WEDNESDAY December 9, 1992 Part VI Environmental Protection Agency 40 CFR Part 180 Zineb; Revocation of Tolerances; Final rule (This reprint was prepared from the electronic file that accompanied the original signed documents transmitted to the Office of the Federal Register. This file was certified to be a true copy of the original.) (This document appeared at 57 FR 58383-58387.) Federal Register / Vol. 57, No. 237 /Wednesday, December 9, 1992 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP - 300268; FRL - 4168 - 4] RIN 2070 - AB78 Zineb; Revocation of Pesticide Tolerances and Its Effect on Imported Agricultural Commodities AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This document establishes expiration dates for the revocation of all zineb tolerances for residues in or on agricultural commodities. All U.S. registrations for ethylene bisdithiocarbamate (EBDC) pesticide products containing zineb have been cancelled. Zineb tolerances for residues in or on all agricultural commodities (except grapes for wine use) will expire on December 31, 1994. The zineb tolerance for grapes designated for wine use will expire on December 31, 1997; however, the wine grape tolerance only applies to grapes grown for wine vintage years 1992 (Northern Hemisphere), 1993 (Southern Hemisphere), and earlier. EFFECTIVE DATE: December 9, 1992. ADDRESSES: Written objections, identified by the document control number, [OPP-300268], may be submitted to: Hearing Clerk (A-110), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. FOR FURTHER INFORMATION CONTACT: David H. Chen, Special Review and Reregistration Division (H7508W), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Special Review Branch, W31F3, Third Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA, (703)-308-8017. SUPPLEMENTARY INFORMATION: Electronic Availability: This document is available as an electronic file on The Federal Bulletin Board at 9 a.m. the day of publication in the Federal Register. By modem dial 202-512-3187 or call 202-512-1530 for disks or paper copies. The file is available in Postscript, Worperfect 5.1, and ASCII. I. Introduction Zineb is an EBDC fungicide that has been manufactured and used on agricultural commodities since the early 1950s. By the mid-1980s, most of zineb's share of the domestic market was replaced by other EBDCs. In 1988, under section 3 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA suspended all zineb product uses because of the failure of an end-use formulator to supply data under the 1987 EBDC Comprehensive Data Call-In. Subsequently, this end-use formulator informed EPA that it would voluntarily cancel its zineb registrations. Between 1989 and 1990, EPA accepted a number of voluntary cancellation requests from affected zineb registrants. Because no one committed to support zineb, in 1991 EPA cancelled all remaining registrations. This document establishes expiration dates for the revocation of all tolerances of zineb under the Federal Food, Drug and Cosmetic Act (FFDCA). II. Legal And Regulatory Background In the Federal Register of July 17, 1987 (52 FR 27172), EPA initiated a second Special Review for the EBDCs (maneb, mancozeb, metiram, nabam, and zineb). This action was prompted by EPA's concern over ethylenethiourea (ETU), a metabolite, contaminant and degradation product of the EBDCs, which the Agency has classified as a B2 carcinogen. In the Federal Register of December 20, 1989 (54 FR 52158), the Agency issued a notice of Preliminary Determination to Cancel Certain Registrations of the EBDCs. In that notice, the Agency proposed to cancel all but 10 food uses of maneb, mancozeb, and metiram. In the Federal Register of May 16, 1990 (55 FR 20416), EPA proposed to reduce and/or revoke certain food tolerances for residues of maneb, mancozeb, metiram, and zineb fungicides in or on agricultural commodities and processed foods under sections 408 and 409 of the FFDCA (21 U.S.C. 346a and 348). The proposed tolerance action was prompted by EPA's intent to cancel most maneb, mancozeb, and metiram uses, and also on the belief that all zineb registrations under FIFRA had been cancelled or that cancellation was imminent. For a description of EPA's cancellation effort, see the Federal Register notices of December 4, 1989 (54 FR 50020) and March 6, 1990 (55 FR 7935). Originally, EPA proposed to revoke all zineb tolerances by October 1990. This proposal was predicated on EPA's belief that all zineb registrations had been cancelled. In fact, EPA did not receive cancellation requests from all zineb registrants in 1989 and 1990. In the Federal Register of July 31, 1990 (55 FR 31164), the Agency provided one additional opportunity for an individual or individuals to support a new zineb registration under the 1988 FIFRA amendments. As no one came forward to support zineb, in January 1991 EPA cancelled all remaining registrations. EPA received comments on the proposed revocation concerning international trade, import, and channels-of-trade issues. The dates of the final cancellations and the comments on channels-of-trade issues caused the Agency to delay final expiration dates for the zineb tolerances (see Units IV. and V. of this preamble). In the Federal Register of March 2, 1992 (57 FR 7484), the Agency issued the EBDC Final Determination and concluded the Special Review for the remaining EBDC fungicides--maneb, mancozeb, and metiram. The Agency will publish a separate notice dealing with these EBDC tolerances. III. Zineb Tolerances Subject To Revocation The following zineb tolerances are found in 40 CFR 180.115 and are set in or on commodities in parts per million (ppm): ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ Parts per Commodity million ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ Corn (grain)..................................................... 