[Federal Register: July 11, 2008 (Volume 73, Number 134)]
[Rules and Regulations]
[Page 39868-39871]
[DOCID:fr11jy08-5]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Nos. USCG-2008-0372 and USCG-2008-0301]
RIN 1625-AA00 and RIN 1625-AA87

Safety Zones; Northeast Gateway Deepwater Port, Atlantic Ocean,
MA and Security Zone; Liquefied Natural Gas Carriers, Massachusetts
Bay, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is extending the duration of two temporary
safety zones of 500 meter radii around the primary components, two
independent submerged turret-loading buoys, of Excelerate Energy's
Northeast Gateway Deepwater Port, Atlantic Ocean, and its accompanying
systems, as well as extending the duration of the temporary security
zone around Liquefied Natural Gas Carrier (LNGC) vessels approaching,
engaging, regasifying, disengaging, mooring, or otherwise conducting
operations at the deepwater port facility in Massachusetts Bay. The
purpose of these temporary safety zones is to protect vessels and
mariners from the potential safety hazards associated with deepwater
port facilities. All vessels, with the exception of deepwater port
support vessels, are prohibited from entering into or moving within
either of the safety zones. The security zone is necessary to protect
LNGC vessels calling on the deepwater port from security threats or
other subversive acts.

DATES: This rule extends the current temporary regulations, which have
been in effect since May 7, 2008 (USCG-2008-0372) (73 FR 28039), and
May 16, 2008 (USCG-2008-0301) (73 FR 31612), through July 17, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0372 and USCG-2008-0301
respectively, are available online at www.regulations.gov. They are
also available for inspection or copying at two locations: The Docket
Management Facility (M-30), U.S. Department of Transportation, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays, and the U.S. Coast Guard, Sector Boston, 427
Commercial Street, Boston, MA 02109, between 7 a.m. and 3 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Chief Petty Officer Eldridge McFadden, Waterways
Management Division, U.S. Coast Guard Sector Boston, at<PHONE_NUMBER>.
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM. The deepwater port facilities
discussed

elsewhere in this rule were recently completed and present potential
safety hazards to vessels, especially fishing vessels, operating in the
vicinity of submerged structures associated with the deepwater port
facility. A more robust regulatory scheme to ensure the safety and
security of vessels operating in the area, has been developed via
separate rulemaking, and is available for review and comment at the Web
site http://www.regulations.gov using a search term of USCG-2007-0087.
That final rulemaking was published in the June 17, 2008, Federal
Register (73 FR 34191) and will go into effect on July 17, 2008. This
rule extends the existing temporary safety zones around the deepwater
port infrastructure, as well as the temporary security zone around
vessels scheduled to arrive in port, currently set to expire on July
12, 2008, until July 17, 2008, the effective date of the larger
rulemaking. This extension is necessary to protect vessels from the
hazards posed by the presence of the currently uncharted, submerged
deepwater infrastructure. Failing to delay the effective day of this
extension pending completion of notice and comment rulemaking is
contrary to the public interest to the extent it could expose vessels
currently operating in the area to the known, but otherwise uncharted
submerged hazards. In addition, it would leave the Coast Guard without
the regulatory enforcement tool that a security zone provides for
vessels scheduled to call on the deepwater port in the near future.
    For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective less than
30 days after publication in the Federal Register.

Background and Purpose

    On May 14, 2007, the Maritime Administration (MARAD), in accordance
with the Deepwater Port Act of 1974, as amended, issued a license to
Excelerate Energy to own, construct, and operate a natural gas
deepwater port, ``Northeast Gateway.'' Northeast Gateway Deepwater Port
(NEGDWP) is located in the Atlantic Ocean, approximately 13 nautical
miles south-southeast of the City of Gloucester, Massachusetts, in
Federal waters. The NEGDWP will accommodate the mooring, connecting,
and offloading of two liquefied natural gas carriers (LNGCs) at one
time. The NEGDWP operator plans to offload LNGC by degasifying the LNG
on board the vessels. The regasified natural gas is then transferred
through two submerged turret-loading buoys, via a flexible riser
leading to a seabed pipeline that ties into the Algonquin Gas
Transmission Pipeline for transfer to shore.
    Excelerate recently completed installation of the STL buoys and
associated sub-surface infrastructure, which includes, among other
things, a significant sub-surface sea anchor and mooring system.
    In December 2007, the Coast Guard established a safety zone around
the submerged turret loading buoys while regulations were developed to
protect the buoys as well as passing vessels. See 73 FR 1274. That
temporary safety subsequently expired and was re-established by the
Coast Guard on May 15, 2008. See 73 FR 28039. That temporary safety
zone is set to expire on July 12, 2008. On June 3, 2008, the Coast
Guard published a rule establishing a security zone around vessels
engaging in operations in the Northeast Gateway Deepwater Port. See 73
FR 31612. The final rule discussed in docket number USCG-2007-0087 was
ultimately published in the Federal Register on June 17, 2008. See 73
FR 34191. Accordingly, it will become effective on July 17. The
temporary zones created by this rule ensure that there is no gap in
authority to ensure safety around the submerged deepwater port
infrastructure or around any vessels calling on the port until the
final rule's effective date of July 17.

Discussion of Rule

    The Coast Guard is re-establishing two temporary safety zones 500
meters around the Northeast Gateway Deepwater Port (NEGDWP) STL buoys
as described above to protect vessels from submerged hazards and
potential security threats or other subversive attacks. All vessels,
other than LNGCs and associated support vessels, are prohibited from
entering into or moving within the safety zones. The Coast Guard is
also re-establishing a temporary security zone encompassing all waters
within a 500-meter radius of any LNGC, which is carrying LNG while it
is approaching, engaging, regasifying, disengaging, mooring, or
otherwise conducting operations at the NEGDWP.
    This rule extends the effective date of the safety zones
established in 73 FR 28039 and the effective date of the security zone
established in 73 FR 31612 through July 17, 2008.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    This regulation may have some impact on the public in excluding
vessels from the areas of these zones. This impact, however, is
outweighed by the safety and security risks mitigated by the enactment
of these zones.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule may affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor within 500 meters of the STL buoys for the deepwater port.
The impact on small entities is expected to be minimal because vessels
wishing to transit the Atlantic Ocean in the vicinity of the deepwater
port may do so, provided they remain more than 500 meters from the
buoys and any LNGC vessels calling on the deepwater port. Vessels
wishing to fish in the area may do so in nearby and adjoining areas
when otherwise permitted by applicable fisheries regulations.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.

    If this rule will affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please call Lieutenant Merridith
Morrison, Assistant Chief, Waterways Management Division, Coast Guard
Sector Boston, at<PHONE_NUMBER>.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b) (2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
and the Department of Homeland Security Management Directive 5100.1,
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded, under the Instruction, that there are no factors in
this case that would limit the use of a categorical exclusion under
section 2.B.2 of the Instruction. Therefore, this rule is categorically
excluded, under figure 2-1, paragraph (34) (g), of the Instruction,
from further environmental documentation as the rule establishes a
safety zone.
    A final ``Environmental Analysis Check List'' and a final
``Categorical Exclusion Determination'' will be available in the docket
where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

Words of Issuance and Regulatory Text

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Amend Sec.  165.T01-0372 to add paragraph (d) to read as follows:

Sec.  165.T01-0372  Safety and Security Zones: Northeast Gateway,
Deepwater Port, Atlantic Ocean, Boston , MA.

* * * * *
    (d) Effective Date. This section is effective from July 3, 2008
until July 17, 2008.

0
3. Amend Sec.  165.T01-0301 to revise paragraph (b) to read as follows:

Sec.  165.T01-0301  Security Zone: Liquefied Natural Gas Carrier
Transit and Anchorage Operations, Massachusetts Bay, MA.

* * * * *

    (b) Effective Date. This section is effective from July 3, 2008
until July 17, 2008.
* * * * *

    Dated: July 3, 2008.
Gail P. Kulisch,
Captain, U.S. Coast Guard, Captain of the Port, Boston.
 [FR Doc. E8-15947 Filed 7-10-08; 8:45 am]

BILLING CODE 4910-15-P


  SEQ CHAPTER \h \r 1

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	9/21/04

	Subject:	Ethofumesate.  Residue Chemistry Considerations for
Reregistration Eligibility Decision.  Case No. 2265.

DP Barcode:	D288646

PC Code:	110601

40 CFR:.	§180.345

	From:	José J. Morales, Chemist

		Reregistration Branch 3

		Health Effects Division (7509C)

	Through:	Alberto Protzel, Branch Senior Scientist

		Toxicology Branch

		Health Effects Division (7509C)

	To:	Nancy McCarrol, Risk Assessor

		Toxicology Branch

		Health Effects Division (7509C)

Executive Summary

Ethofumesate [2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate] is a selective herbicide for the control of broadleaf
and grass weeds in sugar beets and grasses.  In the U.S., ethofumesate
products registered to Bayer CropScience, the basic producer, include a
4 lb/gal flowable concentrate (FlC) and several emulsifiable
concentrates (0.05-1.5 lb/gal EC) that can be applied as pre-plant,
preemergence, and postemergence applications using ground or aerial
equipment.

Ethofumesate is a FIFRA List B reregistration pesticide, and the Phase 4
Review (C. Olinger, 1/31/91) cited numerous deficiencies in the residue
chemistry data base.  Since the Phase 4 Review, numerous submissions of
data have been received and reviewed by the Agency.  The information
contained in this document outlines the current Residue Chemistry
Science Assessments with respect to the reregistration of ethofumesate.

The nature of the residues in plants and animals is adequately
understood based on metabolism studies with sugar beets, ryegrass,
poultry, and ruminants.  The HED Metabolism Committee (6/8/95) has
determined that the residues of concern in plants and animals include
parent ethofumesate and the free and conjugated metabolites
2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate (NC
8493), 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate
(NC 9607), and 2-(2-hydroxy-5-methanesulfonyloxyphenyl) methylpropanoic
acid (NC 20645).

Tolerances are currently established for the combined residues of
ethofumesate and its metabolites NC 8493 and NC 9607, both calculated as
parent, in/on plant and animal commodities [40 CFR §180.345(a)].
Tolerances for plant commodities range from 0.1 ppm in/on sugar beet
roots to 1.0 ppm in/on sugar beet tops and grass straw.  Tolerances on
animal commodities are set at 0.05 ppm. Although the current tolerance
expression does not include the metabolite NC 20645, the expression is
adequate for plant commodities as the acid treatment used in the
tolerance enforcement and data collection methods converts NC 20654 to
NC 9607.  If the requested enforcement method for animal commodities
also includes an acid treatment step, then the current tolerance
expression will also be adequate for animal commodities.

Adequate methods are available for enforcing tolerances and collecting
data on ethofumesate residues in/on plant commodities.  In addition, a
newer gas chromatograph/flame photometric detection in sulfur mode
method (GC/FPD-S) has been successfully validated by an independent
laboratory and using radiolabeled samples.  This method (Bayer
CropScience Method Number XB/01/01) has a limit of quantitation (LOQ) of
0.05 ppm for each analyte and should be forwarded to the Analytical
Chemistry Branch (ACB) for an method validation trial.

