Proposed Rule2024-17204
1-Bromopropane (1-BP); Regulation Under the Toxic Substances Control Act (TSCA)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 8, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is proposing to address the unreasonable risk of injury to human health presented by 1-bromopropane (1-BP) (CASRN 106-94-5), also known as n- propyl bromide, under its conditions of use as documented in EPA's August 2020 Risk Evaluation for 1-BP and the December 2022 Revised Risk Determination for 1-BP prepared under the Toxic Substances Control Act (TSCA). 1-BP is a widely used solvent in a variety of occupational and consumer applications, including vapor degreasing, aerosol degreasing, adhesives and sealants, and in insulation. EPA determined that 1-BP presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to 1-BP, including neurotoxicity, developmental toxicity from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. To address the identified unreasonable risk, EPA is proposing requirements to, among other things, prevent consumer access to the chemical, restrict the industrial and commercial use of the chemical while also allowing for a reasonable transition period where an industrial and commercial use of the chemical is being prohibited, and protect workers from the unreasonable risk of 1-BP while on the job.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 153 (Thursday, August 8, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Proposed Rules]
[Pages 65066-65122]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17204]
[[Page 65065]]
Vol. 89
Thursday,
No. 153
August 8, 2024
Part III
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Part 751
1-Bromopropane (1-BP); Regulation Under the Toxic Substances Control
Act (TSCA); Proposed Rule
Federal Register / Vol. 89 , No. 153 / Thursday, August 8, 2024 /
Proposed Rules
[[Page 65066]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 751
[EPA-HQ-OPPT-2020-0471; FRL-8156-01-OCSPP]
RIN 2070-AK73
1-Bromopropane (1-BP); Regulation Under the Toxic Substances
Control Act (TSCA)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) is
proposing to address the unreasonable risk of injury to human health
presented by 1-bromopropane (1-BP) (CASRN 106-94-5), also known as n-
propyl bromide, under its conditions of use as documented in EPA's
August 2020 Risk Evaluation for 1-BP and the December 2022 Revised Risk
Determination for 1-BP prepared under the Toxic Substances Control Act
(TSCA). 1-BP is a widely used solvent in a variety of occupational and
consumer applications, including vapor degreasing, aerosol degreasing,
adhesives and sealants, and in insulation. EPA determined that 1-BP
presents an unreasonable risk of injury to health due to the
significant adverse health effects associated with exposure to 1-BP,
including neurotoxicity, developmental toxicity from acute and chronic
inhalation exposures and dermal exposures, and cancer from chronic
inhalation exposures. TSCA requires that EPA address by rule any
unreasonable risk of injury to health or the environment identified in
a TSCA risk evaluation and apply requirements to the extent necessary
so the chemical no longer presents unreasonable risk. To address the
identified unreasonable risk, EPA is proposing requirements to, among
other things, prevent consumer access to the chemical, restrict the
industrial and commercial use of the chemical while also allowing for a
reasonable transition period where an industrial and commercial use of
the chemical is being prohibited, and protect workers from the
unreasonable risk of 1-BP while on the job.
DATES: Comments must be received on or before September 23, 2024. Under
the Paperwork Reduction Act, comments on the information collection
provisions are best assured of consideration if the Office of
Management and Budget (OMB) receives a copy of your comments on or
before September 9, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0471, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Bethany Masten, Existing Chemicals Risk
Management Division, Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number (202) 564-8803; email address:
<a href="/cdn-cgi/l/email-protection#407102101f14130301002530216e272f36"><span class="__cf_email__" data-cfemail="6d5c2f3d32393e2e2c2d081d0c430a021b">[email protected]</span></a>.
For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404;
email address: <a href="/cdn-cgi/l/email-protection#da8e89999bf792b5aeb6b3b4bf9abfaabbf4bdb5ac"><span class="__cf_email__" data-cfemail="87d3d4c4c6aacfe8f3ebeee9e2c7e2f7e6a9e0e8f1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
1. General Applicability
You may be potentially affected by the proposed action if you
manufacture (defined under TSCA to include import), process, distribute
in commerce, use, or dispose of 1-BP or products containing 1-BP. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities include:
<bullet> Crude Petroleum Extraction (NAICS code 211120).
<bullet> All Other Specialty Trade Contractors (NAICS code 238990).
<bullet> Broadwoven Fabric Mills (NAICS code 313210).
<bullet> Nonwoven Fabric Mills (NAICS code 313230).
<bullet> Textile and Fabric Finishing Mills (NAICS code 313310).
<bullet> Fabric Coating Mills (NAICS code 313320).
<bullet> Prefabricated Wood Building Manufacturing (NAICS code
321992).
<bullet> Paper Bag and Coated and Treated Paper Manufacturing
(NAICS code 322220).
<bullet> Commercial Screen Printing (NAICS code 323113).
<bullet> Petroleum Refineries (NAICS code 324110).
<bullet> All Other Petroleum and Coal Products Manufacturing (NAICS
code 324199).
<bullet> Other Basic Inorganic Chemical Manufacturing (NAICS code
325180).
<bullet> All Other Basic Organic Chemical Manufacturing (NAICS code
325199).
<bullet> Paint and Coating Manufacturing (NAICS code 325510).
<bullet> Adhesive Manufacturing (NAICS code 325520).
<bullet> Soap and Other Detergent Manufacturing (NAICS code
325611).
<bullet> Polish and Other Sanitation Good Manufacturing (NAICS code
325612).
<bullet> Photographic Film, Paper, Plate, and Chemical
Manufacturing (NAICS code 325992).
<bullet> All Other Miscellaneous Chemical Product and Preparation
Manufacturing (NAICS code 325998).
<bullet> Polystyrene Foam Product Manufacturing (NAICS code
326140).
<bullet> Urethane and Other Foam Product (except Polystyrene)
Product Manufacturing (NAICS code 326150).
<bullet> Tire Manufacturing (except Retreading) (NAICS code
326211).
<bullet> Tire Retreading (NAICS code 326221).
<bullet> Rubber and Plastics Hoses and Belting Manufacturing (NAICS
code 326220).
<bullet> All Other Rubber Product Manufacturing (NAICS code
326299).
<bullet> Other Concrete Product Manufacturing (NAICS code 327390).
<bullet> Gypsum Product Manufacturing (NAICS code 327420).
<bullet> Cement Manufacturing (NAICS code 327310).
<bullet> Iron and Steel Mills and Ferroalloy Manufacturing (NAICS
code 331110).
<bullet> Iron and Steel Pipe and Tube Manufacturing from Purchased
Steel (NAICS code 331210).
<bullet> Rolled Steel Shape Manufacturing (NAICS code 332221).
<bullet> Steel Wire Drawing (NAICS code 331222).
<bullet> Nonferrous Metal (except Aluminum) Smelting and Refining
(NAICS code 331410).
<bullet> Copper Rolling, Drawing, Extruding, and Alloying (NAICS
code 331420).
<bullet> Nonferrous Metal (except Copper and Aluminum) Rolling,
Drawing, and Extruding (NAICS code 331491).
<bullet> Secondary Smelting, Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum) (NAICS code 331492).
<bullet> Nonferrous Metal Die-Casting Foundries (NAICS code
331523).
<bullet> Iron and Steel Forging (NAICS code 332111).
[[Page 65067]]
<bullet> Nonferrous Forging (NAICS code 332112).
<bullet> Custom Roll Forming (NAICS code 332114).
<bullet> Powder Metallurgy Part Manufacturing (NAICS code 332117).
<bullet> Metal Crown, Closure, and Other Metal Stamping (except
Automotive) (NAICS code 332119).
<bullet> Metal Kitchen Cookware, Utensil, Cutlery, and Flatware
(except Precious) Manufacturing (NAICS code 332215).
<bullet> Saw Blade and Handtool Manufacturing (NAICS code 332216).
<bullet> Other Fabricated Wire Product Manufacturing (NAICS code
332618).
<bullet> Metal Window and Door Manufacturing (NAICS code 332321).
<bullet> Machine Shops (NAICS code 332710).
<bullet> Precision Turned Product Manufacturing (NAICS code
332721).
<bullet> Bolt, Nut, Screw, Rivet, and Washer Manufacturing (NAICS
code 332722).
<bullet> Industrial Valve Manufacturing (NAICS code 332911).
<bullet> Metal Heat Treating (NAICS code 332811).
<bullet> Metal Coating, Engraving (except Jewelry and Silverware),
and Allied Services to Manufacturers (NAICS code 332812).
<bullet> Electroplating, Plating, Polishing, Anodizing, and
Coloring (NAICS code 332813).
<bullet> Industrial Valve Manufacturing (NAICS code 332911).
<bullet> Fluid Power Valve and Hose Fitting Manufacturing (NAICS
code 332912).
<bullet> Plumbing Fixture Fitting and Trim Manufacturing (NAICS
code 332913).
<bullet> Other Metal Valve and Pipe Fitting Manufacturing (NAICS
code 332919).
<bullet> Ball and Roller Bearing Manufacturing (NAICS code 332991).
<bullet> Small Arms Ammunition Manufacturing (NAICS code 332992).
<bullet> Ammunition (except Small Arms) Manufacturing (NAICS code
332993).
<bullet> Small Arms, Ordnance, and Ordnance Accessories
Manufacturing (NAICS code 332994).
<bullet> Fabricated Pipe and Pipe Fitting Manufacturing (NAICS code
332996).
<bullet> All Other Miscellaneous Fabricated Metal Product
Manufacturing (NAICS code 332999).
<bullet> Other Industrial Machinery Manufacturing (NAICS code
333249).
<bullet> Air-Conditioning and Warm Air Heating Equipment and
Commercial and Industrial Refrigeration Equipment Manufacturing (NAICS
code 333415).
<bullet> Special Die and Tool, Die Set, Jig, and Fixture
Manufacturing (NAICS code 333514).
<bullet> Cutting Tool and Machine Tool Accessory Manufacturing
(NAICS code 333515).
<bullet> Speed Changer, Industrial High-Speed Drive, and Gear
Manufacturing (NAICS code 333612).
<bullet> Air and Gas Compressor Manufacturing (NAICS code 333912).
<bullet> Measuring, Dispensing, and Other Pumping Equipment
Manufacturing (NAICS code 333914).
<bullet> Elevator and Moving Stairway Manufacturing (NAICS code
333921).
<bullet> Conveyor and Conveying Equipment Manufacturing (NAICS code
333922).
<bullet> Overhead Traveling Crane, Hoist, and Monorail System
Manufacturing (NAICS code 333923).
<bullet> Industrial Process Furnace and Oven Manufacturing (NAICS
code 333924).
<bullet> Power-Driven Handtool Manufacturing (NAICS code 333991).
<bullet> Welding and Soldering Equipment Manufacturing (NAICS code
333992).
<bullet> Packaging Machinery Manufacturing (NAICS code 333993).
<bullet> Industrial Process Furnace and Oven Manufacturing (NAICS
code 333994).
<bullet> Fluid Power Cylinder and Actuator Manufacturing (NAICS
code 333995).
<bullet> Fluid Power Pump and Motor Manufacturing (NAICS code
333996).
<bullet> All Other Miscellaneous General Purpose Machinery
Manufacturing (NAICS code 333998).
<bullet> Audio and Video Equipment Manufacturing (NAICS code
334310).
<bullet> Capacitor, Resistor, Coil, Transformer, and Other Inductor
Manufacturing (NAICS code 334416).
<bullet> Electronic Connector Manufacturing (NAICS code 334417).
<bullet> Printed Circuit Assembly (Electronic Assembly)
Manufacturing (NAICS code 334418).
<bullet> Other Electronic Component Manufacturing (NAICS code
334419).
<bullet> Search, Detection, Navigation, Guidance, Aeronautical, and
Nautical System and Instrument Manufacturing (NAICS code 334511).
<bullet> Automatic Environmental Control Manufacturing for
Residential, Commercial, and Appliance Use (NAICS code 334512).
<bullet> Instruments and Related Products Manufacturing for
Measuring, Displaying, and Controlling Industrial Process Variables
(NAICS code 334513).
<bullet> Instrument Manufacturing for Measuring and Testing
Electricity and Electrical Signals (NAICS code 334515).
<bullet> Residential Electric Lighting Fixture Manufacturing (NAICS
code 335131).
<bullet> Commercial, Industrial, and Institutional Electric
Lighting Fixture Manufacturing (NAICS code 335132).
<bullet> Electric Lamp Bulb and Other Lighting Equipment
Manufacturing (NAICS code 335139).
<bullet> Power, Distribution, and Specialty Transformer
Manufacturing (NAICS code 335311).
<bullet> Motor and Generator Manufacturing (NAICS code 335312).
<bullet> Switchgear and Switchboard Apparatus Manufacturing (NAICS
code 335313).
<bullet> Relay and Industrial Control Manufacturing (NAICS code
335314).
<bullet> Fiber Optic Cable Manufacturing (NAICS code 335921).
<bullet> Current-Carrying Wiring Device Manufacturing (NAICS code
335931).
<bullet> Carbon and Graphite Product Manufacturing (NAICS code
335991).
<bullet> Automobile and Light Duty Motor Vehicle Manufacturing
(NAICS code 336110).
<bullet> Heavy Duty Truck Manufacturing (NAICS code 336120).
<bullet> Motor Vehicle Body Manufacturing (NAICS code 336211).
<bullet> Truck Trailer Manufacturing (NAICS code 336212).
<bullet> Motor Home Manufacturing (NAICS code 336213).
<bullet> Travel Trailer and Camper Manufacturing (NAICS code
336214).
<bullet> Motor Vehicle Gasoline Engine and Engine Parts
Manufacturing (NAICS code 336310).
<bullet> Motor Vehicle Electrical and Electronic Equipment
Manufacturing (NAICS code 336320).
<bullet> Motor Vehicle Steering and Suspension Components (except
Spring) Manufacturing (NAICS code 336330).
<bullet> Motor Vehicle Brake System Manufacturing (NAICS code
336340).
<bullet> Motor Vehicle Transmission and Power Train Parts
Manufacturing (NAICS code 336350).
<bullet> Motor Vehicle Seating and Interior Trim Manufacturing
(NAICS code 336360).
<bullet> Motor Vehicle Metal Manufacturing (NAICS code 336370).
<bullet> Other Motor Vehicle Parts Manufacturing (NAICS code
336390).
<bullet> Aircraft Manufacturing (NAICS code 336411).
<bullet> Aircraft Engine and Engine Parts Manufacturing (NAICS code
336412).
<bullet> Other Aircraft Parts and Auxiliary Equipment Manufacturing
(NAICS code 336413).
<bullet> Guided Missile and Space Vehicle Manufacturing (NAICS code
336414).
<bullet> Guided Missile and Space Vehicle Propulsion Unit and
Propulsion Unit Parts Manufacturing (NAICS code 336415).
<bullet> Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing (NAICS code 336419).
<bullet> Railroad Rolling Stock Manufacturing (NAICS code 336510).
<bullet> Ship Building and Repairing (NAICS code 336611).
[[Page 65068]]
<bullet> Wood Kitchen Cabinet and Countertop Manufacturing (NAICS
code 337110).
<bullet> Upholstered Household Furniture Manufacturing (NAICS code
337121).
<bullet> Nonupholstered Wood Household Furniture Manufacturing
(NAICS code 337122).
<bullet> Institutional Furniture Manufacturing (NAICS code 337127).
<bullet> Wood Office Furniture Manufacturing (NAICS code 337211).
<bullet> Surgical Appliance and Supplies Manufacturing (NAICS code
339113).
<bullet> Dental Equipment and Supplies Manufacturing (NAICS code
339114).
<bullet> Jewelry and Silverware Manufacturing (NAICS code 339910).
<bullet> Sporting and Athletic Goods Manufacturing (NAICS code
339920).
<bullet> Gasket, Packing, and Sealing Device Manufacturing (NAICS
code 339991).
<bullet> Fastener, Button, Needle, and Pin Manufacturing (NAICS
code 339993).
<bullet> All Other Miscellaneous Manufacturing (NAICS code 339999).
<bullet> Metal Service Centers and Other Metal Merchant Wholesalers
(NAICS code 423510).
<bullet> Industrial Machinery and Equipment Merchant Wholesalers
(NAICS code 423830).
<bullet> Drugs and Druggists' Sundries Merchant Wholesalers (NAICS
code 424210).
<bullet> Other Chemical and Allied Products Merchant Wholesalers
(NAICS code 424690).
<bullet> New Car Dealers (NAICS code 441110).
<bullet> Used Car Dealers (NAICS code 441120).
<bullet> Home Centers (NAICS code 444110).
<bullet> Paint and Wallpaper Stores (NAICS code 444120).
<bullet> Electronics and Appliance Retailers (NAICS code 449210).
<bullet> Sporting Goods Stores (NAICS code 459110).
<bullet> Scheduled Passenger Air Transportation (NAICS code
481111).
<bullet> Other Support Activities for Air Transportation (NAICS
code 488190).
<bullet> Other Warehousing and Storage (NAICS code 493190).
<bullet> Miscellaneous Intermediation (NAICS code 523910).
<bullet> Portfolio Management and Investment Advice (NAICS code
523940).
<bullet> Research and Development in the Physical, Engineering, and
Life Sciences (except Nanotechnology and Biotechnology) (NAICS code
541715).
<bullet> Research and Development in the Social Sciences and
Humanities (NAICS code 541720).
<bullet> Janitorial Services (NAICS code 561720).
<bullet> Carpet and Upholstery Cleaning Services (NAICS code
561740).
<bullet> Hazardous Waste Treatment and Disposal (NAICS code
562211).
<bullet> Junior Colleges (NAICS code 611210).
<bullet> Colleges, Universities, and Professional Schools (NAICS
code 611230).
<bullet> General Automotive Repair (NAICS code 811111).
<bullet> Specialized Automotive Repair (NAICS code 811114).
<bullet> Automotive Body, Paint, and Interior Repair and
Maintenance (NAICS code 811121).
<bullet> Automotive Glass Replacement Shops (NAICS code 811122).
<bullet> Automotive Oil Change and Lubrication Shops (NAICS code
811191).
<bullet> All Other Automotive Repair and Maintenance (NAICS code
811198).
<bullet> Other Electronic and Precision Equipment Repair and
Maintenance (NAICS code 811210).
<bullet> Commercial and Industrial Machinery and Equipment (except
Automotive and Electronic) Repair and Maintenance (NAICS code 811310).
<bullet> Home and Garden Equipment Repair and Maintenance (NAICS
code 811411).
<bullet> Other Personal and Household Goods Repair and Maintenance
(NAICS code 811490).
<bullet> Coin-Operated Laundries and Drycleaners (NAICS code
812310).
<bullet> Drycleaning and Laundry Services (except Coin-Operated)
(NAICS code 812320).
2. Applicability to Importers and Exporters
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance in bulk form, as part of a mixture,
or as part of an article (if required by rule) are subject to TSCA
section 13 (15 U.S.C. 2612) import certification requirements and the
corresponding regulations at 19 CFR 12.118 through 12.127; see also 19
CFR 127.28. Those persons must certify that the shipment of the
chemical substance complies with all applicable rules and orders under
TSCA. The EPA policy in support of import certification appears at 40
CFR part 707, subpart B. In addition, any persons who export or intend
to export a chemical substance that is the subject of this proposed
rule are subject to the export notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the technical
information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Under TSCA section 6(a) (15 U.S.C. 2605(a)), if EPA determines
through a TSCA section 6(b) risk evaluation that a chemical substance
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more requirements listed in TSCA section
6(a) to the extent necessary so that the chemical substance or mixture
no longer presents such risk.
