DCN: 50-940002948

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

REGULATION OF A NEW CHEMICAL SUBSTANCE

PENDING DEVELOPMENT OF INFORMATION

In the matter of:

DowElanco

Premanufacture Notice

Number:

P-93-1649

Consent Order and Determinations supporting Consent Order

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-iiTABLE OF CONTENTS

Preamble

I. Introduction

II. Summary of Terms of the Order

III. Contents of PMN

IV. EPA's Assessment of Risk

V. EPA's Conclusions of Law

VI. Information Required to Evaluate Health Effects

Consent Order

I. Terms of Manufacture, Import, Processing, Distribution in

Commerce, Use, and Disposal Pending Submission and

Evaluation of Information

II. Recordkeeping

III. Modification and Revocation of Consent Order

IV. Effect of Consent Order

Attachment A - Definitions

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-iiiI. INTRODUCTION

Under the authority of §5(e) of the Toxic Substances Control

Act ("TSCA") (15 U.S.C. 2604(e», the Environmental Protection

Agency ("EPA" or lithe Agency") issues the attached Order,

regarding premanufacture notice (IlPMN") P-93-1649 submitted by

The DowElanco (lithe company"), to take effect upon expiration of

the PMN review period.

Under §15 of TSCA, it is unlawful for any person to fail or

refuse to comply with any provision of §5 or any order issued

under §5. Violators may be sUbject to various penalties and to

both criminal and civil liability pursuant to §16, and to

specific enforcement and seizure pursuant to §17.

II. SUMMARY OF TERMS OF THE ORDER

The Consent Order for this PMN substance requires the

Company to:

(a) submit to EPA the following toxicity testing 14 weeks before

manufacturing or importing an aggregate production volume of [

] kilograms of the PMN substance: dermal developmental

toxicity study, rats (as described in 40 CFR 798.4900);

(b) submit to EPA the following toxicity testing 14 weeks before

manufacturing or importing an aggregate production volume of [

] kilograms of the PMN substance: 90-day dermal subchronic

study, rats (as described in 40 CFR 798.2250), with functional

observational battery, motor activity, and neuropathology (all

described in NTIS: PB91-154617);

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(c) provide its workers personal protective equipment to prevent

dermal exposure;

(d) demonstrate that each item of chemical protective clothing

selected, including gloves, provides an impervious barrier to

prevent dermal exposure during normal and expected duration and

conditions of exposure within the work area;

(e) label the PMN substance and provide Material Safety Data

Sheets (MSDSs) and worker training in accordance with the

provisions of the Hazard Communication Program section;

(f) not use the PMN substance for other than industrial uses;

(g) distribute the PMN substance only to a person who agrees

to follow the same restrictions (except the testing requirements)

and to not further distribute the PMN substance until it has been

completely reacted; and

(h) maintain certain records.

III. CONTENTS OF PMN

Confidential Business Information Claims (Bracketed in the

Preamble and Order): Chemical identity, impurities, production

volume, processing and use information.

Chemical Identity:

Specific: [ ].

Generic: Alkylated-urea.

specific: [ ] .

Generic: Process raw material.

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-vMaximum 12-Month Production Volume: [

Test Data Submitted with PMN: None.

] kg/yr.

IV. EPA'S ASSESSMENT OF RISK

Health Effects Summary:

Concerns: Neurotoxicity and developmental toxicity.

Basis:

For neurotoxicity: data submitted under TSCA §8(e) [

] .

For developmental toxicity: data on tetramethylurea.

Absorption: Expected via all routes (inhalation, dermal, and GI

tract) .

Exposure Summary:

Import Use

# sites N/A 1

# Persons/site N/A 6-14

# Days/Year N/A 5

Amt. Dermal Exp. N/A 3900 mg/day

Amt. Inhal. Exp. N/A 0.26 mg/day *

* Inhalation exposures during industrial uses of the PMN

substance are not expected to pose significant risks. However,

other non-industrial uses of the substance might result in higher

or less controlled exposures.

Environmental Effects Summary: Low concern. Toxicity values are

predicted to be greater than 100 parts per million (ppm) for the

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-viaquatic toxicity base set (fish, daphnids, and algae).

Concentration of concern is greater than 1 ppm.

Environmental Release Summary:

To water: 1 kg/day, 130 days per year and 2.3 kg/day,S days per

year. This release is not expected to result in surface water

concentrations exceeding the concentration of concern.

To landfill: 760 kg/yr.

v. EPA'S CONCLUSIONS OF LAW

The following findings constitute the basis of the Consent

Order:

A. EPA is unable to determine the potential for neurotoxicity

and developmental toxicity from dermal exposure to the PMN

substance. EPA therefore concludes, pursuant to §5(e) (1) (A) (i)

of TSCA, that the information available to the Agency is

insufficient to permit a reasoned evaluation of the human health

effects of the PMN substance.