New tolerance enforcement and data collection methods are required for
determining residues in animal commodities.  The current tolerance
enforcement method (Method II in PAM Vol. II) for animal commodities
does not detect  NC 8493 and has a LOQ for each analyte (0.1 ppm), which
is above the current tolerances set on animal commodities.  In addition,
there is no evidence that the data collection method (Method
B-93R-04/05) used in the most recent cattle feeding study recovers
residues of NC 20654 from tissues.

Adequate storage stability data are available to support the field
trials and processing study; however, data are required supporting the
stability of residues in frozen milk and animal tissues from the most
recent cattle feeding study.

The most recent cattle feeding study is not adequate and a new feeding
study is required unless the registrant (i) demonstrates that the
GC/FPD-S method used for analysis of cattle tissues in the feeding study
adequately accounts for residues of the Metabolite NC 20654, and (ii)
provides storage stability data for residues in animal tissues and milk.
 Although the existing cattle feeding study is inadequate, the available
data suggest that tolerances will need to be maintained on some animal
tissues.  However, tolerances for poultry and swine commodities are
presently not required as there are currently no uses of ethofumesate on
crops having regulated poultry or swine feed items.

Adequate field trial data and a processing study are available to
support the current use on sugar beets, and additional data are also
available that would support new uses on carrots (WA only) and garden
beets.  However, the Agency no longer consider grass grown for seed
non-food/feed use. Grass grown for seed is a food crop. Label language
restricting the feeding of livestock feed items resulting in a non-food
use is not generally considered practical. Field trial residue data are
required to establish tolerances on grass forage and hay as they are al
food uses by EPA regulations. Tolerances are not required for the straw
and seed screenings resulting from the production of the crop “grass
grown for seed”. Straw and seed screenings are considered
insignificant livestock feed items. Label restrictions prohibiting the
feeding of seed screenings or straw to livestock are not considered
practical.

Adequate confined and limited field rotational crops studies are
available and indicate that extensive field rotational crop studies are
required to support tolerances for inadvertent ethofumesate residues in
rotational crops.

Residue Chemistry Deficiencies

"	Label prohibitions against grazing livestock on ethofumesate-treated
crops should be deleted from labels as the Agency does not allow
prohibitions on the grazing/feeding of sugar beet tops.

"	A new method is required for enforcing ethofumesate tolerances on
livestock commodities as the existing Method II listed in PAM Vol. II is
not sensitive enough to determine residues at the current tolerance
levels.

"	Data are required demonstrating that Metabolite NC 20654 is adequately
recovered (as NC 9607) from cattle tissues using the GC/FPD-S Method
B-93R-04/05.

"	FDA Multiresidue Method Testing data are required for the metabolites
NC 8493, NC 9607, and NC 20654.

"	Data are required demonstrating the stability of residues of
ethofumesate, NC 9607 and NC 8493 in animal tissues for up to 10-12
months.

"	A new cattle feeding study is required unless the registrant (i)
demonstrates that the GC/FPD-S Method B-93R-04/05 used for analysis of
cattle tissues in the feeding study adequately accounts for residues of
the Metabolite NC 20654, and (ii) provides storage stability data for
residues in animal tissues.

"	Analytical reference standards for the regulated ethofumesate
metabolites (NC 8493, NC 9607, and NC 20645) must be submitted to the
National Pesticide Standards Repository.

"	The Agency no longer consider grass grown for seed non-food/feed use.
Grass grown for seed is a food crop. Label language restricting the
feeding of livestock feed items resulting in a non-food use is not
generally considered practical. Field trial residue data are required to
establish tolerances on grass forage and hay as they are al food uses by
EPA regulations. Tolerances are not required for the straw and seed
screenings resulting from the production of the crop “grass grown for
seed”. Straw and seed screenings are considered insignificant
livestock feed items. Label restrictions prohibiting the feeding of seed
screenings or straw to livestock are not considered practical.

"	Extensive field rotational crop trials are required to support
tolerances for inadvertent ethofumesate residues in rotational crops.
The registrant should conduct the extensive field trials at the maximum
seasonal use rate in the representative sugar beet growing regions on
all crops which could be planted in a typical crop rotation sequence
with sugar beets and carrots.

Background

Ethofumesate [2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate] is a selective, benzofuranyl alkylsulfonate type,
herbicide used on sugar beets and grasses for the control of broadleaf
and grass weeds.  In the U.S., ethofumesate products registered to Bayer
CropScience, the basic producer, include a 4 lb/gal flowable concentrate
(FlC) and several emulsifiable concentrates (0.05-1.5 lb/gal EC),
marketed primarily under the trade names Norton® and Progress®
Herbicides.  These formulations can be applied as banded or broadcast
pre-plant, preemergence, and postemergence applications using ground or
aerial equipment.

Ethofumesate is a FIFRA List B reregistration pesticide and was the
subject of a Phase 4 Review (C. Olinger, 1/31/91), which cited numerous
deficiencies in the residue chemistry data base.  Since the Phase 4
Review, numerous submissions of data have been received and reviewed by
the Agency.  The information contained in this document outlines the
current Residue Chemistry Science Assessments with respect to the
reregistration of ethofumesate.

Tolerances are established for the combined residues of ethofumesate
(2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate) and
its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate (NC 8493) and
2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (NC
9607), both calculated as parent, in/on plant and animal commodities [40
CFR §180.345(a)].  Tolerances for plant commodities range from 0.1 ppm
in/on sugar beet roots to 1.0 ppm in/on sugar beet tops and grass straw.
 Tolerances on animal commodities are set at 0.05 ppm.

The PC Code and nomenclature of ethofumesate are listed below in Table 1
and the physicochemical properties of ethofumesate are listed in Table
2.

Table 1.	Ethofumesate Nomenclature

Chemical structure

Common name	Ethofumesate

Molecular Formula	C13H18O5S

Molecular Weight	286.3

IUPAC name	(RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl
methanesulfonate

CAS name	2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate

CAS #	26225-79-6

PC Code	110601

Current Food/Feed Site Registration	Sugar Beets Tops and Roots, Meat,
Fat, Mbyp of Cattle, Goats, Hogs, Horse, Sheep

TABLE 2.	Physicochemical Properties of Ethofumesate

Parameter	Value	Reference (MRID)

Melting point/range	70-72 C

47.6 (onset) -69.0 (completion) C	Farm Chemicals Handbook 2001

D168075, 3/1/93, K. Dockter

pH at 25 C	5.3	D168075, 3/1/93, K. Dockter

Density at 20 C	1.29 ± 0.01	D168075, 3/1/93, K. Dockter

Water solubility at 25 C	0.05 g/L	D168075, 3/1/93, K. Dockter

Solvent solubility at 25 C	>600 g/L in acetone, dichloromethane,
dimethylsulfoxide, and ethyl acetate

300-600 g/L in toluene and xylene

>120-150 g/L in methanol

60-75 g/L in ethanol

25-30 g/L in propanol

4.67 g/L in hexane	D168075, 3/1/93, K. Dockter

Vapor pressure at 25 C	6.5 x 10-4 Pa	D168075, 3/1/93, K. Dockter

Dissociation constant, pKa	Not applicable because of low solubility in
water	D168075, 3/1/93, K. Dockter

Octanol/water partition coefficient at 25 C	P=486, log P=2.7	D168075,
3/1/93, K. Dockter

UV/visible absorption spectrum	Not available

TABLE 3.	Chemical Names and Structures of Ethofumesate and its Residues
of Concern.

Company  Name (Codes)	Chemical Name	Structure

Ethofumesate

(NC 8438;

AE B049913)	2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate

NC 8493

(AE C508493)	2,3-dihydro-2-hydroxy-3,3-dimethylbenzofuran-5-yl
methanesulfonate

,-dimethyl-5-[(methylsulfonyl)oxy]-benzeneacetic acid

RESIDUE CHARACTERIZATION

General Discussion on Residue Chemistry of Ethofumesate

860.1200  Directions for Use

Product List

A query of the Agency’s OPPIN database conducted 8/29/03 identified
six ethofumesate end-use products (EPs) with registered food/feed uses.
With one exception, the products listed below are registered to Bayer
CropScience.

Table 4.	Ethofumesate End-use Products (EPs) with Food/Feed Uses.

EPA Reg. No.	Formulation	Registrant	Product Name

264-612	1.5 lb/gal EC	Bayer CropScience	Norton® EC

264-613	4.0 lb/gal FlC	Bayer CropScience	Norton® SC Herbicide

264-6311	0.5 lb/gal EC	Bayer CropScience	NA 305 Sugar Beet Herbicide

264-632 1	0.6 lb/gal EC 1	Bayer CropScience	Progress® Herbicide

264-633 1	0.5 lb/gal EC	Bayer CropScience	CQ 1451 Sugar Beet Herbicide

73917-2	4.0 lb/gal FlC	AgValue	ETHO SC Suspension Concentrate

1	These are MAI products that also contain phenmedipham and desmedipham
each at  0.5 lb ai/gal (EPA Reg Nos. 264-631 and -633) or each at 0.6 lb
ai/gal (EPA Reg. No. 264-632).

Use Pattern Table

A comprehensive summary of the registered food/feed use patterns of
ethofumesate, as prepared by BEAD, is presented in Appendix 1.  A
tabular summary of the residue chemistry science assessments for
reregistration of ethofumesate is presented in Table 6.  The conclusions
listed in Table 6 regarding the reregistration eligibility of
ethofumesate food/feed uses are based on the use patterns being
supported by the basic producer, Bayer CropScience.  When end-use
product DCIs are developed, RD should require that all end-use product
labels (e.g., MAI labels, SLNs, and products subject to the generic data
exemption) be amended such that they are consistent with the basic
producer’s labels.

A review Bayer’s EP labels and the supporting residue data indicate
that the general label prohibition against grazing livestock on
ethofumesate-treated crops should be deleted from the EP labels as the
Agency does not allow prohibitions on the grazing/feeding of sugar beet
tops.  However, the prohibition on feeding or grazing of treated grass
seed or sod crops grown in CA, ID, NV, OR, and WA is acceptable.

In addition to the currently registered uses on sugar beets and grasses
(grown for seed), the Interregional Research Project Number 4 (IR-4) has
recently submitted data supporting the use of ethofumesate (FlC) for a
regional use on carrots (WA only) and a general use on garden beets.
The proposed use on garden beets in the U.S. is for a single broadcast
preemergence application at up to 2 lb a.i./A in combination with up to
three postemergence broadcast applications at the 1- to 6-leaf stages,
each at 0.16-0.33 lb a.i./A, for a total maximum rate of 2.67 lb
a.i./A/season.  The proposed pre-harvest intervals (PHIs) are 14 days
for tops and 50 days for roots.

The proposed use on carrots grown in WA is for a single broadcast
preemergence application at up to 2 lb a.i./A in combination with a
single postemergence broadcast application at the 3-4 leaf stage at 2 lb
a.i./A, for a total maximum rate of 4 lb a.i./A/season.  The proposed
PHI for carrots is 35 days.  The propose use patterns on garden beets
and carrots are supported by the available field trial data.

