Ametryn, Amitraz, Ammonium Soap Salts of Higher Fatty Acids (C8, 22478-22490 [E9-11172]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 91 (Wednesday, May 13, 2009)]
[Proposed Rules]
[Pages 22478-22490]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11172]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0251; FRL-8412-3]


Ametryn, Amitraz, Ammonium Soap Salts of Higher Fatty Acids 
(C8-C18 saturated; C8-C12 
unsaturated), Bitertanol, Coppers, et al.; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to revoke certain tolerances/tolerance 
exemptions for the fungicides pentachloronitrobenzene and triadimenol, 
the herbicides ametryn, fluazifop-P-butyl, and prometryn; the 
insecticides amitraz and mineral oil; the defoliant/desiccant sodium 
chlorate; and the fungicide/algicide/herbicide coppers. Also, EPA is 
proposing to modify certain tolerances for the fungicide bitertanol and 
the insecticide malathion. In addition, EPA is proposing to establish 
new tolerances/tolerance exemptions for the fungicides coppers and 
pentachloronitrobenzene; the herbicide prometryn; the insecticide 
malathion; and the defoliant/desiccant sodium chlorate; and revise the 
tolerance expression for the ammonium salts of higher fatty acids 
(ammonium soap salts). 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 July 13, 2009.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2009-0251, 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

[[Page 22479]]

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-
2009-0251. 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, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8037; 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 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 proposal, you may also submit an objection 
at the time of the final rule. If you fail to file an objection to the 
final rule within the time period specified, you will have waived the 
right to raise any issues resolved in the final rule. After the

[[Page 22480]]

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/tolerance exemptions for residues of the fungicides 
bitertanol, pentachloronitrobenzene, and triadimenol; the herbicides 
ametryn, fluazifop-P-butyl, and prometryn; the insecticides amitraz, 
malathion, and mineral oil; the defoliant/desiccant sodium chlorate; 
and the fungicide/algicide/herbicide coppers; and revise the tolerance 
expression for the ammonium salts of higher fatty acids (ammonium soap 
salts) 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 ametryn (EPA-HQ-OPP-2004-0411), coppers (EPA-HQ-OPP-
2005-0558), malathion (EPA-HQ-OPP-2004-0348), aliphatic solvents 
(mineral oil) (EPA-HQ-OPP-2006-0284), pentachloronitrobenzene (EPA-HQ-
OPP-2004-0202), and inorganic chlorates (sodium chlorate)(EPA-HQ-OPP-
2005-0507), and TREDs for amitraz (EPA-HQ-OPP-2004-0048), bitertanol 
(EPA-HQ-OPP-2005-0491), fluazifop-P-butyl (EPA-HQ-OPP-2004-0347), and 
triadimenol (EPA-HQ-OPP-2006-0038), at https://www.regulations.gov and 
REDs for soap salts (includes ammonium salts of higher fatty acids) and 
prometryn 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:
     Lawful use (sometimes through a label change) may result 
in a higher residue level on the commodity.
     The tolerance remains safe, notwithstanding increased 
residue level allowed under the tolerance.
In REDs, Chapter IV on ``Risk Management, Reregistration, and Tolerance 
Reassessment'' typically describes the regulatory position, FQPA 
assessment, cumulative safety determination, determination of safety 
for U.S. general population, and safety for infants and children. In 
particular, the human health risk assessment document which supports 
the RED describes risk exposure estimates and whether the Agency has 
concerns. In TREDs, the Agency discusses its evaluation of the dietary 
risk associated with the active ingredient and whether it can determine 
that there is a reasonable certainty (with appropriate mitigation) that 
no harm to any population subgroup will result from aggregate exposure. 
EPA also seeks to harmonize tolerances with international standards set 
by the Codex Alimentarius Commission, as described in Unit III.
    Explanations for proposed modifications in tolerances and 
exemptions and/or establishments of tolerances and exemptions for 
bitertanol, coppers, malathion, pentachloronitrobenzene, prometryn, and 
sodium chlorate 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 bitertanol, 
coppers (included in revised Human Health Chapter), malathion, 
pentachloronitrobenzene, and sodium chlorate (included in the HED 
Chapter of the RED) can be found under their respective public docket 
ID numbers, identified in Unit II.A. Electronic copies of support 
documents for soap salts (including the revised Human Health Assessment 
Scoping Document in Support of Registration Review) are available in 
public docket EPA-HQ-OPP-2008-0519. An electronic copy of the Residue 
Chemistry Chapter for prometryn 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-2009-0251, 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.

[[Page 22481]]

