Fenoxaprop-ethyl, Flufenpyr-ethyl, Imazapyr, Maleic hydrazide, Pyrazon, Quinclorac, Triflumizole, et al.; Proposed Tolerance and Tolerance Exemption Actions

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing to revoke certain tolerances for fenoxaprop-ethyl, flufenpyr-ethyl, maleic hydrazide, pyrazon, and quinclorac in follow up to canceled products or where a commodity is no longer a significant livestock feed item or a tolerance is no longer needed. In addition, EPA is proposing to establish exemptions from certain tolerances for maleic hydrazide and to modify certain tolerances for quinclorac and imazapyr. In accordance with current Agency practice, EPA also is proposing to update the nomenclature for certain tolerances for fenoxaprop-ethyl and triflumizole, to remove expired tolerances for certain pesticide active ingredients, and to conform with rounding class practices for certain existing tolerances of specific pesticide active ingredients.

DATES:

Comments must be received on or before February 5, 2019.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0418, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by 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.

FOR FURTHER INFORMATION CONTACT:

Christina Scheltema, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 308-2201; email address: scheltema.christina@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. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

C. What can I do if I wish the Agency to maintain a tolerance that the Agency proposes to revoke?

This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f), if needed. The order would specify data needed and the timeframes for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

II. Background

A. What action is the Agency taking?

EPA is proposing to revoke or modify specific tolerances, and/or update the nomenclature for specific tolerances, for the fungicide triflumizole and the herbicides fenoxaprop-ethyl, flufenpyr-ethyl, imazapyr, pyrazon, and quinclorac, in or on the commodities specified in the regulatory text. In addition, EPA is proposing to revoke tolerances for maleic hydrazide and concomitantly establish tolerance exemptions to cover the existing food uses for it.

EPA is proposing to revoke certain tolerances because they are no longer needed, because they are on commodities that EPA no longer considers to be significant livestock feed items, or because they are associated with uses that are no longer registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United States (U.S.). EPA is proposing to revoke the tolerance for quinclorac on grain, aspirated fractions because it is no longer needed, and proposing to revoke the fenoxaprop-ethyl tolerance on peanut, hulls because EPA no longer considers the commodity to be a significant livestock feed item (determination can be found in the June 30, 2008 memorandum titled Revisions of Feedstuffs in Table 1 of OPPTS Test Guidelines 860.1000 and Guidance on Constructing Maximum Reasonably Balanced Diets (MRBD), available in docket EPA-HQ-OPPT-2009-0155 at https://www.regulations.gov ). EPA is proposing to revoke all tolerances for flufenpyr-ethyl and pyrazon due to cancellation of associated uses in the United States.

EPA is proposing to remove from 40 CFR part 180, subpart C certain tolerances for boscalid, cyazofamid, endosulfan, fenoxaprop-ethyl, fenpyroximate, mandipropamid, methidathion, pendimethalin, pyraclostrobin, quinclorac, and spiromesifen because those tolerances have expired. EPA also is proposing to modify tolerance levels to conform with rounding class practices for certain existing tolerances of specific pesticide active ingredients.

Detailed explanations for the proposed modifications of tolerances for imazapyr can be found in the May 24, 2017 memorandum titled Imazapyr, Isopropylamine Salt: Amendment of Tolerances for Residues on Livestock Tissues, available in the docket of this proposed rule. Detailed explanations for the proposed modifications of tolerances for quinclorac can be found in the November 6, 2012 Human Health Risk Assessment for Registration Review and the March 10, 2015 Interim Registration Review Decision, available in docket EPA-HQ-OPP-2007-1135 at https://www.regulations.gov. Detailed explanations for the proposed tolerance exemptions for maleic hydrazide can be found in the May 14, 2014 Registration Review Summary of Analytical Chemistry and Residue Data, the June 18, 2014 Human Health Risk Assessment for Registration Review, and the September 11, 2015 Interim Registration Review Decision, available in docket EPA-HQ-OPP-2009-0387 at https://www.regulations.gov.

1. Boscalid. Because the sole tolerance in 40 CFR 180.589(b) for endive, Belgian expired on December 31, 2013, EPA proposes to remove the existing paragraph and table, and reserve the section.

2. Cyazofamid. Because the sole tolerance in 40 CFR 180.601(b) for basil, dried expired on December 31, 2014, EPA proposes to remove the existing paragraph and table, and reserve the section.

3. Endosulfan. Because the tolerances in 40 CFR 180.182 for endosulfan residues of concern all expired on various dates from July 31, 2012 through July 31, 2016, EPA proposes to remove that section in its entirety.

