Document Control Officer (7407 M) Novem ber 2 , 2015

Office of Pollution Prevention and Toxics (OPPT) Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460

– 0001

RE: TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals ; EPA

- HQ

- OPPT

2015

- 0273 ; 80 FR 53151 ( September 2 , 2015 )

Dear Document Control Officer:

The Socie ty of Chemical Manufacturers & Affiliates ( SO CMA) submit s the following response to several specific questions on the renewal Information Collection Request ( ICR) for TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals (OMB Control No. 2070

- 0038)
contained in a consultation email to SOCMA from Jeffrey Taylor of OPPT’s Existing Chemicals
Branch dat ed September 30 , 2015. As we explain below, the ICR is inadequate in its current form because it makes no attempt to estimate the principal burden associated with existing chemical SNURs: the challenge of determining if a chemical that one wishes to manuf acture or process for the first time is subject to a previously

- issued SNUR.

We also offer some additional comments on the ICR referenced above

. Sp ecifically, we identify some of the challenges our members face in understanding SNUR requirements and communicating them downstream . We also offer some suggestions for how EPA could clarify SNUR requirements and otherwise help reduce the burden s associated with SNURs

.

SOCMA is the only US

- based trade asso ciation dedicated solely to the specialty chemical industry

. Over 70% of SOC MA ’s active members are small businesses.

I. Responses to Questions from Jeffrey Taylor

1. Information Collection

Is the information that the Agency seeks under this ICR available from any public source, or already collected by another office at EPA or by another agency?

We are not aware that the information requested in responses to SNURs is readily available anywh ere else

, so the request is not duplicative. Almost by definition, a person proposing to manufacture or process a chemical for a new use is doing something that has not been done before, and so there would be no other way for EPA to obtain that informatio n. The only exception might be where a use occurred in the past but had been discontinued.2

If yes, where can the Agency find the data?

If a use occurred in the past but was discontinued prior to issuance of the SNUR, the
administrative record for that S NUR may contain information on that historic use.

Do you understand that you are required to submit or maintain records of certain data
elements?

Yes.

Is the format of the reporting forms clear, logical, and easy to complete?

Yes.

2. Electronic SNUN Reporting

What, if any, benefits are you experiencing from using the e

- PMN software and submitting your SNUN notices via CDX (e.g., burden reduction, greater efficiency in compiling the information, etc.)?

Ther e are clear benefits t o using CDX for subm issions

, such as having to prepare only one
document electronically in lieu of 3 paper copies. The preparation is also generally easier

. For example

, pulldown menus help streamline filling out the PMN/SNUN form

. P rompts alert the
submitter in case certain fields were not completed

, helping to reduce the margin of error and facilitating accurate data entry . T he preparation of the sanitized version of the form is a particular improvement

, since it is automatically generated . Being able to attach docum ents electronically is great

, particularly if they are large.

Despite the obvious benefits being realized there are also instances

, particularly with small businesses, where trying to deal with the idiosyncrasies of software issue s ha s been a terrible
bur den. It is not uncommon for a small business to not have a dedicated IT depa rtment

- thus some issues have caused tremendous delays in submissions. I n some instanc es , allowing a paper or CD submission could significantly reduce burden

, and should be considered.

Are the online instruction manuals and guidance documents for using the software and submitting SNUN notices electronically accurate and understandable?

The present eTSCA systems are having is sues such as incompatibilities with the IT environments of many companies

, making it so submission s in some cases canno t be made. One SOCMA member company noted that it had spent hundreds of hours trying to overcome IT barriers

, delaying submissions and t hus commercialization. At the same time

, SOCMA understands the burden on EPA is large in dealing with so many IT environments. We appreciate that t he CDX help desk continues to be very responsive and helpful. SOCMA also appreciates EPA’s outreach

on the topic of CDX via recent webinars and at conferences like GlobalChem.3

Do you agree with EPA’s estimated burden and costs?

In many cases, t he greatest burden associated with compliance with a SNUR is the degree of effort required to ascertain whether a particular chemical is subject to a SNUR or proposed

SNUR. In this connection, EPA’s estimates are seriously inadequate.

In the Supporting Statement for the ICR, EPA notes that it “ typically notifies the manufacturer(s) of chemicals subject to a SNUR prior to its issuance. ” (Id. at 10.) This statement ignores the fact that EPA is likely only to know of companies who reported manufacturing the chemical in their responses to the most recent Chemical Data Reporting
Rule. Th ose responses only capture fa cilities that manufactured at least 25,000 lbs of the chemical in one of the years covered by that rule. Outside of commodity chemicals and
confidential PMN chemical s , it is reasonable to assume that, a s a general rule, there are at least as many faciliti es manufacturing a substance below that volume as there are above it

.

The even greater shortcoming with EPA’s burden analysis , however, is that it explicitly disclaims any attempt to estimate the burden of existing chemical SNURs on companies that start to manufacture or process the chemical after the SNUR is issued : “ However, without prior knowledge of chemicals which would be the subject of future SNURs, estimating the number of potentially affected entities subject to 40 CFR 721.5(a)(2) is not possibl e. ” (Id. at 9

- 10. ) While it may be true that EPA cannot predict the precise number of such entities, EPA certainly can make reasonable estimates about what those numbers could be, based on the number of entities affected by prior existing chemical SNURs. At a minimum, EPA could choose a range of
order

- of

- magnitude values to develop some illustrative burden estimates.

