[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Proposed Rules]
[Pages 47507-47517]
From the Federal Register Online via the Government Publishing 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: http://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
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The 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 http://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 http://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:
[email protected].
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 http://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 http://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 http://www.regulations.gov and also at http://www.epa.gov/pesticides/reregistration/status.htm.
The selection of an individual tolerance level is based on crop
field residue studies designed to produce the maximum residues under
the existing or proposed product label. Generally, the level selected
for a tolerance is a value slightly above the maximum residue found in
such studies, provided that the tolerance is safe. The evaluation of
whether a tolerance is safe is a separate inquiry. EPA recommends the
raising of a tolerance when data show that:
1. Lawful use (sometimes through a label change) may result in a
higher residue level on the commodity.
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 http://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 http://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 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) (FRL-5753-1),
respectively, and were provided to the Chief Counsel for Advocacy of
the Small Business Administration. Taking into account this analysis,
and available information concerning the pesticides listed in this
proposed rule, the Agency hereby certifies that this proposed rule will
not have a significant negative economic impact on a substantial number
of small entities. In a memorandum dated May 25, 2001, EPA determined
that eight conditions must
[[Page 47516]]
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 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 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 9,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This proposed rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 4, 2009.
Debra Edwards,
Director, Office of Pesticide Programs.
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 180.3 is amended by revising paragraph (d)(5), to read
as follows:
Sec. 180.3 Tolerances for related pesticide chemicals.
(d)(5) 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.
3. Section 180.110 is amended by revising paragraph (a) to read as
follows:
Sec. 180.110 Maneb; tolerances for residues.
(a) General. 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.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond..................................................... 0.1
Apple...................................................... 2
Banana, preharvest......................................... 4
Bean, dry, seed............................................ 2.5
Beet, sugar, dried pulp.................................... 2.5
Beet, sugar, roots......................................... 1.2
Beet, sugar, tops.......................................... 120
Broccoli................................................... 6
Brussels sprouts........................................... 6
Cabbage.................................................... 21
Cabbage, chinese, bok choy................................. 10
Cabbage, chinese, napa..................................... 10
Cattle, fat................................................ 0.02
Cattle, meat............................................... 0.02
Cattle, meat byproducts.................................... 0.02
Cauliflower................................................ 6
Collards................................................... 10
Corn, sweet, kernel plus cob with husks removed............ 5
Cranberry.................................................. 7
Cucumber................................................... 2
Egg........................................................ 0.02
Eggplant................................................... 2.5
Endive..................................................... 10
Fig........................................................ 7
Goat, fat.................................................. 0.02
Goat, meat................................................. 0.02
Goat, meat byproducts...................................... 0.02
Grape...................................................... 7
Hog, fat................................................... 0.02
Hog, meat.................................................. 0.02
Hog, meat byproducts....................................... 0.02
Horse, fat................................................. 0.02
Horse, meat................................................ 0.02
Horse, meat byproducts..................................... 0.02
Kale....................................................... 10
Kohlrabi................................................... 6
Lettuce.................................................... 10
Melon...................................................... 3
Milk....................................................... 0.02
Mustard greens............................................. 10
Onion, bulb................................................ 6
Onion, green............................................... 7
Papaya..................................................... 10
Pepper..................................................... 7
Potato..................................................... 0.1
Poultry, fat............................................... 0.02
Poultry, meat.............................................. 0.02
Poultry, meat byproducts................................... 0.02
Pumpkin.................................................... 3
Sheep, fat................................................. 0.02
Sheep, meat................................................ 0.02
Sheep, meat byproducts..................................... 0.02
Squash, summer............................................. 2
Squash, winter............................................. 3
Tomato..................................................... 2.5
Turnip, greens............................................. 10
Turnip, roots.............................................. 7
------------------------------------------------------------------------
* * * * *
4. Section 180.132 is amended by revising paragraph (a) to read as
follows:
Sec. 180.132 Thiram; tolerances for residues.
(a) General. 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
[[Page 47517]]
measuring only those thiram residues convertible to and expressed in
terms of the degradate carbon disulfide.
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Apple......................................... 6.0 9/11/10
Peach......................................... 7.0 None
Strawberry.................................... 6.0 None
------------------------------------------------------------------------
* * * * *
5. Section 180.176 is amended by revising paragraph (a) and adding
paragraph (c) to read as follows:
Sec. 180.176 Mancozeb; tolerances for residues.
(a) General. 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.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple...................................................... 0.6
Asparagus.................................................. 0.1
Banana..................................................... 2
Barley, bran............................................... 20
Barley, flour.............................................. 20
Barley, grain.............................................. 5
Barley, pearled barley..................................... 20
Barley, straw.............................................. 25
Beet, sugar, dried pulp.................................... 3.0
Beet, sugar, roots......................................... 1.2
Beet, sugar, tops.......................................... 60
Cattle, kidney............................................. 0.5
Cattle, liver.............................................. 0.5
Corn, field, forage........................................ 40
Corn, field, grain......................................... 0.1
Corn, field, stover........................................ 15
Corn, pop, grain........................................... 0.06
Corn, pop, stover.......................................... 40
Corn, sweet, forage........................................ 70
Corn, sweet, kernel plus cob with husks removed............ 0.1
Corn, sweet, stover........................................ 40
Cotton, undelinted seed.................................... 0.5
Crabapple.................................................. 0.6
Cranberry.................................................. 5
Fennel..................................................... 2.5
Flax, seed................................................. 0.15
Goat, kidney............................................... 0.5
Goat, liver................................................ 0.5
Grape...................................................... 1.5
Hog, kidney................................................ 0.5
Hog, liver................................................. 0.5
Horse, kidney.............................................. 0.5
Horse, liver............................................... 0.5
Oat, flour................................................. 20
Oat, grain................................................. 5
Oat, groats/rolled oats.................................... 20
Oat, straw................................................. 25
Onion, bulb................................................ 1.5
Papaya..................................................... 10
Peanut..................................................... 0.1
Peanut, hay................................................ 65
Pear....................................................... 0.6
Potato..................................................... 0.2
Poultry, kidney............................................ 0.5
Poultry, liver............................................. 0.5
Quince..................................................... 0.6
Rice, grain................................................ 0.06
Rice, straw................................................ 0.15
Rye, bran.................................................. 20
Rye, grain................................................. 5
Rye, straw................................................. 25
Sheep, kidney.............................................. 0.5
Sheep, liver............................................... 0.5
Sorghum, grain, forage..................................... 0.15
Sorghum, grain, grain...................................... 0.25
Sorghum, grain, stover..................................... 0.15
Tomato..................................................... 2.5
Vegetable, cucurbit, group 9............................... 2
Wheat, bran................................................ 20
Wheat, flour............................................... 20
Wheat, germ................................................ 20
Wheat, grain............................................... 5
Wheat, middlings........................................... 20
Wheat, shorts.............................................. 20
Wheat, straw............................................... 25
------------------------------------------------------------------------
* * * * *
(c) Tolerances with regional registrations. 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.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Carrot, roots.............................................. 1
------------------------------------------------------------------------
* * * * *
6. Section 180.217 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 180.217 Metiram; tolerances for residues.
(a) General. 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.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple...................................................... 0.5
Apple, wet pomace.......................................... 2
Potato..................................................... 0.2
------------------------------------------------------------------------
* * * * *
Sec. 180.319 [Amended]
7. Section 180.319 is amended by removing the entry for the
substance ``Coordination product of zinc ion and maneb'' from the
table.
[FR Doc. E9-22302 Filed 9-15-09; 8:45 am]
BILLING CODE 6560-50-S