    1. Ametryn. In the Federal Register notice of December 19, 2007 (72 
FR 71898) (FRL-8343-9), EPA issued a notice regarding EPA's 
announcement on the receipt of requests from the registrant to 
voluntarily cancel specific registrations, which would terminate the 
last ametryn uses for banana and sweet corn. EPA approved cancellation 
of the registration by issuing a cancellation order with the close of 
the comment period, made it effective on June 16, 2008, and permitted 
the registrant for the canceled registration to sell and distribute 
existing stocks until June 16, 2009. Also, EPA permitted persons other 
than the registrant to sell, distribute, and conforming to the EPA-
approved label and labeling of the products, use existing ametryn 
pesticide stocks on banana and sweet corn until they are exhausted. The 
Agency believes that end users will have had sufficient time to exhaust 
those existing stocks and for ametryn treated banana and sweet corn 
commodities to have cleared the channels of trade by June 16, 2010. 
Therefore, EPA is proposing to revoke the tolerances in 40 CFR 
180.258(a) on banana; corn, sweet, forage; corn, sweet, kernel plus cob 
with husks removed; and corn, sweet, stover; each with an expiration/
revocation date of June 16, 2010.
    There are no Codex Maximum Residue Limits (MRLs) for ametryn.
    2. Amitraz. EPA approved cancellation of the last registration for 
use of amitraz on pears by issuing a cancellation order on May 3, 2006 
(71 FR 26083) (FRL-8059-5), and permitted the registrants for the 
canceled registrations to sell and distribute existing stocks for 18 
months (i.e., until November 3, 2007). Also, EPA permitted persons 
other than the registrant to sell, distribute, and conforming to the 
EPA-approved label and labeling of the products, use existing amitraz 
pesticide stocks on pears until they are exhausted. The Agency believes 
that end users have had sufficient time to exhaust those existing 
stocks and for amitraz treated pear commodities to have cleared the 
channels of trade. Therefore, EPA is proposing to revoke the tolerance 
in 40 CFR 180.287(a) on pear.
    There are Codex MRLs for amitraz, including one on pome fruits at 
0.5 milligrams/kilogram (mg/kg).
    3. Ammonium salts of higher fatty acids (C8-
C18 saturated; C8-C12 unsaturated). 
Currently, there is an exemption from a tolerance in 40 CFR 180.1284 
for ammonium salts of higher fatty acids (C8-C18 
saturated; C8-C12 unsaturated) residues in or on 
all food commodities when applied for the suppression and control of a 
wide variety of grasses and weeds. However, since 1993, there are 
existing product labels for the ammonium salts with instructions for 
use in agricultural settings as a deer repellent to growing crops and 
orchards with fruit present. Ammonium salts of fatty acids (ammonium 
soap salts) have low acute toxicity by oral, dermal, or inhalation 
routes of exposure. Due to the lack of effects at high doses in the 
available studies, the nature of the fatty acids and their ubiquity in 
nature, and the unlikelihood of prolonged human exposure via the oral 
route due to the use patterns, the Agency continues to believe that it 
is appropriate to waive all generic mammalian toxicity data 
requirements for the soap salts. Therefore, the Agency determined that 
the introductory text in 40 CFR 180.1284 should be revised from its 
current form where it is limited to herbicide uses to be broad enough 
to cover all the use patterns that exist for currently registered 
products. Consequently, EPA is proposing to revise the introductory 
text containing the tolerance expression in 40 CFR 180.1284 to read as 
follows: ``Ammonium salts of C8-C18 saturated and 
C8-C12 unsaturated higher fatty acids are 
exempted from the requirement of a tolerance for residues in or on all 
food commodities when used in accordance with good agricultural 
practice.''
    There are no Codex MRLs for soap salts, including ammonium soap 
salts.
    4. Bitertanol, [beta]-((1,1''-biphenyl)-4-yloxy)-[alpha]-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol. There have been no U.S. 
registrations for bitertanol, a fungicide, since 1992. Based on 
available foreign data that showed residues of bitertanol, [beta]-
((1,1''-biphenyl)-4-yloxy)-[alpha]-(1,1-dimethylethyl)-1H-1,2,4-
triazole-1-ethanol, as high as 0.76 parts per million (ppm) in or on 
the green peel and 0.36 ppm in or on the green fruit of treated 
unbagged bananas (washed and unwashed samples) at an exaggerated 
application rate of 2X (0.26 lb active ingredient per acre per 
application) the current application rate, the Agency believes residues 
would be as high as 0.38 ppm at the current application rate (0.13 
pounds active ingredient per acre per application). Although intended 
for use on bagged bananas (where residues were <0.2 ppm) only, 
application to unbagged bananas may occur. Therefore, the Agency 
determined that the tolerance should be increased. It is the Agency's 
policy to harmonize its tolerances with the levels established by Codex 
provided that the Agency has sufficient information to make a 
determination that the Codex MRLs meet FFDCA standards. Because the 
dietary exposure and risk are not of concern, the Agency determined 
that the U.S. tolerance for bitertanol residues on banana should be 
increased from 0.2 to 0.5 ppm to harmonize with the Codex MRL (0.5 mg/
kg) on banana. Also, the existing paragraph in 40 CFR 180.457 should be 
designated paragraph (a) because other paragraphs need to be reserved. 
Therefore, EPA is proposing to revise the section heading from its 
chemical name to bitertanol and designate the existing introductory 
text as paragraph (a), add bitertanol as the name of the fungicide in 
the introductory text, and increase the import tolerance for bitertanol 
in 40 CFR 180.457(a) on banana to 0.5 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.
    In accordance with current Agency practice, EPA is proposing to 
revise 40 CFR 180.457 by adding paragraphs (b), (c), and (d), and 
reserving those paragraphs for tolerances with section 18 emergency 
exemptions, regional registrations, and indirect or inadvertent 
residues, respectively.
    There are Codex MRLs for bitertanol, including one on banana at 0.5 
mg/kg.
    5. Coppers. Copper is a natural trace element that is essential for 
homeostasis in human health. As part of the reregistration process for 
copper, the Agency determined that all food use copper compounds should 
maintain their exemptions from the requirement of a tolerance in 40 CFR 
180.1021. These exemptions are supported by the hazard assessment 
(based on available literature and studies there is no indication of 
systemic toxicity) as well as the exposure assessment (minimal 
contribution of copper in the diet from pesticidal use). In general, 
copper has moderate to low acute toxicity. Due to its ubiquitous 
nature, lack of systemic toxicity, homeostatic mechanisms in humans, 
and naturally occurring levels on raw agricultural commodities, the 
Agency does not expect residues from agricultural pesticide use to 
significantly contribute to the overall dietary intake of copper. Some 
copper compounds (copper ammonia complex, copper oxychloride, copper 
oxychloride sulfate, copper salts of fatty and rosin acids, and copper 
sulfate pentahydrate) have registered agricultural uses on food crops, 
and therefore should be included in 40 CFR 180.1021(b). Consequently, 
EPA is proposing to establish exemptions from the requirement of a