Otherwise, EPA’s failure even to attempt to estimate these burdens is a serious shortcoming of the analysis

, because this is where the maj ority of the burden will be experienced . The recent SNUR/SNAc workshops convened by the US/Canadian Regulatory Cooperation Council have highlighted the problems experienced by entities seeking to figure out if a chemical they are
interested in manufacturing or processing is covered by a SNUR. While it may only tak e 10 minutes to verify if a chemical is covered by a SNUR when EPA notifies you (id. at 11 ), it is vastly

more time

- consuming otherwise.

As a starting point, most companies refer to Section 15 of the Safety Data Sheet (SDS) for the chemical to determine if it is subjec t to a SNUR and, if so, what those requirements may be. The absence of any SNUR information in Section 15 is just a trigger for additional due diligence,
h owever , because many companies preparing a n SDS do not include any applicable requirements imposed by other agencies (e.g., EPA) since OSHA does not require them to.

Because of the unreliability of SDS s , companies have been building data systems or subscribing

to services that compile the universe of SNUR chemicals and allow users to search chemicals against them. As explained in the workshop, these systems and subscriptions are highly costly
to build or to maintain. And

, if future SNURs do not list chemicals by CAS number, that task will never be simple.4

The task is further challenging in the case s of (i) proposed SNURs (which are subject to the § 12(b) export notification) and (ii) SNUR chemicals contained in articles where the SNUR has
waived the articles exemption.

In any case, the next source of burden on downstream companies is to determine whether the use they propose to conduct is one of the new uses covered by the SNUR. In the cases where the specific chemical identity specified in the SNUR is CBI, the company has to establish to EPA’s satisfaction that it has a bona fide intent to manufacture or process the chemical, per § 721.11
of EPA’s TSCA rules.

SOCMA believes the foregoing burdens are attributable to the legal requirement to submit a SNUN, an d should be taken into account by EPA in this ICR. To the extent it does not, SOCMA believes the current ICR is inadequate and should be rejected by OMB

.

II. More General Comments in Response to the ICR

As just noted, t he ICR does not ask about the broader burdens of SNURs and how the supply
chain can be impacted . SOCMA feels that it is important to highlight some of the major challenges tha t our members face in communicating and understanding SNURs

, and would like to share some though ts on impr ovements

. SNURs can have a broad reach

, beyond just
manufacturer s and importer s

. EPA c ou ld substantially relieve the burdens experienced by those impacted by these regulations by clarifying how it presents SNUR requirements , by working with OSHA to improv e inclusion of SNUR requirements in SDS, and by greater outreach on SNURs and their most common requirements

.

A. C larifying SNUR Requirements

It can be really difficult to understand the regulatory, hazard communication, and recordkeeping requirements associated with SNURs. The regulatory requirements for SNURs

are presented in a very confusing way since t here is, in essence, a menu of fairly broad requirements at the beginning of 40 CFR Part 721, followed by a very large list of SNUR
chemicals that hav e only CFR code references to which one must refer back to full y understand what is required. This is v ery time consuming, and has a high potential for error.

Since the CFR is electronic, there is no longer any reason to save space by cross

- referencing.

T he Agen cy could dramatically simplify the presentation of SNUR requirements by simply putting them all in one place, spelled out . F or example

, it could express a requir e ment as : “This
is what one must do (or not do)

– don’t discharge to water above N ppb, wear gloves, respirator, etc. If you desire to manufacture or use the substance in a manner that, for any

reason, does not allow you t o abide by these provisions, then you must file a SNUN to obtain prior approval by EPA.”5

As noted earlier, compan ies t yp ically communicate the e xistence of a SNUR via S ection 15 of a Safety Data Sheet ( SDS ) , usually by providing the CFR citation . S ometimes the specific recordkeeping req uirements are outlined as well

. In other case s , however, manufacturers do

not no te the existence of the SNUR. In some cases, they may express the S NUR requirements
in other sections of the SDS

– but again, they may not. Indeed, they may specify worker protections at variance with those specified in the SNUR. For all these reasons, SOCMA would support some sort of harmonization between OSHA and EPA ’s requirements in this connection. We urge EPA to consult more actively with OSHA about how OSHA can encourage employers to
include SNUR information in Section 15

. Such an approach co uld help reduce burden and streamline compliance

.

It would also be helpful if EPA provided more outreach on SNURs that could include background on them, insight on the ir many different types, the various recordkeeping requirements they may entail, and resour ces the regulated community can access. EPA could conduct webinars to do just that.

One resource the agency offers that is very helpful in regards to new chemical SNURs is the list of over 50 chemical categories in the New Chemicals Program. SOCMA commen ds EPA for developing this list and making it public. It helps stakeholders identify potential triggers for SNURs and is an example of guidance that has proven to be somewhat of a guarantee in certain instances that a SNUR is possible on a new chemical su bmission

.

B. Timing and Accuracy of Records

I t is particularly important for EPA to update its records on SNURs as frequently as possible so that they accurately reflect all final SNUR s and do not refer to revok ed one s . It is critical that
these formal records b e accurate, so that manufacturers and their customers are aware of what requir ements may be associated with certai n chemical substance s

. Many companies refer to the TSCA inventory to check the status of a chemi cal . T herefore

, it is important for EPA to update it regularly. SOCMA recommends EPA update this database every month, or at least
every quarter.

SOCMA appreciates the opportunity to provide comments and would be happy to answer any questions or provide more detail

. You can reach me at 202

- 721

- 4158 or newtond@socma.com

.

Sincerely,

Dan Newton
Senior Manager, Government Relations