What would TSCA reform bill HR 5820, if it passed as released, do to companies beyond what they have to do today? This blog deals with my best guess at what the implications are for Chemicals Manufacturers [and Importers - still treated the same] for the following scenarios:
Scenario A. Company manufactures an existing chemical for the same uses as it has for a number of years. The chemical isn’t on anybody’s concern list
Scenario B: Company begins to manufacture a chemical that has been in commerce for years for the first time and for the same use as others have done
Scenario C: Company begins to manufacture or process a chemical it has declared for a use that was not included in its previous declaration (whether or not anyone else had declared the use). The chemical isn’t on a concern list (yet).
Scenario D: Company has invented a new to the US chemical and wants to begin commercial manufacture.
Scenario E: Company already manufactures a chemical that becomes subject to a new safety standard.
Scenario G: Company wants to begin using or selling a one of its manufactured chemical for a use not listed in a safety standard.
See the blog HR 5820: Major Reset of TSCA for the complete list of Scenarios I hope to address.
Scenario A: Company manufactures an existing chemical for the same uses as it has for a number of years. The chemical isn’t on anybody’s concern list; i.e., the likelihood of EPA proceeding with a “safety standard determination” anytime soon is low.
1. DECLARATION. Company has to file a declaration one year after amendment of TSCA that includes:
- the chemical identity of the chemical substance or mixture;
- the name and location of each facility under the control of the manufacturer at which the chemical substance or mixture is manufactured or processed or from which the chemical substance or mixture is distributed in commerce
- the number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure
- a list of health and safety studies reasonably ascertainable by the manufacturer (regardless of whether EPA already knows about it). Also copies of those studies that the company has not previously submitted to EPA.
- the physical, chemical, and toxicological properties of the chemical substance or mixture, including GHS classification of the toxicity.
- the categories or proposed categories of intended use
- the total amount of each substance and mixture manufactured
- reasonable estimates of the total amount to be manufactured
- the amount manufactured for each of its categories of use
- reasonable estimates of the amount to be manufactured for each of its categories of use or proposed categories of use
- a description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture
- exposure information relating to the chemical substance or mixture. EPA will need to define what this means. Will it be life cycle exposures to any and all media by all users and disposal? Assume it will be similar to what is asked for in a PMN today – although EPA does a lot of modeling based on process descriptions which are not called out in the bill. Perhaps EPA will ask for process conditions as a surrogate for exposure information?
- any conditions currently placed on the chemical substance or mixture due to regulation under any Federal law or due to voluntary action (presumably, this would include conditions set out in safety standards, with which the company must comply and possibly include all uses)
- if manufacturer also processes a chemical substance, any information indicating that a mixture including the chemical substance has substance characteristics that are different from the substance characteristics in kind or degree.
- a certification signed by a responsible official of the submitting party that each statement contained in the submission is accurate and reliable; and includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor.’’
2. DECLARATION UPDATES
Company has to update the information
- every 3 years whether or not it has made any changes
- immediately if it would indicate “significant new information” of adverse effects or anything relevant to meeting a safety standard. If this goes the way the old 8(e) did, this will turn out to be any change from that previously reported except for minor volume differences
- within 6 months of manufacture for a use it hasn’t previously declared (as long as there isn’t a significant new use rule or safety standard on it.
- No later than 180 days if the company permanently quits making the chemical (“cessation declaration”).
3. Minimum Data Set
Company has to provide a minimum data set [to be defined by EPA by rule, but expect the REACH set] depending on volume [to be EPA defined] on a schedule of:
- 3 years for high volume
- 4 years for moderate volume
- 5 years for everyone else [REACH gives until 2018 and has a 1000 kg cutoff]
4. WHATEVER ELSE EPA WANTS TO KNOW
- EPA has carte blanche to ask for any other records or reports it wants by rule or order.
- Section 4 test rules and orders will also trigger reporting
5. SIGNIFICANT ADVERSE REACTION ALLEGATIONS AND SUBSTANTIAL RISK INFORMATION
The old 8(c) and 8(e) provisions are unchanged except that allegations records need to be reported annually. And the bill changes the numbering so that those sections become 8(e) and 8(h), respectively.
6. DISCLOSURES TO COMMERCIAL PURCHASERS
Companies have to provide “all known commercial purchasers” (whether they buy from the company or someone else?) with each shipment or on request:
- the chemical identity of the chemical substance or, for mixtures, the chemical identity of all chemical ingredients. Confidentiality for chemical identity appears to be limited to those chemicals with no (known?) health and safety studies and that are not in children’s products or otherwise possibly exposing children.
-all information regarding toxicological properties of the chemical substance or mixture submitted to EPA in the Declaration
- the list of health and safety studies submitted to EPA and copies of the individual studies if requested
- any records of “significant adverse reactions” allegations submitted to EPA (but oddly, not substantial risk notifications)
Implications for existing manufacturers:
INFORMATION MANAGEMENT: A huge multi-disciplinary effort will be needed to create the first declaration. Records will need to be searched, collated and reported for health and safety studies and toxicity information, sales and marketing current and future will need to be calculated, experts will need to determine how to represent exposure information (which EPA will need to carefully lay out in rulemaking), collating all applicable regulatory standards, chemistry experts to identify byproducts and more. A jobs bill? Probably not (at least for the private sector – EPA and consultants will have a hey day, however!). Resources will have to be reallocated to cover these new reporting requirements, since they will not be revenue generators.
This work will need to continuous – to quickly identify “significant new information” and at a minimum redoing the reporting every 3 years.
MINIMUM TESTING: If the Minimum Data Set trigger is hit as a high volume chemical, it will be impossible to do unless the chemical has already been subject to REACH or HPV testing. Presumably EPA would allow time to complete studies, but… in theory production would have to stop until the day is submitted. Consortia as underway for REACH and HPV will be necessary to defray costs and avoid duplicative testing. One must assume EPA will copycat the REACH minimum data set approach, but since governments always try to one-up each other, there will likely be differences leading to higher costs.
RULEMAKING: A lot of work will need to be done to help EPA exercise the provision that declarations will not be “unnecessary or duplicative.” Much will depend on how fine EPA makes reporting categories of information. Regardless, there will need to be mechanisms for the supply chain to communicate what is and is not being reported by each party, especially since processors are also subject to reporting.
CBI: There will be loss of proprietary information: No chemical identity confidentiality is allowed if it is subject to a health or safety study or is used in children’s products. EPA has already begun reversing the historical default of not challenging claims. Much more care will need to go into upfront substantiation of use, exposure, volumes, etc. information. Whether or not the link between a company and a chemical is going to be accepted as a valid claim is unclear.
Fees: Wild card. EPA can charge them and given budget constraints will.
Scenario B: Company begins to manufacture a chemical that has been in commerce for years for the first time and for the same use as others have done (and presumably declared by someone else as above). I.e., the chemical is new to the company. The chemical is not on a concern list.
See Scenario A.
Declaration must be filed within six months of commencing the new activity.
Implications for manufacturers of existing but noncontroversial chemicals and uses:
Same as Scenario A, but with more time to pull declaration information together and, hopefully, be able to buy or rely on other submitters information.
Scenario C: Company begins to manufacture or process a chemical it has declared for a use that was not included in its previous declaration (whether or not anyone else had declared the use). The chemical is not on a concern list; i.e., the likelihood of EPA proceeding with a “safety standard determination” anytime soon is low.
See Scenario A
Declaration must be filed within 6 months of commencing the new use
Implications for manufacturers of existing but noncontroversial chemicals for uses new to them:
Same as Scenario A if someone else has previously declared the use and EPA had no concerns. However, watch for priority listing of the chemical in the future.
If no one has previously declared the use, there is a low risk of possibly triggering a safety standard if the use triggers exposure concerns by EPA. Then see Scenario E.
Scenario D: Company has invented a new to the US chemical and wants to begin commercial manufacture. The chemical is not on a concern list; i.e., there is no applicable safety standard.
Company has to file with EPA 90 days before manufacture a “declaration” containing the following information:
- Minimum data set:
- chemical identity
- substance characteristics
- biological and environmental fate and transport
- toxicological properties
- volume manufactured, processed, or imported
- intended uses
- exposures from all stages of the chemical substance or mixture’s life cycle that are known or reasonably foreseeable to the manufacturer
- any studies that may apply to category under a test rule
- a statement that the chemical substance or mixture is reasonably anticipated to meet or continue to meet the safety standard [not likely to be one for a new to the US chemical, unless it falls within a category] and a justification for such statement.
- A certification signed by a responsible official of the submitting party that each statement contained in the submission is accurate and reliable; and includes all material facts known to, in the possession or control of, or reasonably ascertainable by the manufacturer
He then waits 90 days for EPA to decide if
- the new chemical falls under a category it considers already reviewed and subject to an existing safety standard, or
- it needs to develop a new safety standard
- the proposed use is a “critical use” (since the chemical is new, it’s hard to envision this applying)
If EPA decides a new safety standard is necessary, the company may be asked for additional information and have to wait up to an additional 9 months for EPA to develop the standard. The standard may have a broad range of conditions restricting how he makes the chemical and how it can be used and disposed of. Timing is somewhat murky for how long EPA has to collect more information and make the safety standard determination.
See the blog on safety standards and new uses.
Once the safety standard is set, presumably he must prove and certify that he is in compliance with the standard.
It’s also possible that the new chemical will be covered as a having safe intrinsic properties under a new section 39 of the Act and not have to do the above. But it seems doubtful for a new to the world chemical. Maybe some kinds of polymers, as those currently exempt under PMN rules like polyesters will be covered and some chemically extracted “naturally occurring” chemicals?
Alternatively or simultaneously, the company could submit a request to get classified as a “safer alternative.” It’s doubtful this type of notice will be less onerous than the new PMNs. The data set for safer alternatives require a battery for the new chemical and it’s comparative alternate existing chemical and impacts throughout the life cycle and would appear to be use specific.
No longer exempt from PMN: the current exemptions from what constitute a “new chemical substance” such as polymers, byproduct reactions and impurities (e.g., section5(h)(4)) may not last, unless EPA decides to continue them after a mandatory review.
Notice of Commencement: as now, the company must notify within 30 days. And then must follow Scenario A as well as comply with safety standard conditions.
Implications for manufacturers of new chemicals:
PMNs will be costly in submitting the initial data package and responding to inquiries for additional information as EPA decides whether and what safety standard are necessary. There will be significant and unknown duration for this review.
Only those very confident in commercial success and can afford long delays prior to introduction will be able to commence pre-planning.
Scenario E: Company already manufactures a chemical that later becomes subject to a new safety standard.
As well as dealing with everything from Scenario A, the following will apply:
First, the company will have probably been subject to an extensive reporting rule as EPA tries to collect enough information to be able to do a life cycle assessment of aggregate and cumulative exposures to the chemical. EPA can do this by rule or order (with less recourse for companies to argue the requirement) on anything it thinks would “assist” (not today’s “necessary”) the agency in doing a safety standard. Likely this would sweep in uses that are otherwise exempt from today’s TSCA.
Company will need to comply with any conditions set and be able to prove it. These conditions can be pretty much anything: ban, production limits, use restrictions, hazard communication, monitoring, testing, industrial hygiene measures, disposal, risk reduction plans, etc.
Presumably, EPA will set various recordkeeping, monitoring and other requirements for reporting.
Priority chemicals listed in the bill will be the first to get safety standards (within 18 months of passage) and newly listed (300/yr) within 30 months of listing.
There is a provision for “critical uses” for chemicals that cannot meet the safety standard conditions if the EPA is convinced (the burden of proof is on the company) that the use is “critical or essential” and there is no feasible safer alternative or there is a net benefit to health or the environment compared to alternatives. Feasible conditions will still be set and purchasers must be informed that the supplied chemical is subject to a safety standard. These exemptions are good for 5 year periods. EPA will publish them.
Implications for manufacturers who become subject to safety standards:
New reporting requirements need to be monitored and responded to. These will far exceed current PAIR reporting as EPA needs detailed information to create safety standards.
Compliance with conditions set for safety will entail variable and potentially high costs, e.g., relabeling, market restrictions, monitoring, workplace controls, etc.
Constant vigilance to prevent a “significant new use” will be necessary to allow consideration of whether notification is economically warranted and avoid penalties.
New communication to customers about the safety standard and its meaning for the company’s products will be required, along with requests not to initiate new uses without prior consultation.
More export notifications.
Companies will exit manufacture of safety standard chemicals. Likely only large companies will be able to deal with managing safety standard conditions.
The rate of issuance of safety standards by EPA and the use of categories of chemicals will determine how many companies are affected and the market for the chemicals.
Scenario F. Company wants to begin manufacturing a chemical subject to a safety standard.
See Scenario E.
Notification 90 days prior to manufacture and wait to see what additional conditions EPA may impose.
Implications for manufacturers adding safety standard chemicals to their portfolios:
Fewer companies will want to make such chemicals, unless they already have extensive regulated chemical capabilities. De facto shrinkage of the number of suppliers as existing manufacturers exit and no new ones want to deal with the new restrictions.
Scenario G: Company wants to begin using or selling a one of its manufactured chemical for a use not listed in a safety standard.
See Scenario E.
Notification 90 days prior to manufacture and wait to see what additional conditions EPA may impose.
Implications to manufacturers adding new uses to their safety standard chemical;
It will depend on how broadly EPA defines the categories of use covered in the standard and how hard it will be to prove safety.
Companies need to have a lot of foresight and creativity to cover all use scenarios in the initial submissions to EPA to allow them to do the work once (think patents), but not so broad as to bring down unreasonable restrictions.
Next up: HR 5820 Implications for Chemical Processors. Posted 9/10/11: http://wp.me/pzzO5-6p