Source: https://www.federalregister.gov/documents/2007/06/13/E7-11324/amitraz-atrazine-ethephon-ferbam-lindane-propachlor-and-simazine-proposed-tolerance-actions
Timestamp: 2017-08-18 07:22:01
Document Index: 716122740

Matched Legal Cases: ['§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§\u2009180', '§ 180', '§\u2009180', '§180', '§180']

Federal Register :: Amitraz, Atrazine, Ethephon, Ferbam, Lindane, Propachlor, and Simazine; Proposed Tolerance Actions
A Proposed Rule by the Environmental Protection Agency on 06/13/2007
72 FR 32570
32570-32582 (13 pages)
EPA-HQ-OPP-2007-0187
FRL-8133-3
E7-11324
https://www.federalregister.gov/d/E7-11324 https://www.federalregister.gov/d/E7-11324
EPA is proposing to revoke certain tolerances for the insecticides amitraz and lindane; the herbicides atrazine, propachlor, and simazine; the plant growth regulator ethephon; and the fungicide ferbam. Also, EPA is proposing to modify certain tolerances for the herbicide atrazine, propachlor, and simazine; the insecticide amitraz; the plant growth regulator ethephon; and the fungicide ferbam. In addition, EPA is proposing to establish new tolerances for the herbicide atrazine; the plant growth regulator ethephon. The regulatory actions proposed in this document are in follow-up to the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q).
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0187, by one of the following methods:
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2007-0187. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.
Monisha Dandridge, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone number: (703) 308-0410; e-mail address: dandridge.monisha@epa.gov.
Start Printed Page 32571
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 FFDCA section 408(f) if needed. The order would specify data needed and the time frames 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 is proposing to revoke, remove, modify, and establish specific tolerances for residues of Amitraz, Atrazine, Ethephon, Ferbam, Lindane, Propachlor, and Simazine in or on commodities listed in the regulatory text.
EPA is proposing these tolerance actions to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of the FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each Reregistration Eligibility Decision (RED) and Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision (TRED) for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 1-513-489-8695; internet at http://www.epa.gov/​ncepihom/​ and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 1-800-553-6847 or 703-605-6000; internet at http://www.ntis.gov/​. Electronic copies of REDs and TREDs are available on the internet for amitraz, atrazine, ethephon, ferbam, lindane, propachlor, and simazine and in public dockets EPA-HQ-OPP-2004-0048 (amitraz), EPA-HQ-OPP-2003-0367 (atrazine), EPA-HQ-OPP-2004-0371 (ethephon), EPA-HQ-OPP-2004-0337 (ferbam), EPA-HQ-OPP-2002-0005 (lindane) and EPA-HQ-OPP-2005-0151 (simazine), respectively at http://www.epa.gov/​pesticides/​reregistration/​status.htm.
The selection of an individual tolerance level is based on crop field residue studies designed to produce the maximum residues under the existing or proposed product label. Generally, the level selected for a tolerance is a value slightly above the maximum residue found in such studies, provided that the tolerance is safe. The evaluation of whether a tolerance is safe is a separate inquiry. EPA recommends the raising of a tolerance when data show that: (1) Lawful use (sometimes through a label change) may result in a higher residue level on the commodity and (2) the tolerance remains safe, notwithstanding increased residue level allowed under the tolerance. In REDs, Chapter IV on “Risk Management, Reregistration, and Tolerance Reassessment” typically describes the regulatory position, FQPA assessment, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. In TREDs, the Agency discusses its evaluation of the dietary risk associated with the active ingredient and whether it can determine that there is a reasonable certainty (with appropriate mitigation) that no harm to any population subgroup will result from aggregate exposure. EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III.
Explanations for proposed modifications in tolerances can be found in the RED and TRED document and in more detail in the Residue Chemistry Chapter document which supports the RED and TRED. Copies of the Residue Chemistry Chapter documents are found in the Administrative Record and paper copies for amitraz, ferbam, lindane and simazine can be found under their respective public docket numbers, identified above. Paper copies for atrazine, ethephon and propachlor are Start Printed Page 32572available in the public docket for this proposed rule. Electronic copies are available through EPA's electronic public docket and comment system, regulations.gov at http://www.regulations.gov/​. You may search for docket number EPA-HQ-OPP-2007-0187, then click on that docket number to view its contents.
In addition, EPA is proposing to revoke certain specific tolerances because they are either no longer needed or are associated with food uses that are no longer registered under FIFRA. Registrations were canceled because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide. It is EPA's general practice to propose revocation of those tolerances for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance to cover residues in or on imported commodities or legally treated domestic commodities.
1. Amitraz. According to the TRED, the tolerance expression, which is currently expressed as “residues of the insecticide amitraz (N′-[2,4-dimethylphenyl]-N-[[(2,4-dimethylphenyl)imino] methyl]]-N-methylmethanimidamide) and its metabolites N-(2,4-dimethylphenyl) -N- methyl formamide and N-(2,4-dimethyl-phenyl) -N-methylmethanimidamide (both calculated as the parent) in or on the following raw agricultural commodities (RAC) at the following levels” in 40 CFR 180.287 should be modified. EPA has determined that there is no need to require residue data for 2,4-dimethylaniline because the current analytical enforcement methods detect all residues containing the 2,4-dimethylaniline moiety. The tolerance expression should specify that the terminal residues of concern for enforcement purposes are amitraz and its metabolites containing the 2,4-dimethylaniline moiety. Consequently, EPA is proposing that the tolerance expression in 40 CFR 180.287(a) read as follows: “(a) General. Tolerances are established for residues of the insecticide amitraz (N′-[2,4-dimethylphenyl]-N- [[(2,4-dimethylphenyl)imino] methyl]]-N-methylmethanimidamide) and its metabolites containing the 2,4-dimethylaniline moiety (calculated as the parent) in or on food commodities, as follows:”.
All registered uses of amitraz in beehives have been cancelled and therefore, the Agency determined that the tolerances on honey and honeycomb are no longer needed and should be revoked. Consequently, EPA is proposing to revoke the tolerances in 40 CFR 180.287(a) for residues of amitraz and its metabolites in or on “honey” and “honeycomb.”
There have been no active U.S. registrations for use of amitraz on cotton since May 3, 2006. However, Arysta Life Sciences requested that the tolerance in 40 CFR 180.287 on cotton, undelinted seed be retained for import purposes. EPA requires that Arysta Life Sciences submit information to the Agency about the use pattern in foreign countries and residue data from those countries to support the import tolerance. Certain tolerances were based on cotton as a livestock feed item; however there will no longer be any dietary exposure of livestock to amitraz through feed. Since cotton gin byproducts or cotton gin trash are not allowed to be fed to livestock in Europe, EPA does not expect imported meat to have secondary residues of amitraz. And although cottonseed is imported from Australia, U.S. production of cotton is about 55x greater than that produced in Australia. Therefore, even if such imported cottonseed were fed to animals, the contributions to the diet will be insignificant when compared with direct dermal treatment of amitraz to cattle and hogs. Consequently, the tolerances for egg, poultry, goat, and sheep commodities should be revoked. Therefore, EPA is proposing to revoke the commodity tolerances in 40 CFR 180.287(a) for residues of amitraz and its metabolites in or on “egg;” “goat, fat;” “goat, meat byproducts;” “goat, meat;” “poultry fat/meat;” “poultry, meat byproducts;” “sheep, fat;” “sheep, meat byproducts;” and “sheep, meat.”
