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EPA ID: [EPA-HQ-OPP-2007-0445; FRL-8138-8]
SUBJECT CATEGORY: Acephate, Chlorpyrifos, Fenbutatin-Oxide (Hexakis), Metolachlor, MCPA, Pyrethrins and Triallate; Proposed Tolerance Actions
DOCUMENT SUMMARY: EPA is proposing to revoke certain tolerances for the herbicide metolachlor, and the insecticides acephate, chlorpyrifos, and pyrethrins. Also, EPA is proposing to modify certain tolerances for the herbicide metolachlor, and the insecticides acephate, chlorpyrifos, and pyrethrins. In addition, EPA is proposing to establish new tolerances for the herbicides metolachlor, MCPA, and triallate, and the insecticides chlorpyrifos, fenbutatinoxide (hexakis), and pyrethrins. The regulatory actions proposed in this document are in followup 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).
SUMMARY: Acephate, chlorpyrifos, fenbutatin-oxide (hexakis), etc.,
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.A. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CDROM that you mail to EPA, mark the outside of the disk or CDROM as CBI and then identify electronically within the disk or CDROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments, remember to:
i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
C. What Can I do if I Wish the Agency to Maintain a Tolerance that the Agency Proposes to Revoke?
This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60day 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 issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.
II. Background
EPA is proposing to revoke, remove, modify, and establish specific tolerances for residues of the acephate, chlorpyrifos, fenbutatin oxide, metolachlor, MCPA, pyrethrins, and triallate 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 followup 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 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 452422419, telephone 1004909198; fax 15134898695; internet at http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 18005536847 or 7036056000; internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the internet and in the public dockets EPAHQOPP 20070445 or for EPAHQOPP20040154 (fenbutatinoxide/hexakis), EPA HQOPP20020223 (metolachlor), EPAHQOPP20040156 (MCPA), and EPA HQOPP20050043 (pyrethrins), EPAHQOPP20060586 (triallate) 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 [[Page 44441]]
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 EPA's 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 EPAHQOPP2007
0445 and also EPAHQOPP20040154 (fenbutatinoxide/hexakis), EPAHQ
OPP20020223 (metolachlor), EPAHQOPP20040156 (MCPA), and EPAHQ
OPP20050043 (pyrethrins), EPAHQOPP20060586 (triallate), then click on that docket number to view its contents.
EPA has determined that the aggregate exposures and risks are not of concern for the above mentioned pesticide active ingredients based upon the data identified in the RED or TRED which lists the submitted studies that the Agency found acceptable.
EPA has found that the tolerances that are proposed in this document to be modified, are safe; i.e., that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residues, in accordance with FFDCA section 408(b)(2)(C). (Note that changes to tolerance nomenclature do not constitute modifications of tolerances). These findings are discussed in detail in each RED or TRED. The references are available for inspection as described in this document under SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to revoke certain specific tolerances because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA. Those instances where registrations were canceled were 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 domestic commodities legally treated.
1. Acephate. Tolerances for residues of acephate in/on plant and
animal commodities in 40 CFR 180.108 are currently expressed in terms
of the combined residues of acephate and methamidophos (O,S
dimethylphosphuramidothioate). Although the available plant and animal
metabolism studies indicate that the residues of concern are acephate
and methamidophos, the Agency has determined that acephate tolerances
should be expressed in terms of acephate per se for permanent and regional tolerances because residues of methamidophos (O,S
dimethylphosphuramidothioate) resulting from acephate applications are
regulated under 40 CFR 180.315 and this change also provides
compatibility between the EPA and CODEX in terms of the residue
definition for acephate. Since the tolerance expression is being
revised to acephate per se, the terminology ``of which no more than 1 part per million (ppm) or 0.5 ppm is O,Sdimethyl
acetylphosphoramidothioate'' associated with certain tolerances is no
longer needed in 40 CFR 180.108. Lastly, for clarity, the Agency
determined a footnote is necessary stating that residues of the
acephate metabolite, methamidophos, are regulated under 40 CFR part
180.315. Therefore, the Agency proposes revising the residues for
regulation in 40 CFR part180.108(a)(1), (a)(2) and (c) from ``acephate
(O,Sdimethyl acetylphosphoramidothioate) and its cholinesterase
inhibiting metabolite O,Sdimethylphosphuramidothioate'' to ``acephate
per se (O,Sdimethyl acetylphosphoramidothioate)'' and remove the
terminology ``of which no more than 1 ppm, 0.5 ppm, or 0.1 ppm is O,S
dimethyl acetylphosphoramidothioate'' from the tolerances on bean
(succulent and dry form), Brussels sprouts, cauliflower, celery,
cranberry, lettuce, mint hay, and pepper and adding in 40 CFR
180.108(a)(1) a footnote. 1Residues of the acephate
metabolite, methamidophos, are regulated under 40 CFR 180.315.
