Mancozeb, Maneb, Metiram, and Thiram; Proposed Tolerance Actions, 47507-47517 [E9-22302]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Proposed Rules]
[Pages 47507-47517]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22302]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0431; FRL-8431-4]


Mancozeb, Maneb, Metiram, and Thiram; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke certain tolerances for the 
fungicides mancozeb and maneb. Also, EPA is proposing to modify certain 
tolerances for the fungicides mancozeb, maneb, metiram, and thiram. In 
addition, EPA is proposing to establish new tolerances for the 
fungicides mancozeb, maneb, and metiram. 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).

DATES: Comments must be received on or before November 16, 2009.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2009-0431, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0431. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://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 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.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-evaluation 
Division (7508P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-
0001; telephone number: (703) 308-8037; e-mail address: 
nevola.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially

[[Page 47508]]

affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When 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 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 timeframes for its submission, and would require that within 90 
days some person or persons notify EPA that they will submit the data. 
If the data are not submitted as required in the order, EPA will take 
appropriate action under FFDCA.
    EPA issues a final rule after considering comments that are 
submitted in response to this proposed rule. In addition to submitting 
comments in response to this proposed rule, you may also submit an 
objection at the time of the final rule. If you fail to file an 
objection to the final rule within the time period specified, you will 
have waived the right to raise any issues resolved in the final rule. 
After the specified time, issues resolved in the final rule cannot be 
raised again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to revoke, modify, and establish specific 
tolerances for residues of the fungicides mancozeb, maneb, metiram, and 
thiram 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 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 number: 1-800-490-
9198; fax number: 1-513-489-8695; Internet at https://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 
5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-
553-6847 or (703) 605-6000; Internet at https://www.ntis.gov. Electronic 
copies of REDs and TREDs are available on the Internet in public 
dockets; REDs for mancozeb (EPA-HQ-OPP-2005-0176), maneb (EPA-HQ-OPP-
2005-0178), metiram (EPA-HQ-OPP-2005-0177), and thiram (EPA-HQ-OPP-
2004-0183), at https://www.regulations.gov and also at https://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.
    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,

[[Page 47509]]

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 and 
exemptions and/or establishments of tolerances and exemptions for 
mancozeb, maneb, metiram, and thiram 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 electronic 
copies for mancozeb, maneb, and metiram can be found under their 
respective public docket ID numbers, identified in Unit II.A. 
Electronic copies of support documents for thiram are available in 
public docket EPA-HQ-OPP-2004-0183. An electronic copy of the Residue 
Chemistry Chapter for thiram is available in the public docket for this 
proposed rule. Electronic copies are available through EPA's electronic 
public docket and comment system, regulations.gov at https://www.regulations.gov. You may search for this proposed rule under docket 
ID number EPA-HQ-OPP-2009-0431, then click on that docket ID 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 legally treated domestic 
commodities.
    1. Mancozeb. Currently, tolerances for mancozeb are established in 
40 CFR 180.176(a) for residues of the fungicide mancozeb, a 
coordination product of zinc ion and maneb (manganese 
ethylenebisdithiocarbamate) and calculated as zinc 
ethylenebisdithiocarbamate (zineb). Mancozeb is a member of the class 
of dithiocarbamates, whose decomposition releases carbon disulfide 
(CS2). In order to allow harmonization of U.S. tolerances with Codex 
Maximum Residue Limits (MRLs), the Agency determined that for the 
purpose of tolerance enforcement, residues of mancozeb should be 
calculated as carbon disulfide. Therefore, EPA is proposing to revise 
the introductory text containing the tolerance expression in 40 CFR 
180.176(a) to read as follows:

    Tolerances are established for residues of mancozeb (a 
coordination product of zinc ion and maneb (manganese 
ethylenebisdithiocarbamate)), including its metabolites and 
degradates, in or on the commodities in the table in this paragraph. 
Compliance with the tolerance levels specified in this paragraph is 
to be determined by measuring only those mancozeb residues 
convertible to and expressed in terms of the degradate carbon 
disulfide.

    Also, the Agency determined that the change in tolerance expression 
should also apply to the other dithiocarbamates that are determined by 
the carbon disulfide common moiety and have current tolerances. (That 
document is available in the docket for this proposed rule). Currently, 
according to 40 CFR 180.3(d)(5), total dithiocarbamate residue on the 
same raw agricultural commodity shall not exceed that permitted by the 
highest tolerance for any one member of the class, calculated as zinc 
ethylenebisdithiocarbamate (zineb). Therefore, in the interim, until 
all tolerance expressions can be changed for dithiocarbamates with the 
carbon disulfide moiety and current tolerances, EPA is proposing to 
revise the text in 40 CFR 180.3(d)(5) by adding carbon disulfide as 
part of the calculated residues, to read as follows:

    Where tolerances are established for more than one member of the 
class of dithiocarbamates listed in paragraph (e)(3) of this section 
on the same raw agricultural commodity, the total residue of such 
pesticides shall not exceed that permitted by the highest tolerance 
established for any one member of the class, calculated as zinc 
ethylenebisdithiocarbamate and carbon disulfide.