860.1300 Nature of the Residue - Plants

The qualitative nature of ethofumesate residues in plants is adequately
understood based on the adequate sugar beet and ryegrass metabolism
studies.  The HED Metabolism Committee has determined that the residues
of concern in plants are the combined residues of ethofumesate and its
free and conjugated metabolites NC 8493, NC 9607, and NC 20645 (S. Funk,
8/29/95).

860.1300 Nature of the Residue - Livestock

The qualitative nature of ethofumesate residues in poultry and ruminants
is adequately understood.  The HED Metabolism Committee has concluded
that the residues of concern in animals are ethofumesate, and free and
conjugated NC 8493, NC 9607, and NC 20645 (S. Funk, 8/29/95).

860.1340 Residue Analytical Methods - Plants

Tolerance enforcement methods:  A tolerance enforcement method is listed
as Method I in PAM Vol. II (Section 108.345) for determining the
currently regulated residues in plants, which include ethofumesate and
its metabolites NC 8493 and NC 9607 (free and conjugated).  Although
this method does not specifically address the recovery of free and
conjugated NC 20654.  The acid hydrolysis step used in the method most
likely results in the conversion of NC 20654 to NC 9607.

For Method I, plant samples are initially extracted with
methanol:dichloromethane (MeOH:DCM, 1:9, v/v) and the extract is
partitioned with water.  The resulting organic fraction is concentrated
for further analysis of parent and free metabolites; and the aqueous
fraction is combined with the residual solids and reextracted with
water:MeOH:hexane (9:1:2, v/v) to extract conjugated metabolites.  The
resulting aqueous extract is then acid hydrolyzed by boiling with
concentrated HCl:ethyl acetate (1:1, v/v) for 75 min.  Hydrolyzed
residues are then partitioned into ethyl ether and dried through sodium
sulfate.  Hydrolyzed residues in the organic fraction and free residues
from the initial organic fraction are separately treated with acetic
anhydride and pyridine to acetylate metabolite NC 8493.  Residues are
then further purified by Florisil column chromatography.  Residues are
determined using GC/FID in the sulfur mode with an internal standard.
The reported LOQ for each analyte is 0.02 ppm.

In addition to Method I above, the registrant has proposed a GC/FPD-S
method for enforcing tolerances in plant commodities.  This method,
which was most recently referred to as Bayer CropScience Method Number
XB/01/01, is essentially the same as the data collection GC/FPD-S Method
B-93R-03.  In this two part method, parent and metabolites are isolated
and analyzed separately.  Residues are soxhlet extracted into acetone,
diluted with water, concentrated to an aqueous remainder, and made
basic.  Residues of parent are then partitioned into hexane and cleaned
up using a silica gel column eluted with hexane:DCM.  Residues of parent
are then concentrated to dryness and redissolved in toluene for GC/FPD-S
analysis.

Residues of the free and conjugated metabolites (NC 8493, NC 9607, and
NC 20645) remaining in the extracted solids and initial aqueous fraction
are combined and acid hydrolyzed with concentrated HCl at 80C for 2½
hours.  The solubilized residues are hot filtered, cooled, and
partitioned into diethyl ether, dried through anhydrous sodium sulfate,
and concentrated.   Residues are reconstituted in toluene and
derivatized with acetic anhydride and pyridine to acetylate NC 8493.
Metabolite residues are then evaporated to dryness, redissolved in
DCM:hexane (1:1, v:v) and cleaned up on a silica gel column eluted with
hexane:ethyl acetate (1:1, v:v).  Residues are concentrated to dryness,
redissolved in toluene, and analyzed by GC/FPD-S.  The LOQ for each
analyte is 0.05 ppm.  During the acid hydrolysis step, free and
conjugated residues of NC 20645 are released and recyclized to form NC
9607.

The above GC/FPD-S method has undergone a successful independent
laboratory validation trial (MRID 45818104) and has been successfully
validated (MRID 45818101) using radiolabeled samples of tops and roots
from red beets treated with [14C]ethofumesate.  This method should be
forwarded to the Analytical Chemistry Branch (ACB) for an method
validation trial.

Data collection methods:  The adequate field trials (sugar beet, grass,
garden beet, and carrot), field rotational crop trials, and the sugar
beet processing study all used a version of the proposed GC/FPD-S Method
B-93R-03, which is described above.  Earlier Agency concerns regarding
the recovery of free and conjugated residues of NC 20654 from plant
commodities have been addressed.  The registrant has provided adequate
data indicating that residues of NC 20654 would be recovered as NC 9607
by the above method.  The LOQ for each analyte in the method is 0.05
ppm, for a combined LOQ of 0.15 ppm.

860.1340 Residue Analytical Methods - Livestock Commodities

Tolerance enforcement method:  A tolerance enforcement method is listed
as Method II in PAM Vol. II (Section 108.345) for determining residues
of ethofumesate and its metabolites NC 9607 and ring-open NC 9607 (NC
20645) in milk and cattle tissues.  This method does not determine the
NC 8493 metabolite; however, NC 8493 was not detected in milk or tissues
in the cow metabolism study.

For  the analysis of milk samples, residues are extracted by shaking
with ethyl acetate:MeOH (5:1, v/v), 5% aqueous potassium oxalate and
concentrated HCl.  The resulting ethyl acetate phase is back washed with
water, dried with sodium sulfate, and concentrated.  Residues are then
partitioned between MeOH and hexane, and residues in the MeOH phase are
then cleaned up using a Sephadex LH-20 and analyzed by GC/FPD-S.

For analysis of tissues, residues are extracted with various organic
solvents, depending on the tissues and analytes, and the fractions used
for analysis of NC 20654 are treated with acid to convert the ring open
metabolite to NC 9607.  Residues are purified by solvent partitioning
and cleaned up using a Florisil column eluted with DCM:ethyl acetate
(97:3, v/v).  Residues are then dissolved in ethyl acetate and analyzed
by GC.FPD-S.  The method LOQ is 0.1 ppm for each analyte.

As the current tolerances for residues in livestock commodities are set
at 0.05 ppm, the above method is not adequate as the method LOQ for each
analyte is above the current tolerance.  A new method is required that
will determine all residues of concern in animal tissues.

Data collection method:  In the most recent cattle feeding study, a
GC/FPD-S method (Method B-93R-04/05) was used to determine residues of
parent and free and conjugated NC 8493 and NC 9607.  Adequate validation
data were provided for these residues; however, the Agency requested (L.
Cheng, 8/1/95) additional data validating that the method adequately
recovers free and conjugated NC 20654, which is a major metabolite in
tissues.  The registrant has provided adequate data (MRID 45874703)
indicating that this method adequately accounts for residues of NC 20645
in milk.  However, no data have been submitted indicating that the
method will recover NC 20654 from tissues.  In fact, the analytical
procedures for tissues (describe below) do not include a acid treatment
step, which would result in the conversion of NC 20645 to NC 9607.

In Method B-93R-04/05, residues in whole milk, cream and skim milk
samples are acidified with concentrated HCl and then diluted with water
and a saturated sodium chloride solution (note: the acid treatment
converts NC 20645 to NC 9607).  Residues are then partitioned into ethyl
acetate, centrifuged, dried over sodium sulfate, and concentrated.
Residues are redissolved in hexane-saturated acetonitrile (ACN) and
partitioned with hexane, discarding the hexane phase.  Residues are
concentrated to dryness, redissolved in toluene, and split into two
fractions.  One fraction is analyzed directly by GC/FPD-S for
determination of ethofumesate and NC 9607.  The other fraction is
derivatized with acetic anhydride and pyridine to acetylate NC 8493,
which is then analyzed by GC/FPD-S.

For analysis of residues in tissues, samples are extracted with ethyl
acetate, filtered through sodium sulfate, and concentrated.  Residues
are then redissolved in hexane-saturated ACN and partitioned with
hexane, discarding the hexane phase.  Residues are concentrated to
dryness, redissolved in toluene, split into two fractions, and again
dried.  One fraction is dissolved in hexane and cleaned up using a
silica gel cartridge.  Residues are eluted from the silica gel with
DCM:hexane (90:10, v/v), concentrated to dryness, redissolved in toluene
and analyzed by GC/FPD-S for determination of ethofumesate and NC 9607.
The other fraction is redissolved toluene and derivatized with acetic
anhydride and pyridine to acetylate NC 8493.  The residues are
concentrated, redissolved in hexane, and cleaned up using a silica gel
cartridge eluted with DCM:hexane (90:10, v/v).  The elute is dried and
residues are redissolved in toluene and analyzed by GC/FPD-S.  The
method LOQ was reported to be 0.01 ppm for each analyte.

The registrant has provided radiolabeled validation data indicating that
the above method does adequately extract 14C-residues from kidney
tissues (MRID 45818102).  However, due to low levels of 14C-residues, no
data were provided indicating whether or not the method adequately
recovered the solubilized 14C-residues.  Unless the registrant can
demonstrate that the above method adequately recovers residues of NC
20654 from cattle tissues, a new cattle feeding study will be required.

860.1360 Multiresidue Methods

The FDA PESTDATA database dated 11/01 (PAM Volume I, Appendix I)
indicates that ethofumesate is completely recovered using Multiresidue
Methods Section 302 (Luke Method; Protocol D).  However, no data are
available on the recovery of the metabolites NC 8493, NC 9607, NC 20654
through the FDA Multiresidue Method Testing Protocols. These data are
required.

860.1380 Storage Stability

-15C for up to 18 months in grass forage, 24 months in carrot
roots and barley grain, and 35 months in spinach and sorghum straw.

However, data are required demonstrating the stability of residues of
ethofumesate, NC 9607 and NC 8493 in animal tissues for the appropriate
samples storage interval.  In the feeding study, samples of milk and
tissues were stored frozen for up to 10-12 months prior to analysis.

860.1400 Water, Fish, and Irrigated Crops

Ethofumesate is presently not registered for direct use on water and
aquatic food and feed crops; therefore, no residue chemistry data are
required under these guideline topics.

860.1460 Food Handling

Ethofumesate is presently not registered for use in food-handling
establishments; therefore, no residue chemistry data are required under
this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

Based on the use of ethofumesate on sugar beets, there is the potential
for exposure of livestock to ethofumesate residues in their diet.  The
maximum theoretical dietary burdens (MTDB) of ethofumesate for livestock
are calculated below in Table 5, based on reassessed tolerances.  The
MTDB is 3.6 and 1.8 ppm for beef and dairy cattle, respectively.  As
there are currently no uses on crops having regulated poultry or swine
feed items, feeding studies and tolerances for poultry and swine
commodities are presently not required.

Table 5.	Calculation of Maximum Dietary Burdens of Ethofumesate to
Livestock.