4. Fenoxaprop-ethyl. Because EPA no longer considers peanut hulls to be a significant livestock feed item, the tolerance on peanut, hulls is no longer needed, and therefore should be revoked. Consequently, EPA proposes to revoke the tolerance in 40 CFR 180.430(a) for peanut, hulls.

Also, because all the tolerances (grass, forage and grass, hay) in 40 CFR 180.430(b) expired on December 31, 2016, EPA proposes to remove the paragraph and table, and reserve the section.

In order to conform to current Agency practice, EPA proposes in 40 CFR 180.430(a) to revise the commodity terminology for “soybean” to “soybean, seed.”

Also, in accordance with current Agency rounding class practices for tolerance values, EPA proposes to list the existing tolerance in 40 CFR 180.430(a) for barley, straw at 0.10 ppm.

5. Fenpyroximate. Because the sole tolerance in 40 CFR 180.566(b) for honey expired on December 31, 2013, EPA proposes to remove the existing paragraph and table, and reserve the section.

6. Flufenpyr-ethyl. In the Federal Register of July 8, 2015 (80 FR 39100) (FRL-9928-54), EPA announced its receipt of voluntary requests by registrants to cancel certain pesticide registrations, including requests to cancel the last flufenpyr-ethyl products registered for use on food in the U.S. At the time of their voluntary request to cancel, the flufenpyr-ethyl registrant stated that these products were never manufactured and there were no existing stocks in the channels of trade, and therefore no existing stocks provision was requested. In the Federal Register of September 22, 2015 (80 FR 57179) (FRL-9933-58), EPA published a cancellation order in follow-up to the July 8, 2015 notice and granted the requested product cancellations for flufenpyr-ethyl. No existing stocks provision was requested or needed. Therefore, EPA proposes to revoke the tolerances in 40 CFR 180.595(a)(1) on corn, field, grain; soybean, seed; and sugarcane, cane and to revoke the tolerances in 40 CFR 180.595(a)(2) on corn, field, forage and corn, field, stover.

7. Imazapyr. Based on the lack of human health endpoints for imazapyr, EPA determined there are no hazards and no risks of concern from exposure to residues of imazapyr, and therefore the current U.S. tolerances in livestock kidneys can be increased to harmonize with the current Canadian MRLs in livestock kidneys at 0.3 ppm (the determination is available in the docket of this proposed rule). Consequently, EPA proposes to increase the tolerances in 40 CFR 180.500(a) in or on cattle, kidney; goat, kidney; horse, kidney; and sheep, kidney from 0.20 to 0.30 ppm.

Also, in accordance with current Agency rounding class practices for tolerance values, EPA proposes to list the existing tolerance in 40 CFR 180.500(a) for lentil at 0.20 ppm.

8. Maleic hydrazide. Based on the low toxicity and lack of human health endpoints for maleic hydrazide, EPA determined that there are no risks of concern from exposure to residues of maleic hydrazide. As a result, EPA concluded that the current tolerances for residues of maleic hydrazide in 40 CFR 180.175 are no longer needed and should be revoked, and exemptions from the requirement of a tolerance should be concomitantly established. Therefore, EPA proposes to revoke the tolerances in § 180.175(a)(1) in or on onion, bulb and potato; to revoke the tolerances in § 180.175(a)(2) in or on potato, chips; to remove § 180.175 in its entirety; and to establish exemptions from tolerances in 40 CFR part 180, subpart D, for onion, bulb and potato in newly designated 40 CFR 180.1349(a) and for potato, chips in newly designated 40 CFR 180.1349(b).

9. Mandipropamid. Because the sole tolerance in 40 CFR 180.637(b) for basil, dried expired on December 31, 2015, EPA proposes to remove the existing paragraph and table, and reserve the section.

10. Methidathion. Because the tolerances in 40 CFR 180.298 all expired on December 31, 2016, EPA proposes to remove that section in its entirety.

11. Pendimethalin. Because all the tolerances (Bermuda grass, forage and Bermuda grass, hay) in 40 CFR 180.361(b) expired on December 31, 2010, EPA proposes to remove the existing paragraph and table, and reserve the section.

12. Pyraclostrobin. Because the sole tolerance in 40 CFR 180.582(b) for endive, Belgium expired on December 31, 2013, EPA proposes to remove the existing paragraph and table, and reserve the section.