0.1 Wheat............................................................ 1 Apples........................................................... 2 Cucumber, melons, squash, and tomatoes........................... 4 Celery and corn (sweet K + CWHR)................................. 5 Apricots, beans, beets (garden roots only), black-berries, boysenberries, broccoli, Brussel sprouts, cabbage, carrots, cauliflower, cherries, citrus fruits, cranberries, currants, dewberries, eggplants, gooseberries, grapes, guavas, kohlrabi, loganberries, mushrooms, nectarines, onions, parsley, peaches, peanuts, pears, peas, peppers, plums (fresh prunes), pumpkins, quinces, radishes (with or without tops) or radishes (tops), raspberries, rutabagas (with or without tops), rutabagas (tops), salsify, strawberries, squash (summer), turnips (with or without tops) or turnips (greens), youngberries......................... 7 Endive (escarole), kale, lettuce, mustard greens, and spinach.... 10 Beets (tops), Chinese cabbage, collards, roamine, and Swiss chard 25 Hops............................................................. 60 ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ In addition, there is one interim zineb tolerance set at 0.5 ppm in or on potatoes (used for seed piece treatment) listed in 40 CFR 180.319. This tolerance for potatoes also is subject to the tolerance revocation. IV. Issues Relating To The Revocation Of Zineb Tolerances A. Domestic Zineb Uses As noted earlier, by 1991 all former zineb registrations had been terminated. Under the January 1991 cancellation orders, the affected registrants could ship existing stocks for 1 year after the date of the cancellation order, unless their registrations were subject to an earlier cancellation. It was possible for one or more of the zineb registrants (not subject to an earlier cancellation) to legally sell and distribute their zineb products until January 1992. Any zineb products that could have been legally sold to end-users could be used until stocks were exhausted. The Agency believes that these stocks are minimal and will be depleted by the end of the 1992 growing season. In the proposed EBDC tolerance revocation Federal Register document, EPA estimated October 1990 as the final cancellation date for zineb products, and as the proposed revocation date for zineb tolerances. As noted above, the final zineb cancellations did not occur until January 1991, and use under existing-stocks provisions was allowed for 1 year. EPA estimates it will require about 2 years for zineb-treated commodities to clear the market. Accordingly, EPA has moved the tolerance revocation date for all commodities (except grapes for wine use) to December 31, 1994. To accommodate the longer shelf-life of bottled wines and the longer wine-processing time required before bottling and shipment, the tolerance expiration date for grapes designated for wine use is December 31, 1997. Finally, to ensure that the extended tolerance expiration date for grapes does not encourage the indefinite use of zineb on grapes designated for the manufacture of wines, the grape tolerance extension from January 1, 1995 to December 31, 1997 will apply to wine grapes grown for wine vintage years 1992 (Northern Hemisphere), 1993 (Southern Hemisphere), and earlier. B. Import Commodities Treated With Zineb Despite the cancellation of all U.S. registrations, the Agency understands that zineb continues to be manufactured and applied to sites internationally. With the exception of certain imported wines, the economic impact associated with the loss of zineb use on imported commodities such as citrus, cucurbits, tomatoes, or pineapples is not likely to be significant in terms of market prices in the U.S. If required, the Agency believes that U.S. importers could readily find alternate, zineb-free sources of these commodities. Moreover, the Agency notes that growers in exporting countries have several available alternatives to zineb. Therefore, the revocation dates set forth in this rule should have a negligible impact on the price and the availability of raw agricultural commodities and processed foods imported into the U.S. In the absence of zineb tolerances, any agricultural commodity or processed food imported into the U.S. found to contain EBDC residues that are traceable to a previous zineb use would be a violation of the FFDCA. C. Imported Wines Imported wines are a major food commodity valued at about $1 billion per year in the U.S. This wine represents about 15 percent of total U.S. wine consumption. In 1989, French and Italian wines combined accounted for more than 10 percent of the total U.S. wine consumed. Zineb, as well as other EBDC fungicides, are used on wine grapes grown outside the U.S. The Agency does not have precise information on the volumes of imported wine that were made from grapes treated with zineb; however, based on EPA estimates, it is likely that an immediate revocation of zineb tolerance for grapes may have a significant impact on the existing supplies and contracted purchases of both wine importers and domestic consumers of imported wines. Additionally, unlike zineb residues on other agricultural commodities, zineb residues in wine may not clear