Modified Potato Acetolactate Synthase (StmALS) in Potato; Exemption From the Requirement of a Tolerance, 15915-15918 [2023-04979]

Download as PDF lotter on DSK11XQN23PROD with RULES1 Federal Register / Vol. 88, No. 50 / Wednesday, March 15, 2023 / Rules and Regulations (ii) The amount payable at the 30th consecutive day of ADL loss is an additional $25,000. (iii) The amount payable at the 60th consecutive day of ADL loss is an additional $25,000. (iv) The amount payable at the 90th consecutive day of ADL loss is an additional $25,000. (v) Duration of coma and inability to perform ADLs include date of onset of coma or inability to perform ADLs and the first date on which member is no longer in a coma or is able to perform ADLs. (18) Hospitalization due to traumatic brain injury: (i) The amount payable at the 15th consecutive day of hospitalization is $25,000. (ii) Payment for hospitalization may only replace the first ADL milestone in loss 17. Payment will be made for 15day hospitalization, coma, or the first ADL milestone, whichever occurs earlier. Once payment has been made for the first payment milestone in loss 17 for coma or ADL, there are no additional payments for subsequent 15day hospitalization due to the same traumatic injury. To receive an additional ADL payment amount under loss 17 after payment for hospitalization in the first payment milestone, the member must reach the next payment milestones of 30, 60, or 90 consecutive days. (iii) Duration of hospitalization includes the dates on which member is transported from the injury site to a hospital as defined in 42 U.S.C. 1395x(e) or skilled nursing facility as defined in 42 U.S.C. 1395i–3(a), admitted to the hospital or facility, transferred between a hospital or facility, leaves the hospital or facility for a therapeutic trip, and discharged from the hospital or facility. (iv) In cases where a member is hospitalized for 15 consecutive days for a diagnostic assessment for a mental illness and/or brain or neurologic disorder, and the assessment determines the member has a mental illness or brain or neurologic disorder, and not TBI, this loss is not payable because the loss was due to illness or disease and is excluded from payment. If a member is hospitalized for 15 consecutive days for a diagnostic assessment to determine whether the member has TBI and is diagnosed with TBI, TBI and PTSD, or PTSD and not TBI, the loss is payable for $25,000. If a member is hospitalized for 15 consecutive days for a diagnostic assessment to determine whether the member has PTSD and is diagnosed with TBI or TBI and PTSD, the loss is payable for $25,000. VerDate Sep<11>2014 15:59 Mar 14, 2023 Jkt 259001 (19) Genitourinary losses: (i) Amputation of the glans penis or any portion of the shaft of the penis above glans penis (i.e., closer to the body) or damage to the glans penis or shaft of the penis that requires reconstructive surgery—the amount payable for this loss is $50,000. (ii) Permanent damage to the glans penis or shaft of the penis that results in complete loss of the ability to perform sexual intercourse—the amount payable for this loss is $50,000. (iii) Amputation of or damage to a testicle that requires testicular salvage, reconstructive surgery, or both—the amount payable for this loss is $25,000. (iv) Amputation of or damage to both testicles that requires testicular salvage, reconstructive surgery, or both—the amount payable for this loss is $50,000. (v) Permanent damage to both testicles requiring hormonal replacement therapy—the amount payable for this loss is $50,000. (vi) Complete or partial amputation of the vulva, uterus, or vaginal canal or damage to the vulva, uterus, or vaginal canal that requires reconstructive surgery—the amount payable for this loss is $50,000. (vii) Permanent damage to the vulva or vaginal canal that results in complete loss of the ability to perform sexual intercourse—the amount payable for this loss is $50,000. (viii) Amputation of an ovary or damage to an ovary that requires ovarian salvage, reconstructive surgery, or both—the amount payable for this loss is $25,000. (ix) Amputation of both ovaries or damage to both ovaries that requires ovarian salvage, reconstructive surgery, or both—the amount payable for this loss is $50,000. (x) Permanent damage to both ovaries requiring hormonal replacement therapy—the amount payable for this loss is $50,000. (xi) Permanent damage to the urethra, ureter(s), both kidneys, bladder, or urethral sphincter muscle(s) that requires urinary diversion and/or hemodialysis—the amount payable for this loss is $50,000. (xii) Losses due to genitourinary injuries may be combined with each other, but the maximum benefit for genitourinary losses may not exceed $50,000. (xiii) Any genitourinary loss may be combined with other injuries listed in § 9.21(b)(1)–(18) and treated as one loss, provided that at all losses are the result of a single traumatic event. However, the total payment may not exceed $100,000. PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 15915 (20) Traumatic