13. Pyrazon. In the Federal Register of March 12, 2015 (80 FR 12996) (FRL-9923-27), EPA announced its receipt of voluntary requests by registrants to cancel certain pesticide registrations, including the last pyrazon products registered for use on food commodities in the U.S. In the Federal Register of June 3, 2015 (80 FR 31596) (FRL-9926-88), EPA published a cancellation order in follow-up to the March 12, 2015 notice and granted the requested product cancellations for pyrazon. EPA permitted the registrant to sell and distribute existing stocks of the cancelled pyrazon products until June 2, 2016, and persons other than the registrant to sell, distribute, or use existing stocks of the cancelled pyrazon products until supplies are exhausted. EPA believes that existing stocks in the U.S. are exhausted. However, in a letter dated February 10, 2015, the pyrazon registrant (BASF) notified EPA of a need for the pyrazon tolerances for import purposes through December 31, 2017. Consequently, EPA proposes to revoke the tolerances in 40 CFR 180.316(a) on beet, garden, roots; beet, garden, tops; beet, sugar, molasses; beet, sugar, roots; beet, sugar, tops; cattle, fat; cattle, liver; cattle, meat; cattle, meat byproducts, except liver; goat, fat; goat, liver; goat, meat; goat, meat byproducts, except liver; horse, fat; horse, liver; horse, meat; horse, meat byproducts, except liver; milk; sheep, fat; sheep, liver; sheep, meat; and sheep, meat byproducts, except liver; and in 40 CFR 180.316(d) on corn, field, forage; corn, field, stover; soybean, forage; soybean, hay; wheat, forage; wheat, hay; and wheat, straw each with an expiration/revocation date of [DATE 6 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL RULE] and to add a footnote that there are no U.S. registrations for them.

Also, in accordance with current Agency rounding class practices for tolerance values, EPA proposes to list existing tolerances in 40 CFR 180.316(a) for beet, garden, roots at 0.90 ppm and beet, sugar, roots at 0.20 ppm and to list existing tolerances in 40 CFR 180.316(d) for corn, field, forage; corn, field, stover; soybean, forage; and soybean, hay at 0.50 ppm; for wheat, forage at 0.30 ppm; for wheat, hay at 0.20 ppm; and for wheat, straw at 0.10 ppm.

14. Quinclorac. A tolerance on grain, aspirated fractions exists in 40 CFR 180.463 for residues of quinclorac at 1,200 ppm, a level which EPA originally determined by calculation in the absence of residue data. Since that time, residue data on aspirated grain fractions showed that residues on aspirated grain fractions were no higher than the individual tolerances set on barley, grain (2.0 ppm), rice, grain (5.0 ppm), and wheat, grain (0.5 ppm). Therefore, a separate tolerance on grain, aspirated fractions is no longer needed. Consequently, EPA proposes to revoke the tolerance in 40 CFR 180.463(a)(1) on grain, aspirated fractions.

Based on the recalculated dietary burdens for livestock, which demonstrate Maximum Dietary Burdens (MDBs) for poultry at 5.4 ppm and swine at 6.0 ppm, EPA determined that the existing tolerances in poultry and hog commodities should be reassessed. Based on quinclorac data from the available cattle and poultry feeding studies, which demonstrate that the maximum residues in the commodities are expected to be <0.05 ppm, EPA determined that the tolerances in poultry, meat byproducts; hog, fat; and hog, meat byproducts should be set at 0.05 ppm. This will also harmonize the tolerances with the existing Canadian MRLs at 0.05 ppm. Consequently, EPA proposes to decrease the tolerances in 40 CFR 180.463(a)(1) for poultry, meat byproducts from 0.1 to 0.05 ppm; hog, fat from 0.7 to 0.05 ppm; and hog, meat byproducts from 1.5 to 0.05 ppm.

Also, in accordance with current Agency rounding class practices for tolerance values, EPA proposes to list the existing tolerances in 40 CFR 180.463(a)(1) for cattle, fat; goat, fat; horse, fat; and sheep, fat at 0.70 ppm; for rhubarb; wheat, grain; and wheat, hay at 0.50 ppm; and for wheat, straw at 0.10 ppm.

In the Federal Register of September 28, 2007 (72 FR 55068) (FRL-8149-5), a tolerance was established in 40 CFR 180.463 for residues of quinclorac in or on imported barley, grain. There are no U.S. registrations for the use of quinclorac on barley. Therefore, EPA will add a footnote to the tolerance in 40 CFR 180.463(a)(1) on barley, grain explaining that there are no U.S. registrations as of September 28, 2007.

Because the sole tolerance in 40 CFR 180.463(b) on cranberry expired on December 31, 2012, EPA proposes to remove the existing paragraph and table, and reserve the section.

15. Spiromesifen. Because all the tolerances in 40 CFR 180.607(b) expired on December 31, 2014, EPA proposes to remove the existing paragraph and table, and reserve the section.