Feed Commodity	% Dry Matter1	% Diet1	Reassessed Tolerance (ppm)	Dietary
Contribution (ppm)2

Beef Cattle

Sugar Beet, tops (leaves)	23	20	4.0	3.48

Sugar Beet, molasses	75	10	0.5	0.07

TOTAL BURDEN

30

3.55

Dairy Cattle

Sugar Beet, tops (leaves)	23	10	4.0	1.74

Sugar Beet, molasses	75	10	0.5	0.07

TOTAL BURDEN

20

1.81

1  Table 1 (OPPTS Guideline 860.1000).

2  Contribution = ([tolerance /% DM] X % diet) for beef and dairy
cattle.

A new cattle feeding study was submitted in response to the Phase 4
Review.  In this study, three groups of dairy cows (3 per dose group)
were dosed orally via capsules with ethofumesate at 32.5, 98.8, or 325
mg/day for 28 consecutive days.  Based on a feed consumption of 15
kg/day, these dose levels were equivalent to 2.2, 6.6, and 21.6 ppm of
ethofumesate in the diet.  These dose levels are also equivalent to
0.6x, 1.9x, and 6.1x the MTDB for beef cattle, and 1.2x, 3.6x, and 11.9x
the MTDB for dairy cattle.

10-12 months. However, data demonstrating the stability of
ethofumesate and its metabolites in tissues are required.

Milk and tissue samples were analyzed using a GC/FPD-S method (Method
B-93R-04/05) that specifically determined residues of ethofumesate and
its metabolites NC 8493 and NC 9607.  Adequate method validation data
were provided showing that ethofumesate, NC 8493 and NC 9607 were
adequately recovered at levels down to 0.01 ppm for each analyte.
However, method validation data were not provided for NC 20654, which is
a major animal metabolite.  For analysis of milk, samples were acidified
during the extraction process resulting in the conversion of metabolite
NC 20654 to NC 9607.  Therefore, GC/FPD-S method accounted for all
residues of concern in milk.  However, no acid treatment steps were
included in the analysis of tissues; therefore, residues of NC 20654
were not determined in tissue samples, as they were not converted to NC
9607.

Using the above GC/FPD-S method, residues of ethofumesate, NC 8493, or
NC 9607 were each <0.01 ppm in all milk samples taken from the highest
dose group, whole milk samples taken from the two low dose groups on
days 21, 24 and 28, and in cream and skim milk sample from Day 28 for
all 3 dose groups.  For tissues, residues of ethofumesate, NC 8493, or
NC 9607 were also <0.01 ppm in all tissues samples from each dose group,
with the exception of one fat sample from the highest dose group bearing
residues of ethofumesate at 0.02 ppm.

0.01 ppm) in milk or milk products derive from cows exposed to
ethofumesate residues at up to 10x the MTDB for dairy cattle.
Therefore, tolerances for ethofumesate residues in milk could be
considered to be a 180.6(a)(3) [i.e., there is no reasonable expectation
of finite residues in ruminant commodities].

The existing data for tissues indicate that tolerances will at least
need to be maintained for residues in fat.  However, tolerances for
animal tissues cannot be reassessed at the present time as the current
cattle feeding study is not adequate due to concerns pertaining to
storage stability of residues and the adequacy of the analytical method
for tissues.

A new cattle feeding study is required unless the registrant (i)
demonstrates that the GC/FPD-S Method B-93R-04/05 used for analysis of
cattle tissues in the feeding study adequately accounts for residues of
the Metabolite NC 20654, and (ii) provides storage stability data for
residues in animal tissues.

860.1500 Crop Field Trials

The reregistration requirements for magnitude of the residue in plants
are fulfilled for sugar beets.  An adequate number of tests were
conducted in the appropriate geographical regions at the maximum labeled
use rates. However, the Agency no longer consider grass grown for seed
non-food/feed use. Grass grown for seed is a food crop. Label language
restricting the feeding of livestock feed items resulting in a non-food
use is not generally considered practical. Field trial residue data are
required to establish tolerances on grass forage and hay as they are al
food uses by EPA regulations. Tolerances are not required for the straw
and seed screenings resulting from the production of the crop “grass
grown for seed”. Straw and seed screenings are considered
insignificant livestock feed items. Label restrictions prohibiting the
feeding of seed screenings or straw to livestock are not considered
practical.

For sugar beets, adequate data are available from a total of 10 trails
conducted in representative sugar beet growing regions during 1993.  In
each trail, ethofumesate (4 lb/gal FlC) was initially applied as a
broadcast preemergence application at 2.7-3.1 lb ai/A followed by a
broadcast post-emergence application at the 4-8 leaf stage at 1.4-1.5 lb
ai/A, for a total of 4.2-4.6 lb ai/A/season.  This rate is 1x the
maximum post-emergence application rate and 1.1x the maximum seasonal
rate.  A single sample of roots and tops was collected from each trial
at 81-276 days following the second application.  Combined residues of
ethofumesate, NC 8493, and NC 9607 (including converted NC 20645),
expressed in parent equivalents, were 0.21-3.1 ppm in/on 10 samples of
sugar beet tops and <0.16-0.25 ppm in/on 10 samples of sugar beet roots.
 Average combined residues were 1.08 and 0.18 ppm in/on tops and roots,
respectively.

Although the above field trial data reflect the use of only a FlC
formulation, these data will also support the use of the EC formulations
as the use on sugar beets is for early season applications to the soil
and young plants and the pre-harvest interval is relatively long (90
days).

In addition to the above field trail data, IR-4 has submitted data
supporting the use of  ethofumesate (FlC) as pre- and post-emergence
applications on garden beets and carrots.

For garden beets, adequate data are available from 6 tests conducted in
1996 in representative growing regions reflecting the use of
ethofumesate (FlC) as four broadcast applications, including a
preemergence application at up to 2 lb ai/A, and three foliar
applications up to the 8-leaf stage at 0.16-0.33 lb ai/A, for a total
seasonal rate of 2.67 lb ai/A.  Following the last application of
ethofumesate (4 lb/gal FlC) at rates totaling 2.52-2.67 lb ai/A,
combined residues of ethofumesate, NC 9607, and NC 8493 (expressed as
ethofumesate equivalents) were 0.93-4.28 ppm in/on 10 beet top samples
harvested 13-15 DAT and 0.15-0.30 ppm in/on 12 beet root samples.
Average combined residues in/on beet tops and roots were 1.85 and 0.12
ppm, respectively.  These data support a 14-day PHI for tops and a
50-day PHI for roots.

For carrots, adequate data are available from 3 tests conducted in WA
in1996 reflecting the use of ethofumesate (FlC) two broadcast
applications, pre-emergence and post-emergence at the 3- to 4-leaf
stage, each at 2.0 lb ai/A, for a total of 4.0 lb ai/A/season.
Following the last application of ethofumesate (4 lb/gal FlC) at rates
totaling 4.0 lb ai/A, combined residues of ethofumesate, NC 9607, and NC
8493 (expressed as ethofumesate equivalents) were 3.01-6.34 ppm in/on 6
carrot samples harvested 35-69 DAT.  Average residues in/on carrot roots
were 4.59 ppm.

860.1520 Processed Food and Feed

The reregistration requirements for magnitude of the residue in
processed food/feed are satisfied for sugar beets.  In an adequate sugar
beet processing study conducted in 1993, ethofumesate (4 lb/gal FlC) was
applied to separate plots as a single preplant broadcast application at
7.5 or 11.2 lb a.i./A (1.9 and 2.8x maximum seasonal rate).   Sugar beet
samples were collected at 149 days after application, and subsamples
from the 11.2 lb a.i./A treatment were processed into cossettes, dried
pulp, molasses, and refined sugar using simulated commercial procedures.

Combined residues of ethofumesate, NC 9607, and NC 8493 (expressed in
parent equivalents) were 0.135-0.167 ppm in/on four sugar beet root
(2.8x rate) subsamples and averaged 0.157 ppm.  Average combined
residues from the processed fractions were 0.301 ppm for molasses and
0.081 ppm for cossettes, dried pulp, and refined sugar.  The processing
factors for combined ethofumesate residues were 1.9x in molasses and
0.5x in sugar, dried pulp, and cossettes.

Based on the 1.9x processing factor for molasses and the 0.5x processing
factor for refined sugar, and HAFT residues of 0.25 ppm in roots from
the field trials, the maximum expected combined residues in molasses
would be 0.48 ppm and 0.125 ppm in refined sugar.

860.1650 Submittal of Analytical Reference Standards

As of 10/30/2003, an analytical reference standard for ethofumesate is
available at the EPA National Pesticide Standards Repository, but it
expires at the end of November 2003.  Therefore, a new standard or an
updated certificate of analysis for ethofumesate, lot# R00047, will be
needed.  Analytical reference standards ethofumesate metabolites are not
in the current inventory.

860.1850 Confined Accumulation in Rotational Crops

The reregistration requirements for confined accumulation in rotational
crops are satisfied.

The adequate confined rotational crop study indicated that 14C-residues
(expressed as ethofumesate equivalents) accumulated at levels above 0.01
ppm in/on all commodities of radish, cabbage, and wheat that were
planted at various rotation intervals (96, 157, 276, and 366 days) after
[U-14C-phenyl]ethofumesate was applied to sandy loam soil under
greenhouse conditions at  4.1 lb ai/A (1x).  In radish, 14C-residue
accumulation was higher in immature foliage than in roots.  The maximum
radioactive residues observed in/on various rotational crop commodities
were:  radish tops (31.98 ppm), radish roots (2.14 ppm), cabbage foliage
(3.99 ppm), wheat forage (3.68 ppm), wheat straw (1.27 ppm), wheat chaff
(0.23 ppm), and wheat grain (0.06 ppm).

60% TRR) but was a minor (<3% TRR) component in/on cabbage, wheat
straw, and wheat grain.  The metabolite NC 9607 was the major residue
identified in cabbage (57% of TRR), wheat straw (31% of TRR), and
wheat grain (15% TRR), and substantial levels of metabolite NC 20645
were also detected in radish roots (15% TRR), cabbage (26% TRR),
wheat straw (12% TRR), and wheat grain (6% TRR).  Metabolite NC
8493 accounted for <10% of the TRR on all commodities.

860.1900 Field Accumulation in Rotational Crops

The reregistration requirements for field accumulation in rotational
crops are not satisfied.  The available limited rotational crop studies
indicate the potential for accumulation of residues in rotated crops
planted at the established plant-back interval (PBI) following
applications at the maximum seasonal use rate.  Extensive field
rotational crop studies must be submitted to support tolerances on
rotated crops.

Labels for EPs containing only ethofumesate currently include the
following rotational crop restrictions:  do not rotate to any crop other
than sugar beets or ryegrass for 12 months following applications
totaling more than 0.375 lb a.i./A and for 6 months following
post-emergence applications totaling 0.375 lb a.i./A.

3 and 7 months at one site (CA) and at 10 months at the other site
(ND).  Quantifiable residues (0.05 ppm) of ethofumesate were detected
only in carrots (0.15 ppm) from the 3-month PBI, and residues of NC 8493
were detected only in spinach (0.08 ppm) and barley fodder (0.05 ppm)
from the 3-month PBI.  However, residues of NC 9607 were detectable at
up to the 10-month PBI in cabbage (0.08 ppm) and oat fodder (0.09 ppm).

In another set of limited studies (MRID 45855502) conducted during 1993
in CA (2
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each RAC from each crop was harvested and analyzed using an adequate
GC/FPD-S Method (Aventis Method B-93R-03), which determines
ethofumesate, NC 8493, NC 9607 and NC 20654 (recovered as NC 9607).  The
method has an LOQ of 0.05 ppm for each analyte.