injury, other than traumatic brain injury, resulting in inability to perform at least 2 activities of daily living (ADL): (i) The amount payable at the 15th consecutive day of ADL loss is $25,000. (ii) The amount payable at the 30th consecutive day of ADL loss is an additional $25,000. (iii) The amount payable at the 60th consecutive day of ADL loss is an additional $25,000. (iv) The amount payable at the 90th consecutive day of ADL loss is an additional $25,000. (v) Duration of inability to perform ADL includes the date of the onset of inability to perform ADL and the first date on which member is able to perform ADL. (21) Hospitalization due to traumatic injury other than traumatic brain injury: (i) The amount payable at 15th consecutive day of ADL loss is $25,000. (ii) Payment for hospitalization may only replace the first ADL milestone in loss 20. Payment will be made for 15day hospitalization or the first ADL milestone, whichever occurs earlier. Once payment has been made for the first payment milestone in loss 20, there are no additional payments for subsequent 15-day hospitalization due to the same traumatic injury. To receive an additional ADL payment amount under loss 20 after payment for hospitalization in the first payment milestone, the member must reach the next payment milestones of 60, 90, or 120 consecutive days. (iii) Duration of hospitalization includes the dates on which member is transported from the injury site to a hospital as defined in 42 U.S.C. 1395x(e) or skilled nursing facility as defined in 42 U.S.C. 1395i–3(a), admitted to the hospital or facility, transferred between a hospital or facility, leaves the hospital or facility for a therapeutic trip, and discharged from the hospital or facility. (Authority: 38 U.S.C. 501(a), 1980A) [FR Doc. 2023–05069 Filed 3–14–23; 8:45 am] BILLING CODE 8320–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA–HQ–OPP–2020–0237; 10775–01– OCSPP] Modified Potato Acetolactate Synthase (StmALS) in Potato; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). AGENCY: E:\FR\FM\15MRR1.SGM 15MRR1 15916 ACTION: Federal Register / Vol. 88, No. 50 / Wednesday, March 15, 2023 / Rules and Regulations Final rule. This regulation establishes an exemption from the requirement of a tolerance for residues of modified potato acetolactate synthase (StmALS) in potato when used in accordance with label directions and good agricultural practices. J.R. Simplot Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of StmALS under FFDCA when used in accordance with this exemption. SUMMARY: This regulation is effective March 15, 2023. Objections and requests for hearings must be received on or before May 15, 2023 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). DATES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2020–0237, 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 the OPP Docket is (202) 566–1744. For the latest status information on EPA/DC services and docket access, visit https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460–0001; main telephone number: (202) 566–1400; email address: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: I. General Information lotter on DSK11XQN23PROD with RULES1 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 VerDate Sep<11>2014 15:59 Mar 14, 2023 Jkt 259001 applies to them. Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 174 through the Government Publishing Office’s e-CFR site at https:// www.ecfr.gov/current/title-40/chapter-I/ subchapter-E/part-174?toc=1. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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–2020–0237 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 15, 2023. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although EPA strongly encourages those interested in submitting objections or a hearing request to submit objections and hearing requests electronically. See Order Urging Electronic Service and Filing (April 10, 2020), https://www.epa.gov/ sites/default/files/2020-05/documents/ 2020-04-10_-_order_urging_electronic_ service_and_filing.pdf. At this time, because of the COVID–19 pandemic, the judges and staff of the Office of Administrative Law Judges are working remotely and not able to accept filings or correspondence by courier, personal delivery, or commercial delivery, and the ability to receive filings or correspondence by U.S. Mail is similarly limited. When submitting documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/ eab/eab-alj_upload.nsf. Although EPA’s regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions during this time that the Agency continues to PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 maximize telework due to the pandemic; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. If it is impossible for a person to submit documents electronically or receive service electronically, e.g., the person does not have any access to a computer, the person shall so advise OALJ by contacting the Hearing Clerk at (202) 564–6281. If a person is without access to a computer and must file documents by U.S. Mail, the person shall notify the Hearing Clerk every time it files a document in such a manner. The address for mailing documents is U.S. Environmental Protection Agency, Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460. 