C. What action is the Agency taking?
Pursuant to TSCA section 6(b), EPA determined that 1-BP presents an
unreasonable risk of injury to health, without consideration of costs
or other nonrisk factors, including an unreasonable risk to potentially
exposed or susceptible subpopulations (PESS) and susceptible life
stages identified as relevant to the 2020 Risk Evaluation for 1-BP by
EPA, under the conditions of use (Refs. 1, 2). The term ``conditions of
use'' is defined at TSCA section 3(4) (15 U.S.C. 2602(4)) to mean the
circumstances under which a chemical substance is intended, known, or
reasonably foreseen to be manufactured, processed, distributed in
commerce, used, or disposed of. A detailed description of the
conditions of use that EPA identified, evaluated and determined to
contribute to EPA's determination that 1-BP presents an unreasonable
risk is included in Unit III.B.1. EPA notes that all conditions of use
of 1-BP (excluding the commercial and consumer use of 1-BP in
insulation) are subject to this proposal. Accordingly, to address the
unreasonable risk, EPA is proposing, under TSCA section 6(a), to:
(i) Prohibit the manufacture (including import), processing, and
distribution in commerce of 1-BP for all consumer uses (excluding
insulation for building and construction materials), outlined in Unit
IV.A.1.;
(ii) Prohibit the manufacture (including import), processing and
distribution in commerce of 1-BP for four industrial and commercial
uses, outlined in Unit IV.A.1.;
(iii) Require strict workplace controls, including a 1-BP Workplace
Chemical Protection Program (WCPP), which would include requirements to
meet an inhalation exposure concentration limit,
[[Page 65069]]
for seven occupational conditions of use of 1-BP, outlined in Unit
IV.A.2.;
(iv) Require the use of prescriptive controls for six occupational
conditions of use of 1-BP, outlined in Unit IV.A.3.;
(v) Require purchasers to provide sellers with a self-
certification, which would document the purchaser's commitment to
comply with the 1-BP WCPP, for six occupational conditions of use of 1-
BP, outlined in Unit IV.A.2.; and
(vi) Establish recordkeeping and downstream notification
requirements outlined in Unit IV.A.4.
In addition, in each of the proposed rules under TSCA section 6(a),
EPA is proposing to amend the general provisions of 40 CFR 751, subpart
A, to define ``ECEL,'' and ``exposure group,'' so that these
definitions may be commonly applied to this and other rules under TSCA
section 6 that would be codified in 40 CFR part 751. EPA seeks public
comment on all aspects of this proposed rule.
D. Why is the Agency taking this action?
Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance or mixture no longer presents such
risk.'' 1-BP was the subject of a risk evaluation under TSCA section
6(b)(4)(A) that was issued in August 2020 (Ref. 1). In addition, EPA
issued a revised unreasonable risk determination in December 2022 (Ref.
2), determining that 1-BP, as a whole chemical substance, presents an
unreasonable risk of injury to health under the conditions of use. As a
result, EPA is proposing to take action to the extent necessary so that
1-BP no longer presents such risk. The unreasonable risk is described
in Unit III.B.2. and the conditions of use that contribute to the
unreasonable risk for 1-BP are described in Unit III.B.1.
1-BP's hazards are well established. EPA's 2020 Risk Evaluation for
1-BP considered the hazards associated with exposure to 1-BP and
determined that 1-BP presents an unreasonable risk of injury to health
due to the significant adverse health effects associated with exposure
to 1-BP. While some of the risks of adverse effects from 1-BP exposure
may be acute and experienced for only a short duration, other health
risks may be chronic and result in long-term impacts that are
irreversible (e.g., developmental toxicity, cancer). The most sensitive
adverse health effect of 1-BP exposure is developmental toxicity. Other
significant adverse health effects include reproductive toxicity, liver
toxicity, kidney toxicity, neurotoxicity, other developmental toxicity,
and cancer. For this proposed rulemaking, EPA has determined that
protecting at the cancer endpoint would also address the risk for other
acute or chronic non-cancer endpoints. This proposed rule, once final,
would eliminate the unreasonable risk to human health from the TSCA
conditions of use of 1-BP, as identified in the 2020 Risk Evaluation
for 1-BP and the revised unreasonable risk determination for 1-BP in
December 2022. This proposed rule, once final, is part of EPA's efforts
to advance the Biden Cancer Moonshot policy, reducing exposure to
carcinogens in the environment as part of a national effort to
accelerate the rate of progress against cancer, reduce the cancer death
rate, and improve the life experience of those living with and
surviving cancer and their caregivers.
EPA is not proposing a complete ban on 1-BP. This rule proposes to
allow certain uses of 1-BP to continue provided that sufficient worker
protections are in place to address the unreasonable risk for certain
occupational conditions of use. For the conditions of use for which EPA
is proposing strict workplace controls under a WCPP, EPA expects that
many workplaces already have stringent controls in place that reduce
exposures to 1-BP; for some workplaces, such as those using 1-BP in
vapor degreasing, EPA understands that these existing controls may
already reduce exposure enough to meet the inhalation exposure
concentration limit proposed in this rulemaking (Ref. 1).
Accordingly, EPA is proposing strict workplace controls to address
the unreasonable risk and to allow continued use of 1-BP for several
conditions of use, including processing for incorporation into
formulation, mixture, or reaction products; use in vapor degreasing;
use in cold cleaning; use in aerosol spray degreasers/cleaners; use in
electronic and electronic products and metal products; use in asphalt
extraction and laboratory chemicals; processing as a reactant/
intermediate; and use in coatings for temperature indicators, which, in
total, comprise an estimated 97% of the current production volume of 1-
BP. EPA is proposing to prohibit certain conditions of use of 1-BP,
including manufacture (including import), processing, and distribution
in commerce of 1-BP for all consumer use, excluding the use of 1-BP in
insulation; use in dry cleaning and spot cleaning, adhesives and
sealants, liquid cleaners, automotive care products, anti-adhesive
agents, functional fluids, and arts, crafts, and hobby materials,
comprising an estimated 3% of the current production volume of 1-BP.
Unit IV.A. describes EPA's proposed regulatory action and Unit IV.B.
describes the alternative regulatory actions considered as required
under TSCA section 6(c)(2)(A). The rationale for the proposed
regulatory action and alternative regulatory actions, including what is
feasible and appropriate for each condition of use, is described in
Unit V., and the TSCA section 6 requirements considered in developing
the regulatory actions are described in Unit III.B.3.
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis (EA) of the potential
incremental impacts associated with this rulemaking that can be found
in the rulemaking docket and is briefly summarized here (Ref. 3). The
cost of the proposed rule is estimated to be $14.8 million annualized
over 20 years at a 3% discount rate and $15.5 million annualized over
20 years at a 7% discount rate. These costs take compliance with
implementation of a WCPP into consideration, which would include an
existing chemical exposure limit (ECEL) of 0.05 ppm (0.25 mg/m3) for
inhalation exposures as an 8-hour time-weighted average (TWA),
applicable personal protective equipment (PPE) requirements, and
reformulation costs of numerous products. The estimates discussed in
the preamble reflect the central estimates for the number of sites and
workers affected rather than the low- or high-end estimates. The
sensitivity analysis in Chapter 11 presents the estimated costs,
benefits, and net benefits for low, central, and high estimates of
affected sites, workers, and occupational non-users (ONUs). The
economic impact on users of 1-BP for vapor degreasing is unclear
because some users may not be able to continue using their current
equipment (open-top vapor degreasers). Based on engagement with
industry, including public comments received on the draft risk
evaluation and draft revised unreasonable risk determination for 1-BP,
EPA expects workplaces engaged in vapor degreasing to have the ability
to implement a WCPP that would include an ECEL, PPE requirements, and
ancillary requirements. EPA estimates
[[Page 65070]]
that complying with the WCPP would cost vapor degreasing users $13.8
million while prohibition would cost vapor degreasing users $174.8
million (3% discount rate annualized over 20 years). Vapor degreasing
is used in several advanced manufacturing industries, including
aerospace, automotive, energy, medical devices, and others (Ref. 3).
The actions proposed in this rulemaking are expected to achieve
health benefits for the American public, some of which can be monetized
and others that, while tangible and significant, cannot be monetized.
The monetized benefits of this rulemaking are approximately $27.2
million annualized over 20 years at a 3% discount rate and $12.9
million annualized over 20 years at a 7% discount rate. The monetized
benefits include potential reductions in risk of colon and lung
cancers. Non-monetized benefits include risk reduction of liver
toxicity, kidney toxicity, reproductive toxicity, developmental
toxicity, and neurotoxicity (peripheral neuropathy) (Ref. 3).
As described in more detail in the Economic Analysis, the Agency
analyzed the demographic characteristics of several populations that
would be impacted by this rulemaking (Ref. 3). In general, workers in
affected industries and regions, as well as residents of nearby
communities, are similar to workers and residents nationwide. Data
limitations prevent EPA from conducting a more comprehensive
environmental justice (EJ) analysis that would identify the incremental
impacts of the regulatory options and assess the extent to which they
mitigate or exacerbate any disproportionate impacts in communities with
EJ concerns.
F. What should I consider as I prepare my comments for EPA?
1. Submitting CBI
Do not submit CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or
email. If you wish to include CBI in your comment, please follow the
applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the part or all of the information that
you claim to be CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2 and/or 40 CFR part 703, as appliable.
2. Tips for Preparing Your Comments
When preparing and submitting your comments, see the commenting
tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. Overview of 1-BP
This proposed rule applies to 1-BP (CASRN 106-94-5) and is
specifically intended to address the unreasonable risk of injury to
health EPA has identified in the 2020 Risk Evaluation for 1-BP and the
2022 revised unreasonable risk determination, as described in Unit
III.B.2. 1-BP is a colorless, volatile liquid with a mildly sweet odor
that is produced in and imported into the United States. 1-BP is
manufactured, processed, distributed, used, and disposed of as part of
many industrial, commercial, and consumer conditions of use.
As outlined in further detail in Unit III.B.1., 1-BP is used as a
solvent in cleaning and degreasing operations (including vapor
degreasing, cold cleaning, and aerosol degreasing), spray adhesives,
and dry cleaning. 1-BP is also used as a reactant in the manufacturing
of other chemical substances. Consumer uses of 1-BP include aerosol
degreasers, spot cleaners, and stain removers. 1-BP is also used in
insulation for building and construction materials. According to data
submitted for the 2016 submission period under EPA's Chemical Data
Reporting (CDR) rule, the total aggregate annual production volume of
1-BP in the U.S. increased from 15.4 million pounds to 25.8 million
pounds between 2012 and 2015 (Ref. 4). The total aggregate annual
production volume ranged from 1 to 50 million pounds between 2016 and
2019 according to CDR (Ref. 5).
B. Regulatory Actions Pertaining to 1-BP
Because of its adverse health effects, 1-BP is subject to several
Federal laws and regulations in the United States and is also subject
to regulation by some States and other countries. A summary of EPA
regulations pertaining to 1-BP, as well as other Federal, state, and
international regulations, is in the docket and in Appendix A of the
2020 Risk Evaluation for 1-BP (Refs. 6, 1). EPA acknowledges that
additional 1-BP regulatory steps occurred after 2020, including the
addition of 1-BP as a Hazardous Air Pollutant (HAP) to the Clean Air
Act list in January 2022, as discussed in Unit X.C.5.
C. Consideration of Occupational Safety and Health Administration
(OSHA) Occupational Health Standards in TSCA Risk Evaluations and TSCA
Risk Management Actions
Although EPA must consider and factor in, to the extent
practicable, certain non-risk factors as part of TSCA section 6(a)
rulemaking (see TSCA section 6(c)(2)), EPA must nonetheless still
ensure that the selected regulatory requirements apply ``to the extent
necessary so that the chemical substance or mixture no longer presents
[unreasonable] risk.'' 15 U.S.C. 2605(a). This requirement to eliminate
unreasonable risk is distinguishable from approaches mandated by some
other laws, including the Occupational Safety and Health Act (OSH Act),
which includes both significant risk and feasibility (technical and
economic) considerations in the setting of standards.
Congress intended for EPA to consider occupational risks from
chemicals it evaluates under TSCA, among other potential exposures, as
relevant and appropriate. As noted previously, section 6(b) of TSCA
requires EPA to evaluate risks to PESS identified as relevant by the
Administrator. TSCA section 3(12) defines the term ``potentially
exposed or susceptible subpopulation'' as ``a group of individuals
within the general population identified by the Administrator who, due
to either greater susceptibility or greater exposure, may be at greater
risk than the general population of adverse health effects from
exposure to a chemical substance or mixture, such as infants, children,
pregnant women, workers, or the elderly.''
The OSH Act similarly requires OSHA to evaluate risk specific to
workers prior to promulgating new or revised standards and requires
OSHA standards to substantially reduce significant risk to the extent
feasible, even if workers are exposed over a full working lifetime. See
29 U.S.C. 655(b)(5); Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 642 (1980) (plurality opinion).
Thus, the standards for chemical hazards that OSHA promulgates
under the OSH Act share a broadly similar purpose with the standards
that EPA promulgates under TSCA section 6(a). The control measures OSHA
and EPA require to satisfy the objectives of their respective statutes
may also, in many circumstances, overlap or coincide. However, as this
section outlines, there
[[Page 65071]]
are important differences between EPA's and OSHA's regulatory
approaches and jurisdiction, and EPA considers these differences when
deciding whether and how to account for OSHA requirements (Ref. 6) when
evaluating and addressing potential unreasonable risk to workers so
that compliance requirements are clearly explained to the regulated
community.
1. OSHA Requirements
OSHA's mission is to ensure that employees work in safe and
healthful conditions. The OSH Act establishes requirements that each
employer comply with the General Duty Clause of the Act (29 U.S.C.
654(a)), as well as with occupational safety and health standards
issued under the Act.
a. General Duty Clause of the OSH Act
The General Duty Clause of the OSH Act requires employers to keep
their workplaces free from recognized hazards that are causing or are
likely to cause death or serious physical harm to employees. The
General Duty Clause is cast in general terms, and does not establish
specific requirements like exposure limits, PPE, or other specific
protective measures that EPA could potentially consider when developing
its risk evaluations or risk management requirements. OSHA, under
limited circumstances, has cited the General Duty Clause for regulating
exposure to chemicals. To prove a violation of the General Duty Clause,
OSHA must prove employer or industry recognition of the hazard, the
hazard was causing or likely to cause death or serious physical harm,
and a feasible method to eliminate or materially reduce the hazard was
available. In rare situations, OSHA has cited employers for violation
of the General Duty Clause where exposures were below a chemical-
specific permissible exposure limit (PEL), a TWA based on an employee's
average airborne exposure in any 8-hour work shift of a 40-hour work
week which shall not be exceeded (Ref. 7). In such situations, OSHA
must demonstrate that the employer had actual knowledge that the PEL
was inadequate to protect its employees from death or serious physical
harm. Because of the heavy evidentiary burden on OSHA to establish
violations of the General Duty Clause, it is not frequently used to
cite employers for employee exposure to chemical hazards.
b. OSHA Standards
OSHA standards are issued pursuant to the OSH Act and are found in
title 29 of the CFR. There are separate standards for general industry,
laboratories, construction, maritime and agriculture sectors, and
general standards applicable to a number of sectors (e.g., OSHA's
Respiratory Protection standard). OSHA has numerous standards that
apply to employers who operate chemical manufacturing and processing
facilities, as well as to downstream employers whose employees may be
occupationally exposed to hazardous chemicals.
OSHA sets legally enforceable limits on the airborne concentrations
of hazardous chemicals, referred to as PELs, established for employers
to protect their workers against the health effects of exposure to
hazardous substances (29 CFR part 1910, subpart Z, part 1915, subpart
Z, and part 1926, subparts D and Z). Under section 6(a) of the OSH Act,
OSHA was permitted an initial 2-year window after the passage of the
Act to adopt ``any national consensus standard and any established
Federal standard.'' 29 U.S.C. 655(a). OSHA used this authority in 1971
to establish PELs that were adopted from Federal health standards
originally set by the Department of Labor through the Walsh-Healy Act,
in which approximately 400 occupational exposure limits (OELs) were
selected based on the American Conference of Governmental Industrial
Hygienists (ACGIH) 1968 list of Threshold Limit Values (TLVs). In
addition, about 25 exposure limits recommended by the American
Standards Association (now called the American National Standards
Institute (ANSI) were adopted as PELs.
Following the 2-year window provided under section 6(a) of the OSH
Act for adoption of national consensus and existing Federal standards,
OSHA has issued health standards following the requirements in section
6(b) of the Act. OSHA has established approximately 30 PELs under
section 6(b)(5) as part of comprehensive substance-specific standards
that include additional requirements for protective measures such as
use of PPE, establishment of regulated areas, exposure assessment,
hygiene facilities, medical surveillance, and training. These ancillary
provisions in substance-specific OSHA standards further mitigate
residual risk that could be present due to exposure at the PEL.
OSHA has not established a PEL for 1-BP and for those it has, in
many instances, scientific evidence has accumulated suggesting that the
current limits of many PELs are not sufficiently protective. Unlike
EPA's requirements under TSCA to address unreasonable risk, health
standards issued under section 6(b)(5) of the OSH Act must reduce
significant risk only to the extent that it is technologically and
economically feasible. OSHA's legal requirement to demonstrate that its
section 6(b)(5) standards are technologically and economically feasible
at the time they are promulgated often precludes OSHA from imposing
exposure control requirements sufficient to ensure that the chemical
substance no longer presents a significant risk to workers.
TSCA section 6(b) unreasonable risk determinations may account for
unreasonable risk to more sensitive endpoints and working populations
than OSHA's risk evaluations typically contemplate, and EPA is
obligated to apply TSCA section 6(a) risk management requirements to
the extent necessary so that the unreasonable risk is no longer
presented.
Because the requirements and application of TSCA and OSHA
regulatory analyses differ, it is necessary for EPA to conduct risk
evaluations and, where it finds unreasonable risk to workers, develop
risk management requirements for chemical substances that OSHA also
regulates, and it is expected that EPA's findings and requirements may
sometimes diverge from OSHA's. However, it is also appropriate that EPA
consider the chemical standards that OSHA has already developed to
limit the compliance burden to employers by aligning management
approaches required by the agencies, where alignment will adequately
address unreasonable risk to workers. The following section discusses
EPA's consideration of OSHA standards in its risk evaluation and
management strategies under TSCA.
2. Consideration of OSHA Standards in TSCA Risk Evaluations
When characterizing the risk during risk evaluation under TSCA, EPA
believes it is appropriate to evaluate the levels of risk present in
scenarios where no mitigation measures are assumed to be in place for
the purpose of determining unreasonable risk (see Unit II.C.2.a.). (It
should be noted that there are some cases where scenarios may reflect
certain mitigation measures, such as in instances where exposure
estimates are based on monitoring data at facilities that have existing
engineering controls in place.)
In addition, EPA believes it may be appropriate to also evaluate
the levels of risk present in scenarios considering applicable OSHA
requirements as well as scenarios considering industry or sector best
practices for industrial hygiene that are clearly articulated to the
Agency. EPA may evaluate risk
[[Page 65072]]
under scenarios that consider industry or sector best practices for
industrial hygiene that are clearly articulated to the Agency, when
doing so serves to inform its risk management efforts. Characterizing
risks using scenarios that reflect different levels of mitigation can
help inform potential risk management actions by providing information
that could be used during risk management to tailor risk mitigation
appropriately to address any unreasonable risk identified (see Unit
II.C.2.b. and Unit II.C.3.).
a. Risk Characterization for Unreasonable Risk Determination
When making unreasonable risk determinations as part of TSCA risk
evaluations, EPA cannot assume as a general matter that all workers are
always equipped with and appropriately using sufficient PPE, although
it does not question the veracity of public comments received on the
2020 Risk Evaluation for 1-BP regarding the occupational safety
practices often followed by industry respondents. When characterizing
the risk to human health from occupational exposures during risk
evaluation under TSCA, EPA believes it is appropriate to evaluate the
levels of risk present in scenarios where PPE is not assumed to be used
by workers. This approach of not assuming PPE use by workers considers
the risk to PESS (workers and occupational non-users (ONUs)) who may
not be covered by OSHA standards, such as self-employed individuals and
public sector workers who are not covered by a State Plan. Mitigation
scenarios included in the EPA risk evaluation in order to inform its
risk management efforts (e.g., scenarios considering use of PPE) likely
represent current practice in many facilities where companies
effectively address worker and bystander safety requirements. However,
the Agency cannot assume that all facilities across all uses of the
chemical substances will have adopted these practices for the purposes
of making the TSCA risk determination.
Therefore, EPA makes its determinations of unreasonable risk based
on scenarios that do not assume compliance with OSHA standards,
including any applicable exposure limits or requirements for use of
respiratory protection or other PPE. Making unreasonable risk
determinations based on such scenarios should not be viewed as an
indication that EPA believes there are no occupational safety
protections in place at any location, or that there is widespread
noncompliance with applicable OSHA standards. Rather, it reflects EPA's
recognition that unreasonable risk may exist: (1) for subpopulations of
workers that may be highly exposed because they are not covered by OSHA
standards, such as self-employed individuals and public sector workers
who are not covered by an OSHA State Plan; (2) because EPA finds
unreasonable risk for purposes of TSCA notwithstanding existing OSHA
requirements.
b. Risk Evaluation To Inform Risk Management Requirements
In addition to the scenarios described previously, EPA risk
evaluations may characterize the levels of risk present in scenarios
considering applicable OSHA requirements (e.g., chemical-specific PELs
and/or chemical-specific health standards with PELs and additional
ancillary provisions) as well as scenarios considering industry or
sector best practices for industrial hygiene that are clearly
articulated to the Agency to help inform risk management decisions.