    Oat bran is no longer considered to be a significant food/feed item 
by the Agency, and therefore 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 https://www.epa.gov/opptsfrs/home/guidelin.htm; consequently, the 
Agency has determined that the tolerance for mancozeb on oat, bran at 
20 ppm is no longer needed. Therefore, EPA is proposing to revoke the 
tolerance in 40 CFR 180.176(a) on oat, bran.
    Based on available field trial data that showed mancozeb residues 
on apples as high as 0.55 parts per million (ppm) and on pears as high 
as 0.13 ppm (for a pre-bloom treatment schedule), and 0.65 ppm (for an 
extended treatment schedule), EPA determined that the tolerances should 
be decreased from 7.0 ppm and 10.0 ppm, respectively, to 1 ppm, which 
when converted to carbon disulfide equivalents using a rounded 
conversion factor of 0.6X (based on relative molecular weights) is 
calculated as 0.6 ppm. The Agency determined that data for apple should 
be translated to crabapple because the registered use patterns 
(application method, maximal single application rate, maximal seasonal 
rate, and preharvest interval) associated with given formulations for 
mancozeb are identical for crabapple and apple, and data for pear 
should be translated to quince because the registered use patterns 
associated with given formulations for mancozeb are identical for 
quince and pear, and therefore the tolerances on crabapple and quince 
should each be decreased from 10.0 ppm to 0.6 ppm. Consequently, EPA is 
proposing to decrease the tolerances in 40 CFR 180.176(a) on apple, 
crabapple, pear, and quince, each to 0.6 ppm.
    Based on available field trial data that showed mancozeb residues 
as high as

[[Page 47510]]