For adults, acute dietary risks from use of amitraz on hops, for which an import tolerance exists on dried hops, exceed the Agency's level of concern. The Agency's assessment concluded that the acute dietary risk is driven by the contribution of hops, and the acute dietary exposure estimate for adults 20 to 49 years old is 582% of the acute population adjusted dose (aPAD) at the 99.9th percentile. The Agency has evaluated the human health risks associated with all currently registered uses of amitraz and has determined that there is reasonable certainty that no harm to any population subgroup will result from aggregate non-occupational exposure to amitraz provided the tolerance for residues in or on hops is revoked and the registrant implements the mitigation measures identified in the RED, i.e., to reduce exposure from residential use; the registrant has agreed to reduce the amount of active ingredient in dog collars. Provided that mitigation measures in the RED are implemented and the tolerance on hops, dried cones is revoked, EPA is able to conclude that risk from exposure to amitraz fits within its own risk cup such that the tolerances for amitraz meet the FQPA safety standard. Therefore, under FFDCA section 408(e)(1), EPA is proposing to revoke the import tolerance in or on hop, dried cones in 40 CFR 180.287(a) because it does not meet requirements of FFDCA section 408(b)(2).
Currently, direct animal treatments of amitraz are registered for use on cattle and hogs. Based on the available data following dermal treatment and a 3-day pre-slaughter interval on cattle with amitraz which show combined amitraz residues of concern are as high as 0.09 ppm in fat, 0.02 ppm in muscle, and range from 0.08 to 0.21 ppm in kidney and liver, the Agency determined that the tolerances should be decreased on cattle, meat from 0.05 to 0.02 ppm, cattle, meat byproducts from 0.3 to 0.2 ppm and cattle, fat should remain unchanged at 0.1 ppm. Based on available data following dermal treatment of swine with amitraz which show combined amitraz residues of concern in liver and kidney as high as 0.05 ppm and 0.07 ppm, respectively, the Agency determined that the tolerances on hog, liver and hog, kidney should be decreased, from 0.2 to 0.1 ppm. Therefore, EPA is proposing in 40 CFR 180.287(a) to decrease the tolerances for “cattle, meat byproducts” from 0.3 to 0.2 ppm; “cattle, meat” from 0.05 to 0.02 ppm; “hog, kidney” from 0.2 to 0.1 ppm; “hog, liver” from 0.2 to Start Printed Page 325730.1 ppm; and “milk, fat” from 0.3 to 0.2 ppm.
2. Atrazine. Currently the tolerance expression in 40 CFR 180.220(a)(1) is expressed in terms of residues of atrazine and in paragraph (a)(2) in terms of combined residues of atrazine and its metabolites 2-amino-4-chloro-6-ethylamino-s-triazine, 2-amino-4-chloro-6-isopropylamino-s-triazine, and 2-chloro-4,6-diamino-s-triazine. Because EPA considers residues of chlorinated metabolites of atrazine in both animal and plant commodities to be of toxicological concern, the Agency has determined that atrazine and its chlorinated metabolites (2-amino-4-chloro-6-ethylamino-s-triazine, 2-amino-4-chloro-6-isopropylamino-s-triazine, and 2-chloro-4,6-diamino-s-triazine) should be included in the tolerance expression. Therefore, EPA proposes revising 40 CFR 180.220(a) by combining 40 CFR 180.220(a)(1) and (a)(2) into 40 CFR 180.220(a). Also, EPA is proposing to revise the tolerance expression in proposed recodified § 180.220(a) as follows: “(a) General. Tolerances are established for the combined residues of the herbicide atrazine (2-chloro-4-ethylamino-6-isopropylamino-s-triazine) and its chlorinated metabolites 2-amino-4-chloro-6-isopropylamino-s-triazine, 2-amino-4-chloro-6-ethylamino-s-triazine, and 2,4-diamino-6-chloro-s-triazine, in or on food commodities as follows:”
Currently, there is only one active registration for use of atrazine on perennial rye grass and that use is restricted to the Conservation Reserve Program lands in OK, OR, NE, and TX, and along roadsides in CO, KS, MT, NE, ND, SD, and WY. Because the label restricts grazing and cutting for feed, the Agency has determined that the tolerance on perennial rye grass is no longer needed and should be revoked. Therefore, EPA is proposing to revoke the tolerances in proposed recodified 40 CFR 180.220(a) for the combined residues of atrazine in or on rye grass, perennial at 15 ppm.
Because of the limited acreage, timing of application, restrictions on the use of range grasses for animal feeds, and the dominance of corn as a feed item, range grasses are not expected to impact either the livestock diet or the risk estimates significantly, and consequently were not included in the dietary exposure assessments. Currently, there are active registrations for atrazine use on range grass. Because the registrant has recently submitted new data to the Agency in support of a group tolerance and the range grass use has feeding and grazing restrictions on product labels, the Agency will maintain the existing tolerance. The Agency made a safety finding that atrazine tolerances are safe. Consequently, EPA will not take action to revoke the tolerance for atrazine in 40 CFR 180.220 on range grass at this time. However, in order to reflect current Agency practice the terminology should be revised to read grass, forage and grass, hay. Therefore, EPA is proposing to revise commodity terminology in proposed recodified 40 CFR 180.220(a) to conform to current Agency practice as follows: “grass, range” will be revised to read both “grass, forage” and “grass, hay.”
Because EPA no longer considers sugarcane fodder and forage to be significant livestock feed items their tolerances are no longer needed and therefore should be revoked. Consequently, EPA is proposing to revoke the tolerances in proposed recodified 40 CFR 180.220(a) for sugarcane, fodder and sugarcane, forage. EPA's listing of significant food and feed commodities (raw and processed) can be found in Table 1 of Guideline OPPTS 860.1000 (available at http://www.epa.gov/​opptsfrs/​OPPTS_​Harmonized/​860_​Residue_​Chemistry_​Test_​Guidelines/​Series/​).
Based on available field trial data that showed combined atrazine residues of concern were as high as 0.27 ppm to 1.59 ppm in or on corn, field, stover and corn, sweet, stover, respectively, the Agency determined that the tolerances on corn, pop, stover; corn, fodder, field; and corn, sweet, stover should be decreased from 15 to 0.5 ppm, 15 to 0.5 ppm, and 15 to 2.0 ppm, respectively. Therefore, EPA is proposing to decrease the tolerances in proposed recodified 40 CFR 180.220(a) on “corn, pop, stover” to 0.5 ppm; “corn, fodder, field” to 0.5 ppm and to revise the commodity terminology to “corn, field, stover;” and “corn, sweet, stover” to 2.0 ppm.