3. Consideration of OSHA Standards in TSCA Risk Management Actions
When undertaking risk management actions, EPA: (1) Develops
occupational risk mitigation measures to address any unreasonable risk
identified by EPA, striving for consistency with applicable OSHA
requirements and industry best practices, including appropriate
application of the hierarchy of controls (Ref. 8), when those measures
would address an unreasonable risk; and (2) Ensures that EPA
requirements apply to all potentially exposed workers in accordance
with TSCA requirements. Consistent with TSCA section 9(d), EPA consults
and coordinates TSCA activities with OSHA and other relevant Federal
agencies for the purpose of achieving the maximum applicability of TSCA
while avoiding the imposition of duplicative requirements.
Informed by the mitigation scenarios and information gathered
during the risk evaluation and risk management process, the Agency
might propose rules that require risk management practices that may be
already common practice in many or most facilities. Adopting clear,
broadly applicable regulatory standards will foster compliance across
all facilities (ensuring a level playing field) and assure protections
for all affected workers, especially in cases where current OSHA
standards may not apply to them or not be sufficient to address the
unreasonable risk.
4. 1-BP and OSHA Requirements
EPA incorporated the considerations described earlier in this unit
in the 2020 Risk Evaluation for 1-BP, the December 2022 revised
unreasonable risk determination for 1-BP, and this proposed risk
management rulemaking. Specifically, in the TSCA 2020 Risk Evaluation
for 1-BP, EPA presented risk estimates based on workers' exposures with
and without respiratory protection. EPA determined that even when
respirators with APF 50 are used by workers, most of the conditions of
use evaluated presented an unreasonable risk. Additional consideration
of OSHA standards in the revised unreasonable risk determination is
discussed further in the Federal Register notice announcing that
document (Ref. 9). In Units III.B.3. and V., EPA outlines the
importance of considering the hierarchy of controls utilized by the
industrial hygiene community (hereafter referred to as ``hierarchy of
controls'') when developing risk management actions in general, and
specifically when determining if and how regulated entities may meet a
risk-based exposure limit for 1-BP. The hierarchy of controls is a
prioritization of exposure control strategies from most preferred to
least preferred techniques. In order of precedence, they are:
elimination of the hazard, substitution with a less hazardous
substance, engineering controls, administrative controls such as
training or exclusion zones with warning signs, and, finally, use of
PPE (Ref. 8). Under the hierarchy of controls, the use of respirators
(and all PPE) should only be considered after all other measures have
been taken to reduce exposures. As discussed in Units IV.A. and V.A.1.,
EPA's risk management approach would not rely solely or primarily on
the use of respirators to address unreasonable risk to workers;
instead, EPA is proposing prohibitions for or affecting certain
conditions of use, a WCPP for most occupational conditions of use,
self-certification for certain occupational conditions of use, and
prescriptive controls for certain occupational conditions of use. The
WCPP would require consideration of the hierarchy of controls before
use of respirators and other PPE. The WCPP is discussed in full in
Units IV.A.2. and V.A.1.b.
In accordance with the approach described earlier in Unit II.C.3.,
EPA intends for this regulation to be as consistent as possible with
the existing OSHA standards, with additional requirements as necessary
to address the unreasonable risk. One notable difference between the
WCPP and the OSHA standards are the exposure limits. The WCPP would
include an ECEL of 0.05 ppm as an 8-hour TWA to address unreasonable
risks for chronic cancer and non-cancer and acute non-
[[Page 65073]]
cancer inhalation endpoints. EPA recognizes that there is no OSHA PEL
for 1-BP; however, OSHA and the National Institute for Occupational
Safety and Health (NIOSH) issued a Hazard Alert in 2013, which
indicates a recommended time-weighted average threshold limit value
(TWA-TLV) of 10 ppm by the American Conference of Governmental
Industrial Hygienists (Ref. 10). However, in 2011, ACGIH recommended
0.10 ppm as the TWA-TLV value for 1-BP and adopted this value in 2014.
(Ref. 10). OSHA also released an Enforcement Policy for Respiratory
Hazards Not Covered by OSHA Permissible Exposure Limits that explains
OSHA requirements and the applicability of this policy pertaining to 1-
BP exposure limits under certain conditions (Ref. 11).
The TSCA ECEL value for 1-BP is a lower value than other existing
OELs, discussed in Unit II.C.5., because many of those OELs are
outdated, and they may not fully capture either the complete database
of studies considered in the 2020 Risk Evaluation for 1-BP or more
recent advances in modeling and scientific interpretation of
toxicological data applied in the calculation of the 1-BP ECEL. EPA
considers the 1-BP ECEL to represent the best available science under
TSCA section 26(h) because it was derived from information in the 2020
Risk Evaluation for 1-BP, which was subject to peer review, and which
is the result of a systematic review approach that investigated the
reasonably available information in order to identify relevant adverse
health effects. Additionally, by using the information from the 2020
Risk Evaluation for 1-BP, the ECEL incorporates advanced modeling and
peer-reviewed methodologies, and accounts for exposures to potentially
exposed or susceptible subpopulations, as required by TSCA.
For 1-BP, the TSCA ECEL is an 8-hour occupational inhalation
exposure limit based on cancer inhalation risks and takes into
consideration the uncertainties identified in the 2020 Risk Evaluation
for 1-BP (Ref. 12). The ECEL represents the concentration at which an
adult human, including a member of a PESS, would be unlikely to suffer
adverse effects if exposed for a working lifetime. EPA has determined
as a matter of risk management policy that ensuring exposures remain at
or below the ECEL will eliminate any unreasonable risk of injury to
health from occupational inhalation exposures. In addition to the ECEL,
as part of this rulemaking, EPA is proposing an ECEL action level. An
ECEL action level, similar to other OEL frameworks, is typically a
value lower than the ECEL value, that would trigger additional
monitoring to ensure that workers are not exposed to concentrations
above the ECEL.
For 1-BP, the ECEL of 0.05 ppm is based on the cancer endpoints. As
demonstrated in the ECEL memo, cancer from chronic inhalation exposures
is the basis of the 1-BP ECEL (Ref. 12). As discussed in Units II.D.,
III.B., and VII.D., the TSCA ECEL represents the best available science
at time of publication of the 2020 Risk Evaluation for 1-BP.
5. 1-BP and Other Occupational Exposure Limits
EPA is aware of other OELs for 1-BP, including the California
Division of Occupational Safety and Health (Cal/OSHA) PEL and the ACGIH
TLV. The 2014 8-hour TWA TLV recommended by the ACGIH is 0.10 ppm. This
TLV is based on the potential for neurotoxicity, liver toxicity, and
reproductive/developmental toxicity. While a variety of studies
covering numerous health effects are discussed in the report, the most
relevant study cited (Ref. 13) reported ``diminished vibration
sensation and lower scores in memory and mood tests'' in workers at
measured occupational exposures as low as 0.34 ppm. The TLV appears to
be semi-quantitative and not directly extrapolated from any individual
point of departure. The August 2020 TSCA Risk Evaluation for 1-BP
discussed the Ichihara results (Ref. 1, 13), however they were
considered ambiguous due to 1-BP co-exposures that may have
significantly contributed to the observed neurotoxicity. The TLV report
also discusses the NTP 2011 cancer results that were the basis of the
TSCA ECEL, however linear low-dose extrapolation was not performed in
order to derive a lower TLV.
The 2014 Cal/OSHA PEL is 5 ppm, higher than the ACGIH TLV, and has
a skin notation, meaning that a worker's skin, eyes and mouth should be
protected from any contact with 1-BP (Ref. 14). The Cal/OSHA PEL is
based on reproductive and developmental toxicity (observed in animal
studies) and technological feasibility assessments from industry (Ref.
14).
D. Summary of EPA's Risk Evaluation Activities on 1-Bromopropane
In December 2016, EPA selected 1-BP as one of the first 10
chemicals for risk evaluation under TSCA section 6 (Ref. 15). EPA
published the scope of the 1-BP risk evaluation in June 2017 (82 FR
31592, July 7, 2017), and, after receiving public comments, published
the problem formulation in June 2018 (83 FR 26998, June 11, 2018). In
August 2019, EPA published a draft risk evaluation (84 FR 39830, August
12, 2019), and, after public comment and peer review by the Science
Advisory Committee on Chemicals (SACC), EPA issued the 2020 Risk
Evaluation for 1-BP in August 2020 in accordance with TSCA section 6(b)
(85 FR 48687, August 12, 2020). EPA subsequently issued a draft revised
TSCA unreasonable risk determination for 1-BP (87 FR 43265, July 20,
2022), and after public notice and receipt of comments, published a
revised Unreasonable Risk Determination for 1-BP (87 FR 77603, December
2022). The 2020 Risk Evaluation for 1-BP and supplemental materials are
in docket EPA-HQ-OPPT-2019-0235, with the December 2022 revised
unreasonable risk determination and additional materials supporting the
risk evaluation process are in docket EPA-HQ-OPPT-2016-0741, on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
1. 2020 Risk Evaluation
In the 2020 Risk Evaluation for 1-BP, EPA evaluated risks
associated with 25 conditions of use within the following categories:
manufacture (including import), processing, distribution in commerce,
industrial and commercial use, consumer use, and disposal. Descriptions
of these conditions of use are in Unit III.B.1. The 2020 Risk
Evaluation for 1-BP identified significant adverse health effects
associated with exposure to 1-BP, including developmental toxicity from
acute and chronic inhalation exposures and dermal exposures, and cancer
from chronic inhalation exposures to 1-BP. A further discussion of the
hazards of 1-BP is included in Unit III.B.2.
2. Revised Unreasonable Risk Determination
EPA has been revisiting specific aspects of its first ten TSCA
existing chemical risk evaluations, including the 2020 Risk Evaluation
for 1-BP, to ensure that the risk evaluations upon which risk
management decisions are made better align with TSCA's objective of
protecting human health and the environment. For 1-BP, EPA revised the
original unreasonable risk determination based on the 2020 Risk
Evaluation for 1-BP and issued a final revised unreasonable risk
determination on December 2022 (Ref. 2). EPA revised the risk
determination for the 2020 Risk Evaluation for 1-BP pursuant to TSCA
section 6(b) and consistent with Executive Order 13990, (``Protecting
Public Health and the Environment and Restoring Science to Tackle the
Climate
[[Page 65074]]
Crisis'') and other Administration priorities (Refs. 16, 17, and 18).
The revisions consisted of making the risk determination based on the
whole-chemical substance instead of by individual conditions of use
(which resulted in the revised risk determination superseding the prior
``no unreasonable risk'' determinations and withdrawing the associated
TSCA section 6(i)(1) ``no unreasonable risk'' order); and clarifying
that the risk determination does not reflect an assumption that all
workers are always provided and appropriately wear PPE (Ref. 2).
In determining whether 1-BP presents unreasonable risk under the
conditions of use, EPA considered relevant risk-related factors,
including, but not limited to: the effects of the chemical substance on
health (including cancer and non-cancer risks) and human exposure to
the substance under the conditions of use (including duration,
magnitude, and frequency of exposure); the effects of the chemical
substance on the environment and environmental exposure under the
conditions of use; the population exposed (including any PESS);
susceptible life stages; the severity of hazard (including the nature
of the hazard, the irreversibility of the hazard); and uncertainties.
EPA determined that 1-BP presents an unreasonable risk of injury to
health. The contributions to the unreasonable risk determination are
risks to workers and ONUs (workers who do not directly handle the
chemical but perform work in an area where the chemical is present) due
to occupational exposures to 1-BP (i.e., during manufacture,
processing, industrial and commercial uses, disposal); and to consumers
and bystanders associated with consumer uses of 1-BP due to exposures
from consumer use of 1-BP and products containing 1-BP. EPA did not
identify risks of injury to the environment that contribute to the
unreasonable risk determination for 1-BP. The 1-BP conditions of use
that contribute to EPA's determination that the chemical substance
poses unreasonable risk to health are listed in the unreasonable risk
determination (Ref. 2) and also in Unit III.B.1., with descriptions to
aid chemical manufacturers, processors, and users in determining how
their particular use or activity would be addressed under the proposed
regulatory provisions.
While the 2020 Risk Evaluation for 1-BP estimated different risks
for occupational non-users and workers, the benchmark (and thus the
ECEL value) is the same for both populations. That is, while workers
and occupational non-users may have different exposure patterns, the
level of exposure such that risks are no longer unreasonable is the
same for both workers and occupational non-users. Thus, for the
purposes of risk management, the distinction between worker and
occupational non-user is no longer relevant, and both are encompassed
by the proposed definition of a potentially exposed person, as outlined
in Unit IV.A.2.a. EPA notes that this proposed definition is intended
to apply to occupational workplaces as part of implementation of the
WCPP, and recognizes that other individuals or communities may be
exposed to 1-BP as consumers, members of fenceline communities, or
members of the general population.
3. Fenceline Screening Analysis
The 2020 TSCA Risk Evaluation for 1-BP excluded the assessment of
certain exposure pathways that were or could be regulated under another
EPA-administered statute (see section 1.4.2 of the August 2020 Risk
Evaluation for 1-BP (Refs. 1, 2). This resulted in the ambient air
pathway for 1-BP exposure not being fully assessed for human health
risk to the general population. The August 2020 Risk Evaluation for 1-
BP did assess the water pathway based on fate and monitoring and
modeling data, which determined there was no presence of 1-BP (Ref. 1).
In June 2021, EPA made a policy announcement on the path forward for
TSCA chemical risk evaluations, indicating that EPA would, among other
things, examine whether the exclusion of certain exposure pathways from
the risk evaluations could lead to a failure to identify and protect
fenceline communities (Refs. 9; 15). EPA then conducted a screening
analysis to identify whether there may be potential risks to people
living near the fenceline of facilities releasing 1-BP.
In order to determine whether there may be potential risk to the
general population in proximity to a facility releasing 1-BP, EPA
developed the TSCA Screening Level Approach for Assessing Ambient Air
and Water Exposures to Fenceline Communities Version 1.0, which was
presented to the SACC in March 2022, with a report issued by the SACC
on May 18, 2022 (Ref. 19). This analysis is discussed in Unit VI.A.
III. Regulatory Approach
A. Background
Under TSCA section 6(a), if the Administrator determines, through a
TSCA section 6(b) risk evaluation that the manufacture (including
import), processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or any combination of such activities,
presents an unreasonable risk of injury to health or the environment,
EPA must by rule apply one or more of the following requirements to the
extent necessary so that the chemical substance or mixture no longer
presents such risk.
<bullet> Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture, or
limit the amount of such substance or mixture which may be
manufactured, processed, or distributed in commerce (section 6(a)(1)).
<bullet> Prohibit or otherwise restrict the manufacturing,
processing, or distribution in commerce of the substance or mixture for
a particular use or above a specific concentration for a particular use
(section 6(a)(2)).
<bullet> Limit the amount of the substance or mixture which may be
manufactured, processed, or distributed in commerce for a particular
use or above a specific concentration for a particular use specified
(section 6(a)(2)).
<bullet> Require clear and adequate minimum warning and
instructions with respect to the substance or mixture's use,
distribution in commerce, or disposal, or any combination of those
activities, to be marked on or accompanying the substance or mixture
(section 6(a)(3)).
<bullet> Require manufacturers and processors of the substance or
mixture to make and retain certain records or conduct certain
monitoring or testing (section 6(a)(4)).
<bullet> Prohibit or otherwise regulate any manner or method of
commercial use of the substance or mixture (section 6(a)(5)).
<bullet> Prohibit or otherwise regulate any manner or method of
disposal of the substance or mixture, or any article containing such
substance or mixture, by its manufacturer or processor or by any person
who uses or disposes of it for commercial purposes (section 6(a)(6)).
<bullet> Direct manufacturers or processors of the substance or
mixture to give notice of the unreasonable risk determination to
distributors, certain other persons, and the public, and to replace or
repurchase the substance or mixture (section 6(a)(7)).
As described in Unit III.B.3., EPA analyzed how the TSCA section
6(a) requirements could be applied to address the unreasonable risk
found to be present in the 2020 Risk Evaluation for 1-BP and the final
revised unreasonable risk determination, so that 1-BP no longer
presents such
[[Page 65075]]
unreasonable risk. EPA's proposed regulatory action and two alternative
regulatory actions are described in Unit IV. EPA is requesting public
comment on all elements of the proposed regulatory action and the
alternative regulatory actions and is providing notice that based on
consideration of comments and any new information submitted to EPA
during the comment period on this proposed rule, EPA may in the final
rule modify elements of the proposed regulatory action. The public
should understand that public comments could result in changes to
elements of the proposed and alternative regulatory actions when this
rulemaking is finalized. For example, elements such as timelines for
phase out could be lengthened or shortened, ECELs could be modified, or
the WCPP could have conditions added or eliminated, or uses proposed to
be prohibited could be allowed with a WCPP or uses proposed to be
allowed with a WCPP could be prohibited.
Under the authority of TSCA section 6(g), EPA may consider granting
a time-limited exemption from a requirement of a TSCA section 6(a) rule
for a specific condition of use if EPA finds that: (1) The specific
condition of use is a critical or essential use for which no
technically and economically feasible safer alternative is available,
taking into consideration hazard and exposure; (2) Compliance with the
requirement, as applied with respect to the specific condition of use
would significantly disrupt the national economy, national security, or
critical infrastructure; or (3) The specific condition of use, as
compared to reasonably available alternatives, provides a substantial
benefit to health, the environment, or public safety. At this time, EPA
is not proposing to grant TSCA section 6(g) exemptions in this proposed
rulemaking.
TSCA section 6(c)(2)(A) requires EPA, in proposing and promulgating
TSCA section 6(a) rules, to consider and include a statement addressing
certain factors, including the costs and benefits and the cost
effectiveness of the regulatory action and of the one or more primary
alternative regulatory actions considered by the Administrator. A
description of all TSCA section 6 requirements considered in developing
this proposed regulatory action is in Unit III.B.3., and Unit V.B.
includes more information regarding EPA's consideration of exemptions
and alternatives. TSCA section 6(c)(2)(C) requires that in deciding
whether to prohibit or restrict in a manner that substantially prevents
a specific condition of use and in setting an appropriate transition
period for such action, EPA consider, to the extent practicable,
whether technically and economically feasible alternatives that benefit
health or the environment will be reasonably available as substitutes
when the proposed prohibition or restriction takes effect. Unit IV.B.
includes more information regarding EPA's consideration of
alternatives, and Unit VI. provides more information on EPA's
considerations more broadly under TSCA section 6(c)(2).
EPA carried out required consultations as described in this unit
and also considered impacts on children's environmental health as part
of its approach to developing this TSCA section 6 regulatory action.
1. Consultations
EPA conducted consultations and outreach in developing this
proposed regulatory action. The Agency held a federalism consultation
from October 22, 2020, until January 23, 2021, as part of this
rulemaking process and pursuant to Executive Order 13132 (64 FR 43255,
August 10, 1999). This included a background presentation on September
9, 2020, and a consultation meeting on October 22, 2020. During the
consultation, EPA met with State and local officials early in the
process of developing the proposed action in order to receive
meaningful and timely input into its development (Ref. 20). During the
consultation, participants and EPA discussed preemption, EPA's
authority under TSCA section 6 to regulate identified unreasonable
risks, what activities would be potentially regulated in the proposed
rule; and the relationship between TSCA and existing statutes--
particularly the Clean Air Act (CAA) (Ref. 20).
1-BP is not manufactured (including imported), processed,
distributed in commerce, or regulated by Tribal governments. However,
EPA consulted with Tribal officials during the development of this
proposed action (Ref. 21). The Agency held a Tribal consultation from
October 7, 2020, to January 8, 2021, with meetings on November 12 and
17, 2020. Tribal officials were given the opportunity to meaningfully
interact with EPA risk managers concerning the current status of risk
management. During the consultation, EPA discussed risk management
under TSCA section 6(a), findings from the 2020 Risk Evaluation for 1-
BP, types of information that would be helpful to inform risk
management, principles for transparency during the risk management
process, and types of information EPA is seeking from tribes (Ref. 21).
