[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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-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