B. In light of the potential risk of neurotoxicity and

developmental toxicity posed by the uncontrolled manufacture,

import, processing, distribution in commerce, use, and disposal

of the PMN substance, and the Agency's conclusion that issuing

the Order will not result in any significant loss of benefits to

society, EPA has concluded, pursuant to §5(e) (1) (A) (ii) (I) of

TSCA, that uncontrolled manufacture, import, processing,

distribution in commerce, use, and disposal of the PMN substance

may present an unreasonable risk of injury to human health.

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-viiVI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS

The Order prohibits the company from exceeding a specified

production volume unless the Company submits the information

described in the Testing section of this Order in accordance with

the conditions specified in the Testing section.

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WASHINGTON, 20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

CONSENT ORDER

I. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL

PENDING SUBMISSION AND EVALUATION

OF INFORMATION

The DowElanco (lithe company") is prohibited from

manufacturing, importing, processing, distributing in commerce,

using, or disposing of the chemical substance [

] (lithe PMN substance") in the United States, for

any nonexempt commercial purpose, pending the development of

information necessary for a reasoned evaluation of the

neurotoxicity and developmental toxicity effects of the

SUbstance, and the completion of EPA's review of, and regulatory

action based on, that information, except under the following

conditions:

AecycledIRecyclablilll

Printlld with Say/Canota Ink on paper that

contains at leas! 50% recycilld fiber

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TESTING

(a) Any information on the PMN substance which reasonably

supports the conclusion that the PMN substance presents a

substantial risk of injury to health or the environment required

to be reported under EPA's section 8(e) policy statement at 43

Federal Register 11110 (March 16, 1978) as amended at 52 Federal

Register 20083 (May 29, 1987), shall reference the appropriate

PMN identification number for this substance and shall contain a

statement that the substance is sUbject to this Consent Order.

Additional information regarding section 8(e) reporting

requirements can be found in the reporting guide referenced at 56

Federal Register 28458 (June 20, 1991).

(b) The Company shall notify, in writing, the EPA Laboratory

Data Integrity Assurance Division, Office of compliance

Monitoring (EN-342), u.S. Environmental Protection Agency, 401 M

Street, S.W., Washington, D.C. 20460, of the following

information within 10 days of scheduling any study required to be

performed pursuant to this Order, or within 15 days after the

effective date of this Order, whichever is later:

1. The date when the study is scheduled to commence;

2. The name and address of the laboratory which will

conduct the study; and

3. The name and telephone number of a person at the

Company or the laboratory whom EPA may contact regarding the

study.

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4. The appropriate PMN identification number for each

substance and a statement that the substance is sUbject to this

Consent Order.

(c) Each study required to be performed pursuant to this Order

must be conducted according to TSCA Good Laboratory Practice

standards at 40 CFR Part 792 and using methodologies generally

accepted at the time the study is initiated. Before starting to

conduct any such study, the Company must obtain approval of test

protocols from EPA by sUbmitting written protocols. EPA will

respond to the Company within 4 weeks of receiving the written

protocols. Published test guidelines specified in paragraph (d)

(e.g., 40 CFR 797 or 798) provide general guidance for

development of test protocols, but are not themselves acceptable

protocols.

(d) The Company is prohibited from manufacturing or importing

the PMN substance beyond the following aggregate manufacture and

import volumes ("the production limits"), unless the Company

conducts the following studies on the PMN substance and submits

all final reports and underlying data in accordance with the

conditions specified in this Testing section:

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Production Limit

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study Guideline

[ ] kg dermal developmental

toxicity study, rats

40 CFR 798.4900

] kg 90-day dermal subchronic

study, rats 40 CFR 798.2250

with functional

observational battery,

motor activity, and

neuropathology NTIS: PB91-154617

(e) The Company shall: (1) conduct each study in good faith,

with due care, and in a scientifically valid manner; (2) promptly

furnish to EPA the results of any interim phase of each study;

and (3) sUbmit, in triplicate (with an additional sanitized copy,

if confidential business information is involved), the final

report of each study and all underlying data ("the report and

data") to EPA no later than 14 weeks prior to exceeding the

applicable production limit. The report shall be submitted to

EPA in accordance with the standards for the reporting of study

results in 40 CFR 792.185. underlying data shall be submitted to

EPA in accordance with the applicable "Reporting," "Data and

Reporting," and "Test Report" SUbparagraphs in the applicable

test guidelines. However, with regard to those SUbparagraphs,

the word "shall" will be used in place of the word "should" to

make clear that the submission of such information is mandatory.

EPA will require the submission of raw data such as slides and

laboratory notebooks only if EPA finds, on the basis of

professional jUdgment, that an adequate evaluation of the study

cannot take place in the absence of these items. When the tests

required pursuant to the terms of this Order are not covered by

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test guidelines in Parts 797 and 798 above, EPA shall, in writing

to the Company, describe the type of data required to adequately

evaluate the test data.

(f) The Company is not required to conduct a study specified in

paragraph (d) of this Testing section if notified in writing by

EPA that it is unnecessary to conduct that study.