EPA received no written comments as part of this consultation.
In addition to the formal consultations, EPA also conducted
outreach to advocates of communities that might be subject to
disproportionate risk from the exposures to 1-BP, such as low-income
populations, and indigenous peoples. EPA's Environmental Justice (EJ)
consultation occurred from November 4, 2020, through January 18, 2021.
On November 16 and 19, 2020, EPA held public meetings as part of this
consultation. These meetings were held pursuant to EPA policy to
advance meaningful community engagement as part of the goal of
environmental justice. During the consultations, participants and EPA
discussed risk management under TSCA section 6(a), types of information
that would be helpful to inform risk management, principles for
transparency during the risk management process, and the relationship
between TSCA and existing statutes, particularly the Clean Air Act. In
general, commenters supported strong regulation of 1-BP to protect
lower-income communities and workers. Commenters also supported strong
outreach to affected communities, encouraged EPA to follow the NIOSH
hierarchy of controls in regulating 1-BP, favored prohibitions, and
noted the uncertainties associated with use of personal protective
equipment (e.g., in some cases, use of PPE did not provide adequate
protection given the exposure scenario). (Ref. 22)
As required by section 609(b) of the Regulatory Flexibility Act
(RFA), 5 U.S.C. 601 et seq., EPA convened a Small Business Advocacy
Review (SBAR) Panel to obtain advice and recommendations from small
entity representatives (SERs) that potentially would be subject to this
proposed rule's requirements (Ref. 23). EPA met with SERs before and
during Panel proceedings, on November 5, 2020, and May 11, 2021. Panel
recommendations are in Unit X.C. and in the Initial Regulatory
Flexibility Analysis (IRFA) (Ref. 24); the Panel report is in the
docket (Ref. 23). EPA requests comment on all elements of the IRFA,
and, in particular, the flexibilities that EPA has identified following
input from the SERs during the SBAR process. Additional requests for
comment based on Panel recommendations are in Unit VIII.
Units X.C., X.E., X.F., and X.J. provide more information regarding
the consultations.
[[Page 65076]]
2. Other Stakeholder Engagement
In addition to the formal consultations described in Unit X., EPA
held a webinar on September 30, 2020, providing an overview of the TSCA
risk management process and the risk evaluation findings for 1-BP. EPA
also presented on the risk evaluation and risk management under TSCA
for 1-BP at a Small Business Administration (SBA) Office of Advocacy
Environmental roundtable on September 11, 2020. At both events EPA
staff provided an overview of the TSCA risk management process and the
findings in the 2020 Risk Evaluation for 1-BP (Ref. 25). Attendees of
these meetings were given an opportunity to voice their concerns
regarding the risk evaluation and risk management.
Furthermore, EPA engaged in discussions with representatives from
different industries, non-governmental organizations, technical experts
and users of 1-BP. A list of external meetings held during the
development of this proposed rule is in the docket (Ref. 26); meeting
materials and summaries are also in the docket. The purpose of these
discussions was to create awareness and educate stakeholders and
regulated entities on the provisions for risk management required under
TSCA section 6(a); explain the risk evaluation findings; obtain input
from manufacturers, processors, distributors, users, academics,
advisory councils, and members of the public health community about
uses of 1-BP; identify workplace practices, engineering controls,
administrative controls, PPE, and industrial hygiene plans currently in
use or feasibly adoptable to reduce exposure to 1-BP under the
conditions of use; understand the importance of 1-BP in the various
uses subject to this proposed rule; compile knowledge about critical
uses, substitute chemicals or alternative methods; identify various
standards and performance specifications; and generate potential risk
reduction strategies. EPA has met with, or otherwise communicated with,
a variety of companies, trade associations and non-governmental
organizations to discuss the topics outlined in this paragraph; a list
of external meetings held during the development of this proposed rule
is in the docket. (Ref. 26).
3. Children's Environmental Health
EPA's Policy on Children's Health (Ref. 27) requires EPA to protect
children from environmental exposures by consistently and explicitly
considering early life exposures (from conception, infancy, early
childhood and through adolescence until 21 years of age) and lifelong
health in all human health decisions through identifying and
integrating children's health data and information when conducting risk
assessments. TSCA section 6(b)(4)(A) also requires EPA to conduct risk
evaluations ``to determine whether a chemical substance presents an
unreasonable risk of injury to health or the environment . . .
including an unreasonable risk to a potentially exposed or susceptible
subpopulation identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' Infants, children, and
pregnant women are life stages that are listed as examples of
subpopulations that may be considered relevant ``potentially exposed or
susceptible subpopulations'' in the TSCA section 3(12) definition of
that term. In addition, TSCA section 6(a) requires EPA to apply one or
more risk management requirements under TSCA section 6(a) so that 1-BP
no longer presents an unreasonable risk (including unreasonable risk to
PESS).
The 2020 Risk Evaluation for 1-BP considered impacts on both
children and adults from occupational and consumer use from inhalation
and dermal exposures, as applicable. For occupational use, the risk
evaluation considered males (>16 years of age) and females of
reproductive age (>16 years of age to less than 54 years of age) for
both dermal and inhalation exposures. For consumer use, EPA evaluated
dermal and inhalation exposures for children ages 11-15 and 16-20 years
of age, and the evaluation of inhalation exposures to bystanders
includes infants, toddlers, and older children. Several health effects
of 1-BP exposure are relevant to early life stages, including
developmental toxicity (i.e. increases in post-implantation loss), and
other adverse effects including reproductive toxicity and cancer.
B. Regulatory Assessment of 1-BP
1. Description of Conditions of Use
This unit describes the TSCA conditions of use that contribute to
EPA's unreasonable risk determination for the chemical substance 1-BP.
Condition of use descriptions were obtained from EPA sources such as
CDR use codes, the 2020 Risk Evaluation for 1-BP and related documents,
as well as the Organisation for Economic Co-operation and Development
harmonized use codes and stakeholder engagements. For additional
descriptions of the conditions of use, including process descriptions
and worker activities considered in the risk evaluation, see the
Problem Formulation of the 2020 Risk Evaluation for 1-BP, the 2020 Risk
Evaluation for 1-BP, and supplemental files (Refs. 28, 1, 29). EPA
acknowledges that some of the terms in this unit may be defined under
other statutes, however the descriptions here are intended to provide
clarity to the regulated entities who will implement the provisions of
this rulemaking under TSCA section 6(a).
a. Manufacturing (Including Import)
i. Domestic Manufacture
This condition of use refers to the making or producing of a
chemical substance within the United States (including manufacturing
for export), or the extraction of a component chemical substance from a
previously existing chemical substance or a complex combination of
substances.
ii. Import
This condition of use refers to the act of causing a chemical
substance or mixture to arrive within the customs territory of the
United States.
b. Processing
i. Processing as a Reactant/Intermediate
This condition of use refers to processing 1-BP in chemical
reactions for the manufacturing of another chemical substance or
product. Through processing as a reactant or intermediate, 1-BP serves
as a feedstock in the production of another chemical product via a
chemical reaction in which 1-BP is completely consumed. For example, 1-
BP is used as a reactant in the production of other organic and
inorganic chemicals, pesticides, fertilizers, and other agricultural
chemicals.
ii. Processing: Incorporation Into a Formulation, Mixture, or Reaction
Products
This condition of use refers to when 1-BP is added to a product (or
product mixture) prior to further distribution of the product.
iii. Processing: Incorporation Into Articles
This condition of use refers to when 1-BP becomes an integral
component of an article distributed for industrial, commercial, or
consumer use. An article refers to a manufactured item which: (1) Is
formed to a specific shape or design during manufacture; (2) has end
use function(s) dependent in whole or in part upon its shape or design
during end use; and (3) has either no change of chemical composition
during its end
[[Page 65077]]
use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical
substances, mixtures, or articles, except that fluids are particles
that are not considered articles regardless of shape or design. 40 CFR
704.3
iv. Processing by Repackaging
This condition of use refers to the preparation of a chemical
substance or mixture for distribution in commerce in a different form,
state, or quantity. This includes transferring of 1-BP from a bulk
container into smaller containers.
v. Recycling
This condition of use refers to processing waste streams of 1-BP at
a third-party site for the purpose of recovering materials or otherwise
preparing the waste for reuse instead of disposal. Waste solvents can
be restored via solvent reclamation/recycling. The recovery process may
involve an initial vapor recovery or mechanical separation step
followed by distillation, purification, and final packaging.
c. Industrial and Commercial Use
i. Industrial and Commercial Use as Solvent for Open-Top Batch and In-
Line Conveyorized Vapor Degreasing
This condition of use refers to the industrial and commercial use
of 1-BP as a solvent for cleaning and degreasing through the process of
heating 1-BP to its volatilization point and using its vapors to remove
dirt, oils, greases, and other surface contaminants from metal and
other parts using batch open-top and in-line conveyorized vapor
degreaser machines.
ii. Industrial and Commercial Use as Solvent for Closed-Loop Batch
Vapor Degreasing
This condition of use refers to the industrial and commercial use
of 1-BP as a solvent for cleaning and degreasing through the process of
heating 1-BP to its volatilization point and using its vapors to remove
dirt, oils, greases, and other surface contaminants from metal and
other parts using batch closed-loop degreaser machines.
iii. Industrial and Commercial Use as Solvent for Cold Cleaning
This condition of use refers to the industrial and commercial use
of 1-BP as a non-boiling solvent in cold cleaning machines, including
simple spray sinks and dip tanks, to remove dirt, oils, greases, and
other surface contaminants from metal and other parts.
iv. Industrial and Commercial Use as Solvent for Aerosol Spray
Degreaser/Cleaner
This condition of use refers to the industrial and commercial use
of 1-BP as a solvent in degreasing and cleaning products to remove
dirt, grease, stains, spots, and foreign matter through a process that
uses an aerosolized solvent spray, typically applied from a pressurized
can, to remove residual contaminants from electronics, metals, and
other fabricated materials. This description does not apply to use of
1-BP in products intended for automotive care, anti-adhesive agents for
mold cleaning and release products, adhesive accelerants for arts,
crafts, and hobby materials, or functional fluids, which are described
in ``Other industrial and commercial uses'' in this unit, or dry
cleaning solvents and stain removers, which are described in
``Industrial and commercial use in dry cleaning solvents, spot cleaners
and stain removers'' in this unit.
v. Industrial and Commercial Use in Adhesives and Sealants
This condition of use refers to the industrial and commercial use
of 1-BP as a solvent in spray adhesives and sealants for foam cushion
manufacturing and fabrication (e.g., the furniture industry).
vi. Industrial and Commercial Use in Dry Cleaning Solvents, Spot
Cleaners and Stain Removers
This condition of use refers to the industrial and commercial use
of 1-BP in products for spot cleaning and as a solvent in degreasing
and cleaning applications to remove dirt, grease, stains, spots, and
foreign matter from garments at dry cleaning facilities. This includes
dry cleaning facilities using third generation (dry-to-dry, non-vented
machines with refrigerated condensers), fourth generation (dry-to-dry,
non-vented machines with both refrigerated condensers and carbon
adsorbers as secondary vapor controls), or fifth generation (dry-to-
dry, non-vented machines with secondary vapor controls, a monitor
inside the machine drum, and an interlocking system to ensure the
concentration is below approximately 300 ppm before the loading door
can be opened) 1-BP dry cleaning machines. In addition to use as a
solvent in dry cleaning equipment, 1-BP is found in products to spot
clean garments to remove stains or spots before and after dry cleaning
treatment.
vii. Industrial and Commercial Use in Coin and Scissor Cleaner (Liquid,
Spray, or Aerosol Cleaners)
This condition of use refers to the industrial and commercial use
of 1-BP in aerosol and non-aerosol product formulations, designed to
clean collectible coins and scissors.
viii. Commercial Use in Insulation
This condition of use refers to the commercial use of 1-BP in
insulation material in the form of rigid board insulation, which can be
used for interior and exterior applications including walls, ceilings,
roofs, foundations, basements, and crawl spaces in commercial and
residential buildings.
ix. Other Industrial and Commercial Uses
This condition of use refers to the industrial and commercial uses
of 1-BP in a variety of other aerosol and non-aerosol uses not already
described previously in this unit.
<bullet> Aerosol mold cleaning and release: This refers to the
industrial and commercial use of 1-BP in aerosol mold cleaning and
release products used to coat the molds for injection moldings,
compression molding, blow molding, and extrusion applications.
<bullet> Asphalt extraction: This refers to the industrial and
commercial use of 1-BP for asphalt extraction in centrifuge extractors,
vacuum extractors, and reflux extractors to separate asphalt from the
aggregate and filler material to allow for determination of asphalt
content.
<bullet> Automotive care products: This condition of use also
refers to the industrial and commercial use of 1-BP in aerosolized
products, particularly engine degreasers and brake cleaners, to remove
residual contaminants from fabricated parts.
<bullet> General purpose degreaser: This refers to the industrial
and commercial use of 1-BP in aerosolized and non-aerosolized products
used in industrial settings, with usage varying widely by facility to
clean and maintain equipment (primarily during plant shutdowns) and
also used for heavy duty transportation maintenance (e.g., maintaining
buses, trains, trucks, etc.).
<bullet> High voltage cable cleaner: This refers to the industrial
and commercial use of 1-BP in both aerosolized and non-aerosolized
cleaning products to clean the semi-conductive cores of high voltage
cables when splicing and terminating cables.
<bullet> Refrigerant flush: This refers to the industrial and
commercial use of 1-BP
[[Page 65078]]
in products used to clean refrigeration lines in various industries,
and flush oxygen lines in hospitals and in the aerospace industry.
<bullet> Temperature indicators: This refers to the industrial and
commercial use of 1-BP in temperature-indicating fluids and coatings,
which can be applied to fabrics, rubber, plastics, glass, and/or
polished metals.
<bullet> Other uses: This refers to the industrial and commercial
use of 1-BP in a variety of other products such as an adhesive
accelerant, a coating component for pipes and fixtures, functional
fluids (closed/open systems), cutting oils, and as a laboratory
chemical for research and development.
d. Consumer Use
i. Consumer Use as a Solvent in Aerosol Spray Degreasers/Cleaners
This condition of use refers to the consumer use of 1-BP in
aerosolized products to dissolve oils, greases, and similar materials
from textiles, glassware, metal surfaces, and other articles. This
includes the use of 1-BP in aerosolized products for cleaning or
degreasing in electronic degreasers.
ii. Consumer Use in Spot Cleaners or Stain Removers
This condition of use refers to the consumer use of 1-BP for
cleaning and furniture care in the form of spot cleaners or stain
removers to remove dirt, grease, stains, and foreign matter from
furniture or furnishings, or to cleanse, sanitize, or improve the
appearance of surfaces.
iii. Consumer Use in Liquid Cleaners (e.g., Coin and Scissor Cleaners)
This condition of use refers to the consumer use of 1-BP in liquid
cleaning products to dissolve oils, greases, and stains, or to cleanse,
sanitize, or improve the appearance of surfaces.
iv. Consumer Use in Liquid Spray/Aerosol Cleaners
This condition of use refers to the consumer use of 1-BP in liquid
and aerosolized products for cleaning and furniture care to remove
dirt, grease, and stains, or to cleanse, scour, polish, protect, or
improve the appearance of surfaces.
v. Consumer Use in Arts, Crafts and Hobby Materials (Adhesive
Accelerant)
This condition of use refers to the consumer use of 1-BP in
aerosolized products for arts, crafts, and hobby activities to
accelerate the time it takes for the adhesive to dry.
vi. Consumer Use in Automotive Care Products (Refrigerant Flush)
This condition of use refers to the consumer use of 1-BP in liquid
cleaning products to dissolve and flush out foreign materials from
coils of an automobile AC coil.
vii. Consumer Use in Anti-Adhesive Agents (Mold Cleaning and Release
Products)
This condition of use refers to the consumer use of 1-BP in
products for mold cleaning and release. These products are used as
anti-adhesive agents to prevent bonding between other substances by
discouraging surface attachments.
e. Disposal
This condition of use refers to the process of disposing generated
waste streams of 1-BP that are collected and transported to a third-
party site for their final disposition, such as waste incineration or
landfilling.
f. Terminology in This Proposed Rule
For purposes of this proposed rulemaking, ``occupational conditions
of use'' refers to the TSCA conditions of use described in Units
III.B.1.a., b., c., and e. Although EPA identified both industrial and
commercial uses in the 2020 Risk Evaluation for 1-BP for purposes of
distinguishing scenarios, the Agency clarified then and clarifies now
that EPA interprets the authority Congress gave to the Agency to
``regulat[e] any manner or method of commercial use'' under TSCA
section 6(a)(5) to reach both industrial and commercial uses.
Additionally, in the 2020 Risk Evaluation for the chemical
substance 1-BP, EPA identified and assessed all known, intended, and
reasonably foreseen industrial, commercial, and consumer uses of 1-BP,
and determined in the December 2022 final revised unreasonable risk
determination that 1-BP as a whole chemical substance presents
unreasonable risks to health and the environment. EPA determined that
all industrial, commercial, and consumer uses of 1-BP evaluated in the
2020 Risk Evaluation for 1-BP contribute to the EPA determination that
1-BP presents unreasonable risk of injury to health, except for the use
of 1-BP in insulation. As such, for purposes of this risk management
rulemaking, ``consumer use'' refers to all known, intended, and
reasonably foreseen consumer uses of 1-BP, except for the use of 1-BP
in insulation. Likewise, for the purpose of this risk management
rulemaking, ``industrial and commercial use'' refers to all industrial
and commercial uses, including known, intended, or reasonably foreseen
1-BP industrial and commercial use, except for the use of 1-BP in
insulation.
EPA is not proposing to incorporate the descriptions of known,
intended or reasonably foreseen uses in Unit III.B.1.a. through e. into
the regulatory text as definitions because these uses represent the
specific uses evaluated in the 2020 Risk Evaluation for 1-BP. This risk
evaluation was used to inform EPA's determination that 1-BP presents
unreasonable risk. EPA requests comment on whether EPA should
promulgate definitions for those conditions of use evaluated in the
2020 Risk Evaluation for 1-BP that would not be prohibited, and, if so,
whether the descriptions in this unit are consistent with the
conditions of use evaluated in the 2020 Risk Evaluation for 1-BP and
whether they provide a sufficient level of detail to improve the
clarity and readability of the regulation if EPA were to promulgate a
regulation that contains a list of the industrial and commercial
conditions of use evaluated in the 2020 Risk Evaluation for 1-BP.
EPA also requests comment on whether, rather than just excluding
the consumer and commercial uses of 1-BP in insulation from the
prohibitions and other requirements in this risk management rulemaking,
EPA should more broadly exclude the use of articles under TSCA section
6(c)(2)(E), which would also exclude the use of 1-BP in articles that
were not specifically evaluated in the 2020 Risk Evaluation for 1-BP,
and if so, whether and how to define ``article'' for the purposes of
this rulemaking.
EPA further notes that this proposed rule does not apply to any
substance excluded from the definition of ``chemical substance'' under
TSCA 3(2)(B)(ii) through (vi). Those exclusions include, but are not
limited to, any pesticide (as defined by the Federal Insecticide,
Fungicide, and Rodenticide Act) when manufactured, processed, or
distributed in commerce for use as a pesticide; and any food, food
additive, drug, cosmetic, or device, as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (FFDCA), when manufactured,
processed, or distributed in commerce for use as a food, food additive,
drug, cosmetic or device.
2. Description of Unreasonable Risk Under the Conditions of Use
EPA has determined that 1-BP presents an unreasonable risk of
injury to human health under the conditions of use based on acute and
chronic non-cancer risks and chronic cancer risks (Ref. 2). As
described in the TSCA
[[Page 65079]]
section 6(b) 2020 Risk Evaluation for 1-BP, EPA identified non-cancer
adverse effects from acute and chronic inhalation and dermal exposures
to 1-BP, and cancer from chronic inhalation and dermal exposures to 1-
BP (Ref. 1). For this proposed rulemaking, EPA has determined that
protecting people from 1-BP-related cancer would also protect people
from unreasonable risks for other 1-BP-related acute or chronic adverse
health effects. EPA identified non-cancer adverse effects from acute
inhalation and dermal exposures and non-cancer adverse effects from
chronic inhalation and dermal exposures for all conditions of use (Ref.