1.0 ppm in or on bananas harvested 0 days following the last foliar 
application at 1.3X the maximum single application rate and for bagged 
and unbagged bananas as high as 0.13 ppm and 1.18 ppm, respectively, on 
whole banana fruit including peel harvested 0 days following the last 
foliar application at 1X the maximum single application rate, and to 
harmonize with a Codex MRL of 2 expressed as milligrams (mg) carbon 
disulfide/kilogram (kg) for dithiocarbamates, EPA determined that the 
tolerance should be decreased from 4.0 ppm to 2 ppm. Therefore, EPA is 
proposing to decrease the tolerance in 40 CFR 180.176(a) on banana to 2 
ppm. In addition, because banana pulp is covered by the tolerance for 
banana at the proposed level, a separate tolerance for the obsolete 
commodity term banana, pulp is no longer needed and should be revoked. 
Consequently, EPA is proposing to revoke the tolerance in 40 CFR 
180.176(a) on banana, pulp.
    Based on available field trial data that showed mancozeb residues 
as high as 1.5 ppm and 99.5 ppm for sugar beet roots and tops, 
respectively, EPA determined that tolerances should be set at 2 ppm and 
100 ppm, respectively, which when converted to carbon disulfide 
equivalents using a rounded conversion factor of 0.6X are calculated as 
1.2 ppm and 60 ppm, respectively. Also, based on available processing 
data that showed mancozeb residues concentrated 3X in sugar beet dried 
pulp and a highest average field trial (HAFT) of <1.529 ppm, the Agency 
expected residues as high as 4.59 ppm, the Agency determined that a 
tolerance should be established at 5.0 ppm, which when converted to 
carbon disulfide is calculated at 3.0 ppm. Therefore, EPA is proposing 
to decrease the tolerances in 40 CFR 180.176(a) on beet, sugar, roots 
to 1.2 ppm and beet, sugar, tops to 60 ppm, and establish a tolerance 
on beet, sugar, dried pulp at 3.0 ppm.
    Based on available field trial data that showed mancozeb residues 
as high as 6.72 ppm on cranberry, the Agency determined that the 
tolerance should be set at 7 ppm, which when converted to carbon 
disulfide equivalents using a rounded conversion factor of 0.6X, and to 
harmonize with a Codex MRL of 5 expressed as mg carbon disulfide/kg for 
dithiocarbamates, is calculated as 5 ppm. Therefore, EPA is proposing 
to decrease the tolerance in 40 CFR 180.176(a) on cranberry to 5 ppm.
    Based on available field trial data that showed mancozeb residues 
as high as 2.1 ppm on cucumber, 4.7 ppm on melons treated at 1.3X 
(expect 3.6 ppm at 1X), and 1.75 ppm on summer squash, the Agency 
determined that individual tolerances should be set at 3.0 ppm, 4.0 
ppm, and 2 ppm, respectively, which when converted to carbon disulfide 
equivalents using a rounded conversion factor of 0.6X is calculated as 
1.8 ppm, 2.2 ppm and 1.2 ppm, respectively. Because the representatives 
for crop group 9 include cucumber, muskmelon, and summer squash, EPA 
believes that these tolerances should be combined into a single crop 
group tolerance and decreased from their current individual tolerance 
levels of 4 ppm to 2 ppm. Consequently, EPA is proposing to decrease 
the tolerances in 40 CFR 180.176(a) on cucumber, melon, and squash, 
summer to 2 ppm and combine them into the group tolerance termed 
vegetable, cucurbit, group 9.
    Based on available field trial data that showed mancozeb residues 
as high as 57.4 ppm for field corn forage, 15.2 ppm for field corn 
stover, 87.5 ppm for sweet corn forage, 59.3 ppm for sweet corn stover, 
and translation of sweet corn stover data to pop corn stover, EPA 
determined that tolerances should be increased from 5 ppm each to 65 
ppm, 20 ppm, 120 ppm, 70 ppm, and 70 ppm, respectively, which when 
converted to carbon disulfide equivalents using a rounded conversion 
factor of 0.6X is calculated as 40 ppm, 15 ppm, 70 ppm, 40 ppm, and 40 
ppm, respectively. (The Agency also determined that mancozeb 
registrations for corn use should remove existing feeding/grazing 
restrictions for all types of corn). Therefore, EPA is proposing to 
revise the terminology of tolerances in 40 CFR 180.176(a) for corn, 
forage to corn, field, forage and corn, sweet, forage; and corn, stover 
to corn, field, stover; corn, pop, stover; and corn, sweet, stover; and 
to increase corn, field, forage to 40 ppm, corn, field, stover to 15 
ppm, corn, sweet, forage to 70 ppm; corn, pop, stover to 40 ppm; and 
corn, sweet, stover to 40 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 field trial data that showed mancozeb residues 
at <0.05 ppm on sweet corn (kernel plus cob with husks removed), the 
Agency determined that the tolerance should be decreased from 0.5 ppm 
to 0.1 ppm in order to harmonize with a Codex MRL of 0.1 expressed as 
mg carbon disulfide/kg for dithiocarbamates. Also, the Agency 
determined that the data for sweet corn can be translated to popcorn 
grain, and therefore the tolerance for popcorn grain should be 
decreased from 0.5 ppm to 0.1 ppm, which after conversion is calculated 
as 0.06 ppm. Therefore, EPA is proposing to decrease the tolerances in 
40 CFR 180.176(a) on corn, pop, grain to 0.06 ppm and corn, sweet, 
kernel plus cob with husks removed to 0.1 ppm.
    Based on available field trial data that showed mancozeb residues 
as high as 1.79 ppm for dry bulb onions, EPA determined that the 
tolerance should be increased from 0.5 ppm to 2.0 ppm, which when 
converted to carbon disulfide equivalents using a rounded conversion 
factor of 0.6X is calculated as 1.5 ppm. Therefore, EPA is proposing to 
increase the tolerance in 40 CFR 180.176(a) on onion, bulb to 1.5 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 available field trial data for sorghum seed treatment at 
1.1-1.2X the maximum rate that showed mancozeb residues as high as 0.32 
ppm in or on grain and 0.12 ppm in or on straw, EPA determined that 
tolerances should be established at 0.4 ppm for grain, 0.2 ppm for 
stover, and because the data on straw could be translated to forage, 
0.2 ppm for forage, which when converted to carbon disulfide 
equivalents using a rounded conversion factor of 0.6X are calculated as 
0.25 ppm, 0.15 ppm, and 0.15 ppm, respectively. Therefore, EPA is 
proposing to establish tolerances in 40 CFR 180.176(a) on sorghum, 
grain, grain at 0.25 ppm, sorghum, grain, forage at 0.15 ppm, and 
sorghum, grain, stover at 0.15 ppm.
    Based on available field trial data for flax seed treatment at 0.7-
0.8X the maximum rate that showed mancozeb residues as high as 0.13 ppm 
in or on flax grain, EPA determined that a tolerance should be 
established at 0.2 ppm for flax seed, which when converted to carbon 
disulfide equivalents using a rounded conversion factor of 0.6X is 
calculated as 0.15 ppm. Therefore, EPA is proposing to establish a 
tolerance in 40 CFR 180.176(a) on flax, seed at 0.15 ppm.
    Based on available field trial data for rice seed treatment at 1.2-
1.3X the maximum rate that showed mancozeb residues as high as <0.05 
ppm (non-detectable) in or on rice grain and 0.15 ppm in or on rice 
straw, EPA determined that tolerances should be established at 0.1 ppm 
for rice grain and 0.2 ppm for rice straw, which when converted to 
carbon disulfide equivalents using a rounded conversion factor of 0.6X 
are calculated as 0.06 ppm and 0.15 ppm, respectively. Therefore, EPA 
is proposing to establish tolerances in 40 CFR 180.176(a) on rice, 
grain at 0.06 ppm and rice, straw at 0.15 ppm.