(g) If EPA finds that the data generated by a study are

scientifically equivocal, the Company may continue to manufacture

and import the PMN substance beyond the applicable production

limit. To seek relief from any other restrictions of this

Order, the Company may make a second attempt to obtain

unequivocal data by reconducting the study under the conditions

specified in paragraphs (b), (c), and (e) (1) and (2). The

testing requirements may be modified, as necessary to permit a

reasoned evaluation of the risks presented by the PMN substance,

only by mutual consent of EPA and the Company.

(h) (1) Except as described in sUbparagraph (h) (2), if, within 6

weeks of EPA's receipt of a test report and data, the Company

receives written notice that EPA finds that the data generated by

a study are scientifically invalid, the Company is prohibited

from further manufacture and import of the PMN substance beyond

the applicable production limit.

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(2) The Company may continue to manufacture and import the

PMN substance beyond the applicable production limit only if so

notified, in writing, by EPA in response to the Company's

compliance with either of the following sUbparagraphs (h) (2) (i)

or (h)(2)(ii).

(i) The Company may reconduct the study in compliance

with paragraphs (b), (c), and (e) (1) and (2). If there is

sufficient time to reconduct the study and submit the report and

data to EPA at least 14 weeks before exceeding the production

limit as required by sUbparagraph (e) (3), the Company shall

comply with sUbparagraph (e) (3). If there is insufficient time

for the company to comply with sUbparagraph (e) (3), the Company

may exceed the production limit and shall submit the report and

data in triplicate to EPA within a reasonable period of time, all

as specified by EPA in the notice described in sUbparagraph

(h) (1). EPA will respond to the Company, in writing, within 6

weeks of receiving the Company's report and data.

(ii) The Company may, within 4 weeks of receiving from

EPA the notice described in sUbparagraph (h) (1), submit to EPA a

written report refuting EPA's finding. EPA will respond to the

Company, in writing, within 4 weeks of receiving the Company's

report.

(i) (1) Except as described in sUbparagraph (i) (2), if the

Company becomes aware that circumstances clearly beyond the

control of the Company or laboratory will prevent, or have

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prevented, development of scientifically valid data under the

conditions specified in paragraphs (c) and (e), the Company

remains prohibited from further manufacture and import of the PMN

substance beyond the applicable production limit.

(2) The Company may submit to EPA, within 2 weeks of first

becoming aware of such circumstances, a written statement

explaining why circumstances clearly beyond the control of the

Company or laboratory will cause or have caused development of

scientifically invalid data. EPA will notify the Company of its

response, in writing, within 4 weeks of receiving the Company's

report. EPA's written response may either:

(i) allow the company to continue to manufacture and

import the PMN substance beyond the applicable production limit,

or

(ii) require the Company to continue to conduct, or to

reconduct, the study in compliance with paragraphs (b), (c), and

(e) (1) and (2). If there is sufficient time to conduct or

reconduct the study and submit the report and data to EPA at

least 14 weeks before exceeding the production limit as required

by sUbparagraph (e) (3), the Company shall comply with

sUbparagraph (e) (3). If there is insufficient time for the

Company to comply with sUbparagraph (e) (3), the Company may

exceed the production limit and shall submit the report and data

in triplicate to EPA within a reasonable period of time, all as

specified by EPA in the notice described in sUbparagraph (i) (2) .

EPA will respond to the Company, in writing, within 6 weeks of

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receiving the Company's report and data, as to whether the

company may continue to manufacture and import beyond the

applicable production limit.

(j) (l) EPA may notify the Company in writing that EPA finds

that the data generated by a study are scientifically valid and

unequivocal and indicate that, despite the terms of this Order,

the PMN substance will or may present an unreasonable risk of

injury to human health or the environment. EPA's notice may

specify that the Company undertake certain actions concerning

further testing, manufacture, import, processing, distribution,

use and/or disposal of the PMN substance to mitigate exposures to

or to better characterize the risks presented by the PMN

substance. within 2 weeks from receipt of such a notice, the

Company must cease all manufacture, import, processing,

distribution, use and disposal of the PMN substance, unless

either:

(2) within 2 weeks from receipt of the notice described in

sUbparagraph (j) (1), the Company complies with such requirements

as EPA's notice specifies; or

(3) within 4 weeks from receipt of the notice described in

sUbparagraph (j) (1), the Company submits to EPA a written report

refuting EPA's finding and/or the appropriateness of any

additional requirements imposed by EPA. The Company may continue

to manufacture, import, process, distribute, use and dispose of

the PMN substance in accordance with the terms of this Order

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pending EPA's response to the company's written report. EPA will

respond to the Company, in writing, within 4 weeks of receiving

the Company's report. Within 2 weeks of receipt of EPA's written

response, the company shall comply with any requirements imposed

by EPA's response or cease all manufacture, import, processing,

distribution, use and disposal of the PMN substance.

(k) Regardless of the satisfaction of any other conditions in

this Testing section, the Company must continue to obey all the

terms of this Consent Order until otherwise notified in writing

by EPA. The Company may, based upon submitted test data or other

relevant information, petition EPA to modify or revoke provisions

of this Consent Order pursuant to Part III. of this Consent

Order.