[[Page 22482]]

tolerance in 40 CFR 180.1021(b) for copper ammonia complex (CAS Reg. 
No. 16828-95-8), copper oxychloride (CAS Reg. No. 1332-65-6), copper 
oxychloride sulfate (CAS Reg. No. 8012-69-9), copper salts of fatty and 
rosin acids (CAS Reg. No. 9007-39-0), and copper sulfate pentahydrate 
(CAS Reg. No. 7758-99-8).
    Also, copper oleate and copper linoleate have no active food use 
registrations in the United States, and therefore their tolerance 
exemptions in 40 CFR 180.1021(b) are no longer needed. On October 26, 
1998 (63 FR 57062) (FRL-6035-8), in a batch final rule concerning 
several active ingredients, including copper linoleate and copper 
oleate, the Agency responded to public comments which requested that 
the exemptions when applied to growing crops not be revoked (e.g., if 
they covered copper salts of fatty and rosin acids), by not taking 
action on them at that time. However, since EPA is proposing to 
establish a tolerance exemption on copper salts of fatty and rosin 
acids, that comment is resolved. Therefore, EPA is proposing to revoke 
the tolerance exemptions in 40 CFR 180.1021(b) for copper linoleate and 
copper oleate.
    Bordeaux mixture, copper-lime mixtures, copper sulfate basic, and 
cupric oxide are listed among the copper compounds in 40 CFR 
180.1021(b) which are exempt from the requirement of a tolerance when 
applied as a fungicide to growing crops using good agricultural 
practices. Because Bordeaux mixture and copper-lime mixtures contain 
copper sulfate as the active ingredient, there is no reason for them to 
have separate tolerance exemptions since their use is covered by copper 
sulfate. Also, cupric oxide and copper oxychloride (CAS Reg. No. 1332-
40-7), which is a synonym for basic copper chloride, have no active 
food use registrations in the United States, and therefore their 
tolerance exemptions are no longer needed and should be revoked. 
Therefore, EPA is proposing to revoke tolerance exemptions in 40 CFR 
180.1021(b) for Bordeaux mixture, copper-lime mixtures, copper 
oxychloride (CAS Reg. No. 1332-40-7), and cupric oxide.
    Although the copper RED recommended establishing tolerance 
exemptions in Sec.  180.1021(b) for copper ammonium carbonate, and 
copper in the form of chelates of citrate and gluconate, none of these 
compounds currently has active registrations for application as a 
fungicide to growing crops and therefore, do not need tolerance 
exemptions.
    Many food commodities not treated with copper have naturally-
occurring levels of copper that are higher than those found in or on 
pears as a result of residues from treated wrappers. In addition, the 
Agency determined that toxicological data show that potential copper 
residue levels from the use of treated pear wrappers do not pose a 
significant risk to human health, and therefore, the tolerance in 40 
CFR 180.136 at 3 ppm for residues of basic copper carbonate in or on 
pear from postharvest use is no longer needed and should be revoked. 
Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.136 
for residues of the fungicide basic copper carbonate in or on pear from 
postharvest use of the chemical.
    There is a tolerance in 40 CFR 180.538 at 1 ppm in water, potable 
for residues of copper resulting from use of the algicides or 
herbicides copper carbonate (malachite), copper sulfate, copper 
monoethanolamine, and copper triethanolamine to control aquatic plants 
in reservoirs, lakes, ponds, irrigation ditches, and other potential 
sources of potable water. However, potable water is regulated under the 
Safe Drinking Water Act, and the Office of Pesticide Programs in EPA no 
longer establishes water tolerances. Thus, this tolerance is no longer 
applicable to current regulations for managing copper residues in 
drinking water and should be revoked. Therefore, EPA is proposing to 
revoke the tolerance in 40 CFR 180.538 for residues of copper in 
potable water. The Office of Ground Water and Drinking Water sets 
drinking water standards and currently sets a Maximum Contaminant Level 
Goal (MCLG) of 1.3 ppm and an Action Level of 1.3 ppm for copper.
    There are no Codex MRLs for coppers.
    6. Fluazifop-P-butyl. There have been no active food-use 
registrations for use of fluazifop-P-butyl on spinach for more than 10 
years; although there is currently one active non-food registration on 
spinach grown for seed production which prohibits treated seed from 
distribution for food or feed or portioned (e.g., seed screenings) for 
food or feed. Because there are no current active food-use 
registrations for use of fluazifop-P-butyl on spinach, the tolerance is 
no longer needed and should be revoked. Therefore, EPA is proposing to 
revoke the tolerance in 40 CFR 180.411(a) on spinach.
    There are no Codex MRLs for fluazifop-P-butyl.
    7. Malathion. Currently, tolerances for malathion are established 
in 40 CFR 180.111(a)(1) for residues of the insecticide malathion, O,O-
dimethyl dithiophosphate of diethyl mercaptosuccinate. Based on 
available plant metabolism data, the Agency determined that malathion 
residues of concern in plants should include its metabolite, malaoxon, 
O,O-dimethyl thiophosphate of diethyl mercaptosuccinate. However, in 
the malathion RED, many 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 5% of the Acute Population Adjusted Dose 
(aPAD) for the U.S. population and 11% of aPAD for all infants (<1 year 
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. Nevertheless, the 
available data submitted by the registrants and approved by the Agency 
and comments and feedback from the user community, and communication 
with USDA and the technical registrant (regarding EPA's screening-level 
ecological assessment that resulted in estimated acute risks to birds 
and mammals which only slightly exceeded the Agency's level of concern) 
supported many decreased plant tolerance levels associated with 
specific reductions to use pattern parameters which would need to 
appear on malathion product labels. These reductions may impact on 
reducing potential exposure of non-target terrestrial and aquatic 
organisms to malathion residues of concern. Because the Agency is still 
in the process of obtaining the needed amended malathion product 
labels, their associated plant tolerances will remain at their current 
level in 40 CFR 180.111(a)(1) under the existing tolerance expression 
there. When appropriate malathion 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.
    In order to accommodate a proposed separation of plant and 
livestock tolerances, EPA is proposing to redesignate in 40 CFR 180.111 
currently existing paragraphs (a)(2) through (a)(5) as paragraphs 
(a)(4) through (a)(7), respectively.