Residues of NC 8493 were <0.05 ppm in all RAC samples from the
rotational crops, and residues of ethofumesate were <0.05 ppm in all
samples of lettuce and wheat/barley forage, straw, and grain.  At the
10-month PBI, ethofumesate was detected only in 1 out of 6 samples of
carrot tops (0.207 ppm) and in 2 out of 6 samples of carrot roots (0.051
and 0.115 ppm).  Most samples from the 10-month PBI also had residues of
NC 9607 that were <LOQ; however, NC 9607 was quantifiable in at least
one sample of every RAC except carrot tops.  Residues of NC 9607 were
detected in 1 sample each of carrot tops (0.064 ppm), lettuce (0.108
ppm), and cereal grain (0.052 ppm), and were detected in 2 out of 4
samples of forage (0.069-0.126 ppm) and 2 out of 3 samples of straw
(0.066-0.070 ppm).

The above limited field rotational crop trials are adequate and indicate
that extensive field rotational crop studies are required to support
tolerances for inadvertent ethofumesate residues in rotational crops.
The registrant should conduct the extensive field trials at the maximum
seasonal use rate in the representative sugar beet growing regions on
all crops which could be planted in a typical crop rotation sequence
with sugar beets.

Table 6.	Residue Chemistry Science Assessment for Reregistration of
Ethofumesate (PC Code 110601).

GLN Data Requirements	Current Tolerances (ppm) [§180.345(a)]	Additional
Data Needed?	MRID Nos.1

860.1200:  Directions for Use	NA = Not Applicable	No	See Appendix 1

860.1300:  Nature of the Residue - Plants		NA	No	424959012 42495902

860.1300:  Nature of the Residue - Animals	NA	No	423645043 42364505

860.1340:  Residue Analytical Method

 -	Plant Commodities	NA	No4	00036363  41214206 92063022  92063035
458181015  45818103 45818104  45874703

 -	Animal Commodities	NA	Yes6	41214209  92063023  92063036 45818102
45874703

860.1360:  Multiresidue Method	NA	Yes7	419972068

860.1380:  Storage Stability Data

 -	Plant Commodities	NA	No	00039810  00115057 92063024  92063037
45818105 45818106  45818108 45818109  45818110

 -	Animal Commodities	NA	Yes 9

	860.1400:  Magnitude of the Residue - Water, Fish, and Irrigated Crops
NA	NA

	860.1460:  Magnitude of the Residue - Food Handling	NA	NA

	860.1480:  Magnitude of the Residue - Meat, Milk, Poultry, Eggs

 -	Fat, Meat, and Meat Byproducts of Cattle, Goats, Hogs, Horses, and
Sheep	0.05	Yes10	41214208  92063025  92063038<PHONE_NUMBER>

 -	Milk	None established

 -	Eggs and the Fat, Meat, and Meat Byproducts of Poultry	None
established	No12

860.1500:  Crop Field Trials

Root and Tuber Vegetables

 -  Beet, garden, root

None established

No13

45892001

 -  Beet, sugar, root	0.1	No	00036365  00036366 00037839  00041855
00041856  00048415 41214228  41214241 41214242<PHONE_NUMBER>

92063028  92063029  92063030  92063039  92063041  92063042

 - Carrot, root	None established	No15	45892101

Leaves of Root and Tuber Vegetables

 -  Beet, garden, tops

None established

No

45892001

 -  Beet, sugar, tops	1.0	No	00036365  00036366 00037839  00041855
00041856  00048415 41214228  41214241 41214242  43697201

92063028  92063029  92063030  92063039  92063041  92063042

Grass Forage, Fodder, and Hay

 -  Grass, straw

1.0

Yes16	41214214   41214218-41214224  92053026  92053040<PHONE_NUMBER>

860.1520:  Processed Food/Feed

 -	Beet, sugar, molasses	0.5	No	45855501

860.1850:  Confined Accumulation in Rotational Crops	N/A	No<PHONE_NUMBER>

860.1900:  Field Accumulation in Rotational Crops	N/A	Yes19	43298104
45855502

TOLERANCE REASSESSMENT SUMMARY

Tolerance Reassessments for Ethofumesate

The tolerances listed in 40 CFR §180.345(a) are currently expressed in
terms of the combined residues of the herbicide ethofumesate
(2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate) and
its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate (NC 8493) and
2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate (NC
9607), both calculated as parent compound.

The HED Metabolism Committee has determined that parent and all
metabolites, free and conjugated, are of toxicological concern and
should be considered for tolerance evaluation and for dietary risk
assessment (S. Funk, 8/29/95).  This includes ethofumesate, NC 8493
(free and conjugated), NC 9607, and NC 20645 (free and conjugated).
Although the current tolerance expression does not include the
metabolite NC 20645, the expression is adequate for plant commodities as
the acid treatment used in the current and proposed tolerance
enforcement methods convert NC 20654 to NC 9607.  If the requested
enforcement method for animal commodities also includes an acid
treatment step, then the current tolerance expression will also be
adequate for animal commodities.

A summary of ethofumesate tolerance reassessments is presented in Table
7.

Tolerances Listed Under 40 CFR §180.345(a):

Adequate residue data have been submitted to reassess the established
tolerances for sugar beet tops and roots.  The available sugar beet
field trial data indicate that tolerances on roots and tops should be
increased to 0.3 and 4.0 ppm, respectively.  The adequate sugar beet
processing study indicates that residues may concentrate by 1.9x in
molasses. Based on this processing factor and the HAFT residues of 0.25
ppm in roots from the field trials, the maximum excepted combined
residues in molasses would be 0.48 ppm. Therefore, the current 0.5 ppm
tolerance for molasses is appropriate.

The Agency no longer consider grass grown for seed non-food/feed use.
Grass grown for seed is a food crop. Label language restricting the
feeding of livestock feed items resulting in a non-food use is not
generally considered practical. Field trial residue data are required to
establish tolerances on grass forage and hay as they are al food uses by
EPA regulations. Tolerances are not required for the straw and seed
screenings resulting from the production of the crop “grass grown for
seed”. Straw and seed screenings are considered insignificant
livestock feed items. Label restrictions prohibiting the feeding of seed
screenings or straw to livestock are not considered practical. The
established tolerance for grass straw should be re-evaluated upon
submission of residue data for grass grown for seed.

As there are presently no regulated poultry or swine feed items
associated with the registered uses of ethofumesate, tolerances of
poultry commodities are not required and the existing tolerances for
residues in hog fat, meat, and meat byproducts should be revoked.

With regards to tolerances for milk, the existing cattle feeding study
suggests that residues of ethofumesate and its metabolites of concern
(NC 8493, NC 9607 and NC 20654) are unlikely to be quantifiable (0.01
ppm) in milk or milk products derive from cows exposed to ethofumesate
residues at up to 10x the MTDB for dairy cattle.  Therefore, tolerances
for ethofumesate residues in milk are unlikely to be necessary and could
be considered to be a 180.6(a)(3) [i.e., there is no reasonable
expectation of finite residues in ruminant commodities].

With regards to tolerances for tissues of cattle, goats, horses, and
sheep, the data from the existing cattle feeding study indicate that
tolerances will at least need to be maintained for residues in fat.
However, tolerances for animal tissues cannot be reassessed at the
present time as the current cattle feeding study is not adequate.

Tolerances To Be Proposed Under 40 CFR §180.345(a):

Adequate field trial data are available from IR-4 to support a general
use of ethofumesate on garden beets as a preemergence application at up
to 2.0 lb a.i./A in combination with repeated post-emergence
applications at up to 0.33 lb a.i./A, for a total rate of 2.67 lb
a.i./A/season.  The available residue data indicate that tolerances of
0.5 and 5.0 ppm would be appropriate for garden beet roots and tops,
respectively.

Based on the 0.5x processing factor for refined sugar, and HAFT residues
of 0.25 ppm in roots from the field trials, the maximum expected
combined residues in refined sugar would be 0.125 ppm. A tolerance level
of 0.20 ppm would be appropriate for refined sugar.

Tolerances To Be Proposed Under 40 CFR §180.345(c):

Adequate field trial data are available from IR-4 to support a regional
restriction for the use of ethofumesate as pre- and post-emergence
applications to carrots at up 4.0 lb a.i./A/season.  The use would be
restricted to WA State.  The available residue data indicate that a 7
ppm tolerance would be appropriate for carrot roots.

Table 7.	Tolerance Reassessment Summary for Ethofumesate.

Commodity	Current Tolerance (ppm)	Range of Residues (ppm)	Tolerance
Reassessment (ppm)	Comment/[Correct Commodity Definition]

Tolerances Listed Under 40 CFR §180.345(a):

Beet, sugar, roots	0.1	<0.16-0.25	0.3	Residue data indicate that
tolerances should be increased.

Beet, sugar, tops	1.0	0.21-3.1	4.0

	Grass, straw	1.0	NA

(not applicable)	TBD	The use of ethofumesate on grass is classified as a
non-food/feed use.

Sugar beet molasses	0.5	0.48	0.5	Based on HAFT residues of 0.25 ppm and
the 1.9x processing factor, maximum expected residues are 0.48 ppm.

Beet, sugar, molasses

Cattle, fat	0.05	<0.01 ppm for each analyte in all tissues at a 21.6 ppm
(6.1x) dosing level, except for one fat sample

0.01 ppm) in milk or milk products derive from cows exposed to
ethofumesate residues at up to 10x the MTDB for dairy cattle. Therefore,
tolerances for ethofumesate residues in milk are unlikely to be
necessary and could be considered to be a 180.6(a)(3) [i.e., there is no
reasonable expectation of finite residues in ruminant commodities].

Sheep, fat	0.05	NA	TBD	See note above under cattle.

Sheep, meat	0.05

TBD	See note above under cattle.

Sheep, meat byproducts	0.05

TBD	See note above under cattle.

Tolerances to Be Proposed under 40 CFR 180.345(a):

Beet, garden, root	None	0.15-0.30	0.5	Residue data support a general
registration

Beet, garden, tops	None	0.93-4.28	5.0

	Sugar Beet refined sugar	None	–	0.2

	Tolerances to Be Proposed under 40 CFR 180.345(c):

Carrot, root	None	3.01-6.34 	7.0	Residue data support a regional
registration restricted to WA State

1  TBD = To be determined.

Codex/International Harmonization

As there are no Codex MRLs for residues of ethofumesate there are no
questions with respect to Codex/U.S. tolerance compatibility.  No
Canadian or Mexican MRLs have been established for ethofumesate.