the channels-of-trade until 5 years from the use of zineb on wine grapes. This is attributable to the longer shelf-life of bottled wine and the longer wine processing time required prior to bottling and shipment. All grapes and grape products (including wine) will be covered by the zineb tolerance for grapes, from the effective date of this rule until December 31, 1994. In addition, to minimize the potential economic impact on U.S. wine importers, related businesses and consumers, EPA will extend the expiration date of the tolerance on grapes until December 31, 1997, with two restrictions. The two restrictions on the grape tolerance for the period between January 1, 1995 and December 31, 1997 are: the tolerance applies only to grapes grown for wine use, and the grapes must have been grown for wine vintage years 1992 (Northern Hemisphere), 1993 (Southern Hemisphere), and earlier. In this interim period and until the extended tolerance for grapes expires in 1997, the levels of zineb residues in bottled wines are not expected to pose significant health risks to the average consumer. V. Comments On The Proposed Tolerance Revocation The Agency received more than 100 responses to the EBDC tolerance revocation proposed rule. Many comments dealt with the likely impacts as a consequence of the potential loss of the EBDCs, or more specifically, of maneb, mancozeb, and metiram. Responses to these comments will not be addressed here. Only comments that were related to the revocation of zineb tolerances are addressed below: A. Existing stocks Comments: One grower was unaware of the proposed tolerance action on zineb and had already applied a zineb product to his crops during the 1990 growing season. This grower requested that the tolerance action be deferred to March 1991. In another comment, a registrant asked if the manner by which he had handled existing stocks after a labeling change fully complied with the law, and the timing of the Agency's final tolerance revocation action. Response: The Agency reviewed the question of existing stocks as it affects the timing of the tolerance action and in establishing the tolerance expiration dates. As stated above, the Agency believes that its final decision on the selection of the tolerance revocation dates established by this rule will provide an adequate time period for legally applied zineb residues to clear the market. B. Generalized System of Preferences Comments: Several foreign governments, particularly Chile and Colombia, voiced concerns that the revocation of EBDC tolerances may seriously affect several key export commodities from their countries. The Colombian government stated that this action would be contrary to the intent of the U.S. Generalized System of Preferences (GSP). It stated that over the short term, the GSP was intended to provide preferential access of certain products under a duty-free arrangement to help improve trade competitiveness of countries in the Andean region on the world market. Response: Adequate alternative fungicides to zineb are available for most of the commodities of concern (mainly tropical fruits and vegetables) including the remaining EBDC fungicides maneb, mancozeb, and metiram. Thus, the Agency anticipates minimal impacts to the Andean region. C. International trading Comments: A number of foreign organizations and governments, including the European Community and its member states, commented that for certain food uses of the EBDCs the revocation of tolerances may cause substantial economic losses to both their growers and the U.S. consumers. Several foreign embassies voiced similar concerns that revoking certain major EBDC tolerances could have serious economic impacts from banned shipments and restricted importation of various commodities treated with these fungicides. Other comments suggested that many fruits and vegetables, bottled wines, and other processed foods exported to the U.S. could be affected. Response: The Agency was not provided zineb use data in these comments to evaluate the level of impact to foreign growers and U.S. consumers for every former zineb site. However, the Agency recognizes that zineb use on wine grapes may be occurring in some regions of the world and has taken this into consideration. To minimize the potential economic impact in the U.S., the Agency will not revoke the tolerance for grapes for wine use until the 1997 expiration date (see Unit IV. of this preamble). In addition, EPA will be distributing an international notice announcing this action to health and agricultural officials around the world. The notice will instruct foreign producers of food for the U.S. market of EPA's decision to revoke tolerances for zineb. VI. Conclusions EPA cancelled all remaining zineb registrations in the U.S. in 1991. Because tolerances are generally not required for cancelled uses, the Agency is now establishing expiration dates for the revocation of zineb tolerances. The expiration dates in this Order have been adjusted to take into account the final cancellation and legal use dates of zineb products, as well as response to comments. The Agency believes that the share of zineb-attributable ETU residues in agricultural commodities and processed foods is already at low levels. Overall, these residues are not expected to add significantly to any health risks posed to the average consumer until the tolerances expire in the next several years. VII. Other Regulatory Requirements Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections with the Hearing Clerk, at