[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Rules and Regulations]
[Pages 28881-28889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9912]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0586; FRL-8126-6]


Propanil, Phenmedipham, Triallate, and MCPA; Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is revoking certain tolerances for the herbicides 
propanil, triallate, and MCPA. EPA is modifying certain tolerances for 
the herbicides propanil, phenmedipham, triallate, and MCPA. In 
addition, EPA is establishing tolerances for the herbicides propanil, 
phenmedipham, triallate, and MCPA. The regulatory actions in this 
document are part of the Agency's reregistration program under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended 
by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective May 23, 2007. Objections and 
requests for hearings must be received on or before July 23, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:  EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0586. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as

[[Page 28882]]

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 Office 
of Pesticide Programs (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: Jane Smith, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0048; 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 affected entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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. 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this ``Federal Register'' document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0586 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before July 23, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0586, 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'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.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register of September 27, 2006 (71 FR 56425) (FRL-
8089-5), EPA issued a proposed rule to revoke, modify and establish 
specific tolerances for residues of the herbicides propanil, 
phenmedipham, triallate and MCPA. Also, the proposal of September 27, 
2006 (71 FR 56425) (FRL-8089-5) provided a 60-day comment period which 
invited public comment for consideration and for support of tolerance 
retention under the Federal Food, Drug, and Cosmetic Act (FFDCA) 
standards.
    EPA is revoking, removing, modifying, and establishing specific 
tolerances for residues of the the herbicides propanil, phenmedipham, 
triallate and MCPA in or on commodities listed in the regulatory text.
    EPA is finalizing these tolerance actions in order 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 reregistration and when taking action 
on tolerances and exemptions EPA is required to determine whether each 
of the amended tolerances meets the safety standards under the FQPA. 
The safety finding determination of ``reasonable certainty of no harm'' 
is found in detail in each Reregistration Eligibility Decision (RED) 
and Report on FQPA Tolerance Reassessment Progress and Interim Risk 
Management Decision (TRED) for the active ingredient. REDs and TREDs 
recommend certain tolerance actions to be implemented to reflect 
current use patterns, to meet safety findings and change commodity 
names and groupings in accordance with new EPA policy. Printed copies 
of REDs and TREDs may be obtained from EPA's National Service Center 
for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, 
OH 45242-2419, telephone: 1-800-490-9198; fax: 1-513-489-8695; internet 
at http://www.epa.gov/ncepihom and from the National Technical 
Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 
22161, telephone: 1-800-553-6847 or (703) 605-6000; internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the 
internet at http://www.epa.gov/pesticides/reregistration/status.htm. 
and in public dockets EPA-