[[Page 22483]]

    Because EPA expects certain product label changes will be submitted 
for its approval in the near future, the Agency will herein propose 
tolerance actions recommended in the malathion RED for increasing or 
establishing specific plant tolerances. Therefore, these tolerances 
should be separated from other plant tolerances and moved from 40 CFR 
180.111(a)(1) into a proposed new 40 CFR 180.111(a)(2) with a new 
tolerance expression for the combined residues of malathion and 
malaoxon. Consequently, EPA is proposing to add a new 40 CFR 
180.111(a)(2) with the introductory text containing the tolerance 
expression to read as follows: ``Tolerances are established for the 
combined residues of the insecticide malathion (O,O-dimethyl 
dithiophosphate of diethyl mercaptosuccinate) and its metabolite, 
malaoxon (O,O-dimethyl thiophosphate of diethyl mercaptosuccinate), in 
or on the following food commodities.''
    Based on dietary exposure to malathion, the Agency determined that 
neither malathion nor malaoxon residues were observed in eggs, milk, 
and animal tissues. However, active registrations with malathion use 
for direct animal treatment still exist and need to be amended. 
Furthermore, plant tolerances remaining in 40 CFR 180.111(a)(1) will be 
addressed in the near future and moved under the revised tolerance 
expression. Therefore, the current egg, milk, and livestock tolerances 
in 40 CFR 180.111(a)(1) should be separated from the plant tolerances 
and recodified in 40 CFR 180.111(a)(3). Consequently, EPA is proposing 
to recodify the tolerances on cattle, fat (PRE-S); cattle, meat (PRE-
S); cattle, meat byproducts (PRE-S); goat, fat (PRE-S); goat, meat 
(PRE-S); goat, meat byproducts (PRE-S); hog, fat (PRE-S); hog, meat 
(PRE-S); hog, meat byproducts (PRE-S); horse, fat (PRE-S); horse, meat 
(PRE-S); horse, meat byproducts (PRE-S); poultry, fat (PRE-S); poultry, 
meat (PRE-S); poultry, meat byproducts (PRE-S); sheep, fat (PRE-S); 
sheep, meat (PRE-S); sheep, meat byproducts (PRE-S); milk, fat (from 
application to dairy cows) revised to milk, fat; and egg (from 
application to poultry) revised to egg; from 40 CFR 180.111(a)(1) to a 
proposed new paragraph (a)(3) and establish the introductory text 
containing the tolerance expression in newly added 40 CFR 180.111(a)(3) 
to read as follows: ``Tolerances are established for residues of the 
insecticide malathion (O,O-dimethyl dithiophosphate of diethyl 
mercaptosuccinate), in or on the following food commodities.'' Use of 
the parenthetical ``(PRE-S)'' was discontinued by the Agency in a final 
rule published in the Federal Register on July 1, 2003 (68 FR 39429) 
(FRL-7308-9). Consequently, to comply with established Agency 
nomenclature, the prenthetical will not be transferred to proposed 
Sec.  180.111(a)(3).
    EPA determined that data on wheat straw may be translated to barley 
straw, oat straw, and rye straw. Based on the translation of available 
field trial data from wheat straw that showed combined malathion 
residues of concern on wheat straw as high as 34.38 ppm, EPA determined 
that malathion registrations for barley straw, oat straw, rye straw, 
and wheat straw should specify for barley, rye, and wheat use a 12-hour 
Restricted Entry Interval (REI). For Non-ULV (Non-Ultra-Low-Volume) 
applications, the maximum application rate should specify pounds active 
ingredient per acre per application as 1.25 for barley and 1.0 for 
oats, rye, and wheat; a maximum number of applications per year as two 
for barley, oats, rye, and wheat, and a minimum retreatment interval of 
7 days for barley, oats, rye, and wheat. For ULV (Ultra-Low-Volume) 
applications, the maximum application rate should specify 0.61 pounds 
active ingredient per acre per application for barley, oats, rye, and 
wheat; a maximum number of applications per year as one for rye and two 
for barley, oats, and wheat; and a minimum retreatment interval as 7 
days for barley, oats, rye, and wheat. The Agency also determined that 
tolerances should be established for these straw commodities at 50 ppm. 
Therefore, EPA is proposing to establish tolerances in proposed 40 CFR 
180.111(a)(2) at 50 ppm on barley, straw; oat, straw; rye, straw; and 
wheat, straw.
    In addition, EPA determined that data on wheat forage may be 
translated to oat forage and rye forage. Based on the translation of 
available field trial data from wheat forage that showed combined 
malathion residues of concern on wheat forage as less than 2.35 ppm, 
EPA determined that malathion registrations for oat forage, rye forage, 
and wheat forage should specify for rye and wheat use a 12-hour REI. 
For Non-ULV applications, the maximum application rate should specify 
pounds of active ingredient per acre per application as 1.0 for oats, 
rye, and wheat; a maximum number of applications per year as two for 
oats, rye, and wheat, and a minimum retreatment interval of 7 days for 
oats, rye, and wheat. For ULV applications, the maximum application 
rate should specify 0.61 pounds active ingredient per acre per 
application for oats, rye, and wheat; a maximum number of applications 
per year as one for rye and two for oats and wheat; and a minimum 
retreatment interval as 7 days for oats, rye, and wheat. The Agency 
also determined that tolerances should be established for these forage 
commodities at 4.0 ppm. Therefore, EPA is proposing to establish 
tolerances in proposed 40 CFR 180.111(a)(2) at 4.0 ppm on oat, forage; 
rye, forage; and wheat, forage.
    Based on available field trial data that showed combined malathion 
residues of concern on field corn stover as high as 27.07 ppm, EPA 
determined that malathion registrations for field corn use should 
specify an REI of 72 hours for detasseling and 12 hours for all other 
activities. For Non-ULV applications, the maximum application rate 
should specify 1.0 pounds active ingredient per acre per application 
using ground equipment, a maximum of two foliar applications per year, 
a minimum retreatment interval of 7 days, and a 7-day PHI. For ULV 
applications, the maximum application rate should specify 0.61 pounds 
active ingredient per acre per application using aerial ULV equipment, 
a maximum of two foliar applications per year, a minimum retreatment 
interval of 7 days, and 7-day PHI. The Agency also determined that a 
tolerance should be established on corn, field, stover at 30.0 ppm. 
Therefore, EPA is proposing to establish a tolerance in proposed 40 CFR 
180.111(a)(2) at 30.0 ppm on corn, field, stover.
    Based on available field trial data that showed combined malathion 
residues of concern at less than the combined limit of quantitation 
(LOQ) (<0.1 ppm) on watercress, EPA determined that malathion 
registrations with Emulsifiable Concentrate (EC) formulation should 
specify for watercress use a maximum of five foliar applications per 
growing season at 1.25 pounds active ingredient (ai) per acre per 
application using ground equipment, with minimum retreatment interval 
of 3 days, and a 3-day PHI. The Agency also determined that a tolerance 
should be established for watercress at 0.2 ppm. Therefore, EPA is 
proposing to establish a tolerance in proposed 40 CFR 180.111(a)(2) at 
0.2 ppm on watercress.
    Based on available field trial data that showed combined malathion 
residues of concern on grass, forage and grass, hay as high as <190.2 
ppm and 264 ppm respectively, EPA determined that malathion 
registrations for all pertinent EC formulations should specify for 
grass, forage and grass, hay use a maximum of one foliar application 
per growing season at 1.25 pounds active ingredient per acre per 
application using ground equipment with a 0-day

