[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33054-33057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15597]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300424; FRL-5368-7]
RIN 2070-AC18


Linuron; Proposed Revision of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA has completed the reregistration process and issued a 
Reregistration Eligibility Decision document (RED) for the herbicide 
linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea). In the 
reregistration process, all information to support a pesticide's 
continued registration is reviewed for adequacy and, when needed, 
supplemented with new scientific studies. This proposed action updates 
and corrects the tolerance actions indicated in the RED. Based on the 
RED, tolerance assessment for linuron, and subsequent comments and 
analyses, EPA is proposing to revise food tolerance levels, revoke some 
linuron tolerances, and to revise the tolerance expression for residues 
of linuron (40 CFR 180.184).
DATES: Written comments, identified by the docket number [OPP-300424], 
must be received on or before August 26, 1996.

ADDRESSES: By mail, submit written comments to: Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA. Information submitted and any 
comment(s) concerning this notice may be claimed confidential by 
marking any part or all of that information as ``Confidential Business 
Information'' (CBI). Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
comment(s) that does not contain CBI must be submitted for inclusion in 
the public record. Information not marked confidential may be disclosed 
publicly by EPA without prior notice to the submitter. Information on 
the proposed test and any written comments will be available for public 
inspection in Rm. 1132 at the Virginia address given above, from 8 a.m. 
to 4:30 p.m., Monday through Friday, excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [OPP-300424]. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at 
many Federal Depository Libraries. Additional information on electronic 
submissions can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Paul Parsons, Special Review 
and Reregistration Division (7508W), Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. By telephone: (703) 308-8037. 
Office location: Special Review Branch, Crystal Station #1, 3rd floor, 
2800 Crystal Drive, Arlington, VA 22202, e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION:

[[Page 33055]]

I. Legal Authorization

    The Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 301 et 
seq.] authorizes the establishment of tolerances (maximum legal residue 
levels) and exemptions from the requirement of a tolerance for residues 
of pesticide chemicals in or on raw agricultural commodities pursuant 
to section 408 [21 U.S.C. 346(a)]. Without such tolerances or 
exemptions, a food containing pesticide residues is considered to be 
``adulterated'' under section 402 of the FFDCA, and hence may not 
legally be moved in interstate commerce [21 U.S.C. 342]. To establish a 
tolerance or an exemption under section 408 of the FFDCA, EPA must make 
a finding that the promulgation of the rule would ``protect the public 
health'' [21 U.S.C. 346a(b)]. To establish food additive regulations 
(FARs) to cover pesticide residues in processed foods under section 409 
of FFDCA, EPA must determine that the proposed use of the food additive 
will be safe (21 U.S.C. 348). For a pesticide to be sold, distributed, 
and used in the production of food crops, animals, or processed food, 
the pesticide must not only have appropriate tolerances or FARs under 
the FFDCA, but also must be registered under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.). In 1988, 
Congress amended FIFRA and required EPA to review and reassess the 
potential hazards arising from currently registered uses of pesticides 
registered prior to November 1, 1984. As part of this process, the 
Agency must determine whether a pesticide is eligible for 
reregistration and if any subsequent actions are required to fully 
attain reregistration status. EPA has chosen to include in the 
reregistration process a reassessment of existing tolerances or 
exemptions from the need for a tolerance. Through this reassessment 
process, EPA can determine whether a tolerance must be amended, 
revoked, or established, or whether an exemption from the requirement 
of one or more tolerances must be amended or is necessary.
    The procedure for establishing, amending, or repealing tolerances 
or exemptions from the requirement of tolerances is set forth in the 
Code of Federal Regulations at 40 CFR parts 177 through 180. The 
Administrator of EPA or any person may initiate an action proposing to 
establish, amend, revoke, or exempt a tolerance for a pesticide 
registered for food uses. Each petition or request for a new tolerance, 
an amendment to an existing tolerance, or a new exemption from the 
requirement of a tolerance must be accompanied by a fee or a request 
for a waiver of such fee. Current Agency policy on tolerance actions 
arising from the reregistration process is to administratively process 
some actions without requiring payment of a fee; this waiver of fees 
applies to revisions or revocations of established tolerances, and to 
proposed exemptions from the requirement of a tolerance if the proposed 
exemption requires the concurrent revocation of an established 
tolerance. Comments submitted in response to the Agency's published 
proposals are reviewed; the Agency then publishes its final 
determination regarding the specific tolerance actions.

