green chemistry: latest developments and...

Green Chemistry: Latest Developments and Trends

Tom Lewandowski, Ph.D., DABT, ERT, ATS Gradient, Seattle WA

October 21, 2015

2 Copyright Gradient 2013

Green Chemistry and the New Paradigm for Evaluating Product Safety

• An approach for guiding product design and management

Not entirely new but seeing much broader use

Driven by new regulations as well as industry recognition of potential cost savings

• Goal - Avoid chemical problems & liabilities at all stages of product lifecycle by choosing better chemicals or redesigning processes Lewandowski. 2011; adapted from Anastas and Warner, 1998


Green Chemistry Focusses on Hazard

Risk = Inherent Hazard (e.g., Toxicity) x Exposure

• The standard paradigm since the 1950s is that inherent hazard

AND exposure need to be considered

If you limit exposure, you don’t need to worry about risk

• The Green Chemistry paradigm puts the emphasis on the hazard

If you eliminate the hazard, you don’t need to worry about exposure

Resolves concerns whether all exposure situations have been considered

Level of data needed to indicate a true hazard remains in question

• Is one possibly weak study sufficient?

Exposure does come into play after high hazard chemicals have

been eliminated (or if they can't be eliminated)


Hazard Identification and Ranking

• What it is: A review of the various hazard

properties for chemicals in products and then

ordering the products for overall hazard

Focus on hazard (inherent properties) without considering exposure

Ordering is a challenge, which properties (tox, ecotox, persistence, etc.) have priority?

• Why do it?

Public wants it, retailers want it

To understand product stewardship issues

For regulatory compliance (e.g., SDS preparation)

Evaluate the need for alternatives assessment

Some Companies

using Hazard

Ranking

Regulatory Drivers


Source: www.saferstates.com

Already have alternative analysis requirement

Green Chemistry Regulatory Activity in 2015

Considering legislation requiring /promoting alternatives asst.

Enacted OR considered a ban on microbeads


California Safer Consumer Products Regulations

• "a sea change in the way that California is going to be managing toxic chemicals" (LA Times, 9/26/13)

• CalEPA/DTSC establishes candidate chemicals

Currently ~2000 chemicals listed as "of concern" by various groups

• CA EPA/DTSC identifies priority products containing those chemicals which have the potential to pose "significant or widespread adverse impacts"

• Identified priority products must be evaluated for less hazardous alternatives

Priority products requiring alternatives analyses or regulatory responses

www.dtsc.ca.gov/


SCP Priority Products

• 1st priority products proposed March 13, 2014

• Polyurethane spray foams containing unreacted isocyanates,

• Paint and varnish strippers containing methylene chloride,

• Children's foam sleeping products containing the flame retardant TDCCP

• Formal rulemaking process in late 2015/early 2016

• 2015-2017 work plan outlining future product categories adopted in April 2015

EZ Paint

Stripper


Future Product Categories

• Seven future target product categories identified

1. Beauty, personal care, and hygiene products 2. Certain building products (adhesives, sealants,

and flooring)

3. Cleaning products 4. Clothing products 5. Fishing and angling equipment

6. Consumable elements of office equipment (e.g., inks, toners)

7. Household and office furnishings treated with flame retardants and stain repellants

• DTSC states they will choose 3 products in 2015 (?) and 5+ per year 2016 and 2017


Source: DTSC 2015


Required Responses

• Remove the chemical from the product, stop selling the product in CA, or submit an alternatives assessment to CA DTSC • Not permissible to simply substitute another chemical

• Conducting Alternatives Assessment under SCP • Draft AA guide made public Sept 2015 (1st part)

• Cost for alternatives assessment is unclear but could be at least several $100K

• Key factors: availability of data, the complexity of the product, other regulatory requirements

• Suppliers will be reluctant to provide information for comparing alternative formulations

• Antitrust concerns for trade associations or other industry groups

• Copies of final AAs will be posted for public comment


What Constitutes an "Alternative"?

• According to DTSC

Removing the chemical of concern from the product (e.g., if one determines that the chemical is not needed)

Reformulating/redesigning the product to eliminate or reduce the chemical of concern

Redesigning the product to reduce exposure

Instituting other changes that will reduce the product's adverse effects as cited by DTSC

• How much of a reduction is needed to be a viable alternative?

• Do you have to evaluate alternatives outside your business model?


Other States

• Washington’s Children’s Safe Products Act 65 chemicals

Manufacturers of products containing these chemicals must state presence, quantity, & function • Threshold is the practical quantitation limit (PQL)

• Information is posted on a public website

Alternative assessment requirement has been proposed

• Maine Toxic Chemicals in Children's Products

Act Requires notification of presence and possible

alternatives assessment

Proposal to expand alternative assessment scope

• Vermont Similar to Washington law

Some provisions currently under discussion


Approaches for Product Evaluation


GreenScreenTM for Safer Chemicals

• Published by Clean Production Action, a non-profit

organization (www.cleanproduction.org)

• Considers the three main GHS (Globally Harmonized

System of Classification and Labeling of Chemicals)

categories of human health, environmental, and physical

hazards, and assigns a score to individual endpoints

• Considers not only the chemical, but also any relevant

transformation or degradation products

• Chemicals are placed into one of four "benchmarks"

http://www.cleanproduction.org/


GreenScreenTM Benchmarks

Benchmark 2

Benchmark 4

Benchmark 1

Avoid – Chemical of High

Concern

Benchmark 2

Use but Search for Safer

Substitutes

Benchmark 3

Use but Still Opportunities

for Improvement

Benchmark 4

Prefer – Safer Chemical

Source: Clean Production Action


Example GreenScreenTM Benchmark Analysis

• Greater weight given to priority human effects (carcinogenic, mutagenic, repro/developmental and endocrine) Data gaps (dg) can worsen score (depending on

number/category)

• Overall – Assigned Benchmark 1 ("Avoid") Based only on persistence and bioaccumulative

properties (from worst case study)

Human health hazard is fairly low

Priority Human Effects Other Human Effects

C M R D E AT ST N SnS SnR IrS IrE single repeated single repeated

M L L M M L M L dg L L dg L L

EcoTox Env Fate Physical

AA CA P B Rx F

L M vH vH L M

Decamethylcyclopentasiloxane (D5)

© Gradient, 2015


Other Tools/Frameworks

• NRC Chemical AA Guidance (Oct, 2014) Strategies for making trade-offs and dealing with uncertainty Fairly detailed with some good examples

• IC2 AA Framework Good overall framework but short on details Used to assess copper boat paint alternatives by WA

• ECHA REACH Guidance for Authorization Application Applies to substances of Very High Concern Notable focus on performance/feasibility

• OECD AA Toolbox • US EPA Safer Choices (formerly DfE)

Primarily hazard based

Major new push for this program


Challenges You May Face

• Supply Chain Issues

Need to engage whole supply chain as much as possible (they

have the knowledge!)

• Confidentiality Concerns – Data from multiple suppliers and multiple

supply chain levels

• Competitive Issues - a supplier who has no equally or more profitable

alternative will have an incentive to withhold information

• Working via Industry Consortia/Trade Associations

Considerable cost savings, sharing of expertise, arrival at uniform

decisions

Different levels of interest/commitment/risk

Anti trust issues?


Challenges You May Face (2)

• Organization

Need to have technical people involved - they know the product!

• How Far Do You Go?

Do you want to be incrementally more green or reinvent the product?

• Which Framework/Tools?

Different approaches may give different results

Different weighting of concerns will likely give different results

With transparent discussion, this can be informative but might limit decisions

If there are conflicting results, which is “right”?


Summary

• Increasing interest in green chemistry/green products Due to public pressure, potential cost savings, market advantage

and interest in decreasing product liability

• Increasing focus on chemical hazard rather than risk Poses challenges for customer communication

• Expect more regulatory requirements for alternative assessment Back door market pressures to effectively eliminate certain

chemicals

California as a test case

• Expect standardization in approaches for conducting hazard evaluation and alternative assessment


Thanks for your attention!

[email protected]

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