[[Page 22484]]

PHI, and for 9.79 lb/gal Ready-To-Use (RTU) formulations a maximum of 
one foliar application per growing season at 0.92 pounds active 
ingredient per acre per application using aerial ULV equipment with a 
0-day PHI, and the tolerances on grass, forage and grass, hay in 40 CFR 
180.111(a)(1) should be moved to proposed Sec.  180.111(a)(2) and 
increased from 135 to 200 ppm and 135 to 270 ppm, respectively. 
Therefore, EPA is proposing to move the tolerances on grass, forage and 
grass, hay from 40 CFR 180.111(a)(1) to proposed Sec.  180.111(a)(2) 
and increase them to 200 ppm and 270 ppm, respectively. 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 combined malathion 
residues of concern on cottonseed as high as 19.12 ppm, EPA determined 
that the tolerance on cotton, undelinted seed in 40 CFR 180.111(a)(1) 
should be moved to proposed Sec.  180.111(a)(2) and increased from 2 to 
20 ppm. Therefore, EPA is proposing to move the tolerance on cotton, 
undelinted seed from 40 CFR 180.111(a)(1) to proposed Sec.  
180.111(a)(2) and increase it to 20.0 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.
    In addition, EPA is proposing to revise commodity terminology to 
conform to current Agency practice in 40 CFR 180.111(a)(1) as follows: 
``beet (including tops)'' to ``beet, garden, roots'' and ``beet, 
garden, tops,'' ``clover'' to ``clover, forage'' and ``clover, hay,'' 
``corn, forage'' to ``corn, field, forage'' and ``corn, sweet, 
forage,'' ``garlic'' to ``garlic, bulb,'' ``onion (including green 
onion)'' to ``onion, bulb'' and ``onion, green,'' ``orange, sweet'' to 
``orange,'' ``rutabagas'' to ``rutabaga,'' ``sorghum, forage'' to 
``sorghum, grain, forage,'' ``soybean (dry and succulent)'' to 
``soybean, seed'' and ``soybean, vegetable, succulent,'' ``squash, 
summer and winter'' to ``squash, summer'' and ``squash, winter,'' 
``sunflower, seed (Post-H)'' to ``sunflower, seed, postharvest,'' 
``turnip (including tops)'' to ``turnip, roots'' and ``turnip, tops,'' 
and ``vegetables, leafy, except brassica, group 4'' to ``vegetable, 
leafy, except brassica, group 4.''
    There are Codex MRLs for malathion, including one on cotton seed at 
20 mg/kg.
    8. Mineral oil. In the aliphatic solvents RED, which includes 
mineral oil and aliphatic petroleum hydrocarbons, the Agency 
recommended revoking the tolerances in 40 CFR 180.149(a)(2) on corn, 
grain, postharvest and sorghum, grain, grain, postharvest because there 
are currently no active U.S. registrations for mineral oil use as an 
active ingredient on stored grain and none have existed since 1987; and 
therefore, the tolerances are no longer needed. Consequently, EPA is 
proposing to revoke the tolerances in 40 CFR 180.149(a)(2) on corn, 
grain, postharvest and sorghum, grain, grain, postharvest. However, as 
per the RED, the current exemption from the requirement of a tolerance 
in 40 CFR 180.905 for petroleum oils, when applied to growing crops, in 
accordance with good agricultural practice, is being maintained. The 
Agency has no concerns for food uses of these mineral oils and 
aliphatic petroleum hydrocarbons, as a result of their use as an active 
ingredient. The acute and chronic oral toxicity of these materials is 
extremely low.
    Also, given the proposed revocations in 40 CFR 180.149(a)(2), 
described herein, there is no longer a need for the list of 
characteristics for mineral oil in 40 CFR 180.149(a)(1). Therefore, EPA 
is proposing to remove 40 CFR 180.149 in its entirety.
    There are no Codex MRLs for mineral oil.
    9. Pentachloronitrobenzene. Currently, tolerances for 
