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linuron (Lorox) Proposed Revision of Pesticide Tolerance 6/96

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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: opp-docket@epamail.epa.gov. 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: 
parsons.paul@epamail.epa.gov.
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 thelinuron 
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-
Docket@epamail.epa.gov
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