Based on field trial data that showed atrazine residues of concern as high as 15 ppm on corn, pop, forage, the Agency determined that the tolerance on corn, pop, forage should be decreased from 15 to 1.5 ppm. Therefore, EPA is proposing to decrease the tolerance in proposed recodified 40 CFR 180.220(a) on “corn, pop, forage” to 1.5 ppm.
Based on available field trial data that showed combined atrazine residues of concern were less than 0.2 ppm (less than the combined Limit of Quantitation (LOQs) for atrazine and its chlorometabolites) in or on field corn grain and sweet corn grain, the Agency determined that the tolerances on field corn grain and sweet corn grain should each be decreased from 0.25 to 0.20 ppm. Therefore, EPA is proposing to decrease the tolerances in proposed recodified 40 CFR 180.220(a) from 0.25 to 0.20 ppm for “corn, sweet, kernel plus cob with husks removed” and “corn, grain” and revise the terminology to “corn, field, grain” and “corn, pop, grain.”
Based on available data that indicate combined atrazine residues of concern were as high as <0.05 ppm in or on macadamia nuts, the Agency determined that the tolerance should be decreased to 0.20 ppm. Therefore, EPA is proposing to decrease the tolerance in proposed recodified 40 CFR 180.220(a) for combined residues of atrazine in or on “nut, macadamia” from 0.25 to 0.20 ppm.
Based on available field trial data that indicate the combined atrazine residues of concern as high as 0.20 ppm in or on grain sorghum, and 0.23 ppm in or on sorghum stover, the Agency determined the tolerances should be decreased to 0.20 ppm in or on sorghum, grain; grain; and 0.50 ppm in or on sorghum, stover. EPA is also revising the commodity terminology to reflect current Agency practice. Therefore, EPA proposes decreasing and revising the tolerances in proposed recodified 40 CFR 180.220(a) for the combined residues of atrazine in or on “sorghum, grain” at 0.25 ppm to “sorghum, grain, grain” at 0.20 ppm and “sorghum, fodder” at 15 ppm to 0.50 ppm.
Based on field trial data (at 0.8-2x application rate) that show combined atrazine residues of concern as high as <0.20 ppm in or on sugarcane, the Agency determined that the tolerance should be decreased to 0.20 ppm. Therefore, EPA is proposing to decrease the tolerance in proposed recodified 40 CFR 180.220(a) on sugarcane, cane from 0.25 to 0.20 ppm.
Based on field trial data that showed atrazine residues of concern as high as 0.06 ppm on wheat grain and 0.34 ppm on wheat straw, EPA determined that the tolerances on wheat grain and wheat straw should be decreased from 0.25 to 0.1 ppm and from 5.0 to 0.5 ppm, respectively. Therefore, EPA is proposing in proposed recodified 40 CFR 180.220(a) to decrease the tolerances on wheat, grain to 0.1 ppm and wheat, straw to 0.5 ppm.
In the atrazine RED, the Agency recommends revising the tolerance at 5 ppm on wheat, fodder to wheat, forage and decreasing that tolerance to 1.5 ppm. The Agency believes that a clearer recommendation should have been to establish a tolerance on wheat forage at 1.5 ppm and revise the commodity terminology for the tolerance at 5 ppm on wheat, fodder to “wheat, hay.” Based on field trial data that showed atrazine Start Printed Page 32574residues of concern as high as 1.11 ppm on wheat forage, EPA determined that a tolerance on wheat forage should exist at 1.5 ppm. Nevertheless, sometime between July 1, 2002 and July 1, 2003, the tolerance in 40 CFR 180.220 at 5 ppm on wheat, fodder underwent a revision in nomenclature to “wheat, straw,” which resulted in two tolerances on wheat straw, both at 5 ppm. Because there is already a tolerance on wheat straw in 40 CFR 180.220 (see above proposal to decrease the tolerance on wheat straw to 0.5 ppm, which is considered by the Agency to be the appropriate level based on data), the duplicate wheat straw tolerance should be revoked. Therefore, EPA is proposing in 40 CFR 180.220 to revoke the duplicate tolerance on wheat, straw and establish a tolerance on wheat, forage at 1.5 ppm. In addition, based on field trial data that showed atrazine residues of concern as high as 1.11 ppm on wheat forage and adjusting for the difference in dry matter between hay and forage (88% vs. 25%), the Agency expects combined residues of about 3.9 ppm on wheat hay and therefore determined that a tolerance should be established on wheat hay at 5.0 ppm. Consequently, EPA is proposing to establish a tolerance in 40 CFR 180.220(a) on wheat, hay at 5.0 ppm.
Based on available field trial data that indicate combined atrazine residues of concern as high as 0.20 ppm in or on sorghum forage, the Agency determined the tolerances should be decreased to 0.25 ppm and revise the terminology to read sorghum, grain, forage and sorghum, forage, forage. However, that recommended tolerance level reduction is based on label restrictions which require that all atrazine labels with postemergent sorghum uses have a minimum PHI of 45 days, and preemergent sorghum uses have a minimum PHI of 60 days. In addition, available field trial data indicate that combined atrazine residues of concern as high as 1.11 ppm and 1.15 ppm in or on corn field forage and corn sweet forage respectively, based on atrazine labels for postemergent and preemergent field corn use which require a minimum PHI of 60-days and a PHI of 45 days for sweet corn use, EPA has determined that these tolerances should be decreased from 15 to 1.5 ppm. After EPA has confirmed that active registrations for the use of atrazine on field and sweet corn forage and sorghum forage have been amended to reflect the appropriate pre-harvest intervals (PHIs), the Agency will take action to modify tolerances on field and sweet corn forage; sorghum forage; milk, and the fat, meat and meat byproducts of cattle, goats, horses, and sheep in proposed recodified 40 CFR 180.220. Therefore, EPA will not take action on these tolerances at this time, but will follow-up with the registrants and address the tolerances, if needed, in a future publication in the Federal Register. However, EPA is proposing to revise commodity terminology in 40 CFR 180.220(a) to conform to current Agency practice as follows: “sorghum, forage” to “sorghum, grain, forage” and “sorghum, forage, forage.”
3. Ethephon. Because there have been no registered uses of ethephon on cranberries and figs since January 1991, the Agency determined that the tolerances are no longer needed and should be revoked. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.300(a) on “cranberry” and “fig.”
Based on available processing data which show that residues of ethephon do not concentrate in or on pearled barley, EPA determined that the tolerance is no longer needed, and therefore should be revoked. Consequently, EPA is proposing to revoke the tolerance in 40 CFR 180.300(a) on “barley, pearled barley.”
Because active registrations with use for ethephon on pumpkins prohibit harvesting for human or animal consumption and limit use to seed production only, the Agency has determined that the tolerance on pumpkin is no longer needed. Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.300(a) on “pumpkin.”