II. Regulatory Background and Proposed Actions

A. Regulatory Background

    The proposals described in this action follow the Agency's 
tolerance reassessment that was completed and included in the RED for 
linuron dated March 1995. While the reassessment determined that many 
tolerances established for linuron are adequate and supported by 
sufficient data, changes are needed to other linuron tolerances for 
various reasons, including: increasing or decreasing tolerances based 
on new data and revising commodity terminology, crop group 
designations, and definitions that are not in accordance with the 
revised crop group regulation (40 CFR part 180, 60 FR 26625, May 17, 
1995) or with Table II of Subdivision O of the Pesticide Assessment 
Guidelines.
    The section of the CFR to be amended by this document is 
Sec. 180.184.

B. Proposed Actions

    1. Tolerance expression. The tolerance expression under 40 CFR 
Sec. 180.184 would be revised to: ``Tolerances are established for the 
combined residues of the herbicide linuron (3-(3,4-dichlorophenyl)-1-
methoxy-1- methylurea) and its metabolites convertible to 3,4-
dichloraniline, calculated as linuron....''.
    The food tolerances currently listed in 40 CFR 180.184(a) and (b) 
are for residues of linuron per se. Plant and animal metabolism studies 
indicate the presence of unidentified metabolites of linuron that are 
hydrolyzed to 3,4-dichloroaniline (3,4-DCA) under the enforcement 
analytical method. Since the Agency believes in this case that the 
metabolites converted to 3,4-DCA are unlikely to be more toxic than the 
parent compound, and since the enforcement analytical method detects 
compounds convertible to 3,4-DCA, it is reasonable to express the 
tolerance as the combined residues of linuron and its metabolites 
convertible to 3,4-DCA. Because of the very low levels of 3,4-DCA 
found, the Agency has determined that 3,4-DCA poses no greater than a 
negligible risk in connection with the registered use of linuron and it 
is not necessary to regulate 3,4-DCA separately.
    Adequate enforcement methods are available for the determination of 
linuron residues of concern in/on plant and animal tissues. The current 
enforcement methods determine linuron and all metabolites hydrolyzable 
to 3,4-DCA.
    2. Tolerance revocations. The Agency proposes to revoke the 
tolerances for: barley, forage; barley, grain; barley, hay; barley, 
straw; corn, pop, fodder; corn, pop, forage; oats, forage; oats, grain; 
oats, hay; oats, straw; rye, forage; rye, grain; rye, hay; and rye, 
straw. There are no registered products for these uses, and it is the 
Agency's policy to revoke tolerances in such cases.
    In addition, the Agency proposes to revoke the linuron tolerance 
for parsnips, tops. This commodity is no longer listed as a raw 
agricultural commodity of parsnips, since it has been determined to be 
an insignificant feed item (see Table II of Subdivision O of the 
Pesticide Assessment Guidelines).
    3. Revisions to tolerances and food and feed additive regulations. 
The proposed increases and decreases in linuron tolerances are based on 
new data which indicate that a change is needed in the tolerances. To 
determine whether the proposed tolerance changes are protective of the 
public health, EPA considered all available health effects data. 
Dietary exposure resulting from the changes in this proposed action are 
protective of the public health and do not result in an unreasonable 
chronic or acute risk.
    The reference dose (RfD) is established at 0.0077 mg/kg body 
weight/day based on a no-observed-effect-level (NOEL) of 0.77 mg/kg 
body weight/day for hematological changes and is derived from a 1-year 
chronic toxicity study in dogs. An uncertainty factor of 100 was used 
to account for interspecies extrapolation and intraspecies variability. 
Chronic dietary exposure to the general population with existing and 
proposed tolerances utilize only 2 percent of the RfD. For the two 
subgroups with the highest exposures, non-nursing infants less than 1 
year old and children 1 through 6 years, residues are expected to 
utilize 6 percent and 4 percent of the RfD, respectively.
    The acute dietary toxicological endpoint is based on a NOEL of 25 
mg/

[[Page 33056]]