Based on the available field trial data that indicate residues of acephate average 0.16 ppm in or on cottonseed and 0.32 ppm in/on cottonseed meal (concentration factor 2x) and hulls (4x), the Agency determined that the tolerances should be decreased to 0.5 ppm in/on cottonseed and 1.0 ppm in/on cottonseed hulls and cottonseed meal. Based on the available field trial data that indicate residues of acephate average 9.5 ppm in/on mint, the Agency determined that the tolerance should be increased to 27 ppm in/on mint hay. EPA is also revising commodity terminology to conform to current Agency practice. Therefore, EPA proposes decreasing tolerances in 40 CFR 180.108(a)(1) for residues of acephate per se in/on cotton, undelinted seed from 2 to 0.5 ppm; cotton, hulls from 4 to 1.0 ppm; cotton, meal from 8 to 1.0 ppm; increasing the tolerance in/on mint, hay from 15.0 to 27 ppm; and revising mint, hay to peppermint, tops and spearmint, tops. 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 reevaluation of the soybean processing data that indicate residues of acephate do not concentrate and will not exceed the tolerance on soybeans, the Agency has determined that a separate tolerance is not needed on soybean meal. Therefore, EPA proposes revoking the tolerance in 40 CFR 180.108(a)(1) for the residues of acephate per se in/on soybean, meal at 4 ppm.
EPA is revising commodity terminology to conform to current Agency
practice and removing the term ``additive'' because pesticides are no
longer defined as food additives in FFDCA. Therefore, the Agency
proposes revising tolerances in 40 CFR 180.108(a)(1) from bean
(succulent and dry form) to bean, dry, seed and bean, succulent; and
soybean to soybean, seed; in 40 CFR 180.108(a)(2) delete the [[Page 44442]]
term ``additive''; in 40 CFR 180.108(c) from macadamia nut to nut, macadamia and correcting 180.1(n) to 180.1(m).
The proposed tolerance actions herein for acephate, to implement the recommendations of the acephate TRED will result in harmonized residues for regulation between the U. S. and Codex.
2. Chlorpyrifos. Based on available field trial data that indicate residues of chlorpyrifos are less than the level of detection (0.01 ppm) in/on apples, and less than 0.05 ppm in/on corn, the Agency determined that the tolerances should be decreased to 0.01 ppm in/on apple and 0.05 ppm in/on corn, sweet, kernel plus cob with husks removed. Based on the available processing data that indicate residues of chlorpyrifos concentrate in corn oil by a factor of 3.3x, the Agency has determined the tolerance in/on refined corn oil should be decreased to 0.25 ppm. Based on revisions for calculating processed food tolerances, the Agency has determined the tolerance in/on citrus oil should be decreased from 25 ppm to 20 ppm. Based on available field trial data that indicate residues of chlorpyrifos are less than 0.5 ppm in/on sorghum forage and grain; less than 2.0 ppm in/on sorghum stover and less than 1.0 ppm in/on sunflower seeds, the Agency determined that the tolerances should be decreased to 0.5 ppm in/on sorghum forage; 0.5 ppm in/on sorghum, grain, grain; 2.0 ppm in/on sorghum, grain, stover; and 0.1 ppm in/on sunflower, seed. The Agency is also revising commodity terminology to conform to current Agency practice. Therefore, EPA proposes decreasing the tolerances in 40 CFR 180.342(a)(1) for the combined chlorpyrifos residues of concern in/on apple from 1.5 to 0.01 ppm; corn, sweet, kernel plus cob with husks removed from 0.1 to 0.05 ppm; corn, field, refined oil from 3.0 to 0.25 ppm; citrus, oil from 25.0 to 20 ppm; sorghum, forage from 1.5 to 0.5 ppm; sorghum, grain, grain from 0.75 to 0.50 ppm; sorghum, grain, stover from 6.0 to 2.0 ppm and sunflower, seed from 0.25 to 0.1 ppm; and revise sorghum, forage to sorghum, grain, forage.
Because there are currently no active registrations for uses of chlorpyrifos in/on blueberries and tomatoes, the Agency determined that the tolerances in/on blueberry and tomato are no longer needed. The Agency is revising commodity terminology to conform to current Agency practice. Therefore, EPA proposes revoking the tolerances in 40 CFR 180.342(a)(1) for the combined chlorpyrifos residues of concern in/on blueberry at 2 ppm (of which no more than 1 ppm is chlorpyrifos) and tomato at 0.5 ppm; and revising fruit, citrus to fruit, citrus, group 10; and onion, dry bulb to onion, bulb.
Based on available field trial data that indicate average residues of chlorpyrifos at 0.11 ppm and a concentration factor of 1.7x in/on peanut oil, the Agency determined that the tolerance in/on peanut oil should be decreased to 0.2 ppm and revise the tolerance to conform to current Agency commodity terminology. Therefore, EPA proposes decreasing and revising the tolerance in 40 CFR 180.342(a)(2) for chlorpyrifos per se residues of concern in/on peanut, oil from 0.4 to peanut, refined oil at 0.2 ppm.
Based on revisions for calculating processed food tolerances, the Agency has determined the tolerance in/on wheat milling fractions will be covered by the current wheat, grain tolerance of 0.5 ppm; therefore, the tolerance in/on ``milling fractions (except flour) of wheat'' are no longer needed. Because the grazing of livestock and feeding of soybean forage and hay to livestock is prohibited for foliar type applications to soybeans, the Agency determined that the tolerance for soybean forage is no longer needed. Banana pulp is no longer regulated as a commodity in accordance with Table 1. Raw Agricultural and Processed Commodities and Feedstuffs Derived from Crops which is found in Residue Chemistry Test Guidelines OPPTS 860.1000 dated August 1996, available at http://www.epa.gov/opptsfrs/publications/OPPTS Harmonized/ 860 Residue Chemistry Test Guidelines/Series; consequently, the Agency has determined that a banana pulp tolerance is no longer needed. Therefore, EPA proposes removing the tolerances in 40 CFR 180.342(a)(2) for chlorpyrifos per se residues of concern in/on milling fractions (except flour) of wheat at 1.5 ppm; soybean, forage at 0.7 ppm; and banana pulp at 0.01 ppm.