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– 2020–0237, 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/where-sendcomments-epa-dockets. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https:// www.epa.gov/dockets. II. Background In the Federal Register of June 24, 2020 (85 FR 37806) (FRL–10010–82) EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP IN– 11411) by J.R. Simplot Company, 5369 W Irving Street, Boise, ID 83706. The petition requested that 40 CFR part 174 be amended by establishing an exemption from the requirement of a E:\FR\FM\15MRR1.SGM 15MRR1 Federal Register / Vol. 88, No. 50 / Wednesday, March 15, 2023 / Rules and Regulations tolerance for residues of StmALS in potato. That notice referenced a summary of the petition prepared by the petitioner J.R. Simplot Company, which is available in the docket via https:// www.regulations.gov. EPA received no comments in response to the notice of filing. lotter on DSK11XQN23PROD with RULES1 III. Final Rule A. EPA’s Safety Determination Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ‘‘safe.’’ Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption 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 . . . .’’ Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider ‘‘available information concerning the cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.’’ EPA evaluated the available toxicological and exposure data on StmALS and considered their validity, completeness, and reliability, as well as the relationship of this information to human risk. A full summary of the data upon which EPA relied and its risk assessment based on those data can be found within the document entitled ‘‘Review of the Application for an Experimental Use Permit for Gen 3 Potatoes expressing transgenic Rproteins BLB2, AMR3 and VNT1, PVY Coat Protein Hairpin RNA and inert ingredient StmALS and associated FFDCA Petitions for the Temporary Exemption from a Tolerance for AMR3 and BLB2, as well as FFDCA Petition for the Exemption from a Tolerance for VerDate Sep<11>2014 15:59 Mar 14, 2023 Jkt 259001 StmALS’’ (Human Health Risk Assessment). This document, as well as other relevant information, is available in the docket for this action, EPA–HQ– OPP–2020–0237, as described under ADDRESSES. Available data have demonstrated that, with regard to humans, StmALS is not anticipated to be toxic or allergenic via any reasonably foreseeable route of exposure. StmALS (modified potato acetolactate synthase), is a plantincorporated protectant (PIP) inert ingredient produced within the plant to be a selective marker for PIP transformation events. StmALS is a protein derived from the native acetolactate synthase (ALS) protein found in potato (Solanum tuberosum) and has been modified from the naturally occurring form by two amino acid substitutions. StmALS does not have any pesticidal activity of its own; rather, the modified protein confers tolerance to sulfonylureas and imidazolinone herbicides by interfering with their binding to native ALS protein within the plant. Thus, the herbicide tolerance serves as a positive selectable marker allowing for the identification of transformed PIP plants. There is likely to be dietary exposure to StmALS through consumption of potato-derived foods containing this protein. However, the Agency has concluded that any potential dietary risk from the use of StmALS protein to human health is considered negligible for the following reasons. (1) As described above, the mode-of-action of StmALS protein is tolerance to sulfonylureas and imidazolinone herbicides; the protein is otherwise not pesticidal or toxic. (2) Bioinformatics analyses showed that there is no significant homology between StmALS and known toxins or allergens. (3) Data were submitted to demonstrate that the StmALS protein is denatured and becomes insoluble after heat treatment. Since potatoes are cooked by frying, boiling, or baking at high temperatures, and not consumed raw, StmALS is expected to become denatured during potato processing. (4) Additionally submitted data support the lack of allergenic potential for StmALS. The protein is not glycosylated and is rapidly and completely digested by stomach and pancreatic proteases, indicating that StmALS is not sufficiently stable or persistent enough to interact with the immune system and induce allergy. (5) ALS protein, from which StmALS is derived, has a history of safe use through the consumption of potatoes. The StmALS protein is 99.7% similar to the native ALS found in potato, differing by only two amino PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 15917 acids. These modifications do not affect the mode of action of StmALS and do not result in the production of a toxic protein. Since potatoes are a staple of the human diet, people have long been