1). Additional risks associated with other adverse effects (e.g.,
developmental toxicity, reproductive toxicity, liver toxicity, kidney
toxicity, neurotoxicity) were identified for acute and chronic
exposures. EPA also concluded, based on EPA's Guidelines for Carcinogen
Risk Assessment (Ref. 30), that 1-BP is considered to be carcinogenic
to workers and ONUs by all routes of exposure and calculated cancer
risks from chronic inhalation and dermal exposures. Unit VI.A.
summarizes the health effects and the magnitude of the exposures (Ref.
1).
To make the unreasonable risk determination for 1-BP, EPA evaluated
exposures to workers, ONUs, consumer users, and bystanders to consumer
use, using reasonably available monitoring and modeling data for
inhalation and dermal exposures (Ref. 2). The August 2020 Risk
Evaluation for 1-BP did assess the water pathway based on environmental
fate characteristics and monitoring and modeling data. Based on this
analysis, EPA determined that 1-BP would be unlikely to be present in
surface water (Ref. 1). EPA conducted a screening level analysis to
determine whether there may be potential risks from the ambient air
pathway to fenceline communities. A discussion of EPA's analysis and
the expected effects of this rulemaking on fenceline communities and
the ongoing revisions of National Emission Standards for Hazardous Air
Pollutants (NESHAPs) under the CAA is in Unit VI.A.
For the 2020 Risk Evaluation for 1-BP, EPA considered PESS. EPA
identified the following groups as PESS: workers, ONUs, consumers,
bystanders, and those with certain pre-existing health conditions,
higher body fat content, or particular genetic polymorphisms (Ref. 1).
Furthermore, the developing fetus and (by extension) women of
childbearing age were identified as susceptible life stages (Ref. 1).
All PESS and susceptible life stages are included in the quantitative
and qualitative analyses described in the risk evaluation and were
considered in the determination of unreasonable risk for 1-BP. As
discussed in Units II.D. and VI.A., the 2020 Risk Evaluation for 1-BP
did not fully assess the ambient air exposure pathways to the general
population in the published risk evaluation; this may have caused some
risks to be unaccounted for in the risk evaluation and in EPA's risk
determination. EPA considers people in communities in proximity to
facilities using 1-BP who are exposed to 1-BP through the ambient air
pathway to constitute a subset of the general population and
categorizes them as fenceline communities; they may also be considered
PESS. See Unit VI.A. for further discussion on assessing and protecting
against risk to fenceline communities.
3. Description of TSCA Section 6 Requirements for Risk Management
EPA examined the TSCA section 6(a) requirements (listed in Unit
III.A.) to identify which ones have the potential to eliminate the
unreasonable risk for 1-BP. This unit summarizes the TSCA section 6
considerations for issuing regulations under TSCA section 6(a). Unit V.
outlines how EPA applied these considerations specifically to managing
the unreasonable risk from 1-BP.
As required, EPA developed a proposed regulatory action and one or
more primary alternative regulatory actions, which are described in
Units IV.A. and IV.B., respectively. To identify and select a
regulatory action, EPA considered the two routes of exposure driving
the unreasonable risk, inhalation and dermal, and the exposed
populations. For occupational conditions of use (see Unit III.B.1.f.),
EPA considered how it could directly regulate manufacturing (including
import), processing, distribution in commerce, industrial and
commercial use, or disposal to address the unreasonable risk. EPA does
not have direct authority to regulate consumer use. Therefore, EPA
considered how it could exercise its authority under TSCA to regulate
the manufacturing (including import), processing, and/or distribution
in commerce of 1-BP at different points in the supply chain to
eliminate exposures or restrict the availability of 1-BP and 1-BP-
containing products for consumer use in order to address the
unreasonable risk.
As required by TSCA Section 6(c)(2), EPA considered several
factors, in addition to identified unreasonable risk, when selecting
among possible TSCA section 6(a) requirements. To the extent
practicable, EPA factored into its decisions: (1) the effects of 1-BP
on health and the environment, (2) the magnitude of exposure to 1-BP of
human beings and the environment, (3) the benefits of 1-BP for various
uses, and (4) the reasonably ascertainable economic consequences of the
rule. In evaluating the reasonably ascertainable economic consequences
of the proposed rule, EPA considered (1) the likely effect of the
proposed rule on the national economy, small business, technological
innovation, the environment, and public health, (2) the costs and
benefits of the proposed regulatory action and one or more primary
alternative regulatory actions considered, and (3) the cost
effectiveness of the proposed regulatory action and of the one or more
primary alternative regulatory actions considered. See Unit VI. for
further discussion related to TSCA section 6(c)(2)(A) considerations,
including the statement of effects of the proposed rule with respect to
these considerations.
EPA also considered the regulatory authority under TSCA and other
statutes such as the OSH Act, the Consumer Product Safety Act (CPSA),
and other EPA-administered statutes to examine (1) whether there are
opportunities for all or part of risk management action on 1-BP to be
addressed under other statutes, such that a referral may be warranted
under TSCA sections 9(a) or 9(b); or (2) whether TSCA section 6(a)
regulation could include alignment of requirements and definitions in
and under existing statutes to minimize confusion to the regulated
entities and the general public.
In addition, EPA followed other TSCA requirements such as
considering the availability of alternatives when contemplating
prohibition or a substantial restriction (TSCA section 6(c)(2)(C), as
outlined in Unit V.B.), and setting proposed compliance dates in
accordance with the requirements in TSCA section 6(d)(1) (described in
the proposed and alternative regulatory actions in Unit IV.).
To the extent information was reasonably available, when selecting
regulatory actions, EPA considered pollution prevention and the
hierarchy of controls adopted by OSHA and NIOSH, with the goal of
identifying risk management control methods that are permanent,
feasible, and effective. EPA also considered how to address the
unreasonable risk while providing flexibility to the regulated entities
where appropriate. EPA considered the information presented in the 2020
Risk Evaluation for 1-BP, as well as additional input from stakeholders
(as described in Unit III.A.), and anticipated
[[Page 65080]]
compliance strategies from regulated entities.
Taken together, these considerations led EPA to the proposed
regulatory action and primary alternative regulatory actions described
in Unit IV. Additional details related to how the requirements in this
unit were incorporated into development of those actions are in Unit V.
As demonstrated by the number of distinct programs addressed in
this rulemaking and the structure of this proposed rule in addressing
them independently, EPA generally intends the rule's provisions to be
severable from each other. EPA expects to provide additional detail on
severability in the final rule once the Agency has considered public
comments and finalized the regulatory language.
IV. Proposed and Alternative Regulatory Actions
This unit describes the proposed regulatory action by EPA so that
1-BP will no longer present an unreasonable risk of injury to health.
In addition, as indicated by TSCA section 6(c)(2)(A), EPA must consider
the costs and benefits and the cost-effectiveness of the proposed
regulatory action and one or more primary alternative regulatory
actions. In the case of 1-BP, the proposed regulatory action is
described in Unit IV.A. and the two alternative regulatory actions
considered are described in Unit IV.B. An overview of the proposed
regulatory action and two alternative regulatory actions for each
condition of use is in Unit IV.C. The rationale for the proposed and
alternative regulatory actions and associated compliance timeframes are
discussed in this unit and in more detail in Unit V.A.
A. Proposed Regulatory Action
EPA is proposing under TSCA section 6(a) to: (1) prohibit the
manufacture (including import), processing, and distribution in
commerce of 1-BP for all consumer uses, excluding the use of 1-BP in
insulation, outlined in Unit IV.A.1.b.; (2) prohibit the industrial and
commercial use of 1-BP for four occupational uses, and the manufacture
(including import), processing, and distribution in commerce of 1-BP
for those uses, outlined in Unit IV.A.1.a.; (3) require strict
workplace controls, including a 1-BP WCPP, which would include
requirements to meet an inhalation exposure concentration limit and use
of gloves for seven occupational conditions of use, outlined in Unit
IV.A.2.; (4) require self-certification, which would document the
purchaser's commitment to comply with the 1-BP WCPP, for six
occupational conditions of use, outlined in Unit IV.A.1.4.; (5) require
the use of prescriptive controls for six occupational conditions of
use, outlined in Unit IV.A.1.3.; and (6) establish recordkeeping and
downstream notification requirements, outlined in Unit IV.A.5. Pursuant
to TSCA section 12(a)(2), this proposed rule would apply to 1-BP even
if being manufactured, processed, or distributed in commerce solely for
export from the United States because EPA has determined that 1-BP
presents an unreasonable risk to health within the United States or to
the environment of the United States.
EPA notes that some uses identified for prohibitions, the WCPP, or
self-certification were identified within larger conditions of use in
the 2020 Risk Evaluation for 1-BP. The regulatory action proposed for
each use is described in this unit, and the rationale is provided in
Unit V.
1. Prohibitions of Manufacturing, Processing, Distribution in Commerce,
and Use
a. Prohibition of Certain Industrial and Commercial Uses and
Manufacturing, Processing, and Distribution of 1-BP for Those Uses
EPA is proposing to prohibit the manufacturing, processing,
distribution in commerce, and use of 1-BP for industrial and commercial
uses of 1-BP except for those uses which would continue under the WCPP,
self-certification, and/or prescriptive controls. The proposed
prohibitions under TSCA would not apply to any use of 1-BP that is
excluded from TSCA's definition of ``chemical substance'' under TSCA
section 3(2)(B)(ii)(vi). This proposed prohibition would include a
prohibition on the manufacturing (including import), processing,
distribution in commerce, and use of 1-BP for the following industrial
and commercial uses:
<bullet> In adhesives and sealants;
<bullet> In dry cleaning solvents, spot cleaners and stain
removers;
<bullet> In coin and scissor cleaner (liquid, spray, or aerosol
cleaners); and
<bullet> In other uses in arts, crafts, hobby materials (adhesive
accelerant); automotive care products (engine degreaser, brake cleaner,
refrigerant flush); anti-adhesive agents (mold cleaning and release
product); functional fluids (closed/open-systems)--refrigerant/cutting
oils.
As discussed in Units III.B.3. and V.A., based on consideration of
alternatives under TSCA section 6(c)(2)(C), uncertainty relative to the
feasibility of exposure reduction to sufficiently address the
unreasonable risk across the broad ranges of work environments and
activities, and the irreversible health effects associated with 1-BP
exposures, EPA has determined that prohibition is the best way to
address the unreasonable risks from 1-BP contributed by the conditions
of use identified in this unit. As noted in Unit III.B.1.f., this
proposal does not apply to any substance excluded from the definition
of ``chemical substance'' under TSCA section 3(2)(B)(ii) through (vi).
EPA is proposing to stagger the compliance dates for the proposed
prohibitions described in this unit, such that the requirements would
come into effect in 6 months for manufacturers, 9 months for
processors, 12 months for distributing to retailers, 15 months for all
distributors (including retailers), and 18 months for industrial and
commercial users after the publication date of the final rule. When
proposing these compliance dates as required under TSCA section 6(d),
EPA considered the irreversible health effects and risks associated
with 1-BP exposure. EPA has no reasonably available information
indicating that the proposed compliance dates are not practicable for
the activities that would be prohibited, or that additional time would
be needed for products to clear the channels of trade. For 1-BP, for
the conditions of use EPA is proposing to prohibit, the Agency believes
either 1-BP may no longer be used, or regulated entities would be able
to meet the proposed regulatory compliance timeframes, due to
availability of alternatives. EPA recognizes that for other proposed
regulations under TSCA section 6, including methylene chloride (88 FR
28284, May 3, 2023 (FRL-8155-02-OCSPP), perchloroethylene (88 FR 39652,
June 16, 2023) (FRL-8329-02-OCSPP), and carbon tetrachloride (88 FR
49180, July 28, 2023) (FRL-8206-01-OCSPP), public comments have
provided information in support of longer compliance timeframes.
Similarly, for 1-BP, EPA requests comment on whether additional time is
needed, for example, for products to clear the channels of trade, or
for implementing the use of substitutes; comments should include
documentation such as the specific use of the chemical throughout the
supply chain; concrete steps taken to identify, test, and qualify
substitutes for those uses (including details on the substitutes tested
and the specific certifications that would require updating); and
estimates of the time
[[Page 65081]]
required to identify, test, and qualify substitutes with supporting
documentation. EPA also requests comment on whether there are other
considerations that should apply. EPA may finalize shorter or
significantly longer compliance timeframes based on consideration of
public comments. EPA would also like comment on whether it should
consider a de minimis level of 1-BP in formulations for certain
continuing industrial and commercial uses to account for impurities
(e.g., 0.1% or 0.5%) when finalizing these prohibitions, and, if so,
what level should be considered de minimis.
b. Prohibition of Manufacturing, Processing and Distribution in
Commerce of 1-BP for Consumer Use
In the 2020 Risk Evaluation for 1-BP, EPA evaluated consumer uses
of 1-BP:
<bullet> As a solvent in aerosol spray degreasers/cleaners;
<bullet> In spot cleaners and stain removers;
<bullet> In liquid coin cleaners (e.g., coin and scissor cleaners);
<bullet> In liquid spray/aerosol cleaners;
<bullet> In arts, crafts, hobby materials (adhesive accelerant);
<bullet> In automotive care products (refrigerant flush);
<bullet> In anti-adhesive agents (mold cleaning and release
products); and
<bullet> In building/construction materials in insulation.
The consumer uses evaluated in the 2020 Risk Evaluation for 1-BP
constitute all known, intended, and reasonably foreseen consumer uses
of 1-BP. EPA determined that all of these consumer uses, except for the
use of 1-BP in insulation, contribute to unreasonable risk of injury to
health. As such, for purposes of this risk management rulemaking,
``consumer use'' refers to all consumer uses including known, intended,
and reasonably foreseen consumer uses for 1-BP. EPA is proposing to
prohibit the manufacturing, processing, and distribution in commerce of
1-BP for consumer use, except for the consumer use of 1-BP in
insulation.
As discussed in Units III.B.3. and V.A., based on consideration of
the severity of the hazards of 1-BP in conjunction with the limited
options available to adequately address the identified unreasonable
risk to consumers and bystanders under TSCA section 6(a), EPA is
proposing to address the unreasonable risk from consumer use by
prohibiting the manufacturing (including import), processing, and
distribution in commerce of 1-BP for consumer use, in order to remove
1-BP and products containing 1-BP from the market, thereby effectively
eliminating instances of consumer use that contribute to the
unreasonable risk of injury to health.
Additionally, EPA is proposing to prohibit retailers from
distributing in commerce 1-BP, including any 1-BP-containing products
except insulation products, in order to prevent products intended for
industrial and commercial use from being purchased by consumers. A
retailer is any person or business entity that distributes or makes
available chemical substances or products containing chemical
substances to consumers, including through e-commerce internet sales or
distribution. If a person or business entity distributes or makes
available any product to at least one consumer, then it is considered a
retailer (as EPA proposes to define that term in 40 CFR 751.5). For a
distributor not to be considered a retailer, the distributor must
distribute or make available chemical substances solely to commercial
or industrial end-users or businesses. Prohibiting manufacturers
(including importers), processors, and distributors from distributing
1-BP, or any products except insulation containing 1-BP, to retailers
would prevent retailers from making these products available to
consumers, which would help address that part of the unreasonable risk
associated with consumer use of 1-BP. EPA is requesting comment on
commercial distribution channels or systems that would allow for
distribution to commercial users while preventing retailers from making
these products available to consumers, or feasible distribution
channels for commercial users that have been developed in analogous
situations, including information on whether there are market barriers
to such systems.
EPA is proposing that the prohibitions of manufacturing,
processing, and distribution in commerce of 1-BP for consumer use
described in this unit would become effective in 6 months for
manufacturers, 9 months for processers, 12 months for distributing to
retailers, and 15 months for all other distributors (including
retailers) after the publication date of the final rule in the Federal
Register. EPA considered the irreversible health effects and risks
associated with 1-BP when proposing compliance dates. EPA has no
reasonably available information indicating these proposed compliance
dates are not practicable for the activities that would be prohibited,
or that additional time is needed for products to clear the channels of
trade. However, EPA requests comment on whether additional time is
needed, for example, for products to clear the channels of trade. EPA
may finalize shorter or significantly longer compliance timeframes
based on public comment.
2. Workplace Chemical Protection Program (WCPP)
a. Overview
As described in Unit III.B.3., under TSCA section 6(a), EPA is
required to issue a regulation applying one or more of the TSCA section
6(a) requirements to the extent necessary so that the unreasonable risk
of injury to health or the environment from a chemical substance is no
longer presented. The TSCA section 6(a) requirements provide EPA the
authority to limit or restrict a number of activities, alone or in
combination, including the manufacture, processing, distribution in
commerce, commercial use, and disposal of the chemical substance. Given
this authority, EPA may find it appropriate in certain circumstances to
propose requirements under a WCPP for certain occupational (i.e.,
manufacturing, processing, industrial and commercial use, and disposal)
conditions of use. A WCPP for 1-BP would encompass the inhalation
exposure limit and action level, the associated implementation
requirements, and may include other components, such as respiratory
protection or dermal protection, as described in this unit to ensure
that the chemical substance no longer presents unreasonable risk. Under
a WCPP, owners or operators would have some flexibility, within the
parameters outlined in this unit, regarding how they prevent
exceedances of the identified EPA exposure limit thresholds. In the
case of 1-BP, meeting the EPA exposure limits, in tandem with other
requirements as listed in this proposed rule, for certain occupational
conditions of use would address unreasonable risk to potentially
exposed persons from inhalation and dermal exposure.
EPA uses the term ``potentially exposed person'' in this unit and
in the regulatory text to include workers, occupational non-users,
employees, independent contractors, employers, and all other persons in
the work area where 1-BP is present and who may be exposed to 1-BP
under the conditions of use for which a WCPP would apply. One important
reason to define a potentially exposed person for the purposes of a
WCPP as any person who may be exposed in the workplace is to emphasize
the broad scope of exposures which must be categorized when
[[Page 65082]]
implementing a WCPP. EPA notes that this definition is intended to
apply only in the context of risk management, and specifically in the
context of a WCPP (e.g., workers directly using the chemical, workers
in the vicinity of the use, students in a laboratory setting). The term
is not intended as a replacement for the term Potentially Exposed or
Susceptible Subpopulation as defined by TSCA section 3(12). EPA
additionally recognizes that other individuals or communities may be
exposed to 1-BP as consumers, members of fenceline communities, or
members of the general population, which is separate and apart from
those potentially exposed for the purposes of the regulatory
requirements of the WCPP. In those instances, where regulatory
requirements address exposures unrelated to a WCPP EPA would use
distinct terminology to refer to those other populations. EPA's
intention is to require a comprehensive WCPP that would address the
unreasonable risk from 1-BP to potentially exposed persons directly
handling the chemical or in the area where the chemical is being used.
Similarly, the 2020 risk evaluation for 1-BP did not distinguish
between employers, contractors, or other legal entities or businesses
that manufacture, process, distribute in commerce, use, or dispose of
1-BP. EPA uses the term ``owner or operator'' to describe the entity
responsible for implementing the WCPP for workplaces where an
applicable condition of use of 1-BP is occurring. The term includes any
person who owns, leases, operates, controls, or supervises such a
workplace.
An ECEL is a risk-based inhalation exposure threshold. The ECEL
would be accompanied by monitoring, training, recordkeeping and other
requirements to help ensure that the threshold is not exceeded. With an
ECEL, regulated entities have some flexibility, within certain
parameters outlined in this unit, for preventing exceedances of the
identified exposure threshold. Therefore, EPA generally refers to the
ECEL and ancillary requirements as a non-prescriptive approach. In the
case of 1-BP, the exposure threshold identified by EPA for certain
occupational conditions of use would mitigate unreasonable risks from
inhalation exposure contributed by those conditions of use for
potentially exposed persons.
This unit includes a summary of the proposed 1-BP WCPP, including a
description of the ECEL; proposed implementation requirements and a
TSCA ECEL action level; proposed monitoring requirements; a description
of potential exposure controls, which consider the hierarchy of
controls; information that may be used to inform PPE selection; and
additional requirements proposed for recordkeeping, and worker
training, participation, and notification. This unit also describes
compliance timeframes for these proposed requirements.
b. Existing Chemical Exposure Limit (ECEL)
i. ECEL and ECEL Action Level
To reduce exposures in the workplace and address the unreasonable
risk of injury to health resulting from inhalation exposures to 1-BP
identified under the occupational conditions of use in the TSCA 2020
Risk Evaluation for 1-BP, EPA is proposing an ECEL of 0.05 parts per
million (ppm) (0.25 mg/m3) for inhalation exposures to 1-BP as an 8-
hour TWA. This ECEL is based on the cancer inhalation unit risk (IUR)
at a risk level of 1 x 10<SUP>-4</SUP>, which is the most sensitive
hazard value across acute, chronic non-cancer, and cancer endpoints,
(Refs. 12, 1). As described in the ECEL memo documenting EPA's approach
for determining the exposure limit, EPA expects that, at the ECEL value
of 0.05 ppm based on the cancer endpoint, a worker or ONU is protected
against other endpoints, including developmental effects.