The Agency is revising commodity terminology to conform to current Agency practice. Therefore, EPA proposes revising the tolerances in 40 CFR 180.342(a)(2) for chlorpyrifos per se residues of concern in/on cattle, meat and meat byproducts at 0.05 ppm; to cattle, meat at 0.05 ppm; and cattle, meat byproducts at 0.05 ppm; cherry to cherry, sweet and cherry, tart; corn, forage and fodder at 8 ppm to corn, field, forage; corn, field, stover; corn, sweet, forage; and corn, sweet, stover each at 8 ppm; goat, meat and meat byproducts at 0.05 ppm; to goat, meat at 0.05 ppm; and goat, meat byproducts at 0.05 ppm; hog, meat and meat byproducts at 0.05 ppm; to hog, meat at 0.05 ppm; and hog, meat byproducts at 0.05 ppm; sheep, meat and meat byproducts at 0.05 ppm; to sheep, meat at 0.05 ppm; and sheep, meat byproducts at 0.05 ppm; horse, meat, fat, and meat byproducts at 0.25 ppm; to horse, fat at 0.25 ppm; horse, meat at 0.25 ppm; and horse, meat byproducts at 0.25 ppm; mint, hay to peppermint, tops and spearmint, tops; mint oil to peppermint, oil and spearmint, oil; plum to plum, prune, fresh; poultry, meat, fat, and meat byproducts (inc. turkeys) at 0.1 ppm; to poultry, fat at 0.1 ppm; poultry, meat at 0.1 ppm;, and poultry, meat byproducts at 0.1 ppm; rutabagas to rutabaga; turnip, greens to turnip, tops; and turnip to turnip, roots.
Currently 40 CFR 180.342(a)(1) regulates the combined residues of chlorpyrifos and its metabolite 3,5,6trichloro2pyridinol (TCP). The Agency has concluded that the 3,5,6trichloro2pyridinol (TCP) metabolite is not of toxicological concern and in accordance with FFDCA Sec. 408(a)(3) no longer needs to be regulated. The residue for regulation is chlorpyrifos per se which is the regulated residue in 40 CFR 180.342(a)(2). Therefore, EPA proposes transferring the tolerances in 40 CFR 180.342(a)(1) to (a)(2) and changing the designations of 40 CFR 180.342 (a)(2), (a)(3), and (a)(4) to 40 CFR 180.342(a)(1), (a)(2), and (a)(3).
The established crop group tolerance for tree nut group 14 should be revoked because the use rates are not identical, i.e. the rate on pecans differs. In lieu of the tree nut crop group, the Agency has determined that individual tolerances should be established for hazelnut (the preferred commodity term), and pecan each at 0.2 ppm and there are currently tolerances in place for almonds and walnuts. Therefore, EPA proposes revoking the tolerance in newly proposed 40 CFR 180.342(a)(1) for residues of chlorpyrifos per se in/on nut, tree, group 14 and establishing the tolerances for hazelnut at 0.2 ppm; and pecan at 0.2 ppm.
There is currently a tolerance for ``vegetable, brassica, leafy,
group 5 at 2.0 ppm which covers broccoli; Bussels sprouts; cabbage;
cabbage Chinese; and cauliflower each at 1 ppm; therefore, the Agency
has determined that the individual tolerances on these commodities are
no longer needed and vegetable, brassica, leafy, group 5 at 2.0 ppm
should be decreased to 1 ppm consistent with the individual tolerance
levels. Further, the footnote (of which no more than 1.0 ppm is
chlorpyrifos) associated with the vegetable, brassica, leafy, group 5
at 12.0 ppm is no longer needed since the residues of concern are
chlorpyrifos per se. There is currently a tolerance for ``legume vegetables, succulent or dried (except soybean)'' at
[[Page 44443]]
0.05 ppm which covers lima beans and succulent snap beans; therefore,
the Agency has determined that the tolerances for bean, lima and bean,
snap, succulent are no longer needed. Additionally, the milk fat
tolerance covers the whole milk tolerance and the whole milk tolerance
is no longer needed. EPA is also revising commodity terminology to
conform to current Agency practice. Therefore, EPA proposes removing
the tolerances in newly proposed 40 CFR 180.342(a)(1) for residues of
chlorpyrifos per se in/on broccoli; Bussels sprouts; cabbage; cabbage,
chinese; and cauliflower each at 1.0 ppm; bean, lima and bean, snap,
succulent each at 0.05 ppm; the footnote1 of which no more
than 1.0 ppm is chlorpyrifos; milk, whole at 0.01 ppm; revise ``legume
vegetables, succulent or dried (except soybean)'' to ``vegetable,
legume, group 6, except soybean''; milk fat to milk, fat (reflecting
0.01 ppm in whole milk); and decreasing vegetable, brassica, leafy, group 5 from 2.0 ppm to 1.0 ppm.
Based on the available apple processing data that indicate chlorpyrifos concentrates at 2.1x in wet apple pomace, the Agency has determined that a tolerance should be established in/on apple, wet pomace at 0.02 ppm. Based on available field trial studies that indicate residues of chlorpyrifos are less than 1 ppm in/on lettuce, the Agency determined a tolerance should be established in/on lettuce at 1 ppm. Therefore, EPA proposes establishing a tolerance in newly proposed 40 CFR 180.342(a)(1) for residues of chlorpyrifos per se in/on apple, wet pomace at 0.02 ppm and lettuce at 1.0 ppm.