kg body weight/day, derived from a developmental toxicity study in 
rabbits. Acute, high-end, exposure to women of childbearing age 
(females 13 years of age or older) results in a Margin of Exposure 
(MOE) of 1,667 for developmental toxicity. The Agency generally 
considers an MOE of 100 adequate to protect the public health. Thus, 
dietary exposure to linuron is not expected to result in an 
unreasonable acute effect.
    The Agency considers that linuron ``induces cancer'' within the 
meaning of section 409 of the FFDCA, based on a dose-related increase 
in interstitial cell hyperplasia and adenomas in a two-year rat feeding 
study, and hepatocellular tumors in a two-year mouse feeding study. 
However, the Agency believes that the weight of evidence for the 
carcinogenic potential of linuron in humans is weak and it should not 
be regulated using a linearized multi-stage risk assessment model. 
Therefore, no quantitative assessment of the dietary cancer risk has 
been conducted for linuron; however, such risk is considered to be 
negligible.
    The following section describes the proposed substantive changes in 
the linuron tolerances for food or feed additive regulations.
    a. Field corn grain. EPA has reviewed new data analyzed by a method 
with a lower level of quantitation (0.05 ppm). These data support a 
lower linuron tolerance on field corn grain. The Agency therefore 
proposes to lower the linuron tolerance on field corn grain from 0.25 
ppm to 0.1 ppm.
    b. Field corn fodder (stover). The Agency proposes to increase the 
tolerance on corn, field, fodder from 1 ppm to 6 ppm. A review of data 
based on residue trials indicated the presence of residues ranging from 
0.1 to 5.5 ppm.
    c. Livestock commodities. For meat, fat, and meat byproducts of 
cattle, goats, hogs, horses, and sheep, the established tolerances are 
set at 1.0 ppm. Based on its review of data on residues of linuron in 
these commodities, which show that residues in meat, fat, and meat 
byproducts (except kidney and liver) are at least an order of magnitude 
lower than previously believed, the Agency proposes to lower the 
current tolerances for the meat, fat, and meat byproducts (excluding 
liver and kidney) of cattle, goats, hogs, horses, and sheep to 0.1 ppm, 
and to establish tolerances for the liver and kidney of cattle, goats, 
hogs, horses, and sheep at 1.0 ppm.
    d. Potatoes. The Agency proposes to reduce the tolerance on 
potatoes from 1 ppm to 0.2 ppm. Residue data submitted to support 
reregistration of the potato use support this reduction.
    e. Wheat. EPA has reviewed new data using an analytical method with 
a lower level of quantitation (0.05 ppm). These data support a lower 
linuron tolerance, and therefore the Agency proposes to lower the 
linuron tolerance on wheat grain from 0.25 ppm to 0.1 ppm. The Agency 
also proposes to raise the linuron tolerance on wheat straw from 0.5 
ppm to 2.0 ppm based on a reassessment of residue data which showed 
residues of up to 2 ppm on wheat straw.
    4. Changes from the RED--a. Food additive regulations related to 
potatoes. The RED stated that food and feed additive regulation 
petitions (409 tolerances) would be required for potatoes, granules; 
potatoes, chips; and potatoes, waste from processing. As a result of 
the revised Agency policy (60 FR 31300, June 14, 1995) or with Table II 
of Subdivision O concerning when a food or feed additive regulation is 
needed, the Agency has re-examined its decision in the Linuron RED on 
food or feed additive regulations for potato-related commodities. EPA 
has also considered new data on residue levels of linuron in potatoes 
submitted to support reregistration. These data show that residues of 
linuron in potato processed commodities are unlikely to exceed the 
section 408 tolerance. Therefore, food or feed additive regulations are 
not needed for these commodities.
    b. Sorghum. The tolerance for linuron residues on sorghum grain 
should remain at 0.25 ppm rather than be lowered to 0.2 ppm as proposed 
in the RED. Field studies show that residues are close to the current 
tolerance level of 0.25 ppm.
    c. Wheat, hay, and corn, sweet, fodder. In the RED, the Agency 
stated that the linuron tolerances for wheat, hay, and corn, sweet, 
fodder, should be revoked, since these commodities were no longer raw 
agricultural commodities. However, these commodities are listed as RACs 
in updated versions of Table II of Subdivision O of the Pesticide 
Assessment Guidelines. Consequently, the Agency will not propose to 
revoke the associated tolerances since these tolerances are needed.
    5. Reassessment of tolerances for uses with outstanding data 
requirements. In the RED, the Agency has required additional studies to 
support reassessment of tolerances for: corn, field, grain; corn, 
field, fodder; corn, field, forage; corn, sweet (K + CWHR); corn, 
sweet, forage; sorghum, fodder; sorghum, forage; soybeans, forage; 
soybeans, hay; and wheat, forage. EPA will reassess these tolerances 
once the required data have been submitted and reviewed. Two 
registrants for the cotton use have requested voluntary cancellation of 
this use, but other registrants may support the use. If the use is 
supported, the Agency will require a processing study to support 
reassessment of the tolerance for cottonseed; if the use is not 
supported, the Agency will propose to revoke the cottonseed tolerance. 
In addition, data to support establishing a tolerance for aspirated 
grain fractions for field corn are outstanding; and data are needed to 
support tolerances for corn, sweet, stover and wheat, hay.
    6. Revising commodity definitions. Current linuron tolerances 
include commodity terminology, Crop Group designations, or definitions 
that are not in accordance with the revised Crop Group Regulation (40 
CFR part 180, 60 FR 26625, May 17, 1995) or with Table II of 
Subdivision O of the Pesticide Assessment Guidelines. Most of these 
changes are slight, and not likely to result in any confusion; the 
exception is corn fodder, which has been changed to corn stover for 
both field and sweet corn. The amendments at the end of this notice 
show all changes in commodity terminology.