BIBLIOGRAPHY

Study Citations

00036363 Whiteoak, R.J.; Crofts, M.; Harris, R.J. (1973) Analytical
Method for Residues in Sugar beet Treated with Nortron (3rd revision):
Report No. RESID/73/18/1.  Method dated Dec 1973.  (pp. 8-14 only;
unpublished study received on unknown date under 4G1495; prepared by
Fisons, Ltd., submitted by Fisons Corp., Agricultural Chemicals Div.,
Bedford, Mass.; CDL:093971-Q)

00036365 Whiteoak, R.J.; Crofts, M. (1973) Residue Decline Studies in
Colorado (USA) with Sugarbeet Treated Pre-emergence with Nortron in
1972: Report No. RESID/73/79.  (Unpublished study received on unknown
date under 4G1495; prepared by Fisons, Ltd., submitted by Fisons Corp.,
Agricultural Chemicals Div., Bedford, Mass.; CDL:093971-S)

00036366 Crofts, M.; Whiteoak, R.J.; Hamilton, K.C.; et al. (1974)
Nortron Residue in Harvest Sugarbeet from Nine Regions of the USA in
1972: Report No. RESID/74/7.  Summary of studies 093971-S and 093971-T.
(Unpublished study received on unknown date under 4G1495; prepared in
cooperation with Fisons, Ltd. and others, submitted by Fisons Corp.,
Agricultural Chemicals Div., Bedford, Mass.; CDL:093917-U)

00037839 Whiteoak, R.J.; Crofts, M.; Maggot, W.F. (1974) Residue Data
De- cline Studies in Michigan (USA) with Sugarbeet Treated Preemergence
with Nortron in 1972: Report No. RESID/74/1.  (Unpublished study
received on unknown date under 4G1495; prepared by Fisons, Ltd. in
cooperation with Michigan State Univ., Dept. of Crop and Soil Sciences,
submitted by Fisons Corp., Agricultural Chemicals Div., Bedford, Mass.;
CDL:093971-T)

00039810 Whiteoak, R.J. (1975) Stability of Residues during Storage of
Crop and Soil Samples from Trials with Nortron: RESID/75/40.  Summary of
study 095900-K.  (Unpublished study received Jan 29, 1976 under 6F1735;
prepared by Fisons, Ltd., submitted by Fisons Corp., Agricultural
Chemicals Div., Bedford, Mass.; CXL: 095900-O)

00041855 Crofts, M.; Harris, R.J.; Wilkie, P.M. (1976) Comparison of
Residues in Mature Sugar Beet Treated Pre-emergence with Nortron or TA
or a Tank-Mix of Both Components in the U.S.A. in 1976: Laboratory
Report No. RESID/76/14.  (Unpublished study received Jun 18, 1976 under
6F1735; prepared by Fisons, Ltd., England, submitted by Fisons Corp.,
Agricultural Chemicals Div., Bedford, Mass.; CDL:096752-D)

00041856 Crofts, M.; Harris, R.J.; Wilkie, P.M. (1976) Comparison of
Residues in Mature Sugar Beet Treated Pre-emergence with Nortron or
Pyramid or a Tank-Mix of Both Components in the U.S.A. in 1975:
Laboratory Report No. RESID/76/26.  (Unpublished study received Jun 18,
1976 under 6F1735; prepared by Fisons, Ltd., England, submitted by
Fisons Corp., Agricultural Chemicals Div., Bedford, Mass.; CDL:096752-E)

00048415 Crofts, M.; Whiteoak, R.J. (1976) Nortron Residues in Mature
Sugar Beet following Post-emergence Applications as a Tank-Mix with
Desmedipham in the U.S.A.  (Unpublished study received on un- known date
under 10065-EX-4; prepared by Fisons, Ltd., submitted by Fisons Corp.,
Agricultural Chemicals Div., Bedford, Mass.; CDL:226428-A)

00115057 Whiteoak, R. (1975) Stability of Residues during Storage of
Crop and Soil Samples from Trials with Nortron: RESID/75/40.
(Unpublished study received Jan 29, 1976 under 10065-5; prepared by
Fisons Ltd., Eng., submitted by Fisons Corp., Agricultural Chemicals
Div., Bedford, MA; CDL:225326-L)

41214206 Whiteoak, R.; Crofts, M.; Harris, R. (1978) R93 Nortron
(Ethofumesate): Analytical Method for Residues of Grass Crops Treated
with NORTRON: Proj. ID RESID/78/31.  Unpublished study prepared by
Schering Agrochemicals Ltd.  21 p.

41214208 Ross, D.; Roberts, N.; Harris, R.; et al. (1977) R78 NORTRON
(Ethofumesate): Residues in Milk and Tissues Following a 28-day Feeding
Study with Ethofumesate in Dairy Cows.  Unpublished compilation prepared
with cooperation of Huntingdon Research Center and Schering
Agrochemicals Ltd.  61 p.

41214209  Harris, R.; Whiteoak, R. (1976) R69 NORTRON (Ethofumesate):
Analytical Method for Residues of Ethofumesate and Its Metabolites in
Milk & Cattle Tissues: Proj. ID RESID/76/31.  Unpublished study prepared
by Schering Agrochemicals Ltd.  15 p.

41214214  Bruhl, R. (1984) W29 Ethofumesate: The Adsorption and
Desorption of Ethofumesate in Soil: Proj. ID METAB/84/32.  Unpublished
study prepared by Schering Agrochemicals Ltd.  18 p.

41214218  Crofts, M.; Whiteoak, R. (1977) R79 NORTRON (Ethofumesate):
Decline of Residues in Ryegrass Following the Application of Nortron in
Washington, USA, 1975-76: Proj. ID RESID/77/32.  Unpublished study
prepared by Schering Agrochemicals Ltd.  52 p.

41214219  Crofts, M.; Whiteoak, R. (1977) R82 Nortron (Ethofumesate):
Decline of Residues in Ryegrass and Kentucky Bluegrass Following the
Application of NORTRON in Oregon, USA, 1975-76: Proj. ID RESID/ 77/36.
Unpublished study prepared by Schering Agrochemicals Ltd.  49 p.

41214220  Harris, R.; Whiteoak, R. (1989) R87 NORTRON (Ethofumesate):
Decline of Residues of Ethofumesate and Diuron in Grass after
Application of each Compound Separately and as a Tank-mix (...): Proj.
ID RESID/77/65.  Unpublished study prepared by Schering Agro- chemicals
Ltd.  23 p.

41214221  Harris, R. (1978) R97 NORTRON (Ethofumesate): Residues in
Grass Seed and Hay Following the Application of NORTRON in Oregon, USA
in 1974/75 and 75/76: Proj. ID RESID/78/90.  Unpublished study prepared
by Schering Agrochemicals Ltd.  23 p.

41214222  Crofts, M.; Whiteoak, R. (1979) R106 NORTRON (Ethofumesate):
Residues in Ryegrass and Kentucky Bluegrass at 41 to 115 Days after
Application of NORTRON in Oregon, 1977-78: Proj. ID RESID/79/69.
Unpublished study prepared by Schering Agrochemicals Ltd.  34 p.

41214223  Crofts, M.; Whiteoak, R. (1977) R66 NORTRON (Ethofumesate):
Residue Decline Study Following the Application of NORTRON to
Established Ryegrass in Washington, 1974-75: Proj. ID RESID/76/19/1.
Unpublished study prepared by Schering Agrochemicals Ltd.  39 p.

41214224  Crofts, M.; Whiteoak, R. (1977) R65 NORTRON (Ethofumesate):
Residue Decline Study Following the Application of NORTRON to
Established Ryegrass in Oregon, 1974-75: Proj. ID RESID/76/15/1.  Unpub-
lished study prepared by Schering Agrochemicals Ltd.  41 p.

41214228 Ready, J. (1980) R108 Nortron (Ethofumesate): Residues in
Mature Sugar Beet Treated with Mixtures of Ethofumesate and/or
Phenmedipham and Desmedipham (Commercial EC Formulations) in USA, 19-
79): Project ID RESID/80/38.  Unpublished study prepared by Schering
Agrochemicals Ltd.  15 p.

41214241 Crofts, M. (1975) R42 Nortron (Ethofumesate): Harvest Residues
in Sugarbeet From 1974 Pre-emergence Applications of Nortron in Ca-
nada: Project ID RESID/75/16.  Unpublished study prepared by Schering
Agrochemicals Ltd.  9 p.

41214242 Ready, J. (1980) R109 Nortron (Ethofumesate): Residues in
Mature Sugar Beet Following Pre- plus Post-emergence Application of
Ethofumesate (20EC) in California, 1977: Project ID RESID/80/47.
Unpublished study prepared by Schering Agrochemicals Ltd.  11 p.

41997206  Bowman, M. (1991) Testing of Ethofumesate Through US FDA
Multiresidue Methods: Lab Project Number: ACB/NOR-AM/MRL-3: R312.50. 90.
 Unpublished study prepared by M.C. Bowman & Assoc.  132 p.

42364504 Hawkins, D.; Kirkpatrick, D.; Dean, G.; et al. (1992) M52
Ethofumesate: the Metabolism of ?carbon 14| Ethofumesate in the Cow: Lab
Project Number: TO/92/136-134.  Unpublished study prepared by Huntingdon
Research Center Ltd.   58 p.

42364505 Hawkins, D.; Epsom, L.; Dight on, M.; et al. (1992) M53
Ethofumesate: The Metabolism of (Carbon 14)| Ethofumesate in Laying
Hens: Lab Project Number: TO/92/136-135.  Unpublished study prepared by
Huntingdon Research Center Ltd.  62 p.

42495901 Chaplet, S. (1992) Ethofumesate/M54: The Metabolism of ?carbon
14|-Ethofumesate in Sugar Beet--A Glasshouse Study: Lab Project Number:
ENVER/92/067.  Unpublished study prepared by Interest Research
International Limited.  207 p.

42495902 Chaplet, S. (1992) Ethofumesate/M55: The Metabolism of ?carbon
14|-Ethofumesate in Annual Ryegrass--A Glasshouse Study: Lab Project
Number: ENVER/92/068: ENVER 85B.  Unpublished study prepared by Interest
Research International Limited.  189 p.

42817201 Carlton, R. (1993) W153 Ethofumesate: The Uptake and Metabolism
of Ethofumesate and Its Soil Metabolites in a Confined Rotational Crop
Study: Lab Project Number: 90B: ENVER/93/009.  Unpublished study
prepared by Schering Agrochemicals Ltd.  133 p.

43298103  Brady, S. (1994) Ethofumesate-Derived Residues in or on Grass,
Grass Screenings and Straw Following Treatment with Nortron SC at
Maximum Use Rates USA 1991: Lab Project Number: B/91R/01. Unpublished
study prepared by Nor-Am Chemical Co.  134 p.

43298104 Castro, L. (1994) At-Harvest Residue of Ethofumesate and
Metabolites in Rotational Crops and Soil Following Application of
Nortron EC to Sugarbeets, USA, 1990: Lab Project Number: R312/01/90.
Unpublished study prepared by Nor-Am Chemical Co. 117 p.

43412901 Castro, L. (1994) Ethofumesate-Derived Residues in the Meat and
Milk of Dairy Cows Resulting from Oral Ingestion of Ethofumesate: Lab
Project Number: B-94R-04/05: B-93R-04/05: R179.  Unpublished study
prepared by AgrEvo USA Co.  148 p.