exposed to ALS without documented adverse effects. Oral exposure from ingestion of drinking water is unlikely because StmALS is present at low levels and is confined within the plant cells. If StmALS does enter the water column, it is expected to degrade rapidly in the presence of soil microbes, or upon normal communal water-treatment procedures. In addition, there is unlikely to be residential or nonoccupational exposure given that the inert ingredient is confined within the potato plant. Therefore, the only possible route of non-occupational exposure, other than dietary, is via handling of the plants and plant products. However, there are no risks associated with these exposure routes because, based on bioinformatics analysis and the history of safe use of the highly similar ALS protein, the StmALS protein is not toxic or allergenic. Although FFDCA section 408(b)(2)(C) provides for an additional tenfold margin of safety for infants and children in the case of threshold effects, EPA has determined that there are no such effects due to the lack of toxicity and allergenicity for StmALS. As a result, an additional margin of safety for the protection of infants and children is unnecessary. Based upon its evaluation described above and in the Human Health Risk Assessment, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of StmALS protein in potatoes. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the mode-of-action, history of safe use of the highly similar ALS protein, and lack of toxicity and allergenicity for StmALS protein. B. Analytical Enforcement Methodology EPA has determined that an analytical method is not required for enforcement purposes since the Agency is establishing a temporary exemption from the requirement of a tolerance without any numerical limitation. Nonetheless, the petitioner has submitted an immunoblot assay for detection of StmALS with an antibody that is specific to the protein but does not show cross reactivity with native E:\FR\FM\15MRR1.SGM 15MRR1 15918 Federal Register / Vol. 88, No. 50 / Wednesday, March 15, 2023 / Rules and Regulations potato ALS protein. The assay adequately detects StmALS in potato leaf and tuber tissues. lotter on DSK11XQN23PROD with RULES1 C. Conclusion Based upon its evaluation in the Human Health Risk Assessment, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of StmALS protein in potatoes. Therefore, an exemption from the requirement of a tolerance is established for residues of StmALS protein in potato when used in accordance with label directions and good agricultural practices. IV. Statutory and Executive Order Reviews This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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, 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 exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (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. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on VerDate Sep<11>2014 15:59 Mar 14, 2023 Jkt 259001 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, EPA 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 (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require EPA’s consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. 272 note). V. 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 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: March 7, 2023. Edward Messina, Director, Office of Pesticide Programs. Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows: PART 174—PROCEDURES AND REQUIREMENTS FOR PLANTINCORPORATED PROTECTANTS 1. The authority citation for part 174 continues to read as follows: ■ Authority: 7 U.S.C. 136–136y; 21 U.S.C. 321(q), 346a and 371. 2. Add § 174.544 to subpart W to read as follows: ■ PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 § 174.544 Modified Potato Acetolactate Synthase (StmALS) in potato; exemption from the requirement of a tolerance. Residues of modified potato acetolactate synthase (StmALS) in potato are exempt from the requirement of a tolerance when used as a plantincorporated protectant inert ingredient. [FR Doc. 2023–04979 Filed 3–14–23; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 411, 414, 415, 423, 424, 425, and 455 [CMS–1770–F2] RIN–0938–AU81 Medicare and Medicaid Programs, CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID–19 Interim Final Rules; Corrections Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule; correction and correcting amendment. AGENCY: In the November 18, 2022 issue of the Federal Register, we published a final rule entitled ‘‘Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID–19 Interim Final Rules’’ (referred to hereafter as the ‘‘CY 2023 PFS final rule’’). The effective date was January 1, 2023. This document corrects a limited number of technical and typographical errors identified in the November 18, 2022 final rule. DATES: This document is effective March 15, 2023, and is applicable beginning January 1, 2023. FOR FURTHER INFORMATION CONTACT: Terri Plumb, (410) 786–4481, Gaysha SUMMARY: E:\FR\FM\15MRR1.SGM 15MRR1