EPA has determined, as a matter of risk management policy, that
ensuring exposures remain at or below the ECEL would eliminate the
contribution to the unreasonable risk of injury to health for 1-BP
resulting from inhalation exposures in an occupational setting. EPA is
proposing to establish requirements to meet an ECEL as part of the WCPP
for:
<bullet> Manufacturing (domestic manufacturing);
<bullet> Processing as incorporation into a formulation, mixture,
or reaction products;
<bullet> Industrial and commercial use as a solvent in open-top and
in-line batch vapor degreasing;
<bullet> Industrial and commercial use as a solvent in closed-loop
vapor degreasing;
<bullet> Industrial and commercial use as a solvent for cleaning
and degreasing in cold cleaners;
<bullet> Industrial and commercial use as a solvent in aerosol
spray degreaser/cleaner; and
<bullet> Industrial and commercial use in other uses in electronic
and electronic products and metal products; laboratory chemicals;
asphalt extraction; and coatings for temperature indicators.
Each owner or operator of a workplace where these conditions of use
occur would be responsible for compliance with the ECEL and the
associated requirements. EPA's description for how the requirements
related to an ECEL would address the unreasonable risk resulting from
inhalation exposures and the rationale for this regulatory approach are
outlined in Units III.B.3. and V.A.
If ambient exposures are kept at or below the 8-hour ECEL of 0.05
ppm, EPA expects that a potentially exposed person in the workplace
would be protected against non-cancer effects resulting from
occupational exposures, as well as excess risk of cancer (Ref. 12).
EPA is also proposing to establish an ECEL action level of 0.03 ppm
as an 8-hour TWA for 1-BP. Air concentrations at or above the action
level would trigger more frequent periodic monitoring of exposures to
1-BP, as described in this unit. EPA is proposing to adopt the action
level approach in implementing the TSCA ECEL, consistent with the
action level approach utilized by OSHA in the implementation of OSHA
standards. As explained by OSHA, due to the variable nature of employee
exposures, compliance with an action level provides employers with
greater assurance that their employees will not be exposed to
concentrations above the PELs (Ref. 31). EPA agrees with this reasoning
and, like OSHA, expects the inclusion of an ECEL action level will
stimulate innovation within industry to reduce exposures to levels
below the action level. Therefore, EPA has identified a need for an
action level for 1-BP and is proposing a level that is lower than the
8-hour ECEL, which is in alignment with the precedented approach
established under most OSHA standards. EPA is soliciting comment
regarding an ECEL action level that is lower than the ECEL.
In summary, EPA is proposing that each owner or operator of a
workplace subject to the ECEL must ensure that no person is exposed to
airborne concentration of 1-BP in excess of 0.05 ppm as an 8-hr TWA,
with an action level identified as 0.03 ppm as an 8-hr TWA. For
conditions of use for which requirements to meet an ECEL are being
proposed, EPA believes that the regulated community has the ability to
detect the values for the ECEL and ECEL action level as they are above
the threshold of 1-BP monitoring devices, which can detect
concentration levels as low as <=0.0005 ppm (Ref. 12). The Agency has
also identified personal breathing zone air sampling devices with a
minimum limit of quantitation and level of detection at the ECEL level.
(Ref. 12) EPA is requesting comment on
[[Page 65083]]
issues around the viability of current analytical methods and detection
limits for occupational 1-BP sampling and/or monitoring methods,
including information on the availability of laboratory capacity needed
to meet the proposed standard, and the costs associated with such
testing. EPA's methodology and inputs for the ECEL value are directly
derived from the peer reviewed analysis in the August 2020 Risk
Evaluation, which was also subject to public comment. See Ref 2 for
additional information on the ECEL value and cancer risk. As with all
aspects of this rulemaking, the public is welcome to comment on the
methodology for the ECEL value and ECEL action level.
EPA expects that many workplaces already have stringent controls in
place that reduce exposures to 1-BP; for some workplaces, including
those engaged in vapor degreasing, cold cleaning, and use of 1-BP in
electronics and electronic products, EPA understands that these
existing controls may already reduce 1-BP air concentration levels to
near or below the ECEL (Ref. 32). As discussed further in Unit V.A.1.,
for some conditions of use for which EPA is proposing the ECEL, data
were submitted during the risk evaluation that indicate inhalation
exposures may already be near or below the ECEL for some facilities,
indicating that such facilities may already be in compliance with the
proposed ECEL. As noted previously in this unit, EPA expects that, if
inhalation exposures for affected occupational conditions of use are
kept at or below the ECEL, potentially exposed persons reasonably
likely to be exposed in the workplace would be protected from the
unreasonable risk.
EPA is also proposing to require owners or operators to comply with
additional requirements under the WCPP that would be needed to ensure
successful implementation of the ECEL.
ii. Monitoring Results
Overview. Monitoring requirements are a key component of
implementing EPA's proposed WCPP. Initial monitoring for 1-BP is
critical for establishing a baseline of exposure for potentially
exposed persons; similarly, periodic exposure monitoring assures
continued compliance so that potentially exposed persons in the
workplace are not exposed to levels that would result in an
unreasonable risk of injury. Periodic exposure monitoring frequency
could change if certain conditions are met, which are described in this
unit. Additionally, in some cases, a change in workplace conditions
with potential to impact exposure levels would warrant additional
monitoring, which is also described. To ensure compliance with
monitoring activities, EPA proposes exposure monitoring recordkeeping
requirements outlined in this unit.
Initial Exposure Monitoring. Under the proposed regulation, each
owner or operator of a workplace where any conditions of use listed
earlier in this unit is occurring would be required to perform initial
exposure monitoring to determine the extent of exposure of potentially
exposed persons to 1-BP. Initial monitoring would notify owner or
operators of the magnitude of possible exposures to their potentially
exposed persons with respect to their unique work conditions and
environments. The results of the initial exposure monitoring would
determine the frequency of future periodic monitoring, whether
additional exposure controls are necessary (such as engineering
controls, administrative controls, and/or respiratory protection), and
whether the owner or operator would need to demarcate a regulated area
as described in this unit.
EPA is proposing to require each owner or operator to establish an
initial baseline monitoring sample to determine the magnitude of
exposure for all persons who may be exposed to 1-BP within 33 months
for Federal agencies and Federal contractors acting for or on behalf of
the Federal Government and within 6 months after the date of
publication of the final rule in the Federal Register for non-Federal
owners and operators, or within 30 days of introduction of 1-BP into
the workplace, whichever is later. Where 1-BP is present in the
workplace, each owner or operator would be required to determine each
potentially exposed person's exposure by either taking a personal
breathing zone air sample of each potentially exposed person or taking
personal breathing zone air samples that are representative of each
potentially exposed person's exposure performing the same or
substantially similar operations in each work shift, in each job
classification, and in each work area (hereinafter identified as an
``exposure group''). Personal breathing zone air samples are
representative of the 8-hour TWA of all potentially exposed persons in
an exposure group if the samples are of at least one person's full-
shift exposure who represents the highest potential 1-BP exposures in
that exposure group. Monitoring samples must be taken when and where
the operating conditions are best representative of each potentially
exposed person's full-shift exposures. EPA expects that owners and
operators would attempt to monitor a baseline for all of the tasks
during the same timeframe; however, EPA understands that certain tasks
occur less frequently, and EPA is soliciting comments regarding the
timing of the initial exposure monitoring so that it would be
representative of all tasks involving 1-BP where exposures may approach
the ECEL action level. If the owner or operator chooses a
representative sample, such sampling must include persons that are the
closest to the source of 1-BP, so that the monitoring results are
representative of the most highly exposed persons in the workplace.
EPA also recognizes that some entities may already have exposure
monitoring data. If the owner or operator has monitoring data conducted
within five years prior to the effective date of the final rule and the
monitoring satisfies all other requirements of this section, including
the requirement that the data represent the highest 1-BP exposures
likely to occur under reasonably foreseeable conditions of use, the
owner or operator may rely on such earlier monitoring results for the
initial baseline monitoring sample.
Periodic exposure monitoring. EPA is proposing to require each
owner or operator to conduct, for those exposure groups that exceed the
following airborne concentration levels, the following periodic
monitoring:
<bullet> If samples taken during the initial exposure monitoring
reveal a concentration below the ECEL action level (<0.03 ppm 8-hr
TWA), the owner or operator must repeat the periodic exposure
monitoring at least once every 5 years.
<bullet> If the most recent exposure monitoring indicates that
airborne exposure is above the ECEL (>0.05 ppm 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within 3
months of the most recent exposure monitoring.
<bullet> If the most recent exposure monitoring indicates that
airborne exposure is at or above the ECEL action level (>= 0.03 ppm 8-
hour TWA) but at or below the ECEL (<= 0.05 ppb 8-hour TWA), the owner
or operator must repeat the periodic exposure monitoring within 6
months of the most recent exposure monitoring.
<bullet> If the most recent (non-initial) exposure monitoring
indicates that airborne exposure is below the ECEL action level, the
owner or operator must repeat such monitoring within 6 months of the
most recent monitoring until two consecutive monitoring measurements,
taken at least seven days apart, are below the ECEL action level (<0.03
ppb 8-hour TWA), at which time the owner
[[Page 65084]]
or operator must repeat the periodic exposure monitoring at least once
every 5 years.
Additionally, in instances where an owner or operator does not
manufacture, process, use, or dispose of 1-BP for a condition of use
for which the WCPP is proposed over the entirety of time since the last
required periodic monitoring event, EPA is proposing that the owner or
operator would be permitted to forgo the next periodic monitoring
event. However, documentation of cessation of use of 1-BP would be
required and periodic monitoring would be required to resume should the
owner or operator restart any of the conditions of use listed in Unit
IV.A.2. for which the WCPP is proposed. The timeframe for periodic
monitoring after an owner or operator restarts a condition of use would
be based on the most recent monitoring measurements and the timeframe
would begin from the date of restart.
The proposed periodic monitoring requirements are also outlined in
Table 1. EPA requests comment on the proposed timeframes for periodic
monitoring outlined in this unit. EPA may finalize significantly
shorter or longer compliance timeframes based on public comment.
Table 1--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If initial exposure monitoring is below Periodic exposure monitoring is
the ECEL action level (<0.03 ppm 8- required at least once every
hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within 3 months of
above the ECEL (>0.05 ppm 8-hr TWA). the most recent exposure
monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within 6 months of
or above the ECEL action level, but at the most recent exposure
or below the ECEL (>= 0.03 ppm 8-hr monitoring.
TWA, <= 0.05 ppm 8-hr TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within 5 years of the
taken at least seven days apart within most recent exposure
a 6 month period, indicate exposure is monitoring.
below the ECEL action level (<0.03 ppm
8-hr TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which the ECEL the next periodic monitoring
would be required but does not event. However, documentation
manufacture, process, use, or dispose of cessation of use of 1-BP is
of 1-BP in that condition of use over required and periodic
the entirety of time since the last monitoring would be required
required monitoring event. immediately when the owner or
operator resumes any condition
of use.
------------------------------------------------------------------------
Additional exposure monitoring. In addition to the initial and
periodic exposure monitoring, EPA is proposing that each owner or
operator conduct additional exposure monitoring within 30 days after
there has been a change in the production, process, control equipment,
personnel or work practices that may reasonably be expected to result
in new or additional exposures at or above the ECEL action level, or
when the owner or operator has any reason to believe that new or
additional exposures at or above the ECEL action level have occurred,
for example if an owner or operator receives information from
potentially exposed person(s) suggesting that such new or additional
exposures may have occurred. In the event of start-up, shutdown,
spills, leaks, ruptures or other breakdowns or unexpected releases that
may lead to employee exposure, EPA is proposing that each owner or
operator must conduct exposure monitoring of potentially exposed
persons (using personal breathing zone sampling) within 30 days after
the conclusion of the start-up or shutdown and/or the cleanup of the
spill or repair of the leak, rupture or other breakdown. An additional
exposure monitoring event may result in an increased frequency of
periodic monitoring. For example, if the initial monitoring results
from a workplace are above the ECEL action level, but below the ECEL,
periodic monitoring is required every 6 months. If additional
monitoring is performed because increased exposures are suspected, and
the results are above the ECEL, subsequent periodic monitoring would
have to be performed every 3 months. The required additional exposure
monitoring should not delay implementation of any necessary cleanup or
other remedial action to reduce the exposures to persons in the
workplace.
EPA is requesting comment on the proposed timeframe of within 30
days to conduct additional exposure monitoring after there has been a
change in the production, process, control equipment, personnel or work
practices may reasonably be expected to result in new or additional
exposures at or above the ECEL action level, or when the owner or
operator has any reason to believe that new or additional exposures at
or above the ECEL action level have occurred. EPA is also requesting
comment on the proposed timeframe of within 30 days to conduct
additional exposure monitoring after the cleanup of the spill or repair
of the leak, rupture or other breakdown.
Other monitoring requirements. For each monitoring event, EPA is
proposing to require owners or operators to ensure that their methods
are accurate, to a confidence level of 95 percent, to within plus or
minus 25 percent for airborne concentrations of 1-BP. Also, EPA is
proposing to require use of appropriate sampling and analytical methods
used to determine 1-BP exposure such as use of an analytical method
already approved by EPA, OSHA or NIOSH, or another analytical method
that has been demonstrated to meet the proposed accuracy requirement at
an appropriate level of detection for the ECEL and ECEL action level by
a laboratory in compliance with the Good Laboratory Practice Standards
at 40 CFR part 792, or use of a laboratory accredited by the AIHA or
another industry-recognized program, as required by proposed
751.807(b)(2)(i)(C). Additionally, EPA is proposing to require owners
and operators to re-monitor within 15 working days after receipt of the
results of any exposure monitoring when results indicate non-detect or
air monitoring equipment malfunction, unless an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist reviews the monitoring results and determines re-monitoring
is not necessary.
EPA is also proposing to require that each owner or operator
maintain exposure monitoring records that include the following
information for each monitoring event:
(A) Dates, duration, and results of each sample taken.
(B) All measurements that may be necessary to determine the
conditions (e.g., work site temperatures, humidity, ventilation rates,
monitoring equipment type and calibration dates) that may affect the
monitoring results.
[[Page 65085]]
(C) Name, workplace address, work shift, job classification, and
work area of the person monitored; documentation of all potentially
exposed persons whose exposures the monitoring is intended to represent
if using a representative sample; and type of respiratory protective
device worn by the monitored person, if any.
(D) Use of appropriate sampling and analytical methods, such as
analytical methods already approved by EPA, OSHA or NIOSH, or
compliance with an analytical method verification procedure.
(E) Compliance with the Good Laboratory Practice Standards at 40
CFR part 792.
(F) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of
detection, and any malfunctions.
iii. Incorporation of the Hierarchy of Controls
EPA is proposing to require owners or operators to implement the
WCPP in accordance with the hierarchy of controls and encourages the
use of pollution prevention to control exposures whenever practicable.
Pollution prevention, also known as source reduction, is any practice
that reduces, eliminates, or prevents pollution at its source (e.g.,
elimination and substitution). Similarly, the hierarchy of controls
includes, in order of preference, elimination, substitution,
engineering controls, and administrative controls, prior to relying on
PPE as a means of controlling exposures (Ref. 8). EPA is proposing to
require owners or operators to reduce inhalation exposures to or below
the ECEL in accordance with the hierarchy of controls. EPA expects
that, for conditions of use for which EPA is proposing a WCPP,
compliance at most workplaces would be part of an existing industrial
hygiene program. Workplaces that cannot feasibly eliminate the source
of 1-BP emissions or replace 1-BP with a substitute would have to use
engineering and/or administrative controls to implement process changes
to reduce exposures to the extent feasible, following the hierarchy of
controls (Ref. 8). If an owner or operator chooses to replace 1-BP with
a substitute, EPA recommends that they carefully review the available
hazard and exposure information on the potential substitutes to avoid a
substitute chemical that might later be found to present unreasonable
risks or be subject to regulation (sometimes referred to as a
``regrettable substitute'').
If an effort to identify and implement feasible exposure controls
such as elimination, substitution, engineering controls, and
administrative controls is not sufficient to reduce exposures to or
below the ECEL for all persons in the workplace, EPA proposes to
require each owner or operator to use such controls to reduce 1-BP
concentrations in the workplace to the lowest levels achievable and,
only after levels cannot be further reduced, supplement these controls
using respiratory protection before persons are permitted to enter a
regulated area, as described in this unit. In such cases, EPA would
require that the owner or operator provide those persons exposed or who
may be exposed to 1-BP by inhalation above the ECEL with respirators
sufficient to ensure that their exposures do not exceed the ECEL, as
described in this unit. EPA also proposes to require that each owner or
operator document their evaluation of elimination, substitution,
engineering and administrative exposure control strategies, and if
applicable the reasons why they found these strategies infeasible to
control exposures to or below the ECEL, in an exposure control plan as
described in this unit. In addition, a regulated entity would be
prohibited from rotating work schedules of potentially exposed persons
to comply with the ECEL 8-hour TWA. EPA may require more, less, or
different documentation regarding exposure control strategies in the
final rule based on consideration of public comments.
The Agency understands that certain engineering controls can reduce
exposures to people inside the workplace but may lead to increased
ventilation of 1-BP outside of the workplace, thereby increasing risks
to people in fenceline communities of adverse health effects from
exposures to 1-BP in ambient air. Therefore, EPA is proposing to
prohibit increased releases of 1-BP to outdoor air associated with the
implementation of the WCPP. This proposed requirement is intended to
avoid unintended increases in exposures to people from 1-BP emissions
to ambient air. The proposed rule would require owners and operators to
attest in their WCPP exposure control plan that engineering controls
selected do not increase emissions of 1-BP to ambient air outside of
the workplace and document in their exposure control plan whether
additional equipment was installed to capture emissions of 1-BP to
ambient air. EPA requests comment on how this proposed requirement may
impact the availability, feasibility, or cost of engineering controls
as a means to reduce workplace exposures to or below the proposed ECEL.
iv. Regulated Area
Based on the exposure monitoring, EPA is proposing to require that
owners or operators of workplaces subject to a WCPP demarcate any area
where airborne concentrations of 1-BP exceed or are reasonably expected
to exceed the ECEL. Regulated areas would be demarcated using
administrative controls, such as warning signs or highly visible
signifiers, in multiple languages as appropriate (e.g., based on
languages spoken by potentially exposed persons), placed in conspicuous
areas, and documented through training and recordkeeping. The owner or
operator would be required to restrict access to the regulated area
from any potentially exposed person who lacks proper training, is not
wearing required PPE as described in this unit or is otherwise
unauthorized to enter. EPA is proposing to require owners and operators
to demarcate and establish a regulated area beginning 36 months for
Federal agencies and Federal contractors acting for or on behalf of the
Federal Government and beginning 9 months for non-Federal owners and
operators after the date of publication of the final rule, or within 4
after introduction of 1-BP into the workplace if 1-BP use commences 9
months after the date of publication of the final rule in the Federal
Register. EPA is soliciting comment on requiring warning signs to
demarcate regulated areas, such as the requirements found in OSHA's
General Industry Standard for Beryllium (29 CFR 1910.1024(m)(2)).
v. Notification of Monitoring Results
EPA proposes that the owner or operator must, within 15 working
days after receipt of the results of any exposure monitoring, notify
each person whose exposure is represented by that monitoring in
writing, either individually to each potentially exposed person or by
posting the information in an appropriate location accessible to all
persons whose exposure is represented by the monitoring, such as public
spaces or common areas, outside the regulated area. This notice must
include the exposure monitoring results, identification and explanation
of the ECEL and ECEL action level in plain language, any corresponding
required respiratory protection, if applicable, the quantity, location,
manner of 1-BP use and identified releases of 1-BP that could result in
exposure to 1-BP at the time of monitoring. The notice must also
include a description of actions
[[Page 65086]]
taken by the owner or operator to reduce inhalation exposures to or
below the ECEL, if applicable, or refer to a document available to the
potentially exposed persons which states the actions to be taken to
reduce exposures, and must be posted in multiple languages if necessary
(e.g., notice must be in a language that the potentially exposed person
understands, including a non-English language version representing the
language of the largest group of workers who cannot readily comprehend
or read English).
c. Personal Protective Equipment (PPE) Program
Where elimination, substitution, engineering controls, and
administrative controls are not feasible to reduce the air
concentration to or below the ECEL for all potentially exposed persons,
EPA is proposing to require implementation of a respiratory PPE program
in alignment with OSHA's Respiratory Protection Standard at 29 CFR
1910.134. EPA is also proposing to require implementation of a dermal
PPE program. Owners and operators would be required to provide PPE,
including respiratory protection and dermal protection selected in
accordance with the guidelines described in this unit, that is of safe
design and construction for the work to be performed. EPA is proposing
to require owners and operators to ensure each potentially exposed
person who is required by this unit to wear PPE to use and maintain PPE
in a sanitary, reliable, and undamaged condition. Owners and operators
would be required to select and provide PPE that properly fits each
potentially exposed person who is required by this unit to use PPE and
communicate PPE selections to each affected person.
As part of the PPE program, EPA is also proposing that owners and
operators must comply with OSHA's PPE training requirements at 29 CFR
1910.132(f) or 29 CFR 1910.134(k) for application of a PPE training
program, including providing training on proper use of PPE (e.g., when
and where PPE is necessary, proper application, wear, and removal of
PPE, maintenance, useful life, and disposal of PPE). EPA is proposing
that owners and operators would provide PPE training to each
potentially exposed person who is required by this unit to wear PPE
prior to or at the time of initial assignment to a job involving
potential exposure to 1-BP. Owners and operators would also have to re-
train each affected person at least once annually or whenever the owner
or operator has reason to believe that a previously trained person does
not have the required understanding and skill to properly use PPE, or
when changes in the workplace or in the PPE to be used render the
previous training obsolete.
This unit includes a description of the PPE Program, including
proposed PPE as it relates to respiratory protection, proposed PPE as
it relates to dermal protection, and other proposed requirements such
as additional training for respirators and recordkeeping to support
implementation of a PPE program.
i. Respiratory Protection
Where elimination, substitution, engineering controls, and
administrative controls are not feasible to reduce the air
concentration to or below the ECEL, EPA proposes to set minimum
respiratory PPE requirements based on an entity's most recent measured
air concentration and the level of PPE that EPA determined would be
needed to reduce exposure to the ECEL. In those circumstances, EPA is
proposing to require a respiratory protection PPE program with
worksite-specific procedures and elements for required respirator use.
The respiratory protection PPE program proposed by EPA would be based
on the most recent exposure monitoring concentration measured as an 8-
hour TWA and would be administered by a suitably trained program
administrator. EPA is also proposing to require each owner or operator
select respiratory protection in accordance with the guidelines
described in this unit and 29 CFR 1910.134(a) through (l), except
(d)(1)(iii) for proper respirator use, maintenance, fit-testing,
medical evaluation, and training. EPA is not proposing to cross
reference 29 CFR 1910.134(d)(1)(iii) because the proposed WCPP contains
requirements for identifying 1-BP respiratory hazards in the workplace,
including monitoring requirements.
Required Respiratory Protection. EPA is proposing to require that
each owner or operator supply a respirator, selected in accordance with
this unit, to each person who enters a regulated area within 3 months
after the receipt of any exposure monitoring that indicates exposures
exceeding the ECEL, or receipt of any exposure monitoring that
indicates non-detect or air monitoring equipment malfunction resulting
in an unknown concentration, and thereafter must ensure that all
persons within the regulated area are using the provided respirators
whenever 1-BP exposures exceed or can reasonably be expected to exceed
the ECEL, or receipt that indicate non-detect or air monitoring
equipment malfunction resulting in an unknown concentration. Given the
risks associated with 1-BP exposure above the ECEL, prompt compliance
with the respiratory protection requirements is important, but EPA
expects that most owners or operators will need some time after the
exposure monitoring results are received to acquire the correct
respirators and establish a respiratory protection program, including
training, fit-testing, and medical evaluations. EPA believes that 3
months should be sufficient for this purpose. EPA is also proposing
that owners or operators who are required to administer a respiratory
protection PPE program must supply a respirator selected in accordance
with 29 CFR 1910.134(d)(1) (except (d)(1)(iii)). Additionally, EPA is
proposing that the owner or operator must ensure that all filters,
cartridges and canisters used in the workplace are labeled and color
coded with the NIOSH approval label and that the label is not removed
and remains legible. 29 CFR 1910.134(d)(3)(iii), which EPA is proposing
to cross-reference, requires either the use of respirators with an end-
of-life service indicator certified by NIOSH for the contaminant, in
this case 1-BP, or implementation of a change schedule for canisters
and cartridges that ensures that they are changed before the end of
their service life. EPA is also requesting comment on whether there
should be a requirement to replace cartridges or canisters after a
certain number of hours, such as the requirements found in OSHA's
General Industry Standard for 1,3-Butadiene (29 CFR 1910.1051), or a
requirement for a minimum service life of non-powered air-purifying
respirators such as the requirements found in OSHA's General Industry
Standard for Benzene (29 CFR 1910.1028(g)(3)(D)).
EPA is proposing to establish minimum respiratory protection
requirements, such that any respirator affording a higher degree of
protection than the following proposed requirements may be used. While
this unit includes respirator selection requirements for respirators of
assigned protection factors (APF) of 1,000 or greater, EPA does not
anticipate that respirators beyond APF 50 would be widely or regularly
used to address unreasonable risk, particularly when other controls are
put in place. EPA is proposing the following requirements for
respiratory protection, based on the exposure monitoring concentrations
measured as an 8-hour TWA that exceed the ECEL (0.05 ppm):
<bullet> If the measured exposure concentration is at or below 0.05
ppm: no respiratory protection is required.
[[Page 65087]]
<bullet> If the measured exposure concentration is above 0.05 ppm
and less than or equal to 0.5 ppm (10 times ECEL): Any NIOSH
Approved[supreg] air-purifying half mask respirator equipped with
organic vapor cartridges or canisters; or any NIOSH Approved[supreg]
Supplied-Air Respirator (SAR) or Airline Respirator operated in demand
mode equipped with a half mask; or any NIOSH Approved[supreg] Self-
Contained Breathing Apparatus (SCBA) in a demand mode equipped with a
half mask [APF 10].
<bullet> If the measured exposure concentration is above 0.50 ppm
and less than or equal to 1.25 ppm (25 times ECEL): Any NIOSH
Approved[supreg] Powered Air-Purifying Respirator (PAPR) equipped with
a loose-fitting facepiece or hood/helmet equipped with organic vapor
cartridges or canisters; or any NIOSH Approved[supreg] Supplied-Air
Respirator (SAR) or Airline Respirator in a continuous-flow mode
equipped with a loose-fitting facepiece or helmet/hood [APF 25].
<bullet> If the measured exposure concentration is above 1.25 ppm
and less than or equal to 2.5 ppm (50 times ECEL): Any NIOSH
Approved[supreg] air-purifying full facepiece respirator equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg]
Powered Air-Purifying Respirator (PAPR) with a half mask equipped with
organic vapor cartridges or canisters; any NIOSH Approved[supreg]
Supplied-Air Respirator (SAR) or Airline Respirator in a continuous
flow mode equipped with a half mask; any NIOSH Approved[supreg]
Supplied-Air Respirator (SAR) or Airline Respirator operated in a
pressure-demand or other positive-pressure mode with a half mask; or
any NIOSH Approved[supreg] SCBA in demand-mode equipped with a full
facepiece or helmet/hood [APF 50].
<bullet> If the measured exposure concentration is above 2.5 ppm
and less than or equal to 50 ppm (1,000 times ECEL): Any NIOSH
Approved[supreg] Powered Air-Purifying Respirator (PAPR) equipped with
a full facepiece equipped with organic vapor cartridges or canisters;
any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or Airline
Respirator in a continuous-flow mode equipped with full facepiece; any
NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or Airline
Respirator in pressure-demand or other positive-pressure mode equipped
with a full facepiece and an auxiliary self-contained air supply; or
any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or Airline
Respirator in a continuous-flow mode equipped with a helmet or hood and
has been tested to demonstrate performance at a level of a protection
of APF 1,000 or greater. [APF 1,000].
<bullet> If the measured exposure concentration is greater than 50
ppm (10,000 times ECEL) or the concentration is unknown: Any NIOSH
Approved[supreg] Self-Contained Breathing Apparatus (SCBA) in a
pressure-demand or other positive-pressure mode equipped with a full
facepiece or helmet/hood [APF 10,000].
EPA proposes to require that owners and operators document
respiratory protection used and PPE program implementation. EPA
proposes to require that owners and operators document in the exposure
control plan or other documentation of the facility's safety and health
program information relevant to the respiratory program, including
records on the name, workplace address, work shift, job classification,
work area, and type of respirator worn (if any) by each potentially
exposed person, maintenance, and fit-testing, as described in 29 CFR
1910.134(f), and training in accordance with 29 CFR 1910.132(f) and 29
CFR 1910.134(k).
ii. Dermal Protection
EPA is proposing to require owners or operators to provide and
ensure potential exposed persons use chemically resistant gloves made
of supported polyvinyl alcohol or a multiple-layer laminated material,
in accordance with the OSHA/NIOSH Hazard Alert (Ref. 14), in
combination with specific activity training (e.g., procedure for glove
removal and disposal) for tasks where dermal exposure can be expected
to occur. EPA is proposing that owners and operators must also consider
other glove factors, such as whether gloves are tested using American
Society for Testing Material (ASTM) F73 ``Standard Test Method for
Permeation of Liquids and Gases through Protective Clothing Materials
under Conditions of Continuous Contact, compatibility of multiple
chemicals used simultaneously while wearing 1-BP-resistant gloves,
glove liners, permeation, degree of dexterity required to perform a
task, and temperature, as identified in the Hand Protection section of
OSHA's Personal Protection Equipment Guidance (Ref. 33), when selecting
appropriate dermal PPE. EPA requests comment on the degree to which
additional guidance or requirements related to use of gloves might be
necessary. Additionally, EPA requests comment on whether EPA should
incorporate additional dermal protection requirements into the exposure
control plan for dermal exposures.
d. General WCPP Requirements
i. Exposure Control Plan
EPA proposes to require that owners and operators document their
exposure control strategy and implementation in an exposure control
plan. This may be accomplished by adding EPA-required information to
any existing documentation of a facility's safety and health program
developed as part of meeting OSHA requirements or other safety and
health standards. EPA proposes to require that each owner or operator
document in the exposure control plan the following:
(A) Identification and rationale of hierarchy of controls used or
not used in the following sequence: elimination of 1-BP, substitution
of 1-BP, engineering controls, and administrative controls to reduce 1-
BP exposures in the workplace to either at or below the ECEL or to the
lowest level achievable;
(B) The exposure controls selected based on feasibility,
effectiveness, and other relevant considerations;
(C) If exposure controls were not selected, document the efforts
identifying why these are not feasible, not effective, or otherwise not
implemented;
(D) Actions that must be taken to implement exposure controls
selected, including proper installation, regular inspections,
maintenance, training or other actions;
(E) Description of any regulated area and how it is demarcated, and
identification of authorized persons;
(F) Attestation that exposure controls selected do not increase
emissions of 1-BP to ambient air outside of the workplace and whether
additional equipment was installed to capture or otherwise prevent
increased emissions of 1-BP to ambient air;
(G) Description of activities conducted by the owner or operator to
review and update the exposure control plan as necessary, but at least
every 5 years, to ensure effectiveness of the exposure controls,
identify any necessary updates to the exposure controls, and confirm
that all persons are properly implementing the exposure controls;
EPA is proposing that non-Federal owners or operators implement an
exposure control plan within 12 months after date of publication of the
final rule in the Federal Register. EPA requests comment on any
advantages or drawbacks for this timeline.
[[Page 65088]]
ii. Workplace Information and Training
EPA is also proposing to require implementation of a training
program in alignment with the OSHA Hazard Communication Standard (29
CFR 1910.1200) and the OSHA General Industry Standard for Methylene
Chloride (29 CFR 1910.1052). To ensure that potentially exposed persons
in the workplace are informed of the hazards associated with 1-BP
exposure, EPA is proposing to require that owners or operators of
workplaces subject to the WCPP institute a training and information
program for potentially exposed persons and assure their participation
in the training and information program.
As part of the training and information program, the owner or
operator would be required to provide information and comprehensive
training in an understandable manner (i.e., plain language),
considering factors such as the skills required to perform the work
activity and the existing skill level of the staff performing the work,
and in multiple languages as appropriate (e.g., based on languages
spoken by potentially exposed persons). This information and training
would have to be provided to potentially exposed persons prior to or at
the time of initial assignment to a job involving potential exposure to
1-BP. Owners and operators would be required to provide information and
training, as referenced in the OSHA Hazard Communication Standard, to
all potentially exposed persons that includes: (A) The requirements of
the 1-BP WCPP and how to access or obtain a copy of the requirements of
the WCPP, including but not limited to the exposure control plan,
monitoring requirements, and PPE program; (B) the quantity, location,
manner of use, release, and storage of 1-BP and the specific operations
in the workplace that could results in 1-BP exposure; (C) principles of
safe use and handling of 1-BP in the workplace, including specific
measures the owner or operator has implemented to reduce inhalation
exposure at or below the ECEL or prevent dermal contact with 1-BP, such
as work practices and PPE used; (D) the methods and observations that
may be used to detect the presence or release of 1-BP in the workplace
(such as monitoring conducted by the owner or operator, continuous
monitoring devices, visual appearance or odor of 1-BP when being
released, etc.); and (E) the acute and chronic health hazards of 1-BP
as detailed on relevant SDSs.
In addition to providing training at the time of initial assignment
to a job involving potential exposure to 1-BP, and in alignment with
the OSHA General Industry Standard for Beryllium (20 CFR 1910.1024),
owners and operators subject to the 1-BP WCPP would be required to re-
train each potentially exposed person annually to ensure they
understand the principles of safe use and handling of 1-BP in the
workplace. Owners and operators would also need to update the training
as necessary whenever there are changes in the workplace, such as new
tasks or modifications of tasks, in particular, whenever there are
changes in the workplace that increase exposure to 1-BP or where
potentially exposed persons' exposure to 1-BP can reasonably be
expected to exceed the action level. To support compliance, EPA is
proposing that each owner or operator of a workplace subject to the
WCPP would be required to provide to the EPA, upon request, all
available materials related to workplace information and training.
iii. Workplace Participation
EPA encourages owners and operators to consult with persons that
have potential for exposure on the development and implementation of
exposure control plans and PPE (including respirators) programs. EPA is
proposing to require owners or operators to provide potentially exposed
persons regular access to the exposure control plans, exposure
monitoring records, and PPE program implementation and documentation.
To ensure compliance in workplace participation, EPA is proposing that
the owner or operator document the notice to and ability of any
potentially exposed person to readily access the exposure control
plans, facility exposure monitoring records, PPE program
implementation, or any other information relevant to 1-BP exposure in
the workplace. EPA is also proposing that potentially exposed persons
be permitted to observe exposure monitoring. EPA is requesting comment
on how owners and operators can engage with potentially exposed persons
on the development and implementation of an exposure control plan and
PPE program. EPA is also requesting comment on whether EPA should
include provisions allowing potentially exposed persons to designate a
representative who would then be permitted to observe exposure
monitoring and have regular access to exposure-related information at
the request of the potentially exposed person.
iv. Recordkeeping
To support and demonstrate compliance, EPA is proposing that each
owner or operator of a workplace subject to a WCPP retain compliance
records for five years. EPA is proposing to require records to include:
(A) The exposure control plan; (B) PPE program implementation and
documentation, including as necessary, respiratory protection and
dermal protection used and related PPE training; and (C) information
and training provided to each person prior to or at the time of initial
assignment and any re-training.
In addition, EPA is proposing that owners and operators subject to
the WCPP ECEL requirements maintain records to include: (D) the
exposure monitoring records; (E) notification of exposure monitoring
results; (F) to the extent that the owner or operator relies on prior
exposure monitoring data, records that demonstrates that it meets all
of the requirements of this section; and (G) the occurrence and
duration of any start-up, shutdown, or malfunction of the facility that
causes air concentrations to be above the ECEL, and subsequent
corrective actions taken during start-up, shutdown, or malfunctions to
mitigate exposures to 1-BP.
The owners and operators, upon request by EPA, would be required to
make all records that are maintained as described in this unit
available to EPA. All records required to be maintained by this unit
could be kept in the most administratively convenient form (electronic
or paper).
v. Compliance Timeframes
EPA is proposing to require each non-Federal owner and operator of
a workplace, other than Federal agencies and Federal contractors acting
for or on behalf of the Federal Government, subject to an ECEL conduct
initial baseline monitoring according to the process outlined in this
unit by 6 months after date of publication of the final rule in the
Federal Register or within 30 days of introduction of 1-BP into the
workplace if 1-BP use commences at least 6 months after the date of
publication. EPA is proposing to require each non-Federal owner or
operator ensure the airborne concentration of 1-BP does not exceed the
ECEL for all persons within 9 months after date of publication of the
final rule in the Federal Register, or beginning 4 months after
introduction of 1-BP into the workplace if 1-BP use commences at least
6 months after the date of publication. EPA is also proposing to
require non-Federal
[[Page 65089]]
owners and operators to establish and maintain a regulated area within
9 months after the date of publication of the final rule in the Federal
Register, or beginning 4 months after introduction of 1-BP into the
workplace if 1-BP use commences at least 9 months after the date of
publication. If applicable, each non-Federal owner or operator must
provide respiratory protection sufficient to reduce inhalation exposure
to or below the ECEL to all potentially exposed persons in the
regulated area within 3 months after receipt of the results of any
exposure monitoring that indicates exposures exceeding the ECEL or, if
using monitoring data conducted within 5 years prior to the effective
date of the final rule that satisfies all other requirements of this
section, within 6 months after the date of publication of the final
rule in the Federal Register. Non-Federal regulated entities must then
proceed accordingly to implement an exposure control plan within 12
months after date of publication of the final rule in the Federal
Register. EPA requests comment relative to the ability of owners or
operators to conduct initial monitoring within the timeframes
identified in this unit, and anticipated timelines for any procedural
adjustments needed to comply with the requirements outlined in this
unit, including establishment of a PPE program and development of an
exposure control plan.
With regard to the compliance timeframe for those occupational
conditions of use which are subject to dermal requirements under the
WCPP, EPA is proposing to require each non-Federal owner or operator of
a workplace subject to dermal requirements to provide dermal protection
as outlined in this unit by 9 months after publication of the final
rule in the Federal Register.
However, EPA is concerned about the ability of certain departments
and agencies of the Federal Government, as well as Federal contractors
acting for or on behalf of the Federal Government, to comply with these
timeframes. For example, complying with these timeframes could impact
the ability of the Department of Defense to continue to engage in vapor
degreasing. While, for example, 29 CFR 1960 sets forth procedures and
guidelines for ensuring that Federal workers are protected in
comparable ways to their non-Federal counterparts, EPA believes that
compliance with this proposed rulemaking would require increased and
different preparations on the part of Federal agencies. For example,
Federal agencies must follow procurement requirements which will likely
result in increased compliance timelines. In addition, these
requirements would require support in the Federal budget, which, for
some agencies, is a multi-year process. Therefore, EPA is generally
providing three years for agencies of the Federal Government and their
contractors, when acting for or on behalf of the Federal government, to
comply with the WCPP. Further, because military construction must
follow a lengthy Congressional approval process prior to contracting
for and beginning any actual construction work, which takes a minimum
of 5 years, EPA is also proposing 5 years after the date of the
publication of the final rule for the Department of Defense and Federal
contractors acting for or on behalf of the Department of Defense if
ongoing or planned construction is necessary to implement the feasible
controls required by the WCPP to reduce exposure to or below the ECEL.
When proposing these compliance dates as required under TSCA
section 6(d), EPA considered irreversible health effects and risks
associated with 1-BP exposure. EPA has no reasonably available
information indicating that the proposed compliance dates are not
practicable for the activities that would be impacted, or that
additional time is needed to implement all aspects of the WCPP.
However, EPA requests comment on whether additional time is needed or
if there are available substitutes for these applications. As discussed
in Unit IV.A.1., EPA recognizes that recent proposed rulemakings under
TSCA section 6(a) have received public comments requesting longer
compliance timeframes. For 1-BP, EPA believes that the proposed
compliance timeframes for the WCPP described in this unit may present
fewer compliance challenges for non-Federal owners and operators. than
those described by commenters on other rules; for example, under the
WCPP, owners or operators would have some flexibility, within the
parameters outlined in this unit, regarding how they prevent
exceedances of the ECEL. EPA may finalize shorter or longer compliance
timeframes based on consideration of public comments.
3. Prescriptive Controls
a. Overview
In contrast to the proposed non-prescriptive requirements of the
ECEL where regulated entities would have flexibility to select controls
in accordance with the hierarchy of controls to comply with the
parameters outlined in this unit, EPA may also find it appropriate in
certain circumstances to require specific prescriptive controls for
certain occupational conditions of use. In the 2020 Risk Evaluation for
1-BP, EPA identified that the use of gloves would reduce dermal
exposures from 1-BP adequate to address the unreasonable risk driven by
dermal exposures. Therefore, EPA is proposing to require the use of use
of chemically-resistant gloves made of supported polyvinyl alcohol or
multiple-layer laminated materials for certain occupational conditions
of use, as described in this unit. This unit describes proposed
requirements for the gloves, including additional requirements proposed
for recordkeeping. This unit also describes compliance timeframes for
these proposed requirements.
b. Glove Requirements
For the conditions of use that would not otherwise be prohibited
under this proposed regulation or subject to the WCPP, EPA is proposing
the owner or operator apply prescriptive controls to reduce dermal
exposures in the workplace and address the unreasonable risk of injury
to health resulting from dermal exposures to 1-BP. Specifically, EPA is
proposing that the owner or operator supply and ensure the use of
chemically-resistant gloves made of supported polyvinyl alcohol or
multiple-layer laminated materials, by all persons likely to be
dermally exposed to 1-BP (including industrial and commercial products
containing 1-BP). EPA is proposing to establish glove requirements for:
<bullet> Manufacturing (import);
<bullet> Processing as a reactant;
<bullet> Processing as incorporation into articles;
<bullet> Processing by repackaging;
<bullet> Recycling; and
<bullet> Disposal.
EPA is proposing to require owners or operators of a facility
engaged in one or more uses of 1-BP as listed in this unit, to supply
and ensure proper use of gloves, as described in this unit and in
accordance with the 2020 Risk Evaluation for 1-BP and the OSHA/NIOSH
Hazard Alert (Ref. 14). In the 2020 Risk Evaluation for 1-BP, EPA
identified the use of gloves with a protection factor (PF) of 5 as
adequate to address the unreasonable risk presented by dermal exposures
to 1-BP. As described in the 2020 Risk Evaluation for 1-BP, a glove
with a protection factor of 5 is a glove ``with available permeation
data indicating that the material of construction offers good
protection for the substance.''
To further ensure correct glove usage, owners or operators must
provide
[[Page 65090]]
training in accordance with 29 CFR 1910.132(f) to all persons required
to use gloves prior to or at the time of initial assignment to a job
involving exposure to 1-BP. EPA is proposing such training be conducted
at least annually or whenever the owner or operator has reason to
believe that a previously trained person does not have the required
understanding and skill to properly use gloves, or when changes in the
workplace or in gloves to be used render the previous training
obsolete.
To further ensure compliance, EPA proposes to require that owners
and operators document the following information, as applicable: (A)
The name, workplace address, work shift, job classification, and work
area of each person reasonably likely to directly handle 1-BP or handle
equipment or materials on which 1-BP may present; (B) the type of glove
being used at the facility, either supported polyvinyl alcohol or
multiple-layer laminates; and (C) appropriately sized gloves and
training on proper application, wear, and removal of gloves, and proper
care/disposal of gloves.
EPA is soliciting comments on the requirements proposed in this
unit for glove requirements. In addition, EPA understands that some
workplaces rinse and reuse gloves after minimal use and is therefore
soliciting comments on the impact on effectiveness of rinsing and
reusing gloves. EPA also requests comment on the degree to which
additional guidance related to use of gloves might be appropriate. EPA
notes that disposal of gloves would be addressed by hazardous wastes
requirements under 40 CFR 261.33.
EPA is proposing to require each non-Federal owner or operator
supply chemically-resistant gloves made of supported polyvinyl alcohol
or multiple-layer laminate, in accordance with this unit, to each
potentially exposed person within 6 months after publication of the
final rule.
As described in Unit IV.A.2.d.v, EPA is concerned about the ability
of certain departments and agencies of the Federal Government, as well
as Federal contractors acting for or on behalf of the Federal
Government, to comply with the proposed timeframes for non-Federal
owners and operators. For example, procurement requirements and the
need for Federal budget support to implement these requirements will
likely result in increased compliance timelines. Therefore, EPA is
proposing 36 months for agencies of the Federal Government and their
contractors, when acting for or on behalf of the Federal government, to
provide and ensure the use of gloves that are chemically-resistant to
1-bromopropane, made of supported polyvinyl alcohol or a multiple-layer
laminated materials, by all persons likely to be dermally exposed to 1-
bromopropane (including products containing 1-bromopropane).
4. Self-Certification
To ensure the safe and appropriate use of 1-BP, EPA is proposing to
require most owners or operators who implement the WCPP to also self-
certify as to their implementation of and compliance with the WCPP as a
condition of the ability to purchase and use 1-BP in accordance with
this regulation. EPA is proposing to establish requirements to self-
certify for:
<bullet> Processing as incorporation into a formulation, mixture,
or reaction product;
<bullet> Industrial and commercial use as a solvent in open-top and
in-line batch vapor degreasing;
<bullet> Industrial and commercial use as a solvent in closed-loop
vapor degreasing;
<bullet> Industrial and commercial use as a solvent for cleaning
and degreasing in cold cleaners;
<bullet> Industrial and commercial use as a solvent in aerosol
spray degreaser/cleaner; and
<bullet> Industrial and commercial use in other uses in electronic
and electronic products and metal products; laboratory chemicals;
asphalt extraction; and coatings for temperature indicators.
EPA is proposing a point-of-sale self-certification requirement in
order to purchase and subsequently use 1-BP for those facilities that
have the ability to implement and comply with a WCPP. As discussed
further in Unit V.A.1.d., this self-certification would further ensure
that only facilities able to implement and comply with a WCPP are able
to purchase and use 1-BP. Under a self-certification requirement,
entities would submit a self-certification to the distributor each time
1-BP is purchased. The self-certification would consist of a statement
indicating that the facility is implementing a WCPP that would include
an ECEL, PPE requirements, and ancillary requirements, the self-
certification would be signed and presented by the facility owner or
operator or person authorized to do so.
Self-Certification Statement. Owners or operators who wish to
continue or begin purchasing 1-BP for one or more conditions of use as
outlined in this unit must self-certify that each facility engaged in
one or more such conditions of use is implementing and complying with
all aspects of the WCPP, as outlined in Unit IV.A.2. EPA is proposing
the following self-certification statement:
I certify each of the following statements under penalty of law.
This document was prepared under my direction and supervision. This
facility's implementation of the WCPP for 1-bromopropane was
evaluated by qualified personnel with industrial hygiene
qualifications or similar experience and that this facility has
implemented and complies with the WCPP for 1-bromopropane. Based on
my inquiry of the individual or individuals who manage the facility
and/or those individuals directly responsible for implementing the
1-bromopropane WCPP, and to the best of my knowledge and belief, the
facility is in compliance with the 1-bromopropane WCPP, including
the exposure control plan. I am aware that there are significant
penalties, including the possibility of civil penalties for failing
to comply with these requirements and criminal fines and
imprisonment, for knowingly failing to comply with these
requirements. If this is the first purchase of 1-bromopropane for
this facility, I understand that this certification will serve as a
certification that this facility will properly implement and comply
with the WCPP for 1-bromopropane consistent with the applicable
regulatory timelines.
The self-certification statement must be signed and dated by the
owner or operator of the facility, including a name, title, email
address, and phone number for the owner or operator who is self-
certifying. The self-certification statement must also list the name
and address of the facility that is being certified; the condition of
use, (e.g., solvent for aerosol spray degreaser/cleaner) and examples
of the type of equipment the owner/operator plans to use to meet the
WCPP (e.g., closed loop vapor degreaser); and indicate if this is the
facility's first purchase of 1-BP, after publication of the final rule.
The self-certification statement would be valid for one year, unless
the facility has changed processes or there is an indication that
exposures to 1-BP have changed.
To ensure distributors are only selling 1-BP to owners or operators
of facilities able to implement and comply with the workplace
requirements of the WCPP, EPA is proposing to require owners or
operators who self-certify to provide a copy of the facility's current
self-certification statement to the distributor from whom 1-BP is being
purchased, for every purchase of 1-BP. EPA is also proposing for the
distributors to collect, maintain, and retain a copy of the self-
certification statement. EPA is also proposing to require distributors
to keep records, such as invoices, that indicate the name of the
purchaser and facility, date of sale, and quantity of 1-BP purchased.
Distributors of 1-BP for the uses described in this unit may only
[[Page 65091]]
distribute to those facilities that provide the correct self-
certification statement for purchasing. EPA realizes that some
facilities may not engage in the 1-BP uses listed in this unit at the
time this proposed rule is finalized. Owners or operators that may wish
to purchase 1-BP after the publication of the final rule would still be
required to submit the self-certification statement to the distributor
from whom 1-BP was initially purchased in order to purchase 1-BP,
certifying that the facility for which 1-BP is being purchased will
implement and comply with the WCPP. EPA is also proposing that
distributors review the self-certification statement to ensure it is
appropriately completed to include the owner or operator's and the
facility's information, as outlined in this unit. As proposed,
distributors would have to have a completed and valid self-
certification statement for each sale of 1-bromopropane for the uses
subject to the self-certification requirements. EPA is proposing that
the distributors and owners or operators maintain and retain the self-
certification statement and related invoices in the most
administratively convenient form (electronic or paper) and retain the
statement and supporting documentation for five years. EPA is
requesting comment on the self-certification requirement for ensuring
that only those facilities able to implement and comply with the WCPP
are able to purchase 1-BP. Additionally, EPA is interested in hearing
if there are other requirements such as a tax identification number,
commercial account, or other verification EPA should consider including
to ensure that those workplaces that can implement and comply with the
WCPP are able to purchase 1-BP while other facilities with the same use
who cannot implement the WCPP are unable to do so.
5. Other Requirements
a. Recordkeeping
In addition to the recordkeeping requirements for the WCPP, self-
certification, and prescriptive controls outlined in this unit, for
conditions of use that are not otherwise prohibited under this proposed
regulation, EPA is also proposing that manufacturers, processors,
distributors, and industrial and commercial users (except for the
commercial use of 1-BP in insulation and insulation products) maintain
ordinary business records, such as invoices and bills-of-lading, that
demonstrate compliance with the prohibitions, restrictions, and other
provisions of this proposed regulation; and to maintain such records
for a period of 5 years from the date the record is generated. EPA is
proposing that this requirement begin on the effective date of the
final rule (60 days following publication of the final rule in the
Federal Register). Recordkeeping requirements would ensure that owners
or operators can demonstrate compliance with the regulations if
necessary. EPA may require more, less, or different documentation in
the final rule based on consideration of public comments.
b. Downstream Notification
For conditions of use that are not otherwise prohibited under this
proposed regulation, EPA is proposing that manufacturers (including
importers), processors, and distributors, excluding retailers, of 1-BP
and 1-BP-containing products, except for the manufacture, processing,
distribution in commerce, use, or disposal of 1-BP in building/
construction materials (insulation), provide downstream notification of
the prohibitions through the Safety Data Sheets (SDSs) required by OSHA
under 29 CFR 191.1200(g) by adding to sections 1(c) and 15 of the SDS
the following language:
After [DATE 18 MONTHS AFTER DATE OF PUBLICATION OF THE FINAL
RULE IN THE FEDERAL REGISTER] this chemical/product can only be
distributed in commerce to or by retailers for the commercial and
consumer use of 1-bromopropane in building/construction materials
(insulation). After [DATE 21 MONTHS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER], this chemical/product is and
can only be distributed in commerce or processed for the following
occupational uses: Processing as a reactant/intermediate; Processing
into formulation, mixture, or reaction products; Processing for
incorporation into articles; Processing by repackaging; Recycling;
Industrial and commercial use as solvent for cleaning and degreasing
in vapor degreaser (batch vapor degreaser--open-top, in-line vapor
degreaser); Industrial and commercial use as solvent for cleaning
and degreasing in vapor degreaser (batch vapor degreaser--closed-
loop); Industrial and commercial use as solvent for cleaning and
degreasing in cold cleaners; Industrial and commercial use as
solvent in aerosol spray degreaser/cleaner; Industrial and
commercial use in other uses in electronic and electronic products
and metal products, asphalt extraction, laboratory chemicals, and
temperature indicator--coatings; and Disposal.
The intention of downstream notification is to spread awareness
throughout the supply chain of the restrictions on the use of 1-BP
under TSCA as well as provide information to commercial end users about
allowable uses of 1-BP.
To provide adequate time to update the SDS and ensure that all
affected products in the supply chain include the revised SDS, EPA is
proposing a 2-month period for manufacturers and a 6-month period for
processors and distributors to implement the proposed SDS changes
following publication of the final rule.
EPA requests comments on the appropriateness of identified
compliance timeframes for recordkeeping and downstream notification
requirements described in this unit.
6. Federal Uses
EPA acknowledges that after the issuance of this rule, once
finalized, Federal agencies, their contractors, and other related
entities may become aware of important information which indicates a
particular use, that would otherwise be prohibited, could meet the
criteria of section 6(g) or the requirements of a WCPP. EPA also notes
that there are multiple avenues to ask EPA to revisit issues in this
TSCA section 6(a) rulemaking, both before and after the mandatory
compliance dates that are set consistent with TSCA section 6(d). EPA
has the authority under TSCA section 6(g) to consider whether a time
limited exemption is appropriate and, consistent with TSCA section
6(g)(1), could expeditiously promulgate such exemptions independently
from this rulemaking, including consideration of emergency or interim
rulemaking. EPA will initiate a notice of proposed rulemaking for
public comment on this topic and will add this to the Spring 2024
Regulatory Agenda. Additionally, any person could petition EPA to
request that EPA issue or amend a rule under TSCA section 6.
B. Alternative Regulatory Actions
As indicated by TSCA section 6(c)(2)(A)(iv)(II) through (III), EPA
must consider and publish a statement based on reasonably available
information with respect to the reasonably ascertainable economic
consequences of the rulemaking, including consideration of the costs
and benefits and the cost effectiveness of the proposed regulatory
action and one or more primary alternative regulatory actions
considered by the Agency. This unit includes a description of the
primary alternative regulatory action and the second alternative
regulatory action considered by the Agency. An overview of the proposed
regulatory action and two alternative regulatory actions for each
condition of use is in Unit IV.C.
[[Page 65092]]
1. Primary Alternative Regulatory Action Considered
The primary alternative regulatory action described in this
document and considered by EPA combines prohibitions, requirements for
a WCPP, self-certification, and prescriptive controls to address the
unreasonable risk from 1-BP contributed by the various conditions of
use. The primary alternative regulatory action described in this
document differs from the proposed regulatory action by considering
prescriptive workplace controls and implementation of a PPE program for
some conditions of use that would be subject to a WCPP under the
proposed regulatory action. The primary alternative regulatory action
additionally considers alternative compliance timeframes for
prohibitions and implementation of a WCPP and prescriptive controls, as
described in this unit. EPA is putting forth only alternative
regulatory options that would eliminate the unreasonable risk from 1-BP
and notes that TSCA section 6(a) requires that EPA impose regulatory
requirements to the extent necessary to address unreasonable risk.
Thus, EPA has concluded that it would be most advantageous to put forth
and receive public input on alternative regulatory options that the
Agency could adopt in a final rule consistent with the requirements of
TSCA section 6(a). Where EPA has identified different types of
regulatory requirements that would address the unreasonable risk (e.g.,
a WCPP and prescriptive controls), EPA is seeking public input on each
type of regulatory requirement. However, where EPA has identified only
one type of regulatory requirement that would address the unreasonable
risk (e.g., a prohibition), EPA is seeking public input on the timing
for compliance with such a requirement. EPA requests comment on this
primary alternative regulatory action and whether any elements of the
primary alternative regulatory action described in this unit should be
considered as EPA develops the final regulatory action. EPA also
requests comment on any advantages or drawbacks for the timelines
outlined in this unit compared to the timelines identified for the
proposed regulatory action in Unit IV.A.
a. Prohibitions
The primary alternative regulatory action considered by EPA would
prohibit the manufacturing, processing, distribution in commerce, and
use for the following industrial and commercial uses, which EPA is also
proposing to prohibit as part of the proposed regulatory action:
industrial and commercial use in adhesives and sealants; industrial and
commercial use in dry cleaning solvents, spot cleaners and stain
removers; industrial and commercial use in liquid cleaners (e.g., coin
and scissor cleaner); and industrial and commercial use in arts,
crafts, hobby materials (adhesive accelerant); automotive care products
(engine degreaser, brake cleaner, refrigerant flush); anti-adhesive
agents (mold cleaning and release product); and functional fluids
(close/open-systems)--refrigerant/cutting oils. Additionally, the
primary alternative regulatory action would prohibit the manufacture,
processing, and distribution of 1-BP for all consumer use, except in
insulation. As shown in Unit IV.C., which presents an overview of the
proposed regulatory action and two alternative regulatory actions for
each condition of use, the primary alternative action described in this
document would prohibit the same occupational and consumer conditions
of use as the proposed regulatory action.
Regarding compliance timeframes, the primary alternative regulatory
action would include longer timeframes for implementation of the
prohibitions than the proposed regulatory action. Under the primary
alternative action, the prohibitions would generally take effect 6
months later than in the proposed regulatory action. Under a compliance
timeframe that is 6 months longer than the proposed regulatory action,
the prohibitions for the manufacturing, processing, distribution in
commerce, and use of 1-BP for certain occupational conditions of use
described in this unit would take effect 12 months for manufacturers,
15 months for processers, 18 months for distributing to retailers, 21
months for all other distributors (including retailers), and 24 months
for industrial and commercial users after the publication date of the
final rule. With regard to the compliance timeframe for the
manufacturing, processing, and distribution in commerce for consumer
use (except consumer use in building/construction materials in
insulation), under the primary alternative regulatory action,
prohibitions described in this unit would take effect in 12 months for
manufacturers, 15 months for processors, 18 months for distributing to
retailers, and 21 months for all other distributors (including
retailers) after the publication date of the final rule.
b. Workplace Chemical Protection Program (WCPP)
The primary alternative regulatory action described in this
document would require a WCPP, including requirements to meet an ECEL,
for the following occupational conditions of use: manufacturing
(domestic); processing into formulation, mixture, or reaction products;
industrial and commercial use as solvent for cleaning and degreasing in
cold cleaners; industrial and commercial use as solvent in aerosol
spray degreaser/cleaner; and industrial and commercial use in other
uses in electronic and electronic products and metal products;
laboratory chemicals for asphalt extraction; coatings for temperature
indicator. EPA requests comment on the ways in which 1-BP may be used
in these conditions of use, including whether activities may take place
in a closed system and the degree to which users of 1-BP in these
sectors could successfully implement an ECEL and ancillary requirements
described in Unit IV.A.
As with the compliance timeframes considered as part of the primary
alternative action for prohibition, the primary alternative regulatory
action also includes longer compliance timeframes for implementation of
a 1-BP WCPP by non-Federal owners and operators. The primary
alternative regulatory action does not include longer compliance
timeframes for implementation of a 1-BP WCPP for Federal agencies and
Federal contractors acting for or on behalf of the Federal Government.
Under the primary alternative action, the requirements for the WCPP
would take effect 6 months later than the proposed regulatory action
for non-Federal owners and operators. Under a compliance timeframe that
is 6 months longer than the proposed regulatory action, the
requirements for non-Federal owners and operators to conduct initial
baseline monitoring would take effect 12 months after the date of
publication of the final rule in the Federal Register. Also under the
primary alternative action, the requirements for each non-Federal owner
or operator to provide respiratory protection to all potentially
exposed persons in the regulated ar
[…truncated; see source link]Indexed from Federal Register on August 8, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.