43458701 Castro, L. (1994) Ethofumesate-Derived Residues in the Meat and
Milk of Dairy Cows Resulting from Oral Ingestion of Ethofumesate: Lab
Project Number: B/94R/04/05: B/93R/04/05. Unpublished study prepared by
AgrEvo USA Co.  148 p. (duplicate of MRID 43412901)

43697201 Cole, M. (1995) At-Harvest Ethofumesate-Derived Residues in or
on Sugar Beet Roots and Tops Following Sequential Applications of
NORTRON SC and BETAMIX at the Highest Recommended Pre-Emergence Plus
Post-Emergence Rate Combination, USA 1993: Lab Project Number: B-93R-03:
FSCA: GGH-01.  Unpublished study prepared by AgrEvo USA Co.  97 p.

45818101 Williams, L. (2002) Ethofumesate AE B049913: Radiovalidation of
the Method of Analysis for Ethofumesate and its Metabolites in Plants
Using Gas Chromatography Equipped with Flame Photometric Detection: Lab
Project Number: 02XB31844P: B003865. Unpublished study prepared by
Aventis CropScience.  43 p. {OPPTS 860.1340}

45818102 Williams, L. (2002) Ethofumesate (AE B049913) Radiovalidation
of the Method of Analysis for Ethofumesate and its Metabolites in Animal
Tissues and Using Gas Chromatography Equipped with Flame Photometric
Detection: Lab Project Number: 02XB31844A: B003866: 201-0539B.
Unpublished study prepared by Bayer CropScience.  108 p. {OPPTS
860.1340}

45818103 Tew, E. (2002) Analytical Method for the Determination of
Ethofumesate and its Metabolites, NC 9607, NC 8493 and NC 20645 in Sugar
Beet Roots and Tops (Method Number XB/01/01): Lab Project Number:
B004169: XB/01/01.  Unpublished study prepared by Bayer CropScience.  28
p. {OPPTS 860.1340}

45818104 Eckert, J. (2001) Independent Laboratory Validation of Aventis
CropScience Method--Analytical Method for the Determination of
Ethofumesate and its Metabolites, NC 9607, NC 8493 and NC 20645 in Sugar
Beet Roots and Tops: Lab Project Number: AV-01-01: 01BF28352: B003792.
Unpublished study prepared by Enviro-Bio-Tech, Ltd.  145 p. {OPPTS
860.1340}

45818105 Cole, M. (2000) Stability of Ethofumesate, NC 9607 and NC 8493
in Carrots During Frozen Storage, USA, 1993: Lab Project Number:
B-93R-13: B93R013: B002705.  Unpublished study prepared by Aventis Crop
Science.  42 p.

45818106 Cole, M. (2000) Stability of Ethofumesate, NC 9607 and NC 8493
in Spinach During Frozen Storage, USA, 1993: Lab Project Number:
B-93R-12: B002728: B93R012.  Unpublished study prepared by AgrEvo USA
Company.  42 p.

45818108 Cole, M. (2000) Stability of Ethofumesate, NC 9607 and NC 8493
in Sorghum Straw During Frozen Storage, USA 1993: Lab Project Number:
B-93R-11: B93R011: B002748.  Unpublished study prepared by Aventis
CropScience.  41 p.

45818109 Cole, M. (1995) Stability of Ethofumesate, NC 9607 and NC 8493
in Grass During Frozen Storage, USA 1993: Lab Project Number: B-39R-09:
NC 8438/R185: A54281.  Unpublished study prepared by AgrEvo USA Company.
 44 p.

45818110 Cole, M. (1999) Stability of Ethofumesate, NC 9607 and NC 8493
in Barley Grain During Frozen Storage, USA 1993: Lab Project Number:
B-93R-10: B93R010: A54282.  Unpublished study prepared by Aventis
CropScience.  40 p.

45855501 Cole, M.; Benson, N. (2002) At-Harvest Ethofumesate-Derived
Residues in or on Sugar Beet Roots and Processed Sugar Beet Commodities
Following a Single Application of Nortron SC at Exaggerated Rates, USA,
1993: Lab Project Number: B-93R-02: B93R002: B004036.  Unpublished study
prepared by Bayer CropScience.  145 p. {OPPTS 860.1520}

45855502 Cole, M.; Benson, N. (2002) Ethofumesate-Derived Residues in or
on Rotational Crops Following Sequential Applications of Nortron SC and
Betamix at the Highest Recommended Pre-Emergence Plus Post-Emergence
Rate Combination, USA, 1993: Lab Project Number: B-93R-16: B93R016:
B004038.  Unpublished study prepared by Aventis CropScience.  190 p.
{OPPTS 860.1900}

45874703 Cole, M. (2000) Validation of an Analytical Method for the
Residues of NC 20645 in Sugar Beet Roots and Whole Milk, USA, 1998: Lab
Project Number: B98R001: C004116.  Unpublished study prepared by Aventis
CropScience.  30 p. {OPPTS 860.1500}

45892001 Arsenovic, M. (2002) Ethofumesate: Magnitude of the Residue on
Beet, Garden: Lab Project Number: 00742: 00742.96-MNR02: 00742.96-TX14.
Unpublished study prepared by IR-4 Project Center for Minor Crop Pest
Management.  268 p.

45892101 Arsenvic, M. (2002) Ethofumesate: Magnitude of the Residue on
Carrot: Lab Project Number: 06703: 06703.00-ABC02: 06703.99-WA43.
Unpublished study prepared by ABC Laboratories, Inc., and
USDA/ARS-IAREC.  194 p.

92063022 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 00036363 and Related MRIDs 41214206.  Gas-liquid Chromatographic
Determination of Residues of Ethofumesate and Its Metabolism in Sugar
Beets and Grass: Project ID: RESID/90/59 (NC 8438/R167). Prepared by
Schering Agrochemicals ltd. 25 p.

92063023 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 41214209.  GLC Determination of Residues of Ethofumesate and Its
Metabolites in Milk and Cattle Tissues: Project ID No. RESID/90/62 and
(NC 8438/R169).  Prepared by SCHERING AGROCHEMICALS LIMITED. 17 p.

92063024 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 00115057 and Related MRIDs 00039810.  Stability of Ethofumesate and
Metabolite Residues in Sugarbeet (Roots and Tops) during Deep Freeze
Storage: Project ID: RESID/ 90/60 (NC 8438/R168). Prepared by SCHERING
AGROCHEMICALS LIMITED. 13 p.

92063025 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 41214208.  Residues in Milk and Tissues Following a 28-Day Feeding
Study with Ethofumesate in Dairy Cows: Project ID: RESID/90/61 and (NC
8438/R78).  Prepared by SCHERING AGROCHEMICALS LIMITED. 15 p.

92063026 Crofts, M. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 41214214 and Related MRIDs 41214223, 41214218, 41214219, 41214220,
41214222.  Residue Decline Studies in Oregon and Washington (USA) with
Ryegrass and Kentucky Bluegrass Treated with Ethofumesate (Nortron EC)
in 1972 to 1979: Project ID No. RESID/90/48 (NC 8438/R163).  Prepared by
SCHERING AGROCHEMICALS LIMITED. 12 p.

92063028 Crofts, M. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 00036366 and Related MRIDs 41214241, 00041855, 00041856, 41214219,
41214220.  Residues in Harvest Sugarbeet from Pre-emergence Applications
of Ethofumesate (Nortron EC) in the USA in 1972 to 1979: Project ID:
RESID/90/53 (NC 8438/R164). Prepared by SCHERING AGROCHEMICALS LIMITED.
11 p.

92063029 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 00036365 and Related MRIDs 00037839.  Residue Decline Studies in
Colorado and Michigan (USA) with Sugarbeet Treated Pre-emergence with
Ethofumesate (NORTON EC) in 1972: Project ID: RESID/90/37 (NC
8438/R162).  Prepared by Schering Agrochemicals Ltd. 10 p.

92063030 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Summary of
MRID 00048415 and Related MRIDs 41214234, 41214228, 41214242. Residues
in Harvest Sugar Beet from Post-Emergence Applications Ethofumesate in
the USA in 1975, 1977 and 1979: Project ID: RESID/90/31 (NC 8438/R158).
Prepared by Schering Agrochemicals Ltd. 10 p.

92063035 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Reformat of
MRID 00036363 and Related MRIDs 41214206.  Gas-Liquid Chromatographic
Determination of Residues of Ethofumesate and Its Metabolites in Sugar
Beets and Grass: Project ID: RESID/90/59 (NC 8438/R167).  Prepared by
Schering Agrochemicals Ltd. 25 p.

92063036 Harris, R.; Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3
Reformat of MRID 41214209.  Gas Liquid Chromatographic Determination of
Residues of Ethofumesate and its Metabolites in Milk and Cattle Tissues:
Registration Reference NC 8438/R169. Prepared by SCHERING AGROCHEMICALS
LIMITED. 30 p.

92063037 Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3 Reformat of
MRID 00115057 and Related MRIDs 00039810.  Stability of Ethofumesate and
Metabolite Residues in Sugar Beet (Roots and Tops) during Deep Freeze
Storage: Registration Ref. NC 8438/R168.  Prepared by SCHERING
AGROCHEMICALS LIMITED. 19 p.

92063038 Ross, D.; Roberts, N.; Harris, R.; et al. (1990) Nor-Am
Chemical Company Phase 3 Reformat of MRID 41214208.  Residues in Milk
and Tissues following a 28-Day Feeding Study with Ethofumesate in Dairy
Cows: Registration Reference NC 8438/R78 (2nd Edition). Prepared by
SCHERING AGROCHEMICALS LIMITED. 61 p.

92063039 Crofts, M.; Whiteoak, R.; Browne, P. (1990) Nor-Am Chemical
Company Phase 3 Reformat of MRID 00048415 and Related MRIDs 41214234,
41214228, 41214242.  Residues in Harvest Sugarbeet from Post-emergence
Applications in the USA in 1975, 1977 and 1979: Registration Reference:
NC 8438/R158.  Prepared by Fisons Ltd Chesterford Park Res. Station. 48
p.

92063040 Crofts, M.; Whiteoak, R.; Harris, R.; et al. (1990) Nor-Am
Chemical Company Phase 3 Reformat of MRID 41214214 and Related MRIDs
41214223, 41214218, 41214219, 41214220, 41214222.  Residue Decline
Studies in Oregon and Washington (USA) with Rye-grass and Kentucky
Bluegrass Treated with Ethofumesate (Nortron EC) in 1972 to 1977:
Registration Reference NC 8438/R163.  Prepared by SCHERING AGROCHEMICALS
LIMITED. 149 p.

92063041 Crofts, M.; Whiteoak, R. (1990) Nor-Am Chemical Company Phase 3
Reformat of MRID 00036365 and Related MRIDs 00037839.  Residue Decline
in Colorado and Michigan (USA) with Sugar Beet Treated Pre-emergence
with Ethofumesate (NORTRON: EC) in 1972: Registration Reference: NC
8438/R162.  Prepared by Schering Agrochemicals Ltd. 31 p.

92063042 Harris, R.; Whiteoak, R.; Crofs, M.; et al. (1990) Nor-Am
Chemical Company Phase 3 Reformat of MRID 41214219 and Related MRIDs
00041855, 00041856, 00036366, 41214220, 41214241.  Residues in Harvest
Sugar Beet from Pre-emergence Applications of Ethofumesate (Nortron EC)
in the USA 1972 to 1979: Registration Reference NC 8438/R164.  Prepared
by SCHERING AGROCHEMICALS LIMITED. 86 p.