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HQ-OPP-2003-0348 and EPA-HQ-OPP-2002-0033 (propanil); EPA-HQ-OPP-2004-
0384 (phenmedipham); and EPA-HQ-OPP-2004-0156 and EPA-HQ-OPP-2004-0239 
(MCPA) at http://www.regulations.gov.
    In this final rule, EPA is revoking certain tolerances and 
tolerance exemptions because these specific tolerances and exemptions 
correspond to uses no longer current or registered under FIFRA in the 
United States. The tolerances revoked by this final rule are no longer 
necessary to cover residues of the relevant pesticides in or on 
domestically treated commodities or commodities treated outside but 
imported into the United States. It is EPA's general practice to revoke 
those tolerances and tolerance exemptions 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 or tolerance exemption to 
cover residues in or on imported commodities or domestic commodities 
legally treated.
    EPA's policy is to issue a final rule revoking those tolerances for 
residues of pesticide chemicals for which there are no active 
registrations under FIFRA, unless any person commenting on the proposal 
demonstrates a need for the tolerance to cover residues in or on 
imported commodities or domestic commodities legally treated.
    Generally, EPA will proceed with the revocation of these tolerances 
on the grounds discussed in Unit II.A. if one of the following 
conditions applies:
    1. Prior to EPA's issuance of a section 408(f) order requesting 
additional data or issuance of a section 408(d) or (e) order revoking 
the tolerances on other grounds, commenters retract the comment 
identifying a need for the tolerance to be retained.
    2. EPA independently verifies that the tolerance is no longer 
needed.
    3. The tolerance is not supported by data that demonstrate that the 
tolerance meets the requirements under FQPA.
    This final rule does not revoke those tolerances for which EPA 
received comments stating a need for the tolerance to be retained. In 
response to the proposal published in the Federal Register of September 
27, 2006 (71 FR 56425) (FRL-8089-5), EPA received three comments during 
the 60-day public comment period, as follows:
    Comment. The MCPA Task Force Three submitted a comment requesting 
the published tolerance for ``cattle, meat and meat byproducts'' be 
changed from the proposed 0.1 ppm to 0.5 ppm. The Task force has 
conducted a new Magnitude of the Residues in Meat and Milk Study, 
according to the Agency guidelines, that supports a 0.5 ppm tolerance. 
The new study will be submitted to the Agency as soon as it is issued 
which, according to the MCPA Task Force Three, is well in advance of 
the due date requested by the Agency in the Data Call-In. The task 
force did not take issue with any of the proposed tolerances for 
revocation.
    Agency response. The Agency acknowledges the cooperation and effort 
the MCPA Task Force Three has put forth to fulfill the requirements of 
the reregistration Data Call-In Notice. When the Magnitude of the Meat 
and Milk Study is received, reviewed, a risk assessment conducted and 
safety finding is made, EPA will make a determination as to the whether 
the current tolerance of 0.1 ppm is still appropriate or should be 
changed.
    Comment. A comment was received from a private citizen that 
expressed concern with pesticide residues in general and that pesticide 
residue levels should be zero. Concern was also expressed for the 
number of chemicals found in the bodies of adults and children.
    Agency response. The private citizen's comment did not take issue 
with the Agency's conclusion that specific tolerances in this action 
should be revoked, established and/or modified. The Agency conducts a 
detailed risk assessment to determine whether establishing and/or 
increasing tolerances is safe; i.e., there is a reasonable certainty 
that no harm will result from aggregate exposure to the pesticide 
chemical residue. Also, it is EPA's general practice to propose 
revocation of tolerances for residues of pesticide active ingredients 
on crop uses for which FIFRA registrations no longer exist.
    Comment. A comment was received from the California Rice Commission 
(CRC). CRC expressed concern that the increased U.S. tolerance for 
propanil in/on rice grain from 2 ppm to 10 ppm could result in a trade 
irritant with Japan, a major importer of California rice whose Maximum 
Residue Limit (MRL) on rice grain is 2 ppm. According to the CRC 
propanil is the most important herbicide to the California rice 
industry; a significant percentage of the rice grown in California is 
exported to Japan; propanil residues on California grown rice are non-
detectable for propanil; and the tolerance level of 10 ppm is based on 
an outlier residue level of 8.7 ppm.
    Agency response. The CRC brought this important issue to the 
attention of the Agency when the RED Amendment was released in 2006. 
The U.S. tolerance is a national level based on uses and residue data 
generated on rice grown in Arkansas, California, Louisiana, and Texas 
showing multiple residue detections above 2 parts per million (ppm) up 
to 8.7 ppm supporting a tolerance level of 10 ppm. Avoiding potential 
trade irritants is of paramount interest, unfortunately, no new data 
have been generated or submitted to the Agency to change the basis of 
the tolerance level. If additional propanil field trial residue data on 
rice were generated and provided to the Agency, the tolerance level on 
rice grain would be reconsidered.
    1. Propanil. Currently, in 40 CFR 180.274(a)(1) and (2), tolerances 
are established for the combined residues of propanil and its 
metabolites (calculated as propanil) in or on both raw agricultural 
commodities (RACs) and processed foods and feeds. EPA is revising the 
tolerance expression to specify the residues of concern and combine the 
RACs and processed foods and feed tolerances in accordance with FFDCA 
408 as amended by FQPA (1996) in 40 CFR 180.274(a) to read as follows: 
Tolerances are established for the combined residues of the herbicide 
propanil (3', 4'-dichloropropionanilide) and its metabolites 
convertible to 3, 4-dichloroaniline (3, 4-DCA).
    Tolerances currently exist for rice milling fractions and rice 
polishings. Rice milling fractions are no longer considered significant 
animal feed items as delineated in ``Table 1. - Raw Agricultural and 
Processed Commodities and Feedstuffs Derived from Crops'' which is 
found in Residue Chemistry Test Guidelines OPPTS 860.1000 dated August 
1996, available at http://www.epa.gov/opptsfrs/ publications/OPPTS--
Harmonized/860--Residue--Chemistry--Test--Guidelines/Series/. 
Therefore, EPA is removing the tolerances in 40 CFR 180.274(a) for the 
combined residues of propanil in/on rice milling fractions and rice, 
polishings at 10 ppm.
    The registered uses on barley, oat, and wheat (small grains) have 
been voluntarily cancelled December 10, 2003; 68 FR 68901, FRL-7332-5, 
June 27, 2003; 68 FR 38328, FRL 7310-6. In the absence of registered 
uses, the tolerances associated with the small grains should be 
revoked. Therefore, EPA is revoking the tolerances in 40 CFR 180.274(a) 
for the combined propanil residues of concern in/on barley, straw; oat, 
straw; and wheat, straw at 0.75 ppm; barley, grain at 0.2 ppm; oat, 
grain at 0.2 ppm; and wheat, grain at 0.2 ppm.

