Workshop EE Best Practices for Tackling Tier II (SARA 312), TRI - - PDF document

Workshop EE

Best Practices for Tackling Tier II (SARA 312), TRI (SARA 313) and TSCA Reform

Wednesday, March 22, 2017 8:00 a.m. to 9:15 p.m.

Biographical Information Amanda Jennings Managing Consultant Trinity Consultants 110 Polaris Parkway, Suite 200 Westerville, Ohio 43085 Phone: 614.433.0733 E-mail: ajennings@trinityconsultants.com

• Ms. Jennings is a Managing Consultant in Trinity’s Columbus, Ohio, office and provides air

quality support for various industries in Ohio, including but not limited to, petroleum refining/distribution, chemical manufacturing, surface coating, asphalt processing/shingle manufacturing, and fiberglass and foam insulation manufacturing. She has completed numerous projects over her 12 years of consulting experience ranging from minor and major source state construction permit to install (PTI) or permits to install and operate (PTIO) applications, Fee Emissions Reports (FERs), emissions inventories, Toxic Release Inventory Reports (TRIs), Title V operating permit renewal and modification applications, MACT and GACT general consulting/compliance assistance, and regulatory applicability analyses. Ms. Jennings graduated from Ohio University with a Bachelor of Science Degree in Chemical Engineering.

Ellen Hewitt

Managing Consultant and Business Development Manager Trinity Consultants 110 Polaris Parkway, Suite 200 Westerville, Ohio 43085 Phone: 614.433.0733 E-mail: ehewitt@trinityconsultants.com

• Ms. Hewitt is a Managing Consultant and the Business Development Manager for Trinity’s

Northeast sub region. In her tenure at Trinity, she has prepared several construction permit applications in both West Virginia and Ohio, Title V renewal applications, NSPS and MACT/GACT regulatory determinations, complex emissions calculations, and various regulatory reports including Title V annual certification reports, Fee Emissions Reports (FERs), Toxic Release Inventory Reports (TRIs), and Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) submittals. Additionally, Ms. Hewitt manages business development activities in Trinity’s Northeast sub region. Ms. Hewitt earned a Bachelor of Science degree in Chemical Engineering from The Ohio State University. After graduation she obtained her Six Sigma Greenbelt Certification in June 2005.

Workshop EE – Best Practices for Tackling Tier II (SARA 312), TRI (SARA 313), and TSCA Reform

Cincinnati, OH ♦ March 22, 2017

Amanda Jennings Ellen Hewitt

Objectives

˃ Review Tier II Best Practices ˃ Brush off the cobwebs to prepare for

the 2016 Toxic Release Inventory (TRI)

˃ What is TSCA Reform? A brief overview

and update

Tier II Regulatory Background

˃ Federal Regulation 40 CFR 370 (Sections

311/312 of the federal act)



Apply to any facility required to prepare or have available a safety data sheet (SDS) for a hazardous chemical by the Occupational Safety and Health Administration’s (OSHA’s) Hazardous Communication Standard; and



The hazardous chemical is stored above a threshold level.



SDS reporting (one-time)

♦ 40 CFR 370.30 through 370.33



Inventory reporting (annually by March 1)

♦ 40 CFR 370.40 through 370.45



Submit to the Local Emergency Planning Committees (LEPC), the State Emergency Response Commission (SERC), and the fire department

♦ Tier II inventory information used to develop emergency response plan(s).

When are Updates Required?

˃ SDS reporting is a one-time requirement ˃ Update the information in the following

ways:

 Submit a revised SDS after you discover significant new

information concerning a hazardous chemical for which an SDS was submitted

♦ within 3 months of discovery

 Submit an SDS, or a list for any new hazardous chemical

for which you become subject to these reporting requirements

♦ within 3 months becoming subject for the specific hazardous

chemical.  Submit SDS upon request by LEPC

♦ Within 30 days of request

TRI Basics

˃ Section 313 requires a TRI report annually

for each listed chemical exceeding an activity threshold

 Manufactured, processed, or otherwise used  600+ chemicals listed

˃ Report due July 1, 2017 for reporting year

(RY) 2016

 Submit Form As and/or Rs  Submit via TRI-MEweb

TRI Updates!

˃ New TRI chemicals:

 1-Bromopropane

♦ Solvent (e.g., dry cleaning, adhesives, degreasing) ♦ Starting July 1, 2017

 Hexabromocylcododecane (HBCD) Category

♦ Flame retardant, e.g., foam insulation ♦ Starting July 1, 2018

TRI Updates!

˃ Updates to TRI-MEweb for 2016

 “Modernized” to streamline/simplify

♦ Look for recording…coming soon? ♦ Certifiers can use text message verification instead

• f security questions!

♦ Can use TRI-MEweb for negative declaration

 All Pollution Prevention (P2) entries are

featured in a new TRI P2 Search tool:

♦ https://www3.epa.gov/enviro/facts/tri/p2.html ♦ Facilities may be highlighted in national analysis report

TRI Basics: Two Part Process

˃ Part 1: Applicability & Threshold

Determination

˃ Part 2: Release/Waste Management

Reporting

 Complete Form R or Form A for each 313

chemical exceeding the 25,000 lb or 10,000 lb activity threshold

Get Prepared!

˃ Examples of information to gather:

 Last year’s TRI and calculation spreadsheet  Purchasing/inventory records  SDS; product specifications  Air permits; actual emission calculations  Monitoring records (e.g., CEMS, flow meters)  Water permits; monitoring and discharge reports  Waste manifests  Waste profiles  Annual waste reports  Tier II report

Best Practice #1

˃ Do not assume what was done in the past

is correct!

 Schedule a review or external audit to

evaluate past assumptions

 Document all assumptions clearly for both

reportable and non-reportable compounds.

Recordkeeping Requirements

˃ Facilities must keep a copy of each TRI report

submitted for at least 3 years from the date of submission

˃ Facility must also maintain any documents,

calculations, other forms upon which they relied to gather information to complete prior reports

˃ EPA also recommends facilities also keep records

for those 313 chemicals for which they were not required to file a TRI.

Best Practice #2

˃ Understanding the differences in the

threshold activities

 Manufacture, Process, Otherwise Use

˃ Identify all potential threshold activities

Threshold Determination: Thresholds for Non-PBT

˃ Manufacture more than 25,000 pounds of the

313 chemical during the reporting year

˃ Process more than 25,000 pounds of the 313

chemical during the reporting year, or

˃ Otherwise use more than 10,000 pounds of the

313 chemical during reporting year

˃ Thresholds are mutually exclusive:

 Facility processes 20,000 lbs of Chemical X and

manufactures 6,000 lbs of Chemical X. Chemical X is not reportable.

Threshold Determination: Manufacture

˃ Produce, Prepare, Compound, or Import

 For further on-site use/processing  For sale/distribution  As a byproduct

♦ Coincidental manufacture; following production,

chemical is separated from process stream

 As an impurity

♦ Coincidental manufacture; following production it

is not separated but remains in the product for distribution in commerce

Threshold Determination: Processing

˃ Preparation of the 313 chemical for

distribution in commerce

 Incorporation of the chemical into a

product

Threshold Determination: Processing

˃ Processing:



As a reactant

♦ Used in a chemical reaction for the manufacturer of another

substance



As a formulation component

♦ Added to a product as “performance enhancer” (e.g., flame

retardant, dye)



As an article component

♦ Becomes an integral component of an article that is distributed in

commerce (e.g., paint pigment)



Repackaging

♦ Preparation of distribution in commerce in a different form, state, or

quantity (e.g., transfer of material from bulk container to smaller containers)



As an impurity

♦ Chemical is processed but not separated and remains in the

product (e.g., lead in wood products)

Threshold Determination: Otherwise Use

˃ Use of a 313 chemical not covered by

“manufacture” or “process”

˃ Does not include disposal, stabilization, or

treatment for destruction

 Unless:

♦ Chemical was received from off-site for purposes of further

waste management

♦ Chemical that was disposed, stabilized or treated for

destruction was manufactured as a result of waste management activities on materials received from off-site for purposes of waste management

Threshold Determination: Otherwise Use

˃ As a chemical processing aid

 Added to a reaction mixture to aid in the manufacture

• r synthesis of another substance but is not intended

to remain in or become part of the product (e.g., process solvents, reaction terminators, catalysts, etc.)

˃ As a manufacturing aid

 Aids in manufacturing process but does not become

part of product (e.g., process coolants, refrigerants, hydraulic fluids, etc.)

˃ Ancillary or other use

 Examples: cleaners, degreasers, fuels, water

treatment chemicals, etc.

MPOU Examples

˃ Fuel Combustion

 Acid aerosols (HCl) and metal compounds (PbO) are

coincidentally manufactured as byproducts

 313 chemicals in the fuel prior to combustion are

considered otherwise used

˃ Use of coatings

 Volatile 313 compounds are

• therwise used

 Non-volatile 313 compounds are

processed (e.g., pigments)

Threshold Determination

˃ The following are not TRI Threshold Activities:

 Storage  Remediation of on-site contamination (assuming no

chemical is manufactured during remediation)

 Re-labeling without repackaging  Direct reuse onsite  On-site recycling (not including wastes received form

• ff-site)

 Transfers sent off-site for further waste management

(not recycling)

˃ Still report releases/waste management from these

activities if reporting threshold is exceeded through other non-exempt activities

Threshold Determination: Onsite Reuse

˃ For reuse operations, threshold is

determined based on amount of 313 chemical added during the year, not the total volume in the system

 Example – Ammonia refrigeration unit

˃ Does not apply to 313 chemicals recycled or

reused off-site and then returned to a facility

 Treated as newly purchased material

Threshold Determination: Thresholds for PBTs

˃ Persistent, bioaccumulative, toxic ˃ 20 chemicals/chemical categories are PBT

 Aromatics, metals, and pesticides

˃ Lower thresholds for reporting

 Cannot use Form A  Cannot use de minimis exemption  Cannot use range codes  Report in decimal amounts

PBT Chemicals and Thresholds

(1 of 2)

Chemical Threshold Aldrin 100 lbs Lead (not contained in stainless steel, brass, or bronze alloy) Lead compounds Methoxychlor Pendimethalin Polycyclic aromatic compounds (PACs) Tetrabromobisphenol Trifluralin Dioxin and Dioxin‐like compounds 0.1 g

PBT Chemicals and Thresholds

(2 of 2)

Chemical Threshold Benzo[g,h,i]perylene 10 lbs Chlordane Heptachlor Hexachlorobenzene Isodrin Mercury Mercury Compounds Octachlorostyrene Pentachlorobenzene Polychlorinated biphenyls (PCBs) Toxaphene

Lead and Lead Compounds

˃ 100 lb threshold each; two separate 313 chemicals ˃ 100 lb PBT threshold applies for lead except when in

stainless steel, brass, or bronze alloys



Lead in these alloys subject to the standard thresholds (25,000 lb

• r 10,000 lb)



Lead in alloys is in the elemental form not the lead compound form

˃ Lead typically found in metal ores, coal, wood, oil ˃ Lead compounds from combustion (e.g., PbO), paints,

solders

˃ Guidance document available on-line (see helpful links

slide)

Lead

Adapted from EPA’s Lead and Lead Compounds: Guidance for Reporting Releases and Other Waste Management Quantities of Toxic Chemicals: Lead and Lead Compounds (December 2001)

Polycyclic Aromatic Compounds (PACs)

˃ Examples: Benzo(a)anthracene,

Dibenzo(a,h)pyrene

˃ Found in coal, fuel oil, asphalt ˃ Most uses of blacktop are NOT exempt

 Process roadways – not exempt  Employee parking lot – exempt

˃ Guidance document available on-line

(see helpful links slide)

Polycyclic Aromatic Compounds (PACs)

Adapted from EPA’s Polycyclic aromatic compounds (PACs) (August 2001)

Best Practice #3

˃ Understand the available activity

exemptions

 Otherwise Use Exemptions  Article Exemptions  De minimis Exemptions  Other Exemptions

Otherwise Use Exemptions

˃ Structural component of facility*

 Process unit demolition or construction

˃ Routine janitorial or facility grounds maintenance*

 Asphalt paving

˃ Personal use by employees or other persons* ˃ Maintenance of motor vehicles operated by the

facility

 Does not apply to manufacture of combustion

byproducts in vehicle engines

˃ Chemicals contained in intake water or intake air

*Does not apply for process-related equipment!

Article Exemption

˃ Manufactured item ˃ Must meet all of the following conditions:

• 1. Formed to a specific shape or design during

manufacture

 Item retains initial thickness or diameter

• 2. Has end use function dependent upon its shape or

design during end use

• 3. Does not release a 313 chemical under normal

conditions of processing or use of the item

 0.5 lb or less from the sum of all releases from

processing or otherwise use of all like articles

Article Exemption Examples

˃ Lead in lead acid batteries



Releases negate article status

˃ Welding two metal “articles” together



Article status for metal articles is not negated from releases from welding rods, but welding rods must be considered in threshold determination

˃ Metal wire or metal sheets: cutting, bending, punching,

pressing, stamping



Exempt (no changes thickness or diameter)



Does not apply to extrusion

˃ Watch for processes resulting in releases: welding, melting,

grinding, that negate the exemption

˃ Does not apply to materials in the form of pellets,

granules, which require further processing

De minimis Exemption

˃ Disregard minimal concentrations in mixtures in

threshold and release calculations

˃ 0.1% or 1%, depending on chemical

 Does not apply to PBT chemicals or waste streams

˃ Does not apply to the manufacture of a 313

chemical unless it is an impurity or imported

˃ Concentration can straddle the de minimis

threshold

 TRI chemical with 1% de minimis threshold contained

in mixture at 0.1% - 5%. Exclude amount present at less than 1%.

De minimis Exemption Examples

˃ Facility combusts coal containing non-PBT

chemical (manganese) below de minimis threshold

 Mn in coal is exempt from threshold/release

calculations

 MnO manufactured as a result of coal

combustion is a byproduct - not exempt

 If the ash is sold to another facility (not a

waste), any MnO contained in the ash is eligible for de minimis exemption

Best Practice #4

˃ Beware the chemical qualifiers

Chemical Qualifier Aluminum Only fume or dust Aluminum Oxide Only fibrous form Ammonia Only 10% aqueous form (100% of anhydrous form) Asbestos Only friable form Phosphorus (not phosphate) Only yellow or white form Nitrate Compounds Only in aqueous solution Hydrochloric Acid Only in aerosol form Sulfuric Acid Only in aerosol form Vanadium Except when contained in alloy Zinc Only fume or dust

Ammonia

˃ Anhydrous Ammonia

 100% considered for thresholds and

releases

 Includes air releases from aqueous

ammonia

˃ Aqueous Ammonia (dissolved in water)

 Consider only 10% of total ammonia

present in the aqueous solution for thresholds and releases

Chemical Categories

˃ Sum all individual members of the

categories & compare to MPOU thresholds

˃ Do NOT include chemicals that are also

individually listed

 Example: glycol ethers category and

2-methoxyethanol (109-86-4) and 2-ethoxyethanol (110-80-5)

Metal Compound Category

‐Antimony Compounds ‐Manganese Compounds ‐Arsenic Compounds ‐Mercury Compounds ‐Barium Compounds ‐Nickel Compounds ‐Beryllium Compounds ‐Selenium Compounds ‐Cadmium Compounds ‐Silver Compounds ‐Chromium Compounds ‐Thallium Compounds ‐Cobalt Compounds ‐Vanadium Compounds ‐Copper Compounds ‐Zinc Compounds ‐Lead Compounds

Metal Category Compounds

˃ Two, separate threshold determinations

 If you exceed for both, file a combined report as the

metal category compound*

*unless there is a qualifier [e.g., zinc (as a fume or dust) and zinc compounds]

˃ Threshold Determination:

 Consider the total weight of metal compound (PbO)

˃ Release/Waste Management Calculations:

 Consider only the weight of the metal portion of the

metal compound (Pb)

˃ Watch for chemicals that are part of two metal or

• ther compound categories (e.g., lead chromate,

cadmium cyanide)

Nitrate Compounds

˃ Only reportable when in aqueous solution

(i.e., dissolved in water)

˃ For threshold determination:

 Use entire weight of nitrate compound

(NaNO3)

˃ For release/waste management

calculations:

 Use only the weight of the nitrate portion of

the compound (NO3)

Acid Aerosols

˃ Sulfuric acid and hydrochloric acid only

reportable as aerosols

˃ Guidance documents available on-line

(see helpful links slide)

Acid Aerosol Example

˃ A thermal incinerator combusts a waste

stream containing chlorinated compounds, forming HCl. The waste stream is then sent to a scrubber to remove HCl prior to exhausting to the atmosphere.

 HCl aerosols are manufactured  HCl aerosols are “treated for destruction”

• n-site by the scrubber

 Any recovered HCl in the scrubber fluid is not

reportable

Best Practice #5

˃ Using the correct TRI chemical

concentrations.

Mixtures

˃ Guidelines for determining concentrations of 313

chemicals in mixtures

 If only upper bound of concentration range provided,

use it

 If upper and lower bounds provided, use midpoint  If only lower bound concentration known, determine

a reasonable upper bound and determine a midpoint

 Only lower bound concentration with no other

information, use an upper bound of 100% and determine midpoint

˃ For threshold and release/waste management

calculations

Mixtures Example

˃ Solvent contains xylene (>20%), toluene

(<5%), and ethylbenzene (1-5%)

 Ethylbenzene – Use midpoint

(1%+5%)/2 = 3%

 Toluene – Use upper bound, 5%  Xylene – Subtract out other known

constituents: 100% - 5% - 3% = 92%

♦ Determine midpoint:

(92% + 20%) / 2 = 56% xylene

Best Practice #7

˃ Avoid common Form R or Form A errors

Common Errors

˃ Use of NA vs. 0

 NA = not applicable/no possibility of release or

transfer

 0 = release or transfer was ≤0.5 lb

♦ Use ½ of the detection limit if non-detect but known to be

present

♦ Form R Section 5.5.4 – Other Disposal to Land, includes

spills or leaks

– NA generally not acceptable in this section for VOCs, even if no spills/leaks occurred!

˃ Report in whole numbers (except PBTs)

 4,244 lbs = 4,200 lbs

Common Errors

˃ Section 7 – Report onsite waste treatments that

• ccur, even if the treatment method does not treat

the specific TRI chemical



Metals cannot be treated for destruction



Treatment efficiency is specific to the 313 chemical destruction, degradation, conversion, or removal from the waste stream (not general efficiency)

˃ Don’t forget about container residue



TRI instructions provide table with residue wt% of drum capacity

˃ Discharges of acids (e.g., nitric acid) can be

reported as “0” if discharge has been neutralized to ph6 or above.

Common Errors

˃ Don’t ignore Data Quality Alerts

 Compare current to previous year  Be prepared to explain significant

differences

Helpful Links

˃ 2016 Forms & Instructions



https://ofmpub.epa.gov/apex/guideme_ext/guideme_ext/r/file s/static/v3321/rfi/RY_2016_RFI.pdf



Guidance Documents: General, Industry/Process Specific, and Chemical Specific



https://ofmpub.epa.gov/apex/guideme_ext/f?p=104:80:::NO:::



Frequent Questions



https://tri-epa.zendesk.com/hc/en-us

˃ TRI-Meweb Resources



https://www.epa.gov/toxics-release-inventory-tri- program/electronic-submission-tri-reporting-forms



CDX



https://cdx.epa.gov/

TSCA Reform

Lautenberg Chemical Safety for the 21st Century Act

Introduction

The Toxic Substances Control

Act (TSCA) is a law, passed by

the United States Congress in 1976 and administered by the United States EPA, that regulates the introduction of new or already existing chemicals into US commerce.

Background on the TSCA Inventory

˃ The Toxic Substance Control Act (TSCA) Chemical Substance

Inventory (TSCA Inventory) was established in 1979 to provide a comprehensive listing of chemical substances in commerce at the time.

˃ USEPA adds new chemicals to the TSCA Inventory when

companies submit a Notice of Commencement of Manufacture or Import following completion of Pre- manufacture Notification procedures.

˃ (See www.epa.gov/oppt/newchems/ for further

information.)

˃ The TSCA Inventory currently lists approximately 85,000

chemicals in commerce in the United States.

˃ Some ways to access the TSCA Inventory include:



Through USEPA’s New Chemical website



On www.data.gov



On www.epa.gov/srs

Call for Reform

˃ TSCA in need of modernization ˃ State governments have acted to regulate

toxic chemicals due to gaps in TSCA which makes it difficult for facilities to sell the same product formulations nationwide

˃ Call for more uniform and consistent

regulations at the federal level that pre- empt state law

Overview of Reform

˃ Frank R. Lautenberg Chemical Safety for

the 21st Century Act – also known as TSCA

Reform

˃ Lautenberg Act was signed by President

Obama on June 22, 2016

˃ Received bipartisan support in Congress ˃ Received “reluctant” support from

chemical industry to improve consistency

˃ Bill requires significant new EPA

rulemaking

Key Elements of Lautenberg Act

˃ EPA required to evaluate new and existing chemicals to

determine whether they present an unreasonable risk of injury to health or the environment under the conditions of use.

˃ EPA required to develop list of “active” and “inactive”

chemicals.

˃ Requires EPA to consider potential exposed or susceptible

subpopulations while evaluating chemicals.

˃ Prohibits cost considerations or other non-risk factors. ˃ Allows companies to request EPA evaluation of existing

chemical.

˃ Preempts state chemical regulations under certain conditions ˃ “Least burdensome” requirement eliminated ˃ Limitations on confidential business information (CBI) ˃ Allows for EPA to charge higher fees for chemical reviews

EPA Rulemaking Deadlines

˃ Within one (1) year EPA must enact the following

rulemaking:

 Require reporting for “active” substances

♦ 10 years worth of chemical manufacturing data

 Establish risk-based screening process for

prioritizing chemicals

 Establish process for conducting risk evaluations  Establish plan for reviewing CBI claims for active

substances ˃ Within two (2) years EPA must enact regulation

for reporting by manufacturers and users of mercury and mercury-added products

EPA Policy and Guidance

˃ In addition to rulemaking, EPA must issue

various policy and guidance documents:

 Within one year after enactment, EPA must

develop guidance to assist interested persons in preparing and submitting draft risk evaluations.

 Other policies, etc. must be developed

within two years (e.g., testing policy, completeness policy, CBI related policies,

TSCA Implementation Plan

EPA has identified three (3) areas that it will take immediate action:

• 1. New chemicals
• 2. Confidential Business Information (CBI)
• 3. Ongoing TSCA Section 6 rulemakings

Implementation Plan

˃

New Chemicals or New Uses



EPA must now make affirmative determination on Pre- Manufacture Notices (PMNs) and Significant New Use Notices (SNUNs) within 90-day review period

˃

Confidential Business Information (CBI)



EPA will meet 90-day deadline for incoming CBI claims for chemical identity



Create a plan to link associated information



Develop an approach for routine review of new CBI claims

˃

Ongoing TSCA Section 6 Rulemakings



Continue to move forward with rulemakings to address the risks it has identified with certain uses of trichloroethylene (TCE), methylene chloride (MC) and N-methylpyrrolidone (NMP),

Preemption of State Chemical Regulations

˃ States may not impose new restrictions on a chemical found

by EPA not to present an unreasonable risk or that has been regulated by a Section 6 rule.

CONSISTENCY

CBI Updates –Amended Rule

˃

CBI updates published in Federal Register on January 19, 2017 with an effective date of March 20, 2017

˃

The amended TSCA provides new requirements for assertion, substantiation, and review of CBI claims.

˃

For TSCA submissions filed after March 20, 2017 substantiation must be submitted for all information claimed as CBI. Any CBI claim submitted without substantiation will be deemed deficient and the submitter will be notified. If substantiation not received within 30 days then information will be made public without further notice.

˃

For TSCA submissions filed between June 22, 2016 and March 20, 2017, EPA is giving submitters until September 18, 2017 to provide

• substantiations. After September 18th, if no substantiation has

been received for a claim, then EPA will provide 30 days' notice and a final opportunity to substantiate. If not substantiated the information will be made public without further notice.

Inventory Reset –Active/Inactive

˃

Act requires EPA to promulgate rule requiring companies to report the chemicals they manufactured (or processed) in the previous 10 years in

• rder to designate chemicals as “active” or “inactive” on the TSCA

Inventory.

˃

Manufacturers and processors must provide the information no later than 180 days after rule the rule is published

˃

EPA will develop a list of “active” chemicals and a list of “inactive” chemicals based on these notifications.



Chemicals on the “active” list will be prioritized for purposes of risk

• evaluations. Active chemicals will be designated by EPA as “high” or “low”

priority through on a risk-based prioritization process.



EPA must develop an “interim” list of active chemicals based on the CDR reporting.



If a chemical is designated as “inactive,” a company must notify EPA before it can manufacture or process the chemical.



Once a chemical is moved from the “inactive” list to the “active” list, it is subject to prioritization.

Inventory Rule Update – Draft Regulation

˃

On January 13, 2017, EPA published proposed rule to “reset” the TSCA inventory. (82 Fed Reg. 4255)

˃

Proposed rule requires reporting through Central Data Exchange (CDX).

˃

Comments were due March 14, 2017.

˃

Would require reporting of chemicals manufactured or imported for commercial purposes between June 21, 2006 and June 21, 2016 (the "lookback period").



Substances that appear on both the non-confidential (i.e., "public") portion of the Inventory and on EPA's "interim list" of active substances would not be required to be reported.

˃

Report due no later than 180 days from date final rule is published.

˃

Notifications for substances that were "processed" during this period would not be required but would be accepted.

˃

Properly notified substances will be designated “active”

˃

Substances not reported but on the TSCA list will be “inactive”

˃

EPA is proposing procedures for facilities looking to manufacture/import/process “inactive” chemicals in the future.

˃

The reporting requirements covered by the proposal would apply

• nly to Inventory-listed substances.

˃

Substances added to the Inventory on or after June 22, 2016 would be automatically designated as active and need not be reported.

˃

Exemptions from reporting mirror PMN rule exemptions (except for export-only substances will be required to report)

˃

Reporting is not required for pesticides, food, drugs, cosmetics, medical devices, R&D materials, impurities, byproducts that are disposed (and not used) and some naturally occurring substances.

˃

Unlike the CDR rule, there are no reporting threshold (i.e. 2,500 or 25,000 lbs)

Inventory Rule Update – Draft Regulation (Continued)

˃ Rule proposes “Notice of Activity" (NOA) reporting

forms based on TSCA Notice of Commencement (NOC) forms



Form A – for manufacturers/importers/processors retrospective reporting



From B - for manufacturers/importers/processors forward- looking reporting

˃ Processers not required to report but if a chemical they

are processing is deemed “inactive” it’s processing will be prohibited under TSCA. Therefore, it may benefit processors to retrospectively report in order to maintain “active” status of the material they process.

Inventory Reset Procedures and Timing

˃ Retrospective Reporting (10 year look back):

 Chemical identity,  Type of commercial activity (i.e., manufacture vs.

import),

 Date range of manufacture or import during the

lookback period, and

 Whether the reporter seeks to maintain an existing

CBI claim for a confidential chemical identity.

˃ Forward-looking Reporting

 Must include the actual date by which the inactive

substance is to be domestically manufactured, imported, or processed.

Inventory Reset – What will be reported

NOA Forms Available for Review

https://www.regulations.gov/document?D=EPA‐HQ‐OPPT‐2016‐0426‐0009

Keeping Track of TSCA Reform Related Regulatory Development

˃

Ongoing rulemaking and policies to be released

˃

https://www.epa.gov/assessing-and-managing-chemicals-under- tsca/highlights-key-provisions-frank-r-lautenberg-chemical

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https://www.epa.gov/assessing-and-managing-chemicals-under- tsca/frank-r-lautenberg-chemical-safety-21st-century-act-0

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www.tscablog.com/

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How will the Trump administration affect TSCA rulemaking?

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EPA provided webinars:

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https://www.epa.gov/assessing-and-managing-chemicals- under-tsca/meetings-and-webinars-amended-toxic- substances-control

Questions

Amanda Jennings, Managing Consultant ajennings@trinityconsultants.com Ellen Hewitt, Managing Consultant and BD Manager ehewitt@trinityconsultants.com

Trinity Columbus Office 614-433-0733