Agencies

[Federal Register Volume 88, Number 50 (Wednesday, March 15, 2023)]
[Rules and Regulations]
[Pages 15915-15918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04979]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2020-0237; 10775-01-OCSPP]


Modified Potato Acetolactate Synthase (StmALS) in Potato; 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

[[Page 15916]]


ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of modified potato acetolactate synthase 
(StmALS) in potato when used in accordance with label directions and 
good agricultural practices. J.R. Simplot Company submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of StmALS under FFDCA when used in accordance with this 
exemption.

DATES: This regulation is effective March 15, 2023. Objections and 
requests for hearings must be received on or before May 15, 2023 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-2020-0237, 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 the OPP Docket is (202) 566-1744. For the latest 
status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and 
Pollution Prevention Division (7511M), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (202) 566-1400; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 174 through the Government Publishing Office's e-CFR site at 
https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174?toc=1.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2020-0237 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 15, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b), although EPA 
strongly encourages those interested in submitting objections or a 
hearing request to submit objections and hearing requests 
electronically. See Order Urging Electronic Service and Filing (April 
10, 2020), https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. At this 
time, because of the COVID-19 pandemic, the judges and staff of the 
Office of Administrative Law Judges are working remotely and not able 
to accept filings or correspondence by courier, personal delivery, or 
commercial delivery, and the ability to receive filings or 
correspondence by U.S. Mail is similarly limited. When submitting 
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a 
person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand 
delivery, EPA intends to treat submissions filed via electronic means 
as properly filed submissions during this time that the Agency 
continues to maximize telework due to the pandemic; therefore, EPA 
believes the preference for submission via electronic means will not be 
prejudicial. If it is impossible for a person to submit documents 
electronically or receive service electronically, e.g., the person does 
not have any access to a computer, the person shall so advise OALJ by 
contacting the Hearing Clerk at (202) 564-6281. If a person is without 
access to a computer and must file documents by U.S. Mail, the person 
shall notify the Hearing Clerk every time it files a document in such a 
manner. The address for mailing documents is U.S. Environmental 
Protection Agency, Office of Administrative Law Judges, Mail Code 
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    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-2020-0237, 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/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of June 24, 2020 (85 FR 37806) (FRL-10010-
82) EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance exemption 
petition (PP IN-11411) by J.R. Simplot Company, 5369 W Irving Street, 
Boise, ID 83706. The petition requested that 40 CFR part 174 be amended 
by establishing an exemption from the requirement of a

[[Page 15917]]