Based on the Maximum Theoretical Dietary Burden (MTDB) for dairy cattle and available ruminant feeding data (0.93x), ethephon residues in the milk, fat, meat, kidney, and liver of cattle were expected by the Agency (at 1x MTDB) to be as high as 0.008 ppm, 0.108 ppm, 0.017 ppm, 0.686 ppm, and 0.102 ppm, respectively. Therefore, tolerances on the fat and meat of cattle, goats, hogs, horses, and sheep should be decreased from 0.1 to 0.02 ppm; tolerances on meat byproducts of cattle, goats, horses, and sheep should be separated into “meat byproducts, except kidney,” and “kidney,” and the tolerances on meat byproducts, except kidney should be increased from 0.1 to 0.2 ppm and tolerances on kidney should be increased from 0.1 to 1.0 ppm; and the tolerance on milk should be decreased from 0.1 to 0.01 ppm.
Consequently, EPA is proposing in 40 CFR 180.300(a) to change some commodity terminology by revising the terminology “cattle, meat byproducts;” “goat, meat byproducts;” “hog, meat byproducts;” “horse, meat byproducts;” and “sheep, meat byproducts” to read “cattle, meat byproducts, except kidney;” “cattle, kidney;” “goat, meat byproducts, except kidney;” “goat, kidney;” “hog, meat byproducts, except kidney;” “hog, kidney;” “horse, meat byproducts, except kidney;” “horse, kidney” and “sheep, meat byproducts, except kidney;” and “sheep, kidney;” respectively.
In addition, EPA is proposing to decrease tolerances on “cattle,fat;” “cattle, meat;” “goat, fat;” “goat, meat;” “hog, fat;” “hog, meat;” “horse, fat;” “horse, meat;” “sheep, fat;” and “sheep, meat” to 0.02 ppm.
EPA is also proposing to increase tolerances on “cattle, meat byproducts, except kidney;” ; “goat, meat byproducts, except kidney;” “hog, meat byproducts, except kidney;” “horse, meat byproducts, except kidney;” and “sheep, meat byproducts, except kidney to 0.2 ppm; and to increase tolerances on ”cattle, kidney;“ ”goat, kidney;“ ”hog, kidney;“ ”horse, kidney;“ and ”sheep, kidney“ to 1.0 ppm; and decrease the tolerance on ”milk“ to 0.01 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on the available data that show residues of ethephon as high as 0.49 ppm and 4.93 ppm in or on coffee, bean, green and cotton, undelinted seed, respectively, EPA determined that the tolerances on coffee, bean, green and cotton, undelinted seed should be increased from 0.1 to 0.5 ppm and 2.0 to 6.0 ppm, respectively. Therefore, the Agency is proposing to increase the tolerance on “coffee, bean, green” and on “cotton, undelinted seed” in 40 CFR 180.300(a) to 0.5 ppm, and 6.0 ppm, respectively; and to remove the “(N)” designation to conform to current Agency administrative practice, where the “(N)” designation means negligible residues. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Compatibility exists between the reassessed U.S. tolerance of 5.0 ppm and Codex MRL for ethephon residues in or on apples. However, because data indicate that ethephon residues concentrate (1.6x) in apple juice, EPA determined that a tolerance should be established at 10.0 ppm in apple, juice. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.300(a) in “apple, juice” at 10.0 ppm.
Based on data that show ethephon residues as high as 150.0 ppm in or on cotton gin byproducts, EPA determined that a tolerance on cotton gin byproducts should be established at 180.0 ppm. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.300(a) on “cotton, gin byproducts” at 180.0 ppm.
Based on the available data that show ethephon residues as high as 0.52 ppm in or on filbert, EPA determined that a tolerance on filbert should be established at 0.80 ppm. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.300(a) on “filbert” at 0.80 ppm.
Based on data that show ethephon residues <2.0 ppm in wheat grain and that residues concentrate (1.8x) in wheat germ, EPA determined that a tolerance should be established at 5.0 ppm in or on wheat, germ. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.300(a) on “wheat, germ” at 5.0 ppm.
Based on available exaggerated (1.6x MTDB) poultry feeding data that show residues of ethephon as high as 0.0036 ppm in eggs, 0.032 ppm in fat, 0.015 ppm in meat, and 0.068 ppm in liver, EPA calculated residues to be 0.002 ppm in egg, 0.02 ppm in fat, 0.009 ppm in meat, and 0.04 ppm in liver at the 1x MTDB for poultry. The Agency determined that the tolerances should be established on egg at 0.002 ppm, fat at 0.02 ppm, meat and meat byproducts, except liver at 0.01 ppm, and liver at 0.05 ppm. Therefore, EPA is proposing to establish tolerances in 40 CFR 180.300(a) on “egg” at 0.002 ppm; “poultry, fat” at 0.02 ppm; “poultry, meat” at 0.01 ppm; “poultry, meat byproducts, except liver” at 0.01 ppm; and “poultry, liver” at 0.05 ppm.
Cucumber was not included in the dietary risk assessment for ethephon because the use was to become non-food; i.e., limited to cucumbers grown for seed production and product labels were to include that limitation and a restriction to prohibit the harvesting of treated cucumbers for human or animal consumption. Therefore, the ethephon RED recommended revocation of the tolerance on cucumber. However, based on the estimated acute and chronic dietary risks of ethephon are 77% of the aPAD and 16% of the chronic population adjusted dose (cPAD), the relatively low tolerance level for cucumber (0.1 ppm) and maximum estimate of 1% crop treated (about 2000 acres), the Agency determined that the addition of cucumbers to the dietary risk assessment would not significantly contribute to dietary or drinking water risk estimates. Currently, the Agency is in the process of confirming the completeness of amendments for two active registrations concerning the inclusion of the limitation and restriction on cucumber use (particularly under the product label application instructions for California only). Consequently, the Agency will not propose to take action on the cucumber tolerance in 40 CFR 180.300(a) for ethephon at this time, but expects to address it in a future publication in the Federal Register.
The proposed tolerance actions herein for ethephon, to implement the recommendations of the ethephon TRED, reflect use patterns in the United States which support a different tolerance than the Codex value on cottonseed; chicken eggs; meat of poultry; meat of cattle, goats, hogs, horses, and sheep; and milk of cattle, goats, and sheep. However, compatibility exists between the reassessed U.S. tolerances and Codex MRLs for ethephon residues in or on apples, blueberries, cherries, pineapples, tomatoes, and walnuts.
4. Ferbam. Tolerances for residues of ferbam in or on food and feed commodities are currently established under 40 CFR 180.114(a) for residues of the fungicide ferbam (ferric dimethyldithiocarbamate), calculated as zinc ethylenebisdithiocarbamate (zineb). Current analytical methodology employs common moiety detection in which dithiocarbamate residues are converted to carbon disulfide (CS2). Based on this new methodology, the Agency has determined that the tolerance expression should reflect residues of ferbam (ferric dimethyldithiocarbamate), calculated as carbon disulfide. Therefore, EPA is proposing to modify the tolerance expression in 40 CFR 180.114(a) to residues of the fungicide ferbam (ferric dimethyldithiocarbamate) calculated as carbon disulfide.