the address given above (40 CFR 178.20). The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33 (i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on each such issue, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). A. Executive Order 12291 As stated in the proposed rule, the Agency has determined that this regulation is not a major regulatory action under the terms of Executive Order 12291. The revocation of zineb tolerances will not cause a major increase in prices, nor will the revocation have a significant adverse effect on competition or the ability of U.S. enterprises to compete with foreign enterprises. This rule has been reviewed by the Office of Management and Budget per section 3 of this Order. B. Regulatory Flexibility Act This rule has been reviewed under the Regulatory Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et seq.), and has been determined not to have a significant economic impact on a substantial number of small businesses, small governments, or small organizations. The Agency has concluded that these tolerance revocations should have little or no economic impact at any level of business enterprise. C. Paperwork Reduction Act As stated in the proposed rule, this action does not contain any information collection requirements subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. (section 408(m) of the FFDCA) (21 U.S.C. 346a(m)). List of Subjects in 40 CFR Part 180 Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and record keeping requirements. Dated: November 27, 1992. Victor J. Kimm, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. Therefore, 40 CFR part 180 is amended as follows: PART 180--[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. By revising 180.115, to read as follows: 180.115 Zineb; tolerances for residues. Tolerances for residues of the fungicide zineb (zinc ethylene bisdithiocarbamate) in or on raw agricultural commodities are established as follows: ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ Parts per Commodity million Expiration date ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ Apples.......................... 2 December 31, 1994 Apricots........................ 7 Do. Beans........................... 7 Do. Beets, tops..................... 25 Do. Beets (garden roots only)....... 7 Do. Blackberries.................... 7 Do. Boysenberries................... 7 Do. Broccoli........................ 7 Do. Brussels sprouts................ 7 Do. Cabbage......................... 7 Do. Carrots......................... 7 Do. Cauliflower..................... 7 Do. Celery.......................... 5 Do. Cherries........................ 7 Do. Chinese cabbage................. 25 Do. Citrus fruits................... 7 Do. Collards........................ 25 Do. Corn, grain..................... 0.1 Do. Corn, sweet K+CWHR.............. 5 Do. Cranberries..................... 7 Do. Cucumbers....................... 4 Do. Currants........................ 7 Do. Dewberries...................... 7 Do. Eggplants....................... 7 Do. Endive (escarole)............... 10 Do. Gooseberries.................... 7 Do. Grapes (all except for wine use) 7 Do. Grapes (wine use 7 December 31, 1997 only)\1\. Guavas.......................... 7 December 31, 1994 Hops............................ 60 Do. Kale............................ 10 Do. Kohlrabi........................ 7 Do. Lettuce......................... 10 Do. Loganberries.................... 7 Do. Melons.......................... 4 Do. Mushrooms....................... 7 Do. Mustard greens.................. 10 Do. Nectarines...................... 7 Do. Onions.......................... 7 Do. Parsley......................... 7 Do. Peaches......................... 7 Do. Peanuts......................... 7 Do. Pears........................... 7 Do. Peas............................ 7 Do. Peppers......................... 7 Do. Plums (fresh prunes)............ 7 Do. Pumpkins........................ 7 Do. Quinces......................... 7 Do. Radishes (with or without tops). 7 Do. Radishes, tops.................. 7 Do. Raspberries..................... 7 Do. Romaine......................... 25 Do. Rutabagas (with or without tops) 7 Do. Rutabagas, tops................. 7 Do. Salsify......................... 7 Do. Spinach......................... 10 Do Squash, summer.................. 4 Do. Strawberries.................... 7 Do. Summer squash................... 7 Do. Swiss chard..................... 25 Do. Tomatoes........................ 4 Do. Turnips (with or without tops).. 7 Do. Turnips, greens................. 7 Do. Wheat........................... 1 Do. Youngberries.................... 7 Do. ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ \1\ Wine grapes grown for wine vintage years 1992 (Northern Hemisphere), 1993 (Southern Hemisphere), and earlier. 3. By amending 180.319 in the table therein by revising the entry for zineb, to read as follows: 180.319 Interim tolerances. * * * * * ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ Tolerance in parts per Substance Use million Raw agricultural commodity ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ * * * * * * * Zineb (zinc ethylene Do.......................... 0.52\2\............ Potatoes (to be used only bisdithiocarbamate). for seed piece treatment) ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ \2\ Tolerance expires on December 31, 1994 (see 40 CFR 180.115 Zineb; tolerances for residues). [FR Doc. 92 - 29755 Filed 12 - 8 - 92; 8:45 am] BILLING CODE 6560 - 50 - F