PROTECTION IN THE WORKPLACE

(a) During manufacturing, processing, and use of the PMN

substance at any site controlled by the Company, the company must

establish a program whereby:

(1) Each person who is reasonably likely to be dermally

exposed in the work area to the PMN substance through direct

handling of the substance or through contact with equipment on

which the substance may exist, or because the substance becomes

airborne in a form listed in sUbparagraph (a) (6) of this section,

is provided with, and is required to wear, personal protective

equipment that provides a barrier to prevent dermal exposure to

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the substance in the specific work area where it is selected for

use. Each such item of personal protective equipment must be

selected and used in accordance with 29 CFR 1910.132 and 29 CFR

1910.133.

(2) In addition to the personal protective equipment

described in sUbparagraph (a) (1) of this section, the following

items are required:

(i) Gloves.

(ii) Full body chemical protective clothing.

(iii) Chemical goggles or equivalent eye protection.

(iv) clothing which covers any other exposed areas of

the arms, legs and torso. clothing provided under this

sUbparagraph (a) (2) (iv) need not be tested or evaluated under the

requirements of sUbparagraph (a) (3).

(3) The Company is able to demonstrate that each item of

chemical protective clothing selected, including gloves, provides

an impervious barrier to prevent dermal exposure during normal

and expected duration and conditions of exposure within the work

area by anyone or a combination of the following:

(i) Testing the material used to make the chemical

protective clothing and the construction of the clothing to

establish that the protective clothing will be impervious for the

expected duration and conditions of exposure. The testing must

sUbject the chemical protective clothing to the expected

conditions of exposure, including the likely combinations of

chemical substances to which the clothing may be exposed in the

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work area. Permeation testing shall be conducted according to

the American Society for Testing and Materials (ASTM) F739

"Standard Test Method for Resistance of Protective clothing

Materials to Permeation by Liquids or Gases." Results shall be

recorded as a cummulative permeation rate as a function of time,

and shall be documented in accordance with ASTM F739 using the

format specified in ASTM Fl194-89 "Guide for Documenting the

Results of Chemical Permeation Testing on Protective clothing

Materials." Gloves may not be used for a time period longer than

they are actually tested and must be replaced at the end of each

work shift.

(ii) Evaluating the specifications from the

manufacturer or supplier of the chemical protective clothing, or

of the material used in construction of the clothing, to

establish that the chemical protective clothing will be

impervious to the PMN substance alone and in likely combination

with other chemical substances in the work area.

(b) If the PMN substance is present in the work area only as a

mixture, the Company is exempt from the provisions of this

protection in the workplace section if the concentration of the

PMN substance in the mixture does not exceed 1.0 percent by

weight or volume, or 0.1 percent by weight or volume if paragraph

(g) of the Hazard Communication Program section of this Order

identifies cancer as a potential human health hazard of the PMN

substance. This exemption does not apply if the Company has

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reason to believe that during intended use or processing in the

work area, the PMN substance in the mixture may be reconcentrated

above the 1.0 or 0.1 percent level, whichever is applicable.

HAZARD COMMUNICATION PROGRAM

(a) written hazard communication program. The Company shall

develop and implement a written hazard communication program for

the PMN substance in each workplace. The written program will,

at a minimum, describe how the requirements of this section for

labels, MSDSs, and other forms of warning material will be

satisfied. The Company must make the written hazard

communication program available, upon request, to all employees,

contractor employees, and their designated representatives. The

Company may rely on an existing hazard communication program,

inclUding an existing program established under the occupational

Health and Safety Administration (OSHA) Hazard Communication

Standard (29 CFR 1910.1200), to comply with this paragraph

provided that the existing hazard communication program satisfies

the requirements of this section. The written program shall

include the following:

(1) A list of chemical substances known to be present in

the work area which are SUbject to a TSCA section 5(e) consent

order signed by the Company or to a TSCA section 5(a) (2) SNUR at

40 C.F.R. Part 721, SUbpart E. The list must be maintained in

each work area where the PMN substance is known to be present and

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must use the identity provided on the MSDS for the substance

required under paragraph (c) of this section. The list may be

compiled for the workplace or for individual work areas. If the

Company is required either by another Order issued under section

5(e} of TSCA, or by a TSCA section 5(a} (2) SNUR at 40 CFR Part

721, sUbpart E, to maintain a list of substances, the lists shall

be combined with the list under this sUbparagraph.

(2) The methods the Company will use to inform employees of

the hazards of non-routine tasks involving the PMN substance

(e.g., cleaning of reactor vessels), and the hazards associated

with the PMN substance contained in unlabeled pipes in their work

area.

(3) The methods the Company will use to inform contractors

of the presence of the PMN substance in the Company's workplace

and of the provisions of this Order if employees of the

contractor work in the Company's workplace and are reasonably

likely to be exposed to the PMN substance while in the company's

workplace.

(b) Labeling. (1) The Company shall ~nsure that each container

of the substance in the workplace is labeled in accordance with

this sUbparagraph (b) (1).

(i) The label shall, at a minimum, contain the

following information:

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(A) A statement of the health hazards(s} and

precautionary measure(s}, if any, identified in paragraph (g) of

this section or by the Company, for the PMN substance.

(B) The identity by which the PMN substance may

be commonly recognized.

(C) A statement of the environmental hazard(s}

and precautionary measure(s}, if any, identified in paragraph (g)

of this section, or by the Company, for the PMN substance.

(D) A statement of exposure and precautionary

measure(s}, if any, identified in paragraph (g) of this section,

or by the Company, for the PMN substance.

(ii) The Company may use signs, placards, process

sheets, batch tickets, operating procedures, or other such

written materials in lieu of affixing labels to individual

stationary process containers, as long as the alternative method

identifies the containers to which it is applicable and conveys

information specified by subparagraph (b) (1) (i) of this section.

Any written materials must be readily accessible to the employees

in their work areas throughout each work shift.

(iii) The Company need not label portable containers

into which the PMN substance is transferred from labeled

containers, and which are intended only for the immediate use of

the employee who performs the transfer.

(iv) The Company shall not remove or deface an

existing label on containers of the PMN substance obtained from

persons outside the Company unless the container is immediately

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relabeled with the information specified in sUbparagraph

(b) (1) (i) of this section.

(2) The Company shall ensure that each container of the

substance leaving its workplace for distribution in commerce is

labeled in accordance with this sUbparagraph (b) (2).

(i) The label shall, at a minimum, contain the

following information:

(A) The information prescribed in subparagraph

(b) (1) (i) of this section.

(B) The name and address of the manufacturer or a

responsible party who can provide additional information on the

substance for hazard evaluation and any appropriate emergency

procedures.

(ii) The label shall not conflict with the

requirements of the Hazardous Materials Transportation Act (18

U.S.C. 1801 et. seq.) and regulations issued under that Act by

the Department of Transportation.

(3) The label, or alternative forms of warning, shall be

legible and prominently displayed.

(4) The label, or alternative forms of warning, shall be

printed in English; however, the information may be repeated in

other languages.

(5) If the label or alternative form of warning is to be

applied to a mixture containing the PMN substance in combination

with any other substance that is either sUbject to another TSCA

section 5(e) Order applicable to the Company, or sUbject to a

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TSCA section Sea) (2) SNUR at 40 CFR Part 721, sUbpart E, or

defined as a "hazardous chemical" under the occupational Safety

and Health Administration (OSHA) Hazard Communication Standard

(29 CFR 1900.1200), the Company may prescribe on the label, MSDS,

or alternative form of warning, the measures to control worker

exposure or environmental release which the Company determines

provide the greatest degree of protection. However, should these

control measures differ from the applicable measures required

under this Order, the Company must seek a determination of

equivalency for such alternative control measures pursuant to 40

CFR 721.30 before prescribing them under this sUbparagraph

(b)(S).

(c) Material Safety Data Sheets. (1) The Company must obtain

or develop an MSDS for the PMN substance.

(2) The MSDS shall contain, at a minimum, the following

information:

(i) The identity used on the container label of the

PMN substance under this section, and, if not claimed

confidential, the chemical and common name of the PMN substance.

If the chemical and common name are claimed confidential, a

generic chemical name must be used.

(ii) Physical and chemical characteristics of the

substance known to the Company, (e.g., vapor pressure, flash

point) .

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(iii) The physical hazards of the substance known to

the company, including the potential for fire, explosion, and

reactivity.

(iv) The potential human and environmental hazards as

specified in paragraph (g) of this section.

(v) signs and symptoms of exposure, and any medical

conditions which are expected to be aggravated by exposure to the

PMN substance known to the Company.

(vi) The primary routes of exposure to the PMN

substance.

(vii) Precautionary measures to control worker

exposure and/or environmental release required by this Order, or

alternative control measures which EPA has determined under 40

CFR 721.30 provide sUbstantially the same degree of protection as

the identified control measures.

(viii) Any generally applicable precautions for safe

handling and use of the PMN substance which are known to the

Company, including appropriate hygienic practices, protective

measures during repair and maintenance of contaminated equipment,

and procedures for response to spills and leaks.

(ix) Any generally applicable control measures which

are known to the Company, such as appropriate engineering

controls, work practices, or personal protective equipment.

(x) Emergency first aid procedures known to the

Company.

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(xi) The date of preparation of the MSDS or of its

last revision.

(xii) The name, address, and telephone number of the

Company or another responsible party who can provide additional

information on the chemical substance and any appropriate

emergency procedures.

(3) If no relevant information is found or known for any

given category on the MSDS, the Company must mark the MSDS to

indicate that no applicable information was found.

(4) Where mUltiple mixtures containing the PMN substance

have similar compositions (i.e., the chemical ingredients are

essentially the same, but the specific composition varies from

mixture to mixture) and similar hazards, the Company may prepare

one MSDS to apply to all of these mUltiple mixtures.

(5) If the Company becomes aware of any significant new

information regarding the hazards of the PMN substance or ways to

protect against the hazards, this new information must be added

to the MSDS within 3 months from the time the Company becomes

aware of the new information. If the PMN substance is not being

manufactured, imported, processed, or used in the Company's

workplace, the Company must add the new information to the MSDS

before the PMN substance is reintroduced into the workplace.

(6) The Company must ensure that persons receiving the PMN

substance from the Company are provided an appropriate MSDS with

their initial shipment and with the first shipment after an MSDS

is revised. The Company may either provide the MSDS with the

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shipped containers or send it to the person prior to or at the

time of shipment.

(7) The Company must maintain a copy of the MSDS in its

workplace, and must ensure that it is readily accessible during

each work shift to employees when they are in their work areas.

(8) The MSDS may be kept in any form, including as

operating procedures, and may be designed to cover groups of

substances in a work area where it may be more appropriate to

address the potential hazards of a process rather than individual

substances. However, in all cases, the required information must

be provided for the PMN substance and must be readily accessible

during each work shift to employees when they are in their work

areas.

(9) The MSDS must be printed in English; however, the

information may be repeated in other languages.

(d) Employee information and training. The Company must ensure

that employees are provided with information and training on the

PMN substance. This information and training must be provided at

the time of each employee's initial assignment to a work area

containing the PMN substance and whenever the PMN substance is

introduced into the employee's work area for the first time.

(1) The information provided to employees under this

paragraph shall include:

(i) The requirements of this section.

EPA SANITIZED Page 26 of 38
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(ii) Any operations in the work area where the PMN

substance is present.

(iii) The location and availability of the written

hazard communication program required under paragraph (a) of this

section, including the list of substances required by

sUbparagraph (a) (1) of this section and MSDSs required by

paragraph (c) of this section.

(2) The training provided to employees shall include:

(i) Methods and observations that may be used to

detect the presence or release of the PMN substance in or from an

employee's work area (such as monitoring conducted by the

Company, continuous monitoring devices, visual appearance, or

odor of the substance when being released).

(ii) The potential human health and environmental

hazards of the PMN substance as specified in paragraph (g) of

this section.

(iii) The measures employees can take to protect

themselves and the environment from the PMN substance, including

specific procedures the Company has implemented to protect

employees and the environment from exposure to the PMN substance,

including appropriate work practices, emergency procedures,

personal protective equipment, engineering controls, and other

measures to control worker exposure and/or environmental release

required under this Order, or alternative control measures which

EPA has determined under 40 CPR 721.30 provide the same degree of

protection as the specified control measures.

EPA SANITIZED Page 27 of 38
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(iv) The requirements of the hazard communication

program developed by the Company under this section, including an

explanation of the labeling system and the MSDS required by this

section and guidance on obtaining and using appropriate hazard

information.

(e) Low concentrations in mixtures. If the PMN substance

is present in the work area only as a mixture, the Company is

exempt from the provisions of this section if the concentration

of the PMN substance in the mixture does not exceed 1.0 percent

by weight or volume, or 0.1 percent by weight or volume if

paragraph (g) of this section identifies cancer as a potential

human health hazard of the PMN substance. However, this

exemption does not apply if the Company has reason to believe

that during intended use or processing in the work area, the PMN

substance in the mixture may be reconcentrated above the 1.0 or

0.1 percent level, whichever is applicable.

(f) Existing hazard communication program. The Company need not

take additional actions if existing programs and procedures

satisfy the requirements of this section.

(g) Human health, environmental hazard, exposure, and

precautionary statements. The following human health and

environmental hazard and precautionary statements shall appear on

EPA SANITIZED Page 28 of 38
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each label as specified in paragraph (b) and the MSDS as

specified in paragraph (c) of this section:

(1) Human health hazard statements. This substance may

cause:

(i) central nervous system effects.

(ii) developmental effects.

(2) Human hazard precautionary statements. When using this

substance:

(i) avoid skin contact.

(ii) avoid ingestion.

(iii) use skin protection.

(5) Each human and environmental hazard and precautionary

statement on the label prepared pursuant to paragraph (b) of this

section must be followed by the statement: "See the MSDS for

details."

MANUFACTURING

(a) (1) The Company shall not cause, encourage, or suggest the

manufacture or import of the PMN substance by any other person.

(2) SUbparagraph (a) (1) shall expire 75 days after

promulgation of a final significant new use rule ("SNUR")

governing the PMN substance under section 5(a) (2) of TSCA unless

the Company is notified on or before that day of an action in a

Federal Court seeking jUdicial review of the SNUR. If the

Company is so notified, sUbparagraph (a) (1) shall not expire

until EPA notifies the Company in writing that all Federal Court

EPA SANITIZED Page 29 of 38
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actions involving the SNUR have been resolved and the validity of

the SNUR affirmed.

(3) When EPA promulgates a final SNUR for the PMN substance

and sUbparagraph (a) (1) expires in accordance with sUbparagraph

(a) (2), the Company shall notify each person whom it causes,

encourages or suggests to manufacture or import the PMN substance

of the existence of the SNUR. Such notification must be in

writing and must specifically include all limitations contained

in the SNUR which are defined as significant new uses, and which

would invoke significant new use notification to EPA for the PMN

substance. Such notice must also reference the pUblication of

the SNUR for this PMN substance in either the Federal Register or

the Code of Federal Regulations.

USE

(a) The Company shall use the PMN substance only for industrial

applications.

DISTRIBUTION

(a) The Company shall distribute the PMN substance outside the

Company, including for disposal, only to a person who has agreed

in writing prior to the date of distribution, to:

(1) Not further distribute the PMN substance to any other

person, including for disposal, until after the PMN substance has

been completely reacted.

(2) Comply with the same requirements and restrictions, if

any, required of the Company in the Protection in the Workplace

section of this Order.

EPA SANITIZED Page 30 of 38
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(3) Comply with the same requirements and restrictions, if

any, required of the Company in the Hazard Communication Program

section of this Order.

(4) Use the PMN substance only for industrial applications.

(b) If, at any time after commencing distribution in commerce of

the PMN substance, the Company obtains knowledge that a recipient

of the substance has failed to comply with any of the conditions

specified in paragraph (a) of this Distribution section or, after

paragraph (a) expires in accordance with sUbparagraph (c) (I), has

engaged in a significant new use of the PMN substance (as defined

in 40 CFR Part 721, SUbpart E) without sUbmitting a significant

new use notice to EPA, the Company shall cease supplying the

substance to that recipient, unless the Company is able to

document each of the following:

(1) That the Company has, within 5 working days, notified

the recipient in writing that the recipient has failed to comply

with any of the conditions specified in paragraph (a) of this

Distribution section, or has engaged in a significant new use of

the PMN substance without sUbmitting a significant new use notice

to EPA.

(2) That, within 15 working days of notifying the recipient

of the noncompliance, the Company received from the recipient, in

writing, a statement of assurance that the recipient is aware of

the terms of paragraph (a) of this Distribution section and will

comply with those terms, or is aware of the terms of the

EPA SANITIZED Page 31 of 38
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significant new use rule for the PMN substance and will not

engage in a significant new use without sUbmitting a significant

new use notice to EPA.

(3) If, after receiving a statement of assurance from a

recipient under sUbparagraph (b) (2) of this Distribution section,

the Company obtains knowledge that the recipient has failed to

comply with any of the conditions specified in paragraph (a) of

this Distribution section, or has engaged in a significant new

use of the PMN substance without sUbmitting a significant new use

notice to EPA, the Company shall cease supplying the PMN

substance to that recipient, shall notify EPA of the failure to

comply, and shall resume supplying the PMN substance to that

recipient only upon written notification from the Agency.

(c) (1) Paragraph (a) of this Distribution section shall

expire 75 days after promulgation of a final SNUR for the PMN

substance under section 5(a) (2) of TSCA, unless the Company is

notified on or before that day of an action in a Federal Court

seeking jUdicial review of the SNUR. If the Company is so

notified, paragraph (a) of this Distribution section shall not

expire until EPA notifies the Company in writing that all Federal

Court actions involving the SNUR have been resolved and the

validity of the SNUR affirmed.

(2) When EPA promulgates a final SNUR for the PMN substance

and paragraph (a) of this Distribution section expires in

accordance with sUbparagraph (c) (1), the Company shall notify

EPA SANITIZED Page 32 of 38
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each person to whom it distributes the PMN substance of the

existence of the SNUR. Such notification must be in writing and

must specifically include all limitations contained in the SNUR

which are defined as significant new uses, and which would invoke

significant new use notification to EPA for the PMN substance.

Such notice must also reference the pUblication of the SNUR for

this PMN substance in either the Federal Register or the Code of

Federal Regulations.

II. RECORDKEEPING

(a) The Company shall maintain the following records until 5

years after the date they are created and shall make them

available for inspection and copying by EPA in accordance with

section 11 of TSCA:

A. RECORDS

(1) Records documenting the aggregate manufacture and

importation volume of the PMN substance and the corresponding

dates of manufacture and import;

(2) Records documenting the names and addresses (including

shipment destination address, if different) of all persons

outside the site of manufacture or import to whom the Company

directly sells or transfers the PMN substance, the date of each

sale or transfer, and the quantity of the substance sold or

transferred on such date;

EPA SANITIZED Page 33 of 38
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(3) Records documenting establishment and implementation of

a program for the use of any applicable personal protective

equipment required pursuant to the Protection in the Workplace

section of this Order;

(4) Records documenting the determinations required by the

Protection in the Workplace section of this Order that chemical

protective clothing is impervious to the PMN substance;

(5) Records documenting establishment and implementation of

the hazard communication program required by the Hazard

Communication program section of this Order;

(6) copies of labels required under the Hazard

Communication Program section of this Order;

(7) Copies of material safety data sheets required by the

Hazard Communication Program section of this Order;

(8) Records documenting compliance with any applicable

manufacturing, use, and distribution restrictions in the

Manufacturing, Use, and Distribution sections of this Order,

including distributees' written agreement to comply with the

Distribution section of this Order;

(9) The Company shall keep a copy of this Order at each of

its sites where the PMN substance is manufactured, imported,

processed or used.

EPA SANITIZED Page 34 of 38
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III. MODIFICATION AND REVOCATION OF CONSENT ORDER

The Company may petition EPA at any time, based upon new

information on the health effects of, or human exposure to, the

PMN sUbstance, to modify or revoke substantive provisions of this

Order. The exposures and risks identified by EPA during its

review of the PMN substance and the information EPA determined to

be necessary to evaluate those exposures and risks are described

in the preamble to this Order. However, in determining whether

to amend or revoke this Order, EPA will consider all relevant

information available at the time the Agency makes that

determination, including, where appropriate, any reassessment of

the test data or other information that supports the findings in

this order, an examination of new test data or other information

or analysis, and any other relevant information.

EPA will issue a modification or revocation if EPA

determines that the activities proposed therein will not present

an unreasonable risk of injury to health or the environment and

will not result in significant or substantial human exposure or

substantial environmental release in the absence of data

sufficient to permit a reasoned evaluation of the health or

environmental effects of the PMN substance.

In addition, the Company may petition EPA at any time to

make other modifications to the language of this Order. EPA will

issue such a modification if EPA determines that the

modification is useful, appropriate, and consistent with the

structure and intent of this Order as issued.

EPA SANITIZED Page 35 of 38
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IV. EFFECT OF CONSENT ORDER

By consenting to the entry of this Order, the Company waives

its rights to file objections to this Order pursuant to section

5(e) (1) (C) of TSCA, to receive service of this Order no later

than 45 days before the end of the review period pursuant to

section 5(e) (1) (B) of TSCA, and to challenge the validity of this

Order, or modifications made thereto, in any sUbsequent action.

consenting to the entry of this Order, and agreeing to be bound

by its terms, does not constitute an admission by the Company as

to the facts or conclusions underlying the Agency's

determinations in this proceeding. This waiver does not affect

any other rights that the company may have under TSCA.

Lynn R. Goldman, M.D.

Assistant Administr or

for Prevention, Pesticides and

Toxic Substances

Date

Date Ibtf 1?) /C(!J/Y

TitIe: Vice President

Global Agricultural Products R&D

Company: DowElanco Company

EPA SANITIZED Page 36 of 38
ATTACHMENT A

DEFINITIONS

"Chemical name" means the scientific designation of a

chemical substance in accordance with the nomenclature system

developed by the International Union of Pure and Applied

Chemistry or the chemical Abstracts Service's rules of

nomenclature, or a name which will clearly identify a chemical

substance for the purpose of conducting a hazard evaluation.

"Chemical protective clothing" means items of clothing that

provide a protective barrier to prevent dermal contact with

chemical substances of concern. Examples can include, but are

not limited to: full body protective clothing, boots, coveralls,

gloves, jackets, and pants.

"Company" means the person or persons sUbject to this Order.

"Common name" means any designation or identification such

as code name, code number, trade name, brand name, or generic

chemical name used to identify a chemical substance other than by

its chemical name.

"container" means any bag, barrel, bottle, box, can,

cylinder, drum, reaction vessel, storage tank, or the like that

contains a hazardous chemical. For purposes of this section,

pipes or piping systems, and engines, fuel tanks, or other

operating systems in a vehicle, are not considered to be

containers.

"Identity" means any chemical or common name used to

identify a chemical substance or a mixture containing that

substance.

"Immediate use." A chemical substance is for the "immediate

use" of a person if it is under the control of, and used only by,

the person who transferred it from a labeled container and will

only be used by that person within the work shift in which it is

transferred from the labelled container.

"Impervious." Chemical protective clothing is "impervious"

to a chemical substance if the substance causes no chemical or

mechanical degradation, permeation, or penetration of the

chemical protective clothing under the conditions of, and the

duration of, exposure.

"MSDS" means material safety data sheet, the written listing

of data for the chemical substance.

EPA SANITIZED Page 37 of 38
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"Non-industrial use" means use other than at a facility

where chemical substances or mixtures are manufactured, imported,

or processed.

"PMN substance" means the chemical substance described in

the Premanufacture notice submitted by the Company relevant to

this Order.

"Personal protective equipment" means any chemical

protective clothing or device placed on the body to prevent

contact with, and exposure to, an identified chemical substance

or substances in the work area. Examples include, but are not

limited to, chemical protective clothing, aprons, hoods, chemical

goggles, face splash shields, or equivalent eye protection, and

various types of respirators. Barrier creams are not included in

this definition.

"scientifically invalid" means any significant departure

from the EPA-approved protocol or the Good Laboratory Practice

standards at 40 CFR Part 792 without prior or sUbsequent Agency

approval that prevents a reasoned evaluation of the health or

environmental effects of the PMN substance.

"scientifically equivocal data" means data which, although

developed in apparent conformity with the Good Laboratory

Practice Standards and EPA-approved protocols, are inconclusive,

internally inconsi~tent, 9r otherwise insufficient to permit a

reasoned evaluation of the potential risk of injury to human

health or the environment of the PMN substance.

"Work area" means a room or defined space in a workplace

where the PMN substance is manufactured, processed, or used and

where employees are present.

"Workplace" means an establishment at one geographic

location containing one or more work areas.

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