III. Public Comment Procedures

    EPA invites interested persons to submit written comments, 
information, or data in response to this proposed rule. Comments must 
be submitted by August 26. 1996. Comments must bear a notation 
indicating the document control number. Three copies of the comments 
should be submitted to either location listed under ADDRESSES.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA) as amended, which contains any of the 
ingredients listed herein, may request within 30 days after publication 
of this proposed rule in the Federal Register that this rulemaking 
proposal be referred to an Advisory Committee in accordance with 
section 408(e) of the FFDCA.
     A record has been established for this rulemaking under docket 
number [OPP-300424] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs,

[[Page 33057]]

Environmental Protection Agency, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document.

IV. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in a rule: (1) having an annual effect on the 
economy of $100 million or more, or adversely and materially affecting 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities (also referred to as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raising novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles set forth 
in this Executive Order. Pursuant to the terms of this Executive Order, 
it has been determined that this rule is not a ``significant regulatory 
action,'' because it does not meet any of the regulatory-significance 
criteria listed above.

B. Regulatory Flexibility Act

    This proposed rule has been reviewed under the Regulatory 
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et 
seq.] and EPA has determined that it will not have a significant 
economic impact on a substantial number of small businesses, small 
governments, or small organizations.
    Accordingly, I certify that this proposed rule does not require a 
separate regulatory flexibility analysis under the Regulatory 
Flexibility Act.

C. Paperwork Reduction Act

    This proposed regulatory action does not contain any information 
collection requirements subject to review by OMB under the Paperwork 
Reduction Act of 1980, 44 U.S.C. 3501 et seq.

D. Unfunded Mandates Reform Act

    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration as required by Executive Order 12898 (59 FR 7629, 
February 16, 1994).

List of Subjects in 40 CFR Part 180

    Administrative practice and procedure, Agricultural commodities, 
Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: June 11, 1996.

Lois Rossi,

Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR, chapter I, part 180 is proposed to be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.


    2. Section 180.184 is revised to read as follows:


Sec. 180.184  Linuron, tolerances for residues.

     (a) Tolerances are established for the residues of the combined 
residues of the herbicide linuron (3-(3,4-dichlorophenyl)- 1-methoxy-1-
methylurea) and its metabolites convertible to 3,4- dichloroaniline, 
calculated as linuron, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Asparagus..................................................            7
Carrot.....................................................            1
Cattle, fat................................................          0.1
Cattle, kidney.............................................            1
Cattle, liver..............................................            1
Cattle, meat...............................................          0.1
Cattle, mbyp (except liver and kidney).....................          0.1
Celery.....................................................          0.5
Corn, field, forage........................................          0.1
Corn, field, grain.........................................          0.1
Corn, field, stover........................................            6
Corn, sweet (K+CWHR).......................................         0.25
Corn, sweet, forage........................................            1
Corn, sweet, stover........................................            1
Cottonseed.................................................         0.75
Goats, fat.................................................          0.1
Goats, kidney..............................................            1
Goats, liver...............................................            1
Goats, meat................................................          0.1
Goats, mbyp (except liver and kidney)......................          0.1
Hogs, fat..................................................          0.1
Hogs, kidney...............................................            1
Hogs, liver................................................            1
Hogs, meat.................................................          0.1
Hogs, mbyp (except liver and kidney).......................          0.1
Horses, fat................................................          0.1
Horses, kidney.............................................            1
Horses, liver..............................................            1
Horses, meat...............................................          0.1
Horses, mbyp (except liver and kidney).....................          0.1
Parsnips, roots............................................          0.5
Potatoes...................................................          0.2
Sheep, fat.................................................          0.1
Sheep, kidney..............................................            1
Sheep, liver...............................................            1
Sheep, meat................................................          0.1
Sheep, mbyp (except liver and kidney)......................          0.1
Sorghum, fodder............................................            1
Sorghum, forage............................................            1
Sorghum, grain.............................................         0.25
Soybeans...................................................            1
Soybeans, forage...........................................            1
Soybeans, hay..............................................            1
Wheat, forage..............................................          0.5
Wheat, grain...............................................          0.1
Wheat, hay.................................................          0.5
Wheat, straw...............................................          2.0
------------------------------------------------------------------------

     (b) Tolerances with regional registration, as defined in 
Sec. 180.1(n) are established for the residues of the combined residues 
of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1- 
methylurea) and its metabolites convertible to 3,4-dichloroaniline, 
calculated as linuron, in or on the following raw agricultural 
commodities:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Parsley....................................................         0.25
------------------------------------------------------------------------


[FR Doc. 96-15597 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F