Agency Memoranda Citations

Table 8.	Agency Memoranda Citations.

Date	DP Barcode	CB No.	From	To	MRID Nos.	Subject

12/11/91	None	None	J. Smith	L. Sawyer, FDA	41997206	Letter -  Forwarding
Multiresidue Method Testing Data for Ethofumesate to FDA.

12/3/92	D180705	10214	S. Funk	R. Gebken	42364504, 42364505
Reregistration of Ethofumesate.  Nature of the Residue in Ruminants and
Poultry.

2/17/93	D183664	10755	S. Funk	R. Gebken	42495901, 42495902
Reregistration of Ethofumesate.  171-4(a): Nature of the Residue in
Ryegrass and in Sugar Beets.  Revision of Tolerance Expression and
Addendum to CBRS No. 10214.

1/4/94	D192914	12338	L. Cheng	R. Gebken	42817201	Ethofumesate.
Registrants’ Response to Reregistration. Confined Rotational Crop
Study.

8/29/95	None	None	S. Funk	HED Metabolism Committee	None	Ethofumesate.
Metabolism in Plants and Animals.  The Metabolism Committee Meeting Held
on June 8, 1995.

8/1/95	D210002 and D209084	14808 and 15433	L. Cheng	R. Gebken	43412901,
43458701	Ethofumesate.  Magnitude of the Residue in Meat and Milk.

2/29/96	D217384	15947	S. Funk	R. Gebken	43697201	Reregistration of
Ethofumesate (list B, chemical 110601, case 2265).  171-4(k):  Magnitude
of the Residue in/on Sugar Beets.

6/16/97	D207770	14440	L. Cheng	K. Whitby	43298101, 43298102, 43298103,
43298104	Ethofumesate.  Case No. 2265.  GLN 860.1500. Magnitude of
Residue in Grass, Screenings and Straw. GLN 860.1550. Limited Rotational
Crop Study.

APPENDIX 1

Food/Food Use Pattern Table for Ethofumesate

Generated by BEAD/OPP

TABLE A2. FOOD/FEED USE PATTERNS SUMMARY FOR Ethofumesate (ANSI) (CASE
2265)

Current As Of: 11/30/2001								Printed On: 04/29/2002

SITE NAME	Product/Site Limitations

Application Type (for any Reg.# at any rate) (aggregate)

Application Timing (for any Reg.# at any rate)

Application Equipment (for any Reg.# at any rate) (aggregate) 	Max.
Single Appl.

 Rate to a Single

 Site

(AI unless noted

otherwise)	Max

Seasonal

Rate

	Max. # Apps Per Crop Cycle (cc) and Year (at any rate) 	Min Retmt Intv
(days) (at any rate) 	PHI/PGI/PSI

Use Limitations (at any rate) (May not apply to all Reg. #s within
group)

SUGAR BEET	75  day(s) preharvest interval.

Rotational/plant back crop restriction.

This pesticide is toxic to aquatic organisms.

This product is toxic to fish.

Broadcast

At emergence through seedling stage

Aircraft/Ground	.1125 lb A	.6525

lb/cc	NS

NS	5

	Band treatment/Broadcast/Spray

Established plantings

Aircraft/Ground/Tank	.3831 lb A	.9661

lb/cc   	NS

NS 	5

	Broadcast

Evening

Aircraft/Ground	.2498 lb A	.9994

lb/cc   	NS

NS 	7

	Band treatment/Broadcast

Foliar

Aircraft/Ground/Sprayer	.3831 lb A	.9994

lb/cc   	NS

NS 	5

	SUGAR BEETS (INCL. TOPS)                    	Do not apply directly to
water, or to areas where surface water is present or to intertidal areas
below the mean high water mark.

Do not apply through any type of irrigation system.

Do not contaminate water by cleaning of equipment or disposal of
equipment wash waters.

Do not contaminate water, food, or feed by storage or disposal.

Do not graze livestock in treated areas.

For terrestrial uses, do not apply directly to water or to areas where
surface water is present or to intertidal areas below the mean high
water mark.

Rotational/plant back crop restriction.

Band treatment/Broadcast/Soil incorporated treatment

At planting

Ground/Sprayer	3.75 lb A	3.8598

lb/cc   	NS

NS 	NS 	Geographic allowable: Central

States (Label verbatim) MI

Northeast OH Southeast

Band treatment

Fall

Ground                                                           	1.172
lb A       	NS      	NS

NS 	NS 	Geographic allowable: Central

States (Label verbatim) MI

Northeast OH Southeast

Band treatment/Broadcast

Foliar

Sprayer	.2412 lb A	3.8598

lb/cc	NS

NS	NS 	Geographic allowable: Central

States (Label verbatim) MI

Northeast OH Southeast

Band treatment/Broadcast

Postemergence

Ground/Sprayer

3.619 lb A       	3.8598

lb/cc   	NS

NS	NS 	Geographic allowable: Central

States (Label verbatim) MI MN ND

Northeast OH Southeast

Geographic disallowable: MN ND

Broadcast

Postplant

Sprayer                                                          	3.75
lb A        	NS      	NS

NS	NS	Geographic allowable: Central

States (Label verbatim) MI MN ND

Northeast OH Southeast

Geographic disallowable: MN ND

Band treatment/Broadcast

Preemergence

Ground/Sprayer	3.619 lb A	3.8598

lb/cc   	NS

NS 	NS 	Geographic allowable: Central

States (Label verbatim) MI MN ND

Northeast OH Other Southeast

Geographic disallowable: MN ND

Band treatment/Broadcast/Soil incorporated treatment

Preplant

Ground/Sprayer                                                   	3.75
lb A	3.8598

lb/cc   	NS

NS 	NS 	Geographic allowable: Central

States (Label verbatim) MI MN ND

Northeast OH Other Southeast

Geographic disallowable: MN ND

Band treatment

Spring

Ground                                                           	1.172
lb A	NS	NS

NS 	NS 	Geographic allowable: Central

States (Label verbatim) MI MN ND

Northeast OH Other Southeast

Geographic disallowable: MN ND

Band treatment/Broadcast

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Ground/Sprayer                                                   	3.75
lb A        	NS	NS

NS 	NS 	Geographic allowable: Central

States (Label verbatim) MI MN ND

Northeast OH Other Southeast

Geographic disallowable: MN ND

Band treatment/Broadcast

Winter

Sprayer	2.625 lb A	3.8598

lb/cc	NS

NS	NS	Geographic allowable: CA Central

States (Label verbatim) MI MN ND

Northeast OH Other Southeast

Geographic disallowable: MN ND

Product Number(s) Contained in this Report:

000264-00612<PHONE_NUMBER>3<PHONE_NUMBER>1<PHONE_NUMBER>2<PHONE_NUMBER>3
073917-00002

Ethofumesate	Residue  Chemistry Considerations - RED	Barcode:  D288646

  PAGE

Ethofumesate	Residue  Chemistry Considerations - RED	Barcode:  D288646

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	(continued)

Ethofumesate	Residue  Chemistry Considerations - RED	Barcode:  D288646

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	(continued)

Ethofumesate	Residue  Chemistry Considerations - RED	Barcode:  D288646

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Ethofumesate	Residue  Chemistry Considerations - RED	Barcode:  D288646

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	(continued)

1.	Bolded references were cited in the Ethofumesate Phase 4 Review,
dated 1/31/91.  All other references were reviewed as noted.

2.	DP Barcode D183664, 2/17/93, S. Funk.

3.	DP Barcode D180705, 12/3/92, S. Funk.

4.	The proposed GC/FPD-S method (Bayer CropScience Method Number
XB/01/01) for determining residues of ethofumesate and the free and
conjugated metabolites NC 8493, NC 9607, and NC 20654 should be
forwarded to ACB for a method validation trial.  The method has
undergone a successful ILV trial and radiolabeled method validation
trial.

5.	DP Barcode D288646.

6.	A new method is required for enforcing ethofumesate tolerances on
livestock commodities as the existing Method II listed in PAM Vol. II is
not sensitive enough to determine residues at the current tolerance
levels.

To support the existing cattle feeding study, data are required
demonstrating that Metabolite NC 20654 is adequately recovered (as NC
9607) from cattle tissues using the GC/FPD-S data collection method
(Method B-93R-04/05).

7.	FDA Multiresidue Method Testing data are available for parent;
however, no data are available for the metabolites of concern.  The
metabolites NC 8493, NC 9607, and NC 20654 should be tested using FDA
Multiresidue Method Testing Protocols.

8.	Forwarded to FDA for review (12/11/91, J. Smith).

9.	Storage stability data are required from animal tissues stored frozen
for up to 12 months.

10.	A new cattle feeding study is required unless the registrant can
upgrade the current cattle feeding study by (i) demonstrating that the
GC/FPD-S Method B-93R-04/05 used for analysis of cattle tissues
adequately accounts for residues of the Metabolite NC 20654, and (ii)
providing storage stability data for residues in animal tissues.

11.	DP Barcodes D210002 and D209084, 8/1/95, L. Cheng.

12.	There are no poultry or swine feed items associated with the use of
ethofumesate; therefore, residue data and tolerances on poultry and hog
commodities are not required.

13.	Sufficient field trail data (6 tests) are available from
representative growing regions to support a use of ethofumesate (FlC) on
garden beets as four broadcast applications, including a preemergence
application at up to 2 lb ai/A, and three foliar applications up to the
8-leaf stage at 0.16-0.33 lb ai/A, for a total seasonal rate of 2.67 lb
ai/A.  The residue data support a 14-day PHI for tops and a 50-day PHI
for roots.

14.	DP Barcode D217384, 2/29/96, L. Cheng.

15.	Sufficient field trail data (3 tests) are available to support a use
of ethofumesate (FlC) in WA State on carrots as two applications (pre-
and post-emergence) at up to 2 lb ai/A/application for a total seasonal
rate of 4 lb ai/A, with a 35-day PHI.  To establish a Section 3
registration on carrots, additional field trial data would be required.

16.	The Agency no longer consider grass grown for seed non-food/feed
use. Grass grown for seed is a food crop. Label language restricting the
feeding of livestock feed items resulting in a non-food use is not
generally considered practical. Field trial residue data are required to
establish tolerances on grass forage and hay as they are al food uses by
EPA regulations. Tolerances are not required for the straw and seed
screenings resulting from the production of the crop “grass grown for
seed”. Straw and seed screenings are considered insignificant
livestock feed items. Label restrictions prohibiting the feeding of seed
screenings or straw to livestock are not considered practical.

17.	DP Barcode D207770, 6/16/97, L. Cheng.

18.	DP Barcode D192914, 1/4/94. L. Cheng.

19.	The available limited field rotational crop trials indicate that
extensive field rotational crop studies will be required to support
tolerances for inadvertent ethofumesate residues in rotational crops.
Extensive field rotational crop studies must be submitted for all crops
the registrant wishes to allow to be rotated after application of
ethofumesate to sugar beets and carrots.