Based on current U.S. use patterns of chlorpyrifos on grapes the residues are expected to be less than the level of quantitation (< 0.01 ppm); therefore, the Agency has determined the tolerance should be decreased in/on grapes to 0.01 ppm. Therefore, EPA proposes decreasing the tolerance in 40 CFR 180.342(c)(1) for residues of chlorpyrifos per se in/on grape from 0.05 to 0.01 ppm.
Currently 40 CFR 180.342(c)(1) regulates the combined residues of chlorpyrifos and its metabolite 3,5,6trichloro2pyridinol (TCP). The Agency has concluded that the 3,5,6trichloro2pyridinol (TCP) metabolite is not of toxicological concern and no longer needs to be regulated. The residue for regulation is chlorpyrifos per se which is the regulated residue in 40 CFR 180.342(c)(2). Additionally, because there are currently no active registrations having uses on leeks, cherimoya, feijoa, and sapote, the Agency has determined the tolerances on leek, cherimoya, feijoa and sapote should be revoked. Therefore, EPA proposes transferring the tolerances in 40 CFR 180.342(c)(1) in/on asparagus, grape and leek (of which no more than 0.2 ppm is chlorpyrifos) to (c)(2) for residues of chlorpyrifos per se; revoking the tolerances in proposed recodified 40 CFR 180.342(c)(2) in/on leek (of which no more than 0.2 ppm is chlorpyrifos) at 0.5 ppm, cherimoya at 0.05 ppm, feijoa (pineapple guava) at 0.05 ppm and sapote at 0.05 ppm; and redesignate 40 CFR 180.342(c)(2) to 40 CFR 180.342(c).
The proposed tolerance actions herein for chlorpyrifos, to implement the recommendations of the chlorpyrifos TRED, reflect use patterns in the U.S. which support a different tolerance than the Codex level on broccoli (vegetable, brassica, leafy, group 5) and grape, because of differences in good agricultural practices. However, compatibility exists for eggs, field corn (maize) and will exist between the proposed reassessed U.S. tolerances and Codex MRLs for chlorpyrifos residues in or on Chinese cabbage, citrus fruits, sorghum, and cabbage head.
3. Fenbutatinoxide (Hexakis). The Interregional Research Project No. 4 (IR4) submitted a petition (PP 6E7052) which published as a notice of filing document in the Federal Register of July 5, 2006 (71 FR 38153) (FRL80741), requesting a tolerance of 0.5 ppm for residues of fenbutatinoxide in pistachio. Currently, there are individual tolerances for almonds, pecans, and walnuts each at 0.5 ppm. The Agency proposed that the data for almond, pecan, and walnut support a crop group tolerance for the nut, tree, group 14 at 0.5 ppm in a document published in the Federal Register of August 4, 2004 (69 FR 47051) (FRL 73687). The Agency has determined that the data to support the tree nut crop group should also be used to support a separate tolerance for pistachio at 0.5 ppm. Therefore, EPA proposes establishing a tolerance in 40 CFR 180.362(a) for the combined fenbutatinoxide residues of concern in/on pistachio at 0.5 ppm.
Currently, there are no Codex MRLs in place for fenbutatinoxide on pistachio.
4. MCPA. Based on available data that indicate MCPA residues of concern as high as 2.6 ppm, the Agency determined that a tolerance should be established in/on aspirated grain fractions at 3.0 ppm. This action was inadvertently omitted in the proposal of September 27, 2006 (71 FR 56429)(FRL80895). Therefore, EPA proposes establishing the tolerance in 40 CFR 180.339(a)(1) for the combined MCPA residues of concern in/on grain, aspirated fractions at 3.0 ppm.
5. Metolachlor (including SMetolachlor). Tolerances for residues
of metolachlor in/on barley, buckwheat, millet, oats, rice, rye, wheat,
and the nongrass livestock feeds group were initially established to
cover residues of metolachlor in these crops when planted as rotational
crops following a primary crop that was treated with metolachlor;
therefore, the Agency has determined that these tolerances should be
considered inadvertent or indirect residues in a new subsection 40 CFR
180.368(d)(1). Further, based on available field trial data that
indicate the combined metolachlor residues of concern were as high as
0.54 ppm in/on nongrass forage and < 0.47 ppm in/on nongrass hay, the
Agency determined the tolerance should be decreased to 1.0 ppm in/on
nongrass animal feed (forage, fodder, straw, hay), group 18. The Agency
is also revising the commodity terminology for certain tolerances to
current Agency practice. Therefore, EPA proposes transferring
tolerances from 40 CFR 180.368(a)(1) to a new section designated 40 CFR
180.368 (d)(1) for the combined residues (free and bound) of the herbicide metolachlor [(2chloroN(2ethyl6methylphenyl)N(2
methoxy1methylethyl)acetamide] and its metabolites, determined as the
derivatives, 2[(2ethyl6methylphenyl)amino]1propanol and 4(2
ethyl6methylphenyl)2hydroxy5methyl3morpholinone, each expressed
as the parent compound, in or on barley, grain at 0.1; barley straw at
0.5 ppm; buckwheat, grain at 0.1 ppm; millet, fodder at 0.5 ppm;
millet, forage at 0.5 ppm; millet, grain at 0.1 ppm; oat, forage 0.5
ppm; oat, grain at 0.1 ppm; oat, straw at 0.5 ppm; rice, grain at 0.1
ppm; rice, straw at 0.5 ppm; rye, forage 0.5 ppm; rye, grain at 0.1
ppm; rye, straw at 0.5 ppm; wheat, forage at 0.5 ppm; wheat, grain at
0.1 ppm; and wheat, straw at 0.5 ppm; decreasing and revising nongrass
animal feed (forage, fodder, straw, and hay), group 18 from 3.0 to
animal feed, nongrass, group 18 at 1.0 ppm; revising millet, fodder to
millet, straw; and changing the designation of 40 CFR 180.368(d) to 40 CFR 180.368(d)(2).