In order to account for the conversion of ferbam residues previously calculated as zineb to that calculated as carbon disulfide, EPA determined that a conversion factor of 0.55x should be applied to existing tolerance levels. Consequently, the tolerances for apples, cherries, cranberries, citrus fruit, grapes, mangoes, nectarines, peaches, and pears currently at 7 ppm should be decreased to 4 ppm. Also, because mango has only one active FIFRA section 24(c) registration for use in Florida, the tolerance should be moved from § 180.114(a) to § 180.114(c) for regional tolerances. Therefore, EPA is proposing to decrease the tolerances in 40 CFR 180.114(a) on “apple;” “cherry;” “cranberry;” “grape;” “nectarine;” “peach;” and “pear;” each to 4.0 ppm; “fruit, citrus” to 4.0 ppm; revise the commodity terminology for fruit, citrus to read “fruit, citrus, group 10” to decrease the tolerance on mango to 4.0 ppm and recodify the entry for mango into § 180.114(c).
There have been no active ferbam registrations on apricot, asparagus, blueberries, boysenberries, cucumbers, peas, squash, and tomatoes in the United States since 1998. There have been no active ferbam registrations on blackberries, dewberries, loganberries, or youngberries in the United States since October, 2004. Because their tolerances are no longer needed, EPA is proposing to revoke the commodity tolerances in 40 CFR 180.114(a) for residues of ferbam in or on “apricot;” “blackberry;” “blueberry;” “boysenberry;” “dewberry;” “loganberry;” “pea;” “squash;” and “youngberry.” There have been no active ferbam registrations on beans, cabbage, lettuce, and raspberries since July 3, 2006 and existing stocks were allowed by the Agency to be sold and distributed until October 27, 2006 (70 FR 62112, October 28, 2005) (FRL-7743-6). The Agency believes that end users will have sufficient time to exhaust existing stocks and for treated commodities to have cleared the channels of trade by October 27, 2007. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.114(a) for residues of ferbam on “bean,” “cabbage,” “lettuce,” and “raspberry” with an expiration/revocation date of October 27, 2007. On October 26, 1998 (63 FR 57067)(FRL-6035-6), EPA published a final rule in the Federal Register in which it responded to the comment by Interregional Research Project No. 4 (IR-4) that it would support uses of ferbam on guava and papaya. However, in a correspondence to the Agency dated February 24, 2005, IR-4 withdrew its support for the use of ferbam on papaya. Also, in recent correspondence, the IR-4 no longer expressed that it was interested in supporting the use of ferbam on guava. Because there are no active registrations for ferbam use on guava and papaya and there is no longer an expressed need for their tolerances, these tolerances should be revoked. Therefore, the Agency is proposing to revoke the tolerances in 40 CFR 180.114(a) on guava and papaya. Also, on October 26, 1998 (63 FR 57067)(FRL-6035-6), EPA published a final rule in the Federal Register in which it responded to the Canadian Horticultural Council's comment asking that certain tolerances, including those in 40 CFR 180.114 for ferbam use on Start Printed Page 32576asparagus, cucumbers, and tomatoes, not be revoked. At that time, the Agency responded that it would not revoke the tolerances on asparagus, cucumbers, and tomatoes in 40 CFR 180.114. However, in the interim, no interested party has declared a need for tolerances on asparagus, cucumber, or tomato commodities and interest in providing the appropriate data for import purposes. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.114 on asparagus, cucumber, and tomato.
There are no Codex Maximum Residue Limits (MRLs) for ferbam use per se. However, Codex MRLs exist for the dithiocarbamates from the use of various dithiocarbamates and they are currently expressed as total dithiocarbamates, determined or carbon disulfide (milligrams/kilogram (mg/kg)). The proposed modification of the U.S. tolerance expression for ferbam to be calculated as carbon disulfide will improve the comparison between U.S. tolerances on ferbam with Codex MRLs on total dithiocarbamates. The proposed U.S. tolerances of 4.0 ppm for ferbam residues (calculated as carbon disulfide) on cranberry and citrus fruit are different from the Codex MRLs of 5.0 and 10.0 mg/kg for total dithiocarbamate residues (calculated as carbon disulfide) on cranberry and mandarins, respectively. The difference may reflect different use patterns in the United States which support a different tolerance level and/or result from Codex's inclusion of various dithiocarbamates in its tolerance definition.
5. Lindane. In July 2006, EPA created an addendum to the July 2002 Lindane RED. Both documents are available in public docket EPA-HQ-OPP-2002-0202. In the 2006 Lindane RED Addendum, which reflects the Agency's conclusions on the lindane seed treatment uses in light of the information gathered since the 2002 RED, the Agency established that lindane seed treatment uses are ineligible for reregistration and that the existing lindane fat tolerances should be revoked. In the addendum, the Agency concludes that the risks of continued use of lindane outweigh the benefits. In addition, the addendum noted that as of July 27, 2006, the Agency had received requests from all lindane technical and end-use product registrants to voluntarily cancel all lindane product registrations. Consequently, in the Federal Register notice of August 23, 2006 (71 FR 49445) (FRL-8089-1), EPA published its receipt of requests to voluntarily cancel lindane registrations and provided a public comment period. The Agency did not receive any comments that required further review of the cancellation requests. Further, the registrants did not withdraw their requests. Accordingly, EPA sent final cancellation orders to the registrants granting the requested cancellations and published a notice announcing these cancellation orders in the Federal Register on December 13, 2006 (71 FR 74905) (FRL-8103-4). In that notice, EPA announced issuance of final orders cancelling the registrations of all pesticide products containing the pesticide lindane, including those concerning lindane registrations for use as a seed treatment on grain. The cancellation of manufacturing-use products was effective on October 4, 2006, and the cancellation of end-use products is effective on July 1, 2007. The Agency has established in the cancellation orders that July 1, 2007 is the last day on which these lindane manufacturing-use products can be used and October 1, 2009 is the last day on which these lindane end-use products can be used. FFDCA section 408(l)(5) protects treated commodities that are still in the channels of trade after revocation if they were lawfully treated. Because lindane seed treatment registrations are canceled as described above, EPA believes that the associated tolerances for the fat of cattle, goats, hogs, horses, and sheep fed lindane-treated seeds will no longer be needed after October 1, 2009. Therefore, EPA is proposing to revoke tolerances in 40 CFR 180.133 on “cattle, fat;” “goat, fat;” “hog, fat;” “horse, fat;” and “sheep, fat” with an expiration/revocation date of October 2, 2009. Also, because the time-limited tolerances on “broccoli;” “brussels sprouts;” “cabbage;” and “cauliflower” expired on April 26, 2007, EPA is proposing to remove them from 40 CFR 180.133.
6. Propachlor. Currently, propachlor tolerances are established in 40 CFR 180.211(a) for residues of propachlor and its metabolites, calculated as propachlor. The Agency determined that residues of concern are propachlor and its metabolites which contain the N-isopropylaniline moiety. Therefore, EPA is proposing to revise the tolerance expression in 40 CFR 180.211(a) as follows: “(a) General. Tolerances are established for the combined residues of the herbicide 2-chloro -N- isopropylacetanilide and its metabolites containing the N-isopropylaniline moiety, calculated as 2-chloro -N- isopropylacetanilide, in or on the following raw agricultural commodities:”
Also, in 40 CFR 180.211(a), EPA is proposing to remove the “(N)” designation from all entries to conform to current Agency administrative practice, where the “(N)” designation means negligible residues.