[[Page 47511]]

    Based on available field trial data at 1X the maximum rate that 
showed mancozeb residues as high as 0.017 ppm in or on peanut nutmeat 
and 1.5X the maximum rate that showed mancozeb residues as high as 5.1 
ppm in or on tomatoes, EPA determined that the tolerance on peanut 
should be decreased from 0.5 ppm to 0.1 ppm and the tolerance on tomato 
should remain at 4 ppm, which when converted to carbon disulfide 
equivalents using a rounded conversion factor of 0.6X are calculated as 
0.1 ppm (unchanged, but in harmony with Codex MRL of 0.1 expressed as 
mg carbon disulfide/kg for dithiocarbamates) and 2.5 ppm, respectively. 
Therefore, EPA is proposing to decrease the tolerances in 40 CFR 
180.176(a) on peanut to 0.1 ppm and tomato to 2.5 ppm.
    On March 2, 1992 (57 FR 7484) (FRL-4045-8), EPA published a 
Conclusion of the Special Review for Ethylene bisdithiocarbamates 
(EBDCs PD4), and among its actions, the Agency disallowed mancozeb use 
on carrots and celery. However, the Mancozeb Task Force requested the 
reinstatement of mancozeb use on carrots grown in FL, MI, and WI, and 
celery grown in FL. The available data showed mancozeb residues applied 
at 1X the maximum proposed single and seasonal rate were as high as 
0.709 ppm on carrots. EPA determined that the data for carrots are 
sufficient to support a regional tolerance and the tolerance should be 
redesignated from 180.176(a) to 180.176(c), and after conversion to 
carbon disulfide equivalents, should be decreased from 2 ppm to 1 ppm. 
Also, the available data showed mancozeb residues applied at 2X the 
maximum proposed seasonal rate were as high as 2.19 ppm on celery. The 
Agency concluded that the submitted data are not fully adequate because 
the field trials were conducted at 2X the maximum proposed seasonal 
rate, and as a condition for full registration recommended the 
submission of additional field trials at 1X and 2X rates in each FL 
trial location. However, there have been no active registrations in the 
United States for mancozeb use on celery since 1992, and therefore, the 
celery tolerance is no longer needed and should be revoked. 
Consequently, EPA is proposing to revoke the mancozeb tolerance on 
celery in 40 CFR 180.176(a) and redesignate the tolerance on carrot, 
roots from 40 CFR 180.176(a) to (c), and decrease it to 1 ppm. In 
addition, because that section is currently reserved, EPA is proposing 
to add introductory text for the tolerance expression in 40 CFR 
180.176(c) to read as follows:

    A tolerance with regional registrations is established for 
residues of the fungicide mancozeb, (a coordination product of zinc 
ion and maneb (manganese ethylenebisdithiocarbamate)), including its 
metabolites and degradates, in or on the commodity in the table in 
this paragraph. Compliance with the tolerance levels specified in 
this paragraph is to be determined by measuring only those mancozeb 
residues convertible to and expressed in terms of the degradate 
carbon disulfide.

    Because data for celery treated with 7 to 17 foliar applications of 
mancozeb at 1X the maximum single application rate harvested at 14 days 
following the last application are available, EPA determined that the 
data can be translated to fennel, and no additional residue data for 
fennel, a very minor crop use, are required. Based on the data 
translated from celery, the Agency determined that the tolerance for 
fennel should be decreased from 10 ppm to 4 ppm, which when converted 
to carbon disulfide equivalents, is calculated as 2.5 ppm. Therefore, 
EPA is proposing to decrease the tolerance in 40 CFR 180.176(a) on 
fennel to 2.5 ppm.
    Based on available field trial data at 1X the maximum single and 
0.8X the maximum seasonal application rate that showed mancozeb 
residues as high as 1.83 ppm in or on grapes, EPA determined that the 
tolerance on grape should be decreased from 7 ppm to 2 ppm, which when 
converted to carbon disulfide equivalents using a rounded conversion 
factor of 0.6X are calculated as 1.5 ppm. Therefore, EPA is proposing 
to decrease the tolerance in 40 CFR 180.176(a) on grape to 1.5 ppm.
    Based on available field trial data that showed mancozeb residues 
as high as 0.2 ppm in or on potatoes, EPA determined that there are now 
sufficient data to reassign the tolerance on potato from interim to 
permanent and that it should be decreased from 1.0 ppm to 0.2 ppm when 
converted to carbon disulfide equivalents. Therefore, EPA is proposing 
to revoke the interim tolerance in 40 CFR 180.319 for residues of the 
coordination product of zinc ion and maneb (mancozeb) in or on potato 
at 1.0 ppm (calculated as zinc ethylenebisdithiocarbamate) and 
establish a tolerance in 40 CFR 180.176(a) for residues of mancozeb 
(calculated as carbon disulfide) on potato at 0.2 ppm.
    In addition, EPA is proposing to revise commodity terminology to 
conform to current Agency practice in 40 CFR 180.176(a) as follows: 
``asparagus (negligible residue)'' to ``asparagus''; ``barley, milled 
feed fractions'' to ``barley, bran,'' ``barley, flour,'' and ``barley, 
pearled barley''; ``kidney'' to ``cattle, kidney,'' ``goat, kidney,'' 
``hog, kidney,'' ``horse, kidney,'' ``poultry, kidney,'' and ``sheep, 
kidney''; ``liver'' to ``cattle, liver,'' ``goat, liver,'' ``hog, 
liver,'' ``horse, liver,'' ``poultry, liver,'' and ``sheep, liver''; 
``papaya (whole fruit with no residue present in the edible pulp after 
the peel is removed and discarded)'' to ``papaya''; ``oat, milled feed 
fractions'' to ``oat, flour'' and ``oat, groats/rolled oats''; ``wheat, 
milled byproducts'' to ``wheat, bran,'' ``wheat, flour,'' ``wheat, 
germ,'' ``wheat, middlings,'' and ``wheat, shorts.''
    In the mancozeb RED, certain plant commodity tolerances are 
recommended to be decreased concomitant with product label changes to 
their use patterns. No mitigation is required to address either acute 
or chronic dietary risks from food alone. Acute dietary exposure from 
food alone are below the Agency's level of concern at the 99.9th 
percentile of exposure; i.e., exposure is <1% of the Acute Population 
Adjusted Dose (aPAD) for females 13-49 years old, the most highly 
exposed population subgroup. Chronic dietary exposure from food alone 
are below the Agency's level of concern; i.e., exposure is <1% of the 
Chronic Population Adjusted Dose (cPAD) for the U.S. population and all 
population subgroups, including children 1-2 years old, the most highly 
exposed population subgroup. However, because the Agency is still in 
the process of obtaining the needed amended mancozeb product labels, 
their associated plant tolerances will not be proposed to be decreased 
at this time. The RED for mancozeb recommended a decrease in the 
tolerance for field corn grain (from 0.1 ppm to 0.06 ppm) contingent 
upon limiting use of mancozeb on hybrid seed corn type only. However, 
the Agency has not yet verified that all active mancozeb registrations 
for field corn grain are limited to hybrid seed corn type only. 
Therefore, EPA will not propose action on the tolerance in 40 CFR 
180.176(a) for corn, field, grain at this time. In addition, except for 
the tolerance on oat bran which was recommended for revocation, the RED 
for mancozeb recommended tolerance reassessment actions for papaya and 
the grains, milled feed fractions, and straw of barley, oat, rye, and 
wheat that are contingent upon label revisions. However, the Agency has 
not yet verified that all mancozeb registrations for them have been 
revised. Therefore, EPA will not propose action on the