Extrapolating the residue data from the ruminant feeding study to a
1x feeding level for cattle, goats, horses, and sheep the maximum
combined residues of concern for metolachlor would be 0.011 ppm in fat,
0.057 ppm in liver, 0.016 ppm in meat and < 0.04 ppm in meat byproducts; therefore, the Agency determined that the tolerances
[[Page 44444]]
should be increased for cattle, goat, horse, and sheep fat to 0.04 ppm,
liver to 0.10 ppm, meat to 0.04 ppm, and meat byproducts (except kidney
and liver) at 0.04 ppm. Based on feeding studies in hens dosed up to
3.9x the maximum theoretical dietary burden, metolachlor residues of
concern were not detected (< 0.04 ppm the combined levels of
quantitation (LOQ)) in eggs, liver, meat and meat byproducts;
therefore, the Agency determined the tolerance for eggs, poultry meat,
poultry fat, and poultry meat byproducts should each be increased to
0.04 ppm and revoked for poultry liver. Therefore, EPA proposes
increasing the tolerances in 40 CFR 180.368(a)(1) for the combined
metolachlor residues of concern in/on cattle, fat; goat, fat; horse,
fat; and sheep, fat from 0.02 to 0.04 ppm; cattle, liver; goat, liver;
horse, liver; and sheep, liver from 0.05 to 0.10 ppm; cattle, meat;
goat, meat; horse, meat; and sheep, meat from 0.02 to 0.04 ppm; cattle,
meat byproducts (except kidney and liver); goat, meat byproducts
(except kidney and liver); horse, meat byproducts (except kidney and
liver); and sheep, meat byproducts (except kidney and liver) from 0.02
to 0.04 ppm; egg; poultry, fat; poultry, meat; and poultry, meat
byproducts (except liver) from 0.02 to 0.04 ppm; revoking poultry,
liver at 0.05 ppm and revising poultry meat byproducts (except liver)
to poultry meat byproducts. 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.
There are no longer any active registrations with uses of
metolachlor on cabbage, celery, stone fruits, and bell peppers;
therefore, the Agency determined the tolerances for these commodities
are no longer needed. The tolerances for sorghum cover the tolerances
for milo; therefore, the tolerances for milo are not needed. Rice
forage and peanut forage are no longer regulated commodities in
accordance with Table 1.Raw Agricultural and Processed Commodities
and Feedstuffs Derived from Crops which is found in Residue Chemistry
Test Guidelines OPPTS 860.1000 dated August 1996, available at http://www.epa.gov/opptsfrs/publications/OPPTS Harmonized/860 Residue
Chemistry Test Guidelines/Series; consequently, the Agency has
determined that the rice, forage and peanut forage tolerances are no
longer needed. Therefore, EPA proposes revoking the tolerances in 40
CFR 180.368 (a)(1) for the combined residues of metolachlor in/on
cabbage at 1.0 ppm; celery at 0.1 ppm; fruit, stone, group 12 at 0.1
ppm; bell, pepper at 0.1 ppm; milo, fodder 0.5 ppm; milo, forage at 0.5
ppm; milo, grain at 0.1 ppm; peanut, forage at 30 ppm and rice, forage at 0.5 ppm.
Based on the available field trial data that indicate the combined residues of metolachlor were as high as 2.28 ppm on field corn stover, 5.54 ppm in/on sweet corn stover, 3.02 ppm on field corn forage, and 5.75 ppm in/on sweet corn forage, the Agency determined the tolerances for corn, fodder and corn, forage should be decreased to 6.0 ppm. Based on the available field trial data that indicate the combined residues of metolachlor were as high as 0.19 ppm in/on peanut, 16.5 ppm in/on peanut hay, 0.45 ppm in/on sorghum forage, 3.19 ppm in/on sorghum fodder, and 4.37 ppm in/on soybean forage; the Agency determined the tolerances should be decreased to 0.20 ppm in/on peanut, 20.0 ppm in/on peanut hay; 5.0 ppm in /on soybean, forage, and 1.0 ppm in/on sorghum, forage and increased to 4.0 ppm in/on sorghum fodder. The EPA is also revising commodity terminology. Therefore, EPA proposes decreasing the tolerances in 40 CFR 180.368 (a)(1) for the combined residues of metolachlor in/on corn, fodder from 8.0 to 6.0 ppm; corn, forage from 8.0 to 6.0 ppm; peanut from 0.5 to 0.20 ppm; and peanut, hay from 30 to 20.0 ppm; and sorghum, forage from 2.0 to 1.0 ppm; soybean, forage from 8.0 to 5.0 ppm; increasing sorghum, fodder from 2.0 to 4.0 ppm; and revising corn, fodder to corn, field, stover and corn, sweet, stover; corn, forage to corn, field, forage and corn, sweet, forage; corn, grain to corn, field, grain; sorghum, forage to sorghum, grain, forage; sorghum, fodder to sorghum, grain, stover; sorghum, grain to sorghum, grain, grain and soybean to soybean, seed.