Based on poultry feeding data and MTDB for poultry, EPA determined that there is no reasonable expectation of finite residues of propazine residues of concern in eggs (<0.02 ppm at 60x MTDB) and in the fat, meat, and meat byproducts of poultry (as high as 0.02 ppm at 60x MTDB) resulting from the feeding of propachlor treated commodities. Therefore, the tolerances on fat, meat, meat byproducts for poultry are no longer needed in accordance with 40 CFR 180.6(a)(3). Consequently, the Agency is proposing to revoke the tolerances in 40 CFR 180.211 on “egg;” “poultry, fat;” “poultry, meat;” and “poultry, meat byproducts.”
Based on available exaggerated cattle feeding data that show combined propachlor residues of concern at the dose level of 1.3x MTDB as high as 0.12 in kidney, and 0.04 ppm in fat and liver, EPA determined that tolerances on the fat and meat byproducts of cattle, goats, horses, and sheep should be increased from 0.02 to 0.05 ppm, and individual tolerances on the kidney of goats, horses, and sheep should be separated from “meat byproducts” and increased to 0.2 ppm. Therefore, the Agency is proposing to increase the tolerances in 40 CFR 180.211 on “cattle, fat;” “goat, fat;” “horse, fat;” and “sheep, fat” to 0.05 ppm; revise their commodity terminologies to read “cattle, meat byproducts, except kidney;” “goat, meat byproducts, except kidney;” “horse, meat byproducts, except kidney;” and “sheep, meat byproducts, except kidney;” increase tolerances on cattle, meat byproducts, except kidney; goats, meat byproducts, except kidney; horse, meat byproducts, except kidney; and sheep, meat byproducts, except kidney; to 0.05 ppm and establish separate tolerances for “cattle, kidney;” “goat, kidney;” “horse, kidney;” and “sheep, kidney” at 0.2 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data that showed combined propachlor residues of concern as high as 7.67 ppm and 10.59 ppm in or on sorghum forage and stover, respectively, EPA determined that the tolerances on sorghum forage and sorghum, grain, stover should each be increased from 5.0 to 8.0 ppm and 12.0 ppm, respectively. Therefore, EPA is proposing in 40 CFR 180.211 to revise the commodity terminology “sorghum, Start Printed Page 32577forage” to read “sorghum, grain, forage” and “sorghum, forage, forage” and increase the tolerance from 5.0 to 8.0 ppm; and increase “sorghum, grain, stover” from 5.0 to 12.0 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data that showed combined propachlor residues of concern as high as 0.19 ppm and 2.12 ppm in or on corn grain and forage, respectively, EPA determined that the tolerances on corn grain and corn forage should be increased from 0.1 to 0.2 ppm and 1.5 to 3.0 ppm, respectively. Therefore, the Agency is proposing in 40 CFR 180.211 to revise the commodity terminology for “corn, grain” to read “corn, field, grain” and to increase the tolerance on corn, field, grain to 0.2 ppm, to increase “corn, forage” to 3.0 ppm, and revise the commodity terminology to read “corn, field, forage” and “corn, sweet, forage.” The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data that showed combined propachlor residues of concern no greater than 1.0 ppm in or on corn stover, EPA determined that the tolerance on corn stover should be established at 1.0 ppm. Therefore, the Agency is proposing to establish a tolerance in 40 CFR 180.211(a) on corn, field, stover at 1.0 ppm.
In addition, EPA is proposing to revise commodity terminology in 40 CFR 180.211 to conform to current Agency practices as follows: “sorghum, grain” to “sorghum, grain, grain.”
7. Simazine. Because there are no active food use U.S. registrations on bermuda grass and no active U.S. registrations for simazine use associated with banana and fish, their tolerances are no longer needed and therefore should be revoked. Consequently, EPA is proposing to revoke in 40 CFR 180.213(a)(1) the tolerances on “bermuda grass;” “bermudagrass, forage;” and “bermudagrass, hay” and proposing to revoke in 40 CFR 180.213(a)(2) the tolerances on “banana” and “fish” and remove § 180.213(a)(2).
Currently, simazine tolerances are established in 40 CFR 180.213(a)(1) for residues of simazine only. The Agency determined that residues of concern are simazine and its two chlorinated degradates. Therefore, EPA is proposing to revise 40 CFR 180.213(a) to read as follows: “(a) General. Tolerances are established for the combined residues of the herbicide simazine (2-chloro-4,6-bis(ethylamino)-s-triazine) and its two chlorinated degradates (2-amino-4-chloro-6-ethylamino-s-triazine and 2,4-diamino-6-chloro-s-triazine), the total residue to be measured in or on the following food commodities:”. The revision of 180.213(a) will eliminate paragraph designations (a)(1) and (a)(2).
Because there are no active food use U.S. registrations on alfalfa and sugarcane, molasses, the Agency has determined the tolerances in or on alfalfa and sugarcane, molasses should be revoked. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.213 in or on “alfalfa;” “alfalfa, forage;” “alfalfa, hay;” and “sugarcane, molasses.” Also, because the time-limited tolerances on “artichoke, globe;” “asparagus;” and “sugarcane, cane” expired on December 31, 2000, EPA is proposing to remove them from 40 CFR 180.213.
Because there no longer are registered uses of simazine on pasture and rangeland grasses, the tolerances on grass, grass forage, and grass hay are no longer needed. Consequently, EPA is proposing to revoke the tolerances in 40 CFR 180.213 on “grass;” “grass, forage;” and “grass, hay.”
Because the use of simazine on boysenberry and dewberry is covered by the reassessed tolerance on blackberry, the tolerances on boysenberry and dewberry are no longer needed and therefore should be revoked. Consequently, EPA is proposing to remove the tolerances in 40 CFR 180.213 on “boysenberry” and “dewberry,” in accordance with 40 CFR 180.1(g), since the tolerance on blackberry covers boysenberry and dewberry.
Based on poultry feeding data and MTDB for poultry, EPA determined that there is no reasonable expectation of finite residues of simazine residues of concern in the fat, meat, and meat byproducts of poultry resulting from the feeding of simazine treated commodities. Therefore, the tolerances on fat, meat, meat byproducts for poultry are no longer needed in accordance with 40 CFR 180.6(a)(3). Consequently, the Agency is proposing to revoke the tolerances in 40 CFR 180.213 on “poultry, fat;” “poultry, meat;” and “poultry, meat byproducts.” However, because detectable residues of 2,4-diamino-6-chloro-s-triazine were found in egg at 6.3x the MTDB, the Agency determined that the tolerance on egg should be increased from 0.02 ppm and set at the combined LOQ of 0.03 ppm. Therefore, the Agency is proposing to increase the tolerance in 40 CFR 180.213 on “egg” to 0.03 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on ruminant feeding data and MTDB for swine, EPA determined that there is no reasonable expectation of finite residues of simazine residues of concern in the fat, meat, and meat byproducts of hogs resulting from the feeding of simazine treated commodities. Therefore, the tolerances on fat, meat, meat byproducts for hogs are no longer needed inaccordance with 40 CFR 180.6(a)(3). Consequently, the Agency is proposing to revoke the tolerances in 40 CFR 180.213 on “hog, fat;” “hog, meat;” and “hog, meat byproducts.”