pentachloronitrobenzene (PCNB) in 40 CFR 180.291(a) are established for 
PCNB and tolerances in 40 CFR 180.291(b) are established for combined 
residues of PCNB and its metabolites pentachloroaniline (PCA) and 
methyl pentachlorophenyl sulfide (MPCPS). While there are currently 80 
identified metabolites of PCNB, the Agency determined that for 
enforcement purposes that the residues of concern in primary and 
rotational crops and livestock are PCNB, PCA, and 
pentachlorothioanisole (PCTA, the IUPAC name for MPCPS). Therefore, EPA 
is proposing to revise the introductory text containing the tolerance 
expression in 40 CFR 180.291(a) to read as follows: ``Tolerances are 
established for the combined residues of the fungicide 
pentachloronitrobenzene (PCNB) and its metabolites pentachloroaniline 
(PCA), and pentachlorothioanisole (PCTA), in or on the following food 
commodities.''
    In accordance with current Agency practice, EPA is proposing to 
redesignate the regional tolerances from 40 CFR 180.291(b) as Sec.  
180.291(c), and revise the commodity terminology ``mustard greens'' to 
read ``mustard, greens.'' In addition, EPA is proposing to revise the 
introductory text containing the tolerance expression in newly 
designated 40 CFR 180.291(c) to read as follows: ``Tolerances with 
regional registrations, as defined in Sec.  180.1(m), are established 
for the combined residues of the fungicide pentachloronitrobenzene 
(PCNB) and its metabolites pentachloroaniline (PCA), and 
pentachlorothioanisole (PCTA), in or on the following food 
commodities.''
    Also, in accordance with current Agency practice, EPA is proposing 
to amend 40 CFR 180.291 by adding paragraphs (b) and (d), and reserving 
those paragraphs for tolerances with section 18 emergency exemptions, 
and indirect or inadvertent residues, respectively.
    Based on available field trial data for seed treatment use that 
showed combined PCNB residues of concern as high as <0.015 ppm on 
soybean seed and forage, and <0.016 ppm for soybean hay, the Agency 
determined that tolerances should be established on soybean, seed; 
soybean, forage; and soybean, hay; each at 0.02 ppm. Therefore, EPA is 
proposing to establish tolerances in 40 CFR 180.291(a) on soybean, 
seed; soybean, forage; and soybean, hay; each at 0.02 ppm.
    In addition, the Agency determined that the interim tolerances in 
40 CFR 180.319 for PCNB on bean, broccoli, Brussels sprouts, cabbage, 
cauliflower, garlic, pepper, potato, and tomato at 0.1 ppm and peanut 
at 1.0 ppm should be converted to permanent tolerances for combined 
PCNB residues of concern in 40 CFR 180.291(a). Also, the Agency 
determined that the tolerances at 0.1 ppm on broccoli, Brussels 
sprouts, cabbage, and cauliflower should be combined into a crop 
subgroup tolerance (Brassica, head and stem, subgroup 5A at 0.1 ppm) 
and the tolerances at 0.1 ppm on pepper and tomato should be combined 
into a crop group tolerance (vegetable, fruiting, group 8 at 0.1 ppm). 
Therefore, EPA is proposing to revoke the interim tolerances in 180.319 
on bean, broccoli, Brussels sprouts, cabbage, cauliflower, garlic, 
pepper, potato, and tomato at 0.1 ppm and peanut at 1.0 ppm. In 
addition, EPA is proposing to establish permanent tolerances in 
180.291(a) at 0.1 ppm on bean; Brassica, head and stem, subgroup 5A; 
garlic, bulb; potato; and vegetable, fruiting, group 8, and at 1.0 ppm 
on peanut.
    There are no Codex MRLs for PCNB.
    10. Prometryn. There have been no active registrations for use of 
prometryn on corn since 1989, and therefore, the tolerance is no longer 
needed and should be revoked. Consequently, EPA