Based on the available field trial data that indicate the metolachlor residues of concern were as high as 4.37 ppm in/on soybean forage and 6.9 ppm in/on soybean hay, the Agency determined tolerances should be separated and decreased to 5.0 ppm on soybean, forage and maintained at 8.0 ppm in/on soybean hay. Therefore, EPA proposes decreasing and separating the tolerances in 40 CFR 180.368(a)(1) for the combined metolachlor residues of concern from soybean, forage and hay at 8.0 ppm to soybean, forage at 5.0 ppm and soybean, hay at 8.0 ppm.
EPA is revising commodity terminology to current Agency practice. The current terminology for seed and pod vegetables (except soybean) crop group is vegetable, legume, edible podded, subgroup 6A; pea and bean, succulent shelled, subgroup 6B; and pea and bean, dried shelled, except soybean, subgroup 6C. Based on the available field trial data that indicate the combined residues of metolachlor were as high as 0.11 ppm in/on dried shelled peas and beans and 0.44 ppm in/on ediblepodded legumes, the Agency determined the tolerances should be increased on ediblepodded legumes from 0.3 to 0.5 ppm and decreased in/on dried shelled peas and beans from 0.3 to 0.10 ppm. Therefore, EPA proposes revising the tolerances in 40 CFR 180.368(a)(1) for the combined metolachlor residues of concern in/on seed and pod vegetables (except soybean) at 0.3 ppm to vegetable, legume, edible podded, subgroup 6A at 0.5 ppm; pea and bean, succulent shelled, subgroup 6B at 0.3 ppm; and pea and bean, dried shelled, subgroup 6C, except soybean at 0.10 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 field trial and processing data that indicate the metolachlor residues of concern were as high as 3.2 ppm in/on cotton gin byproducts and < 3.83 ppm in/on peanut meal, the Agency determined tolerances should be established in/on cotton, gin byproducts at 4.0 ppm and peanut, meat at 0.40 ppm. Therefore, EPA proposes establishing tolerances in 40 CFR 180.368(a)(1) for the combined metolachlor residues of concern in/on cotton, gin byproducts at 4.0 ppm and peanut, meal at 0.40 ppm.
There are no longer any active registered uses of metolachlor in/on dry bulb onions, chili peppers and cubanelle peppers; therefore, the tolerances are no longer needed. EPA is also revising commodity terminology. Finally, the regional registrations are defined in 40 CFR 180.1(m) rather than 180.1(n) as currently appears in the 40 CFR 180.368(c). Therefore, EPA proposes revoking the tolerances in 40 CFR 180.368 (c)(1) for the combined metolachlor residues of concern in/on onion, dry bulb; pepper, chili; and pepper, cubanelle; and revising in 40 CFR 180.368(c)(1) and (2) the terms pepper, tabasco to pepper, nonbell and 180.1(n) to 180.1(m).
Subsequent to the revised TRED, the tolerance expression for S
metolachlor was modified to include the Renantiomer; therefore, the
Agency has determined the tolerances in 40 CFR 180.368(a)(2) and 40 CFR
180.368(a)(3) should be combined and regulated in accordance with the tolerance
[[Page 44445]]
expression in 40 CFR 180.368(a)(3) which includes regulation of the R
enantiomer. Therefore, EPA proposes combining 40 CFR 180.368(a)(2) and
(a)(3) by transferring the tolerances from 40 CFR 180.368(a)(2) on
asparagus at 0.1 ppm; beet, sugar, molasses at 2.0 ppm; beet, sugar,
roots at 0.5 ppm; beet, sugar, tops at 15 ppm; grass, forage at 10 ppm;
grass, hay at 0.2 ppm; spinach at 0.5 ppm; sunflower, seed at 0.5 ppm;
sunflower, meal at 1 ppm to 40 CFR 180.368(a)(3) and changing the
designation of 40 CFR 180.368(a)(3) to 40 CFR 180.368(a)(2).
EPA is revising commodity terminology to current Agency practice. Therefore, EPA proposes revising the tolerance in the proposed recodified 40 CFR 180.368(d)(2) from nongrass, animal feed (forage, fodder, straw, hay) group 18 to animal feed, nongrass, group 18 and revising the tolerance in proposed recodified 40 CFR 180.368 (a)(2) from vegetable, fruiting group 8, (except tabasco pepper) to vegetable, fruiting, group 8, except nonbell pepper and onion, dry bulb to onion, bulb.
Currently, there are no Codex MRLs in place for metolachlor.
6. Pyrethrins. Currently, the tolerance expression in 40 CFR
180.128(a)(1) is for the residues of the insecticide pyrethrins
(insecticidally active principles of chrysanthemum cinerariaefolium).