Based on ruminant feeding data for (5.6 to 6.0x MTDB) simazine that show combined residues were <0.03 ppm (below the combined LOQ of 0.03 ppm), EPA determined that there is no reasonable expectation of finite combined simazine residues of concern in the fat of cattle, goats, horse, and sheep. Therefore, the tolerances on the fat for cattle, goats, horses and sheep are no longer needed in accordance with 40 CFR 180.6(a)(3). Consequently, the Agency is proposing to revoke the tolerances in 40 CFR 180.213 on “cattle, fat;” “goat, fat;” “horse, fat;” and “sheep, fat.”
In addition, based on available exaggerated ruminant feeding data that show combined residues were quantifiable at the dose level of 11.2 to 12.0x MTDB of simazine, EPA determined that tolerances on the meat and meat byproducts of cattle, goats, horses, and sheep, and milk should be set at the combined LOQ of 0.03 ppm and increased from 0.02 to 0.03 ppm. Therefore, the Agency is proposing to increase the tolerances in 40 CFR 180.213 on “cattle, meat;” “cattle, meat byproducts;” “goat, meat;” “goat, meat byproducts;” “horse, meat;” “horse, meat byproducts;” “sheep, meat;” “sheep, meat byproducts;” and “milk” to 0.03 ppm. The Agency determined that the increased tolerances are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Based on available data that showed combined simazine residues of concern as high as <0.15 ppm in or on apples, avocados, corn, forage, corn, grain, grapes, olives, and peaches, and <0.20 ppm in or on plums, EPA determined that the tolerances on these commodities should each be decreased from 0.25 to 0.20 ppm. Therefore, the Start Printed Page 32578Agency is proposing to decrease the tolerances in 40 CFR 180.213 on “apple,” “avocado,” “corn, forage;” “corn, grain;” “grape,” “olive,” “peach,” and “plum” to 0.20 ppm and to revise the commodity terminology for “corn, forage” to read “corn, field, forage” and “corn, sweet, forage” and for “corn, grain” to read “corn, field, grain” and “corn, pop, grain.” In addition, EPA is proposing to revise the commodity terminology in 40 CFR 180.213 for “corn, stover” to read “corn, field, stover;” “corn, pop, stover;” and “corn, sweet, stover.”
Based on available data that showed combined simazine residues of concern as high as <0.15 ppm in or on blueberries and raspberries, EPA determined that the tolerances on these commodities should each be decreased from 0.25 to 0.20 ppm. Also, the Agency believes that data for the two chlorinated degradates of simazine can be translated from raspberries to blackberries and loganberries. From the translated data and existing data for simazine residues only on blackberry and loganberry, EPA determined that the tolerances on blackberry and loganberry should also be decreased from 0.25 to 0.20 ppm. Therefore, the Agency is proposing to decrease the tolerances in 40 CFR 180.213 on “blueberry,” “blackberry,” “loganberry,” and “raspberry” to 0.20 ppm.
Based on available data that showed combined simazine residues of concern as high as <0.20 ppm in or on pecans, EPA determined that the tolerance on pecans should be increased from 0.1 to 0.20 ppm. Also, the Agency believes that data can be translated from pecans to filberts, and that the tolerance on filbert should be decreased from 0.25 to 0.20 ppm. Therefore, the Agency is proposing in 40 CFR 180.213 to decrease the tolerance on “filbert” to 0.20 ppm, increase the tolerance on “pecan” to 0.20 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.
Also, in 40 CFR 180.213, EPA is proposing to remove the “(N)” designation from all entries to conform to current Agency administrative practice, where the “(N)” designation means negligible residues.
In addition, in 40 CFR 180.213, EPA is proposing to revise commodity terminology for “orange, sweet” to read “orange” to conform to current Agency practice.
EPA is proposing these tolerance actions in follow-up to the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). The safety finding determination under section 408 of the FFDCA standard is discussed in detail in each Post-FQPA RED and TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, to meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed and electronic copies of the REDs and TREDs are available as provided in Unit II.A.
EPA has issued Post-FQPA REDs for atrazine, ferbam, lindane, propachlor, and simazine, and TREDs for amitraz, and ethephon, whose REDs were both completed prior to FQPA. REDs and TREDs contain the Agency's evaluation of the data base for these pesticides, including requirements for additional data on the active ingredients to confirm the potential human health and environmental risk assessments associated with current product uses, and in REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FFDCA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs and TREDs that are proposed in this document do not need such assessment when the tolerances are no longer necessary.
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 section 408 of the FFDCA, 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 Start Printed Page 32579longer 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.
EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov/​. On the Home Page select “Laws, Regulations, and Dockets,” then select Regulations and Proposed Rules and then look up the entry for this document under “Federal Register—Environmental Documents.” You can also go directly to the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.
EPA has evaluated certain specific meat, milk, poultry, and egg tolerances proposed for revocation in this proposed rule and has concluded that there is no reasonable expectation of finite pesticide residues of concern in or on those commodities.
With the exception of certain tolerances for ferbam and lindane for which EPA is proposing specific expiration/revocation dates, the Agency is proposing that the actions herein become effective on the date of publication of the final rule in the Federal Register. With the exception of the revocation of specific tolerances for ferbam and lindane, 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 had sufficient time for passage through the channels of trade. EPA is proposing an expiration/revocation date of October 27, 2007 for the ferbam tolerances on bean, cabbage, lettuce, and raspberry and an expiration/revocation date of October 2, 2009 for the lindane tolerances on the fat of cattle, goats, hops, horses, and sheep. The Agency believes that these revocation dates allow users to exhaust stocks and allow sufficient time for passage of treated commodities through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider extending the expiration date of the tolerance. 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 section, 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:
The tolerance actions in this proposal are not discriminatory and are designed to ensure that both domestically produced and imported foods meet the food safety standards established by the FFDCA. The same food safety standards apply to domestically produced and imported foods.
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, as required by Section 408(b)(4) of the FFDCA. The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA Section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level in a notice published for public comment. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs and TREDs, and in the Residue Chemistry document which supports the RED and TRED, as mentioned in Unit II.A. Specific tolerance actions in this rule and how they compare to Codex MRLs (if any) are discussed in Unit II.A.
In this proposed rule, EPA is proposing to establish tolerances under FFDCA section 408(e), and also 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 and 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, Start Printed Page 32580Distribution, 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 of 1995 (UMRA) (Public Law 104-4). 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 action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (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 establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, 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 on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020), 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 action 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. Furthermore, for the pesticides named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change the EPA's previous analysis. Any comments about the Agency's determination should be submitted to the EPA along with comments on the proposal, and will be addressed prior to issuing a final rule. In addition, the Agency has determined that this action 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 action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. 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 6, 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.