[[Page 28884]]

    Two studies depicting the magnitude of regulated propanil residues 
in/on rice grain exceeded the established tolerance of 2 ppm in/on 
treated rice grain samples demonstrating residues ranging from 0.03 ppm 
to 8.7 ppm. Based on these data, the EPA determined the tolerance 
should be 10 ppm on rice grain. Therefore, EPA is increasing the 
tolerance in 40 CFR 180.274(a) for the combined propanil residues of 
concern in/on rice, grain from 2 ppm to 10 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.
    A rice processing study showed no concentration of residues in 
polished rice and average concentration factors of 3.5x for rice hulls 
and 4.6x for rice bran. The highest average field trial (HAFT) propanil 
residues found in rice were 8.7 ppm. Based on this HAFT and the 
observed concentration factors, the maximum expected residues are 30.45 
ppm in/on rice hulls (8.7 ppm x 3.5) and 40.02 ppm in/on rice bran (8.7 
ppm x 4.6). These expected residues are higher in the processed 
commodities than the reassessed tolerance of 10 ppm for rice, grain. 
Based on these data, EPA has determined that the tolerances should be 
30 ppm on rice, hulls and 40 ppm on rice, bran. Therefore, EPA is 
increasing tolerances in 40 CFR 180.274(a) for the combined propanil 
residues of concern in or on rice, hulls from 10 to 30 ppm and rice, 
bran from 10 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.
    The potential for secondary transfer of propanil residues to animal 
commodities exists because the herbicide is registered for use on rice, 
which may be used as animal feed. Based on a maximum theoretical 
dietary burden (x) and using the residue levels found in dairy cattle 
and milk fed 15 ppm (0.75x) resulted in residues of: 0.035 ppm in milk, 
0.31 ppm in liver, 0.77 ppm in kidney, <0.05 ppm (non-detectable) in 
muscle, and 0.10 ppm in fat. Based on these data, the Agency determined 
the tolerances should be 0.05 ppm in cattle, meat; goat, meat; hog, 
meat; horse, meat; and sheep, meat and 1.0 ppm in cattle, meat 
byproducts; goat, meat byproducts; hog, meat byproducts; horse, meat 
byproducts; and sheep, meat byproducts. In addition, the term 
``negligible residue'' and its designation, ``(N)'' associated with the 
milk and animal tissue tolerances is being removed to conform to 
current Agency policy and practice. Therefore, EPA is maintaining and 
revising tolerances in 40 CFR 180.274(a) for the combined propanil 
residues of concern in/on milk from 0.05(N) ppm to 0.05 ppm and cattle, 
fat; goat, fat; hog, fat; horse, fat; and sheep, fat from 0.1(N) ppm to 
0.10 ppm; decreasing and revising the tolerances in/on cattle, meat; 
goat, meat; hog, meat; horse, meat; and sheep, meat from 0.1(N) to 0.05 
ppm; and increasing and revising the tolerances in/on cattle, meat 
byproducts; goat, meat byproducts; hog, meat byproducts; horse, meat 
byproducts; and sheep, meat byproducts from 0.1(N) to 1.0 ppm. The 
Agency determined that the increased tolerances are safe; i.e. there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue.
    Maximum propanil residues were 0.212, and 0.372 ppm, respectively, 
in eggs from hens dosed with propanil 15 ppm (0.9x), and 50 ppm (3.1x). 
Residues in liver from hens in the 15 ppm (0.9x), and 50 ppm (3.1x) 
dose groups were 0.183 - 0.236, and 0.824 - 1.755 ppm, respectively. 
Residues in muscle were <0.050 - 0.076 and 0.087 - 0.161 ppm from the 
0.9x and 3.1x dose groups, respectively. In fat, propanil residues of 
concern were <0.05 ppm (