[[Page 22485]]

is proposing to revoke the tolerance in 40 CFR 180.222(a) on corn, 
grain.
    Although no prometryn residue data are available for cotton gin 
byproducts, based on available prometryn residue data for cotton forage 
showing residues as high as 0.84 ppm for applications up to 1.5X and a 
cotton metabolism study, EPA determined that the tolerance on cotton, 
gin byproducts should be established at 1.0 ppm. Therefore, the Agency 
is proposing to establish a tolerance in 40 CFR 180.222(a) on cotton, 
gin byproducts at 1.0 ppm.
    Available rotational field trials, where wheat and barley were 
rotated with prometryn-treated cotton (1X treatment), showed residues 
of prometryn as high as 0.13 ppm in five samples of forage and 0.09 ppm 
in two samples of straw from the rotated crops. The other 23 forage and 
16 straw samples, and all 18 grain samples had non-detectable (<0.05 
ppm) residues of prometryn. Based on the available rotational data, the 
Agency determined that a tolerance on small grains, forage and straw 
should be established at 0.3 ppm, with a 3-month plant back interval 
(PBI), under indirect or inadvertent residues because small grains are 
rotated with prometryn treated cotton and recommended it in the 1995 
RED. However, the Agency's current practice is to list small grains 
with separate tolerances. Therefore, EPA is proposing to establish 
tolerances for indirect and inadvertent residues in a revised 40 CFR 
180.222(d) on barley, forage; barley, straw; oat, forage; oat, straw; 
rye, forage, rye, straw; triticale, forage; triticale, straw; wheat, 
forage; and wheat, straw; each at 0.3 ppm. Also, because 40 CFR 
180.222(d) is currently reserved, EPA is proposing to establish the 
introductory text as follows: ``Tolerances are established for indirect 
or inadvertent residues of the herbicide prometryn, 2,4-
bis(isopropylamino)-6-methylthio-s-triazine, in or on the following 
food commodities.''
    The Agency determined that the available rotational data on small 
grain forage could be translated to hay by using a dry-matter 
conversion; i.e., using a concentration factor of 2.9X based on the 
percentage of dry matter in barley hay to barley forage (88% to 30%). 
Based on the concentration factor of 2.9X, the Agency determined that a 
tolerance on small grains, hay should be established at 1.0 ppm under 
indirect or inadvertent residues because small grains are rotated with 
prometryn treated cotton and recommended it in the 1995 RED. However, 
the Agency's current practice is to list small grains with separate 
tolerances. Therefore, EPA is proposing to establish tolerances for 
indirect and inadvertent residues in proposed 40 CFR 180.222(d) on 
barley, hay; oat, hay; rye, hay; triticale, hay; and wheat, hay; each 
at 1.0 ppm.
    There are no Codex MRLs for prometryn.
    11. Sodium chlorate. Flax straw 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 a flax, straw exemption 
from a tolerance is no longer needed. Therefore, EPA is proposing to 
revoke the exemption from a tolerance in 40 CFR 180.1020(a) on flax, 
straw.
    Because the only time-limited exemption from a tolerance in 40 CFR 
180.1020(b) for section 18 emergency exemptions for use of sodium 
chlorate on wheat expired on December 31, 2006, EPA is proposing to 
remove Sec.  180.1020(b) in it entirey and to redesignate 180.1020(a) 
as Sec.  180.1020.
    According to current Agency practice, EPA is proposing to revise 
the commodity terminology in newly designated Sec.  180.1020 as 
follows: ``beans, dry, edible'' to ``bean, dry, seed,'' ``corn, 
fodder'' to ``corn, field, stover,'' ``corn, pop, stover,'' and ``corn, 
sweet, stover,'' ``corn, forage'' to ``corn, field, forage,'' and 
``corn, sweet, forage,'' ``corn, grain'' to ``corn, field, grain'' and 
``corn, pop, grain,'' ``cottonseed'' to ``cotton, undelinted seed,'' 
``flaxseed'' to ``flax, seed,'' ``guar beans'' to ``guar, seed,'' 
``peas, southern'' to ``pea, southern,'' ``peppers, chili'' to 
``pepper, nonbell,'' ``potatoes'' to ``potato,'' ``rice'' to ``rice, 
grain,'' safflower, grain'' to ``safflower, seed,'' ``sorghum, grain'' 
to ``sorghum, grain, grain,'' ``sorghum, fodder'' to `` sorghum, grain, 
stover,'' ``sorghum, forage'' to ``sorghum, grain, forage'' and 
``sorghum, forage, forage,'' ``soybeans'' to ``soybean, seed,'' and 
``sunflower seed'' to ``sunflower, seed.''
    Based on available wheat field trial data that showed residues of 
sodium chlorate as high as <2 ppm on the surface of their outer hulls 
and rice without hulls data that showed no detectable residues (<1 
ppm), EPA determined that registrations should specify for wheat use a 
maximum of one application per season at 6 pounds active ingredient per 
acre per application with a 3-day PHI and that no detectable residues 
(<1 ppm) are expected once the hulls are removed from wheat grain 
(either at harvest or during processing). Therefore, the Agency 
believes that an exemption from the requirement of a tolerance is 
appropriate for wheat, grain. Consequently, EPA is proposing to 
establish an exemption from a tolerance in newly designated 40 CFR 
180.1020 on wheat, grain.
    In addition, the Agency believes that the introductory text in 
newly designated 40 CFR 180.1020 should be revised to specify defoliant 
and desiccant use only and use on crops rather than raw agricultural 
commodities since it is registered for preharvest and foliar 
applications as a defoliant or desiccant. Consequently, EPA is 
proposing to revise the introductory text in newly designated 40 CFR 
180.1020 to read as follows: ``Sodium chlorate is exempted from the 
requirement of a tolerance for residues when used as a defoliant or 
desiccant in accordance with good agricultural practice on the 
following crops:''
    There are no Codex MRLs for sodium chlorate.
    12. Triadimenol, Beta-(4-chlorophenoxy)-a-(1,1-dimethylethyl)-1H-
1,2,4-triazole-1-ethanol. In the Federal Register notice of September 
12, 2008 (73 FR 53007) (FRL-8380-7), EPA issued a notice regarding 
EPA's announcement on the receipt of requests from the registrant to 
voluntarily cancel specific triadimenol registrations and therefore 
terminate the last triadimenol uses for sorghum. EPA approved 
cancellation of the registrations by issuing letters as the final 
cancellation order with the close of the comment period, and made the 
last one for sorghum effective on March 11, 2009, and permitted the 
registrants for the canceled registrations to sell and distribute 
existing stocks until September 11, 2009. Also, EPA permitted persons 
other than the registrant to sell, distribute, and conforming to the 
EPA-approved label and labeling of the products, use existing 
triadimenol pesticide stocks on sorghum until they are exhausted. The 
Agency believes that end users will have had sufficient time to exhaust 
those existing stocks and for triadimenol treated sorghum commodities 
to have cleared the channels of trade by September 11, 2010. Therefore, 
EPA is proposing to revise the terminology in 40 CFR 180.450(a) for the 
term ``sorghum, forage'' to read ``sorghum, grain, forage'' and revoke 
the tolerances in 40 CFR 180.450 on ``sorghum, grain, forage,'' 
``sorghum, grain, grain,'' and ``sorghum, grain, stover,'' each with an 
``expiration/revocation'' date of September 11, 2010. With these 
changes EPA is proposing to revise the commodity table in 40 CFR 
180.450(a).