[[Page 47512]]

tolerances in 40 CFR 180.176(a) for barley, grain; barley, straw; oat, 
grain; oat, straw; rye, grain; rye, straw; and wheat, grain at this 
time. With the exception of proposing to revise the tolerance 
nomenclatures for papaya (whole fruit with no residue present in the 
edible pulp after the peel is removed and discarded) and the milling 
feed fractions of barley, oat, and wheat, as described herein, no other 
action will be taken on them in 40 CFR 180.176(a) at this time. Also, 
although the Agency determined that the available processing data for 
wheat bran and flour may be translated to barley bran and flour, 
bridging processing data on pearled barley are still required. When 
appropriate mancozeb product label changes for specific plant commodity 
uses are provided to and approved by the Agency, EPA expects to follow 
up and propose the recommended tolerance decreases in a future 
publication in the Federal Register. Also, the Mancozeb Task Force 
requested removal of the foliar use on cotton and EPA has determined 
that use of mancozeb as a seed treatment on cottonseed is a non-food 
use (document available in the docket for this proposed rule). However, 
the Agency has not yet verified that all active mancozeb registrations 
for cotton do not have a foliar use on cotton. Therefore, EPA will not 
propose action on the tolerance in 40 CFR 180.176(a) for cotton, 
undelinted seed at this time.
    There are MRLs for dithiocarbamates which are determined as carbon 
disulfide mg/kg. The tolerance definition for mancozeb proposed herein 
would be harmonized with that for Codex MRLs with respect to residue 
determination as carbon disulfide. However, the Codex limits are listed 
for total dithiocarbamates, which also include dithiocarbamates other 
than mancozeb.
    2. Maneb. Currently, tolerances for maneb are established in 40 CFR 
180.110(a) for residues of the fungicide maneb (manganese 
ethylenebisdithiocarbamate), calculated as zinc 
ethylenebisdithiocarbamate. Maneb is a member of the class of 
dithiocarbamates, whose decomposition releases a common moiety, carbon 
disulfide (CS2). In order to allow harmonization of U.S. tolerances 
with Codex MRLs, the Agency determined that for the purpose of 
tolerance enforcement, residues of maneb should be calculated as carbon 
disulfide. Therefore, EPA is proposing to revise the introductory text 
containing the tolerance expression in 40 CFR 180.110(a) to read as 
follows:

    Tolerances are established for residues of maneb (manganese 
ethylenebisdithiocarbamate), including its metabolites and 
degradates, in or on the commodities in the table in this paragraph. 
Compliance with the tolerance levels specified in this paragraph is 
to be determined by measuring only those maneb residues convertible 
to and expressed in terms of the degradate carbon disulfide.
    Maneb use on certain crops were disallowed for reregistration by 
EPA, as announced in a notice published in the Federal Register of 
March 2, 1992 (57 FR 7484) (FRL-4045-8). In that notice, the Agency 
announced its conclusion of Special Review (PD4) regarding ethylene 
bisdithiocarbamates (EBDCs), including maneb, and its intent to cancel 
any EBDC product registrations bearing food uses that included, among 
others, apricots, succulent beans, carrots, celery, nectarines, and 
peaches. There have been no U.S. registrations for maneb use associated 
with apricots, succulent beans, nectarines, and peaches since 1992, and 
carrots and celery since 1994. Therefore, the maneb tolerances on these 
commodities are no longer needed and should be revoked. Consequently, 
EPA is proposing to revoke the tolerances in 40 CFR 180.110(a) for 
maneb residues of concern in or on apricot; bean, succulent; carrot, 
roots; celery; nectarine; and peach.
    Based on available field trial data that showed maneb residues as 
high as <4.0 ppm for dry beans, 10.0 ppm for broccoli, <4.0 ppm for 
cucumber, <4.0 ppm for tomato, and calculation of 2.93 ppm for melon at 
1X (based on maneb residues as high as of 4.39 ppm for melon treated at 
1.5X), EPA determined that the tolerances should be decreased for dry 
beans from 7 ppm to 4 ppm, maintained for broccoli at 10 ppm, 
maintained for both cucumber and tomato at 4 ppm, and maintained for 
melon at 4 ppm, which when converted to carbon disulfide equivalents 
using a rounded conversion factor of 0.6X are calculated as 2.5 ppm, 6 
ppm, 2 ppm, 2.5 ppm, and 3 ppm, respectively. In addition, the Agency 
determined that the broccoli data could be translated to Brussels 
sprouts, cauliflower, and kohlrabi, and that the tolerances on Brussels 
sprouts, cauliflower, and kohlrabi should, after conversion, be 
decreased from 10 ppm to 6 ppm. Also, the Agency determined that the 
melon data could be translated to pumpkin and winter squash, and that 
the tolerances on pumpkin and winter squash should, after conversion, 
be decreased from 7 ppm to 3 ppm and 4 ppm to 3 ppm, respectively. 
Moreover, the Agency determined that the cucumber data could be 
translated to summer squash, and that the tolerance on summer squash, 
after conversion, be decreased from 4 to 2 ppm. Furthermore, the Agency 
determined that the tomato data could be translated to eggplant, and 
that the tolerance on eggplant, after conversion, be decreased from 7 
ppm to 2.5 ppm. Therefore, EPA is proposing to decrease the tolerances 
in 40 CFR 180.110(a) on bean, dry, seed to 2.5 ppm, broccoli to 6 ppm, 
Brussels sprouts to 6 ppm, cauliflower to 6 ppm, cucumber to 2 ppm, 
eggplant to 2.5 ppm, kohlrabi to 6 ppm, melon to 3 ppm, pumpkin to 3 
ppm, squash, summer to 2 ppm, squash, winter to 3 ppm, and tomato to 
2.5 ppm.
    Geographic representation of data for green onion was incomplete 
and not conducted according to the maximum registered use pattern. 
However, based on available field trial data for dry bulb onion that 
showed maneb residues of concern as high as 10.1 ppm (in or on one 
sample harvested 7 days following treatments at 0.5-0.8X the maximal 
seasonal rate), the Agency determined that the current tolerance for 
onion should be separated into onion, bulb and onion, green, and that 
the tolerance on onion, bulb should be increased from 7 ppm to 
approximately 10.1 ppm, but which after the 0.6X conversion to carbon 
disulfide, should be decreased to 6 ppm. Therefore, EPA is revising the 
tolerance in 40 CFR 180.110(a) on onion into onion, green and onion, 
bulb, and decreasing the tolerance on onion, bulb to 6 ppm, maintaining 
the tolerance on onion, green at 7 ppm at this time, while reiterating 
that additional data are required for green onions.
    Based on available field trial data that showed maneb residues of 
concern as high as 36.8 ppm on untrimmed cabbage at 1.2X the seasonal 
rate allowed by PD4, the Agency determined that the tolerance for 
cabbage should be increased from the current level of 10 ppm, which 
after a 0.6X conversion to carbon disulfide is 21 ppm. Therefore, EPA 
is proposing to increase the tolerance in 40 CFR 180.110(a) for cabbage 
to 21 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 available field trial data that showed maneb residues of 
concern as high as 154 ppm, the Agency determined that the tolerance 
for sugar beet tops should be increased from 45 to 200 ppm, which after 
a 0.6X conversion to carbon disulfide is 120 ppm. Also, based on 
available field trial data that showed maneb residues of concern as 
high as 1.72 ppm, the

[[Page 47513]]