Since residues of pyrethrins are identified by a marker compound, the
Agency has determined that tolerances in 40 CFR 180.128(a)(1) should be
updated. Therefore, EPA proposes the tolerance expression be revised in
40 CFR 180.128(a)(1) for residues of pyrethrins ((1S)2methyl4oxo3
(2Z)2,4pentadienylcyclopenten1yl (1R,3R)2,2dimethyl3(2methyl
1propenyl)cyclopropanecarboxylate (pyrethrin 1), (1S)2methyl4oxo 3(2Z)2,4pentadienyl2cyclopenten1yl (1R,3R)3[(1E)3methoxy2
methyl3oxo1propenyl]2,2dimethylcyclopropanecarboxylate
(pyrethrin 2), (1S)3(2Z)2butenyl2methyl4oxo2cyclopenten1yl
(1R,3R)2,2dimethyl3(2methyl1propenyl)cyclopropanecarboxylate (cinerin 1), (1S)3(2Z)2butenyl2methyl4oxo2cyclopenten1yl
(1R,3R)3[(1E)3methoxy2methyl3oxo1propenyl]2,2
dimethylcyclopropanecarboxylate (cinerin 2), (1S)2methyl4oxo3 (2Z)2pentenyl2cyclopenten1yl (1R, 3R)2,2dimethyl3(2methyl1
propenyl)cyclopropanecarboxylate (jasmolin 1), and (1S)2methyl4oxo 3(2Z)pentenyl2cyclopenten1yl (1R,3R)3[(1E)3methoxy2methyl
3oxo1propenyl]2,2dimethylcyclopropanecarboxylate (jasmolin 2)),
the insecticidally active principles of Chrysanthemum cinerariaefolium,
which are measured as cumulative residues of pyrethrin 1, cinerin 1, and jasmolin 1.
The last active product involving uses of pyrethrins on food stored
in multiwalled paper or cloth bags was cancelled October 15, 1989.
Therefore, the Agency has determined that the stored food tolerances in
40 CFR 180.128(a)(2)(iii)(B), 180.128(a)(2)(iii)(D) and 180.128(a)(3)
(all subsections) should be removed. Also, the language in 40 CFR
180.128(a)(2)(iv) is outdated and no longer used in the CFR, therefore,
the Agency has determined it should be removed. Therefore, EPA is proposing to remove 40 CFR 180.128(a)(2)(iii)(B),
180.128(a)(2)(iii)(D), 180.128(a)(3)(i)(A, B), (ii), (iii), (iv), (v), and 180.128(a)(2)(iv).
Currently, 40 CFR 180.128(a)(2)(iii)(C) refers to ``foods treated
in accordance with 180.367(a)(2)''. To provide clarity, the citation 40
CFR 180.367(a)(2) is being replaced with the statement to which the citation refers as follows:
Currently, 40 CFR 180.128(a)(2)(i)(A)(E) and (ii) indicate use in
combination with other active ingredients (piperonyl butoxide and MGK
264). The Agency has determined that all references to the use of
multiple chemicals should be removed from the CFR because 40 CFR
180.128 is solely for the regulation of pyrethrins. Therefore, EPA
proposes removing the 40 CFR 180.128 (a)(2)(i)(AE) and (ii) and
recodify 40 CFR 180.128(a)(2)(iii)(A) to newly revised 40 CFR 180.128(a)(2) to read as follows:
``A tolerance of 1.0 ppm is established for residues of the
insecticide pyrethrins in or on milled fractions derived from grain,
cereal when present as a result of its use in cereal grain mills and in
storage areas for milled cereal grain products.'' As a result of all
the changes in 40 CFR 180.128(a), EPA is also proposing to change the designation of 40 CFR 180.128(a)(2)(v) to 180.128(a)(4).
Because 40 CFR 180.128 (a)(2)(i)(D) and (E) have been removed, 40 CFR 180.128(a)(2)(iii)(E) which refer to these sections is no longer relevant and also should be removed. Therefore, EPA is proposing to remove 40 CFR 180.128(a)(2)(iii)(E).
The Agency is revising commodity terminology to conform to current Agency practice. Therefore, EPA proposes revising commodity terminology for tolerances in 40 CFR 180.128(a)(1) as follows: Barley, postharvest to barley, grain, postharvest; bean, postharvest to bean, succulent, postharvest; pea, postharvest to pea, dry, seed, postharvest; rye, postharvest to rye, grain, postharvest; and wheat, postharvest to wheat, grain, postharvest.
Based on the maximum dietary burden and assuming a linear relationship between feeding levels and tissue concentrations, estimated residues are calculated to be as high as < 0.05 ppm, in milk, meat, and meat byproducts of cattle, goats, horses, hogs and sheep and 0.5 ppm in/on the fat of cattle, goats, horses, hogs, and sheep. The Agency determined the tolerances for cattle, goats, hogs, horses, and sheep meat and meat byproducts and milk should be decreased to 0.05 ppm and tolerances for the fat of cattle, goats, hogs, horses, and sheep should be increased to 1.0 ppm. Also the ``N'' indicating negligible residues should be deleted in accordance with current Agency practice. Therefore, EPA is proposing in 40 CFR 180.128(a)(1) for pyrethrins residues of concern to decrease the tolerances in/on milk fat (reflecting negligible residues in milk) from 0.5 to 0.05 ppm; cattle, meat; cattle, meat byproducts; goat, meat; goat, meat byproducts; hog, meat; hog, meat byproducts; horse, meat; horse, meat byproducts; sheep, meat; sheep, meat byproducts from 0.1(N) to 0.05 ppm and increase the tolerances in/on cattle, fat; goat, fat; hog, fat; horse, fat; and sheep, fat from 0.1(N) to 1.0 ppm.