[[Page 22486]]

    There are no Codex MRLs for triadimenol on sorghum.

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 ametryn, coppers, malathion, aliphatic 
solvents (mineral oil), pentachloronitrobenzene, prometryn, inorganic 
chlorates (sodium chlorate), and soap salts (includes ammonium salts of 
higher fatty acids), and TREDs for amitraz, bitertanol, fluazifop-P-
butyl, and triadimenol. 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 for which FIFRA registrations no longer exist, unless someone 
expresses a need for such tolerances. Through this proposed rule, the 
Agency is inviting individuals who need these import tolerances to 
identify themselves and the tolerances that are needed to cover 
imported commodities.
    Parties interested in retention of the tolerances should be aware 
that additional data may be needed to support retention. These parties 
should be aware that, under FFDCA section 408(f), if the Agency 
determines that additional information is reasonably required to 
support the continuation of a tolerance, EPA may require that parties 
interested in maintaining the tolerances provide the necessary 
information. If the requisite information is not submitted, EPA may 
issue an order revoking the tolerance at issue.
    When EPA establishes tolerances for pesticide residues in or on raw 
agricultural commodities, consideration must be given to the possible 
residues of those chemicals in meat, milk, poultry, and/or eggs 
produced by animals that are fed agricultural products (for example, 
grain or hay) containing pesticides residues (40 CFR 180.6). When 
considering this possibility, EPA can conclude that:
    1. Finite residues will exist in meat, milk, poultry, and/or eggs.
    2. There is a reasonable expectation that finite residues will 
exist.
    3. There is a reasonable expectation that finite residues will not 
exist. If there is no reasonable expectation of finite pesticide 
residues in or on meat, milk, poultry, or eggs, tolerances do not need 
to be established for these commodities (40 CFR 180.6(b) and (c)).

C. When Do These Actions Become Effective?

    With the exception of certain tolerances for ametryn and 
triadimenol for which EPA is proposing specific expiration/revocation 
dates, the Agency is proposing that these revocations, modifications, 
establishments of tolerances/tolerance exemptions, and revisions of 
tolerance nomenclature become effective on the date of publication of 
the final rule in the Federal Register. With the exception of the 
proposed revocation of specific tolerances for ametryn and triadimenol, 
the Agency believes that existing stocks of pesticide products labeled 
for the

[[Page 22487]]

uses associated with the tolerances/tolerance exemptions proposed for 
revocation have been completely exhausted and that treated commodities 
have cleared the channels of trade. EPA is proposing expiration/
revocation dates of June 16, 2010 for ametryn tolerances on banana; 
corn, sweet, forage; corn, sweet, kernel plus cob with husks removed; 
and corn, sweet, stover; and September 11, 2010 for triadimenol 
tolerances on sorghum, grain, forage; sorghum, grain, grain; and 
sorghum, grain, stover. The Agency believes that these revocation dates 
allow users to exhaust stocks and allow sufficient time for passage of 
treated commodities through the channels of trade. However, if EPA is 
presented with information that existing stocks would still be 
available and that information is verified, the Agency will consider 
extending the expiration date of the tolerance. If you have comments 
regarding existing stocks and whether the proposed effective date 
allows sufficient time for treated commodities to clear the channels of 
trade, please submit comments as described under SUPPLEMENTARY 
INFORMATION.
    Any commodities listed in this proposal treated with the pesticides 
subject to this proposal, and in the channels of trade following the 
tolerance revocations, shall be subject to FFDCA section 408(l)(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 applicatio