2. Section 180.114 is amended by revising paragraph (a) and adding text to paragraph (c) to read as follows:
(a) General. Tolerances are established for residues of the fungicide ferbam (ferric dimethyldithiocarbamate), calculated as carbon disulfide, in or on food commodities as follows:
Apple 4.01 None
Bean 7.01 10/27/07
Cabbage 7.01 10/27/07
Cherry 4.01 None
Cranberry 4.01 None
Fruit, citrus, group 10 4.01 None
Grape 4.01 None
Lettuce 7.01 10/27/07
Nectarine 4.01 None
Peach 4.01 None
Pear 4.01 None
Raspberry 7.01 10/27/07
1 Some of these tolerances were established on the basis of data acquired at the public hearings held in 1950 (formerly § 180.101) and the remainder were established on the basis of pesticide petitions presented under the procedure specified in the amendment to the Federal Food, Drug, and Cosmetic Act by Public Law 518, 83d Congress (68 Stat.511)
(c) Tolerances with regional registrations. A tolerance with regional registrations, as defined in § 180.1(m), is established for residues of the fungicide ferbam (ferric dimethyldithiocarbamate), calculated as carbon disulfide, in or on food commodities as follows:Start Printed Page 32581
Mango 4.01
1 This tolerance was established on the basis of data acquired at the public hearings held in 1950 (formerly §180.101) and the remainder was established on the basis of pesticide petitions presented under the procedure specified in the amendment to the Federal Food, Drug, and Cosmetic Act by Public Law 518, 83d Congress (68 Stat.511)
3. Section 180.133 is amended by revising the table in paragraph (a) to read as follows:
§180.133
(a) General * * *
Cattle, fat 7.0 10/2/09
Goat, fat 7.0 10/2/09
Hog, fat 4.0 10/2/09
Horse, fat 7.0 10/2/09
Sheep, fat 7.0 10/2/09
4. Section 180.211 is amended by revising the section heading and paragraph (a) to read as follows:
(a) General. Tolerances are established for the combined residues of the herbicide 2-chloro -N- isopropylacetanilide and its metabolites containing the N-isopropylaniline moiety, calculated as 2-chloro -N- isopropylacetanilide, in or on the following raw agricultural commodities:
Cattle, kidney 0.2
Cattle, meat byproducts, except kidney 0.05
Goat, kidney 0.2
Goat, meat byproducts, except kidney 0.05
Horse, kidney 0.2
Horse, meat byproducts, except kidney 0.05
Sheep, kidney 0.2
Sheep, meat byproducts, except kidney 0.05
Sorghum, forage, forage 8.0
Sorghum, grain, forage 8.0
Sorghum, grain, grain 0.25
Sorghum, grain, stover 12.0
5. Section 180.213 is amended by revising paragraph (a) to read as follows:
(a) General. Tolerances are established for the combined residues of the herbicide simazine (2-chloro-4,6-bis(ethylamino)-s-triazine) and its two chlorinated degradates (2-amino-4-chloro-6-ethylamino-s-triazine and 2,4-diamino-6-chloro-s-triazine), the total residue to be measured in or on the following food commodities:
Almond 0.25
Almond, hulls 0.25
Avocado 0.20
Blackberry 0.20
Blueberry 0.20
Cattle, meat byproducts 0.03
Cherry 0.25
Corn, field, grain 0.20
Corn, field, stover 0.25
Corn, pop, grain 0.20
Corn, pop, stover 0.25
Corn, sweet, forage 0.20
Corn, sweet, kernel plus cob with husks removed 0.25
Corn, sweet, stover 0.25
Cranberry 0.25
Currant 0.25
Filbert 0.20
Goat, meat byproducts 0.03
Grapefruit 0.25
Horse, meat byproducts 0.03
Lemon 0.25
Loganberry 0.20
Nut, macadamia 0.25
Olive 0.20
Pear 0.25
Pecan 0.20
Plum 0.20
Raspberry 0.20
Sheep, meat byproducts 0.03
Strawberry 0.25
6. Section 180.220 is amended by revising paragraph (a) to read as follows:
(a) General. Tolerances are established for the combined residues of the herbicide atrazine (2-chloro-4-ethylamino-6-isopropylamino-s-triazine) and its chlorinated metabolites 2-amino-4-chloro-6-isopropylamino-s-triazine, 2-amino-4-chloro-6-ethylamino-s-triazine, and 2,4-diamino-6-chloro-s-triazine, in or on food commodities as follows:
Corn, field, forage 15
Corn, field, stover 0.5
Corn, pop, forage 1.5
Corn, pop, stover 0.5
Corn, sweet, forage 15
Corn, sweet, kernel plus cob with husks removed 0.20
Corn, sweet, stover 2.0
Grass, forage 4.0
Grass, hay 4.0
Guava 0.05
Sorghum, forage, forage 15
Sorghum, grain forage 15
Sugarcane, cane 0.20
Wheat, forage 1.5
Wheat, hay 5.0
7. Section 180.287 is amended by revising paragraph (a) to read as follows:
(a) General. Tolerances are established for residues of the insecticide amitraz (N′-[2,4-dimethylphenyl]-N-[[(2,4-dimethylphenyl)imino] methyl]]-N-methylmethanimidamide) and its metabolites containing the 2,4-dimethylaniline moiety (calculated as the parent) in or on food commodities, as follows:
Cotton, undelinted seed1 1.0
Hog, meat byproducts 0.3
Milk, fat 0.2
1 There are no U.S. registrations on cotton, undelinted seed as of May 3, 2006.
8. Section 180.300 is amended by revising the table in paragraph (a) to read as follows:
Apple 5.0
Apple, juice 10.0
Barley, grain 2.0
Barley, straw 10.0
Blackberry 30.0
Blueberry 20.0
Cantaloupe 2.0
Cattle, kidney 1.0
Cattle, meat byproducts, except kidney 0.2
Cherry 10.0
Coffee, bean, green 0.5
Cotton, gin byproducts 180.0
Cotton, undelinted seed 6.0
Egg 0.002
Filbert 0.80
Goat, kidney 1.0
Goat, meat byproducts, except kidney 0.2
Grape, raisin 12.0
Hog, kidney 1.0
Hog, meat byproducts, except kidney 0.2
Horse, kidney 1.0
Horse, meat byproducts, except kidney 0.2
Nut, macadamia 0.5
Pepper 30.0
Pineapple 2.0
Poultry, meat byproducts, except liver 0.01
Sheep, kidney 1.0
Sheep, meat byproducts, except kidney 0.2
Sugarcane, molasses 1.5
Walnut 0.5
Wheat, germ 5.0
Wheat, grain 2.0
Wheat, middlings 5.0
Wheat, shorts 5.0
Wheat, straw 10.0
[FR Doc. E7-11324 Filed 6-12-07; 8:45 am]