Based on exaggerated feed and premise treatment studies, there are
no reasonable expectations of finite residues in poultry, meat, meat
byproducts, fat and eggs (Category 3 of 40 CFR 180.6(a)(3)). Therefore,
the Agency has determined that the tolerances for pyrethrins residues
of concern in poultry commodities are not needed and should be revoked.
Therefore, the Agency proposes revoking the tolerances in 40 CFR [[Page 44446]]
180.128(a)(1) for egg at 0.1 ppm; and poultry, fat; poultry, meat; poultry, meat byproducts each at 0.2 ppm.
The proposed tolerance actions herein for pyrethrins, to implement the recommendations of the pyrethrins RED, reflect use patterns in the United States which support a different tolerance than the Codex level because of differences in good agricultural practices and the specified postharvest application timing.
7. Triallate. Based on the available field trial data that indicate
triallate residues of concern as high as 0.42 ppm, the Agency
determined that a tolerance should be established in/on wheat forage at
0.5 ppm. This action was inadvertently omitted in the proposal of
September 27, 2006 (71 FR 56429) (FRL80895). Therefore, EPA proposes
establishing the tolerance in 40 CFR 180.314(c) for the combined
triallate residues of concern in/on wheat, forage at 0.5 ppm. B. What is the Agency's Authority for Taking this Action?
``A tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by the FQPA of 1996, Public Law 104170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore,
``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such
food may not be distributed in interstate commerce (21 U.S.C. 331(a)).
For a fooduse pesticide to be sold and distributed, the pesticide must
not only have appropriate tolerances under the FFDCA, but also must be
registered under FIFRA (7 U.S.C. 136 et seq.). Fooduse pesticides not
registered in the United States must have tolerances in order for
commodities treated with those pesticides to be imported into the United States.
EPA is proposing these tolerance actions in followup to the tolerance recommendations made during the reregistration and tolerance reassessment processes (including followup on canceled or additional uses of pesticides). The safety finding determination under section 408 of FFDCA standard is discussed in detail in each PostFQPA 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 a PostFQPA RED for pyrethrins , MCPA, triallate,
and TREDs for acephate, chlorpyrifos, fenbutatinoxide and metolachlor,
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.
EPA's general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as ``import tolerances,'' are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under section 408 of 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 longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities.
Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue.
When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, consideration must be given to the possible residues of those chemicals in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticides residues (40 CFR 180.6). When considering this possibility, EPA can conclude that:
1. Finite residues will exist in meat, milk, poultry, and/or eggs.
2. There is a reasonable expectation that finite residues will exist.
3. There is a reasonable expectation that finite residues will not
exist. If there is no reasonable expectation of finite pesticide
residues in or on meat, milk, poultry, or eggs, tolerances do not need
to be established for these commodities (40 CFR 180.6(b) and (c)). [[Page 44447]]
EPA has evaluated certain specific meat, milk, poultry, and egg
tolerances proposed for revocation in this rule and has concluded that
there is no reasonable expectation of finite pesticide residues of concern in or on those commodities.
1. EPA is proposing that modifications, establishment, commodity terminology revisions, and revocation of these tolerances become effective on the date of publication of the final rule in the Federal Register because:
i. With respect to the revocations, their associated uses have been canceled for several years.
ii. None of the other tolerance actions proposed here are expected to result in adulterated commodities.
The Agency believes that, with respect to the tolerances proposed for
revocation, treated commodities have had sufficient time for passage
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.
2. 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 FDA that:
i. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.
ii. The residue does not exceed the level that was authorized at
the time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the pesticide was applied to such food.
III. Are the Proposed Actions Consistent with International Obligations?
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 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 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 standardssetting 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. IV. Statutory and Executive Order Reviews
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, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 1044). Nor does it require any special
considerations as required by Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
LowIncome 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
104113, 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. This Agency
document is available in the docket of this proposed rule).
Furthermore, for the pesticide 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
[[Page 44448]]
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. List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: July 26, 2007.
Debra Edwards,
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
PART 180[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2.Section 180.108 is amended by revising paragraph (a)(1), paragragh (a)(2) introductory text, and (c) to read as follows:
Sec. 180.108 Acephate; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
acephate per se (O,Sdimethyl acetylphosphoramidothioate) in or on the following food commodities1:
Commodity Parts per million
Bean, dry, seed...................................... 3.0
Bean, succulent...................................... 3.0
Brussels sprouts..................................... 3.0
Cattle, fat.......................................... 0.1
Cattle, meat......................................... 0.1
Cattle, meat byproducts.............................. 0.1
Cauliflower.......................................... 2.0
Celery............................................... 10
Cotton, undelinted seed.............................. 0.5
Cotton, hulls........................................ 1.0
Cotton, meal......................................... 1.0
Cranberry............................................ 0.5
Egg.................................................. 0.1
Goat, fat............................................ 0.1
Goat, meat........................................... 0.1
Goat, meat byproducts................................ 0.1
Hog, fat............................................. 0.1
Hog, meat............................................ 0.1
Hog, meat byproducts................................. 0.1
Horse, fat...........................................
FOR FURTHER INFORMATION CONTACT Jane Smith, Special Review and [[Page 44440]]
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 204600001; telephone number: (703) 3080048; email
address: smith.janescott@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 50 CFR Part 622 26 CFR Part 301 39 CFR Part 111 40 CFR Part 300 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 50 CFR Part 665 47 CFR Part 76 50 CFR Part 229 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522