; horse, byproducts at 0.02 ppm and sheep, byproducts at 0.02 ppm. Compliance with the tolerance levels specified below is to be determined by measuring tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate and metabolite MT–2153 [1-ethyl-5-hydroxy-1H-pyrazol-4-yl-3-(2-methoxyethoxy)-4-mesyl-2-methylphenyl ketone], in or on the commodity.

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: November 16, 2023.

Charles Smith,

Director, Registration Division, Office of Pesticide Programs.

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

1. The authority citation for part 180 continues to read as follows:

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

2. Amend § 180.696 by:

a. Designating the introductory text of paragraph (a) as paragraph (a)(1) and the table in newly designated paragraph (a)(1) as table 1 to paragraph (a)(1).

b. Adding, in alphabetical order, in newly designated table 1 to paragraph (a)(1), the entries “Barley, grain”; “Barley, hay”; “Barley, straw”; “Wheat, forage”; “Wheat, grain”; “Wheat, hay”; and “Wheat, straw”.

c. Add paragraph (a)(2).

The additions read as follows:

§ 180.696

Tolpyralate; tolerances for residues.

(a) * * *

(1) * * *

Table 1 to Paragraph (a)(1)

Commodity	Parts per million
Barley, grain	0.01
Barley, hay	0.2
Barley, straw	0.08
*    *    *    *    *
Wheat, forage	0.02
Wheat, grain	0.01
Wheat, hay	0.05
Wheat, straw	0.03

(2) Tolerances are established for residues of tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate and metabolite MT–2153 [1-ethyl-5-hydroxy-1H-pyrazol-4-yl-3-(2-methoxyethoxy)-4-mesyl-2-methylphenyl ketone], in or on the livestock commodities in table 2 to this paragraph (a)(2). Compliance with the tolerance levels specified in table 2 to this paragraph (a)(2) is to be determined by measuring tolpyralate, 1-[[1-ethyl-4-[3-(2-methoxyethoxy)-2-methyl-4-(methylsulfonyl)benzoyl]-1H-pyrazol-5-yl]oxy]ethyl methyl carbonate and metabolite MT–2153 [1-ethyl-5-hydroxy-1H-pyrazol-4-yl-3-(2-methoxyethoxy)-4-mesyl-2-methylphenyl ketone], in or on the commodity.

Table 2 to Paragraph (a)(2)

Commodity	Parts per million
Cattle, byproducts	0.02
Goat, byproducts	0.02
Horse, byproducts	0.02
Sheep, byproducts	0.02

* * * * *