16. Triflumizole. In order to conform to current Agency practice, EPA proposes in 40 CFR 180.476(a)(l) to revise the commodity terminology for “Cilantro, leaves” to “Cilantro, fresh leaves.”

B. What is the Agency's authority for taking this action?

A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under FFDCA section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce, 21 U.S.C. 331(a). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA, 7 U.S.C. 136 et seq. Food-use pesticides not registered in the U.S. must have tolerances in order for commodities treated with those pesticides to be imported into the United States.

EPA's general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the U.S. of food containing such pesticide residues. However, when there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.

Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under FFDCA section 408, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops uses for which FIFRA registrations no longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities.

Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue.

C. When do these actions become effective?

EPA is proposing that the actions herein become effective 6 months after the date of publication of the final rule in the Federal Register. EPA is proposing this effective date for these actions to allow a reasonable interval for producers in exporting members of the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the requirements of a final rule. With the exception of the proposed revocation of tolerances with expiration dates for pyrazon, the Agency believes that existing stocks of pesticide products labeled for the uses associated with the tolerances proposed for revocation have been completely exhausted and that treated commodities have cleared the channels of trade. Where EPA is proposing revocation with expiration dates for pyrazon, the Agency believes that existing stocks in the U.S. are exhausted and that the proposed date allow sufficient time for passage of treated commodities through the channels of trade for import purposes as requested by the manufacturer. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION.

Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:

1. The residue is present as the result of an application or use of the pesticide at a time and in a manner, that was lawful under FIFRA, and

2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.

III. 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 U.S. 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 MRLs for pyrazon, fenoxaprop-ethyl, or flufenpyr-ethyl.

The Codex has not established MRLs for quinclorac in or on grain, aspirated fractions; hog, fat; hog, meat byproducts; and poultry, meat products.

The Codex has established MRLs for maleic hydrazide in or on various commodities including onion, bulb at 15 milligrams per kilogram (mg/kg) and potato at 50 mg/kg. These MRLs are the same as the current tolerances for maleic hydrazide in the United States. However, because the tolerances are not needed, EPA is proposing to revoke the U.S. tolerances for maleic hydrazide and to establish exemptions from tolerances in or on onion, bulb; potato; and potato, chips.

The Codex has established MRLs for imazapyr in or on various commodities including edible offal (mammalian) at 0.2 mg/kg, which is the same as the current U.S. tolerances, and will be covered by the proposed U.S. tolerances for imazapyr in or on cattle, kidney; goat, kidney; horse, kidney; and sheep, kidney at 0.3 ppm, a higher level than the MRL.

IV. Statutory and Executive Order Reviews

In this proposed rule, EPA is proposing to establish tolerance exemptions under FFDCA 408(e), and also to modify and revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (e.g., establishment of a tolerance/tolerance exemption, modification of a tolerance, and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), or 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.). Nor does it require any special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This proposed rule 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether exemptions from tolerances, raising of tolerance levels, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations, were published in the Federal Register of May 4, 1981 (46 FR 24950) and December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this proposed rule, the Agency hereby certifies that this proposed rule will not have a significant negative economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket of this proposed rule). Furthermore, for the pesticides named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposed rule that would change EPA's previous analysis. Any comments about the Agency's determination should be submitted to the EPA along with comments on the proposed rule, and will be addressed prior to issuing a final rule. In addition, the Agency has determined that this proposed rule will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States. This proposed rule does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

Therefore, it is proposed that 40 CFR part 180 be 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. Remove §§ 180.175, 180.182, and 180.298.

3. In § 180.316, revise the tables in paragraphs (a) and (d) to read as follows:

4. In § 180.361, revise paragraph (b) to read as follows:

5. In § 180.430, revise the table in paragraph (a) and paragraph (b) to read as follows:

6. In § 180.463, revise the table in paragraph (a)(1) and paragraph (b) to read as follows:

7. In § 180.476, in the table in paragraph (a)(1), remove the entry for “Cilantro, leaves” and add an entry for “Cilantro, fresh leaves” in its place to read as follows:

8. In § 180.500, revise the table in paragraph (a) to read as follows:

9. In § 180.566, revise paragraph (b) to read as follows:

10. In § 180.582, revise paragraph (b) to read as follows:

11. In § 180.589, revise paragraph (b) to read as follows:

12. Remove § 180.595.

13. In § 180.601, revise paragraph (b) to read as follows:

14. In § 180.607, revise paragraph (b) to read as follows:

15. In § 180.637, revise paragraph (b) to read as follows:

16. Add § 180.1349 to subpart D to read as follows: