U.S. EPA, Polymer Exemption Guidance Manual (1997) (ELR Order No. 4064)

• Author: Carolyne R. Hathaway/William K. Rawson/Ann Claassen/Julia A. Hatcher
• Pages: 465-518

Polymer Exemption Guidance Manual Page 465

United States Office of Pollution EPA 744-B-97-001

Environmental Protection Prevention and Toxics June 1997

Agency (7406)

Polymer Exemption

Guidance Manual

Page 466 TSCA Deskbook

POLYMER EXEMPTION GUIDANCE MANUAL

5/22/97

A technical manual to accompany, but not supersede the

"Premanufacture Notification Exemptions; Revisions of Exemptions

for Polymers; Final Rule" found at 40 CFR Part 723, (60) FR

16316-16336, published Wednesday, March 29, 1995

Environmental Protection Agency

Office of Pollution Prevention and Toxics

401 M St., SW.,

Washington, DC 20460-0001

Copies of this document are available through the TSCA

Assistance Information Service at (202) 554-1404 or by faxing

requests to (202) 554-5603.

Polymer Exemption Guidance Manual Page 467

TABLE OF CONTENTS

LISTOFEQUATIONS............................ ii

LISTOFFIGURES............................. ii

LISTOFTABLES ............................. ii

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2. HISTORY............................... 2

3. DEFINITIONS............................. 3

4. ELIGIBILITY REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . 4

4.1. MEETING THE DEFINITION OF A POLYMER AT 40 CFR §723.250(b) . . . 5

4.2. SUBSTANCES EXCLUDED FROM THE EXEMPTION AT 40 CFR §723.250(d) . 7

4.2.1. EXCLUSIONS FOR CATIONIC AND POTENTIALLY CATIONIC

POLYMERS . . . . . . . . . . . . . . . . . . . . . . . 8

4.2.1.1. CATIONIC POLYMERS NOT EXCLUDED FROM EXEMPTION 8

4.2.2. EXCLUSIONS FOR ELEMENTAL CRITERIA . . . . . . . . . . . 9

4.2.3. EXCLUSIONS FOR DEGRADABLE OR UNSTABLE POLYMERS . . . . 9

4.2.4. EXCLUSIONS BY REACTANTS . . . . . . . . . . . . . . . . 9

4.2.5. EXCLUSIONS FOR WATER-ABSORBING POLYMERS . . . . . . . . 10

4.3. CATEGORIES WHICH ARE NO LONGER EXCLUDED FROM EXEMPTION . . . . 10

4.4. MEETING EXEMPTION CRITERIA AT 40 CFR §723.250(e) . . . . . . . 10

4.4.1. THE (e)(1) EXEMPTION CRITERIA . . . . . . . . . . . . . 10

4.4.1.1. LOW-CONCERN FUNCTIONAL GROUPS AND THE (e)(1)

EXEMPTION . . . . . . . . . . . . . . . . . . 11

4.4.1.2. MODERATE-CONCERN FUNCTIONAL GROUPS AND THE (e)(1)

EXEMPTION . . . . . . . . . . . . . . . . . . 11

4.4.1.3. HIGH-CONCERN FUNCTIONAL GROUPS AND THE

(e)(1) EXEMPTION . . . . . . . . . . . . . . 11

4.4.2. THE (e)(2) EXEMPTION CRITERIA . . . . . . . . . . . . . 12

4.4.3. THE (e)(3) EXEMPTION CRITERIA . . . . . . . . . . . . . 12

5. NUMERICAL CONSIDERATIONS . . . . . . . . . . . . . . . . . . . . . . 15

5.1. CALCULATING NUMBER-AVERAGE MOLECULAR WEIGHT . . . . . . . . . . 15

5.1.1. GEL PERMEATION CHROMATOGRAPHY . . . . . . . . . . . . . 17

5.1.2. MEMBRANE OSMOMETRY . . . . . . . . . . . . . . . . . . 17

5.1.3. VAPOR-PHASE OSMOMETRY . . . . . . . . . . . . . . . . . 17

5.1.4. VAPOR PRESSURE LOWERING . . . . . . . . . . . . . . . . 18

5.1.5. EBULLIOMETRY . . . . . . . . . . . . . . . . . . . . . 18

5.1.6. CRYOSCOPY . . . . . . . . . . . . . . . . . . . . . . . 18

5.1.7. END-GROUP ANALYSIS . . . . . . . . . . . . . . . . . . 18

5.2. THE TWO PERCENT RULE AND CHEMICAL IDENTITY . . . . . . . . . . 18

5.2.1. PERCENT CHARGED METHOD . . . . . . . . . . . . . . . . 20

5.2.2. PERCENT INCORPORATED METHOD . . . . . . . . . . . . . . 21

5.2.3. METHODS FOR DETECTION OF POLYMER COMPOSITION . . . . . 24

5.2.3.1. MASS SPECTROMETRY . . . . . . . . . . . . . . 25

5.2.3.2. GAS CHROMATOGRAPHY . . . . . . . . . . . . . 25

5.2.3.3. INFRARED SPECTROSCOPY . . . . . . . . . . . . 25

5.2.3.4. NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY . . . 25

5.2.3.5. X-RAY DIFFRACTION ANALYSIS . . . . . . . . . 25

5.3. CALCULATING FUNCTIONAL GROUP EQUIVALENT WEIGHT . . . . . . . . 25

5.3.1. END-GROUP ANALYSIS . . . . . . . . . . . . . . . . . . 27

5.3.2. MORE COMPLEX FGEW CALCULATIONS . . . . . . . . . . . . 29

5.3.3. DETERMINING FGEW BY NOMOGRAPH . . . . . . . . . . . . . 34

6. OTHER REGULATIONS AND REQUIREMENTS . . . . . . . . . . . . . . . . . 34

7. COMMON QUESTIONS AND ANSWERS . . . . . . . . . . . . . . . . . . . . 36

8. REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

9. FEDERAL REGISTER REFERENCES . . . . . . . . . . . . . . . . . . . . . 49

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