tolerance for residues of StmALS in potato. That notice referenced a 
summary of the petition prepared by the petitioner J.R. Simplot 
Company, which is available in the docket via https://www.regulations.gov. EPA received no comments in response to the notice 
of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance or tolerance exemption 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 . . . .'' Additionally, FFDCA section 408(b)(2)(D) 
requires that EPA consider ``available information concerning the 
cumulative effects of [a particular pesticide's] . . . residues and 
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on 
StmALS and considered their validity, completeness, and reliability, as 
well as the relationship of this information to human risk. A full 
summary of the data upon which EPA relied and its risk assessment based 
on those data can be found within the document entitled ``Review of the 
Application for an Experimental Use Permit for Gen 3 Potatoes 
expressing transgenic R-proteins BLB2, AMR3 and VNT1, PVY Coat Protein 
Hairpin RNA and inert ingredient StmALS and associated FFDCA Petitions 
for the Temporary Exemption from a Tolerance for AMR3 and BLB2, as well 
as FFDCA Petition for the Exemption from a Tolerance for StmALS'' 
(Human Health Risk Assessment). This document, as well as other 
relevant information, is available in the docket for this action, EPA-
HQ-OPP-2020-0237, as described under ADDRESSES.
    Available data have demonstrated that, with regard to humans, 
StmALS is not anticipated to be toxic or allergenic via any reasonably 
foreseeable route of exposure. StmALS (modified potato acetolactate 
synthase), is a plant-incorporated protectant (PIP) inert ingredient 
produced within the plant to be a selective marker for PIP 
transformation events. StmALS is a protein derived from the native 
acetolactate synthase (ALS) protein found in potato (Solanum tuberosum) 
and has been modified from the naturally occurring form by two amino 
acid substitutions. StmALS does not have any pesticidal activity of its 
own; rather, the modified protein confers tolerance to sulfonylureas 
and imidazolinone herbicides by interfering with their binding to 
native ALS protein within the plant. Thus, the herbicide tolerance 
serves as a positive selectable marker allowing for the identification 
of transformed PIP plants.
    There is likely to be dietary exposure to StmALS through 
consumption of potato-derived foods containing this protein. However, 
the Agency has concluded that any potential dietary risk from the use 
of StmALS protein to human health is considered negligible for the 
following reasons. (1) As described above, the mode-of-action of StmALS 
protein is tolerance to sulfonylureas and imidazolinone herbicides; the 
protein is otherwise not pesticidal or toxic. (2) Bioinformatics 
analyses showed that there is no significant homology between StmALS 
and known toxins or allergens. (3) Data were submitted to demonstrate 
that the StmALS protein is denatured and becomes insoluble after heat 
treatment. Since potatoes are cooked by frying, boiling, or baking at 
high temperatures, and not consumed raw, StmALS is expected to become 
denatured during potato processing. (4) Additionally submitted data 
support the lack of allergenic potential for StmALS. The protein is not 
glycosylated and is rapidly and completely digested by stomach and 
pancreatic proteases, indicating that StmALS is not sufficiently stable 
or persistent enough to interact with the immune system and induce 
allergy. (5) ALS protein, from which StmALS is derived, has a history 
of safe use through the consumption of potatoes. The StmALS protein is 
99.7% similar to the native ALS found in potato, differing by only two 
amino acids. These modifications do not affect the mode of action of 
StmALS and do not result in the production of a toxic protein. Since 
potatoes are a staple of the human diet, people have long been exposed 
to ALS without documented adverse effects.
    Oral exposure from ingestion of drinking water is unlikely because 
StmALS is present at low levels and is confined within the plant cells. 
If StmALS does enter the water column, it is expected to degrade 
rapidly in the presence of soil microbes, or upon normal communal 
water-treatment procedures. In addition, there is unlikely to be 
residential or non-occupational exposure given that the inert 
ingredient is confined within the potato plant. Therefore, the only 
possible route of non-occupational exposure, other than dietary, is via 
handling of the plants and plant products. However, there are no risks 
associated with these exposure routes because, based on bioinformatics 
analysis and the history of safe use of the highly similar ALS protein, 
the StmALS protein is not toxic or allergenic.
    Although FFDCA section 408(b)(2)(C) provides for an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects, EPA has determined that there are no such effects 
due to the lack of toxicity and allergenicity for StmALS. As a result, 
an additional margin of safety for the protection of infants and 
children is unnecessary.
    Based upon its evaluation described above and in the Human Health 
Risk Assessment, EPA concludes that there is a reasonable certainty 
that no harm will result to the U.S. population, including infants and 
children, from aggregate exposure to residues of StmALS protein in 
potatoes. This includes all anticipated dietary exposures and all other 
exposures for which there is reliable information. The Agency has 
arrived at this conclusion based on the mode-of-action, history of safe 
use of the highly similar ALS protein, and lack of toxicity and 
allergenicity for StmALS protein.

B. Analytical Enforcement Methodology

    EPA has determined that an analytical method is not required for 
enforcement purposes since the Agency is establishing a temporary 
exemption from the requirement of a tolerance without any numerical 
limitation. Nonetheless, the petitioner has submitted an immunoblot 
assay for detection of StmALS with an antibody that is specific to the 
protein but does not show cross reactivity with native

[[Page 15918]]

potato ALS protein. The assay adequately detects StmALS in potato leaf 
and tuber tissues.

C. Conclusion

    Based upon its evaluation in the Human Health Risk Assessment, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the U.S. population, including infants and children, from aggregate 
exposure to residues of StmALS protein in potatoes. Therefore, an 
exemption from the requirement of a tolerance is established for 
residues of StmALS protein in potato when used in accordance with label 
directions and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to EPA. 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, 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 
exemption in this action, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 (2 U.S.C. 
1501 et seq.).
    This action does not involve any technical standards that would 
require EPA's consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (15 U.S.C. 272 note).

V. 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 174

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 7, 2023.
Edward Messina,
Director, Office of Pesticide Programs.

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

PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED 
PROTECTANTS

0
1. The authority citation for part 174 continues to read as follows:


    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  174.544 to subpart W to read as follows:


Sec.  174.544  Modified Potato Acetolactate Synthase (StmALS) in 
potato; exemption from the requirement of a tolerance.

    Residues of modified potato acetolactate synthase (StmALS) in 
potato are exempt from the requirement of a tolerance when used as a 
plant-incorporated protectant inert ingredient.

[FR Doc. 2023-04979 Filed 3-14-23; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.