Agency determined that a tolerance should be established on sugar beet 
roots at 2 ppm, which after a 0.6X conversion to carbon disulfide is 
1.2 ppm. In addition, based on available processing data that showed a 
concentration factor of 2X for dried pulp, and a HAFT of 1.72 ppm for 
sugar beet roots, EPA determined that the expected maneb residues of 
concern in dried sugar beet pulp are 3.44 ppm, which is greater than 
the reassessed tolerance for sugar beet roots of 2.0 ppm, and therefore 
a tolerance should be established for dried sugar beet pulp at 4 ppm, 
which after a 0.6X conversion to carbon disulfide is 2.5 ppm. 
Consequently, EPA is proposing to establish tolerances in 40 CFR 
180.110(a) for beet, sugar, roots at 1.2 ppm and beet, sugar, dried 
pulp at 2.5 ppm, and increase the tolerance in 40 CFR 180.110(a) for 
beet, sugar, tops to 120 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 available poultry and ruminant metabolism data, the Agency 
determined that tolerances should be established on livestock 
commodities at the limit of quantitation of the analytical method. 
Therefore, EPA is proposing to establish tolerances in 40 CFR 
180.110(a) on cattle, fat; cattle, meat; cattle, meat byproducts; goat, 
fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat 
byproducts; horse, fat; horse, meat; horse, meat byproducts; poultry, 
fat; poultry, meat; poultry, meat byproducts; sheep, fat; sheep, meat; 
sheep, meat byproducts; egg; and milk; each at 0.02 ppm.
    In addition, EPA is proposing to revise commodity terminology to 
conform to current Agency practice in 40 CFR 180.110(a) as follows: 
``banana (not more than 0.5 parts per million) shall be in the pulp 
after peel is removed and discarded (preharvest application only)'' to 
``banana, preharvest''; and ``cabbage, chinese'' to ``cabbage, chinese, 
bok choy'' and ``cabbage, chinese, napa.''
    Although the RED for maneb recommended tolerance revocation based 
on requests for voluntary cancellation of registrations associated with 
certain commodities, EPA is still in the process of verifying whether 
active registrations currently exist for them and therefore will not 
propose action on tolerances for apple; fig; grape; corn, sweet, kernel 
plus cob with husks removed; or turnip, roots at this time.
    There are Codex MRLs for dithiocarbamates which are determined as 
carbon disulfide mg/kg. The tolerance definition for maneb proposed 
herein would be harmonized with that for Codex MRLs with respect to 
residue determination as carbon disulfide. However, the Codex limits 
are listed for total dithiocarbamates, which also include 
dithiocarbamates other than maneb.
    3. Metiram. Currently, tolerances for metiram are established in 40 
CFR 180.217(a) for residues of the fungicide metiram, a mixture of 5.2 
parts by weight of ammoniates of (ethylenebis (dithiocarbamato)) zinc 
with 1 part by weight ethylenebis (dithiocarbamic acid) bimolecular and 
trimolecular cyclic anhydrosulfides and disulfides, calculated as zinc 
ethylenebisdithiocarbamate. Metiram is a member of the class of 
dithiocarbamates, whose decomposition releases a common moiety, carbon 
disulfide (CS2). In order to allow harmonization of U.S. tolerances 
with Codex MRLs, the Agency determined that for the purpose of 
tolerance enforcement, residues of metiram should be calculated as 
carbon disulfide. Therefore, EPA is proposing to revise the section 
heading from its chemical name to metiram and also revise the 
introductory text containing the tolerance expression in 40 CFR 
180.217(a) to read as follows:

    Tolerances are established for residues of metiram (a mixture of 
5.2 parts by weight of ammoniates of (ethylenebis (dithiocarbamato)) 
zinc with 1 part by weight ethylenebis (dithiocarbamic acid) 
bimolecular and trimolecular cyclic anhydrosulfides and disulfides), 
including its metabolites and degradates, in or on the commodities 
in the table in this paragraph. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only 
those metiram residues convertible to and expressed in terms of the 
degradate carbon disulfide.

    Also, EPA is proposing in 40 CFR 180.217 to revise the section 
heading from the chemical name ``ammoniates of [ethylenebis 
(dithiocarbamato)] zinc and ethylenebis [dithiocarbamic acid] 
bimolecular and trimolecular cyclic anhydrosulfides and disulfides'' to 
``metiram.''
    Based on available field trial data that showed combined metiram 
residues of concern as high as <0.53 ppm in or on apples, and <0.03 ppm 
in or on potatoes, the Agency determined that tolerances should be 
decreased, which when converted to carbon disulfide equivalents using a 
rounded conversion factor of 0.6X, should be decreased from 2.0 ppm to 
0.5 ppm for apple and from 0.5 ppm to 0.2 ppm for potato. Therefore, 
EPA is proposing to decrease tolerances in 40 CFR 180.217(a) on apple 
to 0.5 ppm and on potato to 0.2 ppm.
    Based on available processing data that showed metiram residues of 
concern concentrated 5X in wet apple pomace and a HAFT of 0.53 ppm, the 
Agency expected residues as high as 2.65 ppm, and the Agency determined 
that a tolerance should be established, which when converted to carbon 
disulfide is calculated at 2 ppm. Therefore, EPA is proposing to 
establish a tolerance in 40 CFR 180.217(a) on apple, wet pomace at 2 
ppm.
    There are Codex MRLs for dithiocarbamates which are determined as 
carbon disulfide mg/kg. The tolerance definition for metiram proposed 
herein would be harmonized with that for Codex MRLs with respect to 
residue determination as carbon disulfide. However, the Codex limits 
are listed for total dithiocarbamates, which also include 
dithiocarbamates other than metiram.
    4. Thiram. Currently, tolerances for thiram are established in 40 
CFR 180.132(a) for residues of the fungicide thiram (tetramethyl 
thiuram disulfide). Thiram is a member of the class of 
dithiocarbamates, whose decomposition releases a common moiety, carbon 
disulfide (CS2). In order to allow harmonization of U.S. tolerances 
with Codex MRLs, the Agency determined that for the purpose of 
tolerance enforcement, residues of thiram should be calculated as 
carbon disulfide. Therefore, EPA is proposing to revise the 
introductory text containing the tolerance expression in 40 CFR 
180.132(a) to read as follows:

    Tolerances are established for residues of thiram, tetramethyl 
thiuram disulfide, including its metabolites and degradates, in or 
on the commodities in the table in this paragraph. Compliance with 
the tolerance levels specified in this paragraph is to be determined 
by measuring only those thiram residues convertible to and expressed 
in terms of the degradate carbon disulfide.

    In the Federal Register of September 12, 2008 (73 FR 53007) (FRL-
8380-7), EPA issued a notice regarding EPA's announcement of the 
receipt of requests from registrants to voluntarily cancel certain 
pesticide registrations, including cancellation of the last apple use 
from thiram registrations. EPA approved the cancellation for the thiram 
registration with the last apple use and made it effective on March 11, 
2009, and permitted the registrant to sell and distribute product under 
the previously approved labeling until September 11, 2009. The Agency 
believes that end users will have had sufficient time to exhaust 
existing stocks and for thiram-treated apple commodities to have

[[Page 47514]]

cleared the channels of trade by September 11, 2010. Also, based on 
available field trial data that showed thiram residues of concern as 
high as 8.65 ppm on apples, the Agency determined that the tolerance 
for apple should be 9 ppm, but which after a 0.6X conversion to carbon 
disulfide is determined by the Agency to be appropriate at 6.0 ppm. 
Therefore, during the interim period prior to its expiration, the 
tolerance should be decreased from 7.0 ppm to 6.0 ppm. Consequently, 
EPA is proposing to revoke the tolerance in 40 CFR 180.132(a) for apple 
with an expiration/revocation date of September 11, 2010, and decrease 
the tolerance level to 6.0 ppm.
    Based on available field trial data that showed thiram residues of 
concern at <9 ppm on strawberries, the Agency determined that the 
tolerance for strawberry should be 9 ppm, but which after a 0.6X 
conversion to carbon disulfide is determined by the Agency to be 
appropriate at 6.0 ppm. Therefore, EPA is proposing to decrease the 
tolerance in 40 CFR 180.132(a) on strawberry to 6.0 ppm.
    There are Codex MRLs for dithiocarbamates which are determined as 
carbon disulfide mg/kg. The tolerance definition for thiram proposed 
herein would be harmonized with that for Codex MRLs with respect to 
residue determination as carbon disulfide. However, the Codex limits 
are listed for total dithiocarbamates, which also include 
dithiocarbamates other than thiram.

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 FQPA of 1996, Public Law 104-170, 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 food-use pesticide to be sold and distributed, the pesticide must 
not only have appropriate tolerances under the FFDCA, but also must be 
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not 
registered in the 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 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 FQPA. The safety finding determination 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 REDs for mancozeb, maneb, metiram, and thiram. REDs 
and TREDs contain the Agency's evaluation of the database 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

[[Page 47515]]

products (for example, grain or hay) containing pesticide 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)).

C. When Do These Actions Become Effective?

    With the exception of the thiram tolerance for apple for which EPA 
is proposing a specific expiration/revocation date, 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 proposed revocation of the thiram tolerance for apple, 
tolerances that are considered by EPA to no longer be significant food/
feed items, and tolerances whose commodity use is covered by another 
tolerance, the Agency believes that existing stocks of pesticide 
products labeled for the uses associated with the tolerances proposed 
for revocation in this document have been completely exhausted and that 
treated commodities have cleared the channels of trade. EPA is 
proposing an expiration/revocation date of September 11, 2010, for the 
thiram tolerance for apple. The Agency believes that this revocation 
date allows users to exhaust stocks and allows 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 Unit I.B.
    Any commodities listed in this proposed rule treated with the 
pesticides subject to this proposal, and in the channels of trade 
following the tolerance revocations, shall be subject to FFDCA section 
408(1)(5), as established by FQPA. Under this unit, any residues of 
these pesticides in or on such food shall not render the food 
adulterated so long as it is shown to the satisfaction of the Food and 
Drug Administration that:
    1. The residue is present as the result of an application or use of 
the pesticide at a time and in a manner that was lawful under FIFRA, 
and
    2. The residue does not exceed the level that was authorized at the 
time of the application or use to be present on the food under a 
tolerance or exemption from tolerance. Evidence to show that food was 
lawfully treated may include records that verify the dates when the 
pesticide was applied to such food.

III. Are the Proposed Actions Consistent with International 
Obligations?

    The tolerance actions in this proposed rule 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 MRLs established by 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 proposed 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, entitled Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 
This proposed rule does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 
et seq., or impose any enforceable duty or contain any unfunded mandate 
as described under Title II of the Unfunded Mandates Reform Act 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