EPA’s New Rule Requires Electronic Reporting

Posted on April 18, 2012 by Chris Jellen

Time to buff up your stuff — meaning your data archives and processes. The U.S. Environmental Protection Agency (EPA) has announced a proposed rule to require electronic reporting for certain information submitted to the agency under the Toxic Substances Control Act (TSCA). Now’s the time to get data management under control so reports aren’t being fired off from your internal ops over to EPA willy-nilly.

You’ll recall last year when a similar rule was launched. EPA set up a page for that rule called Requirements for Submitting Electronic Pre-manufacture Notices (PMNs).

Today’s proposed rule would require electronic reporting rather than paper-based reporting for various TSCA actions including submission of information relating to chemical testing, health and safety studies, and other information. When final, EPA will only accept data, reports, and other information submitted through EPA’s Central Data Exchange, a centralized portal that enables streamlined, electronic submission of data via the Internet.

EPA will be soliciting comments on this proposed rule for 60 days.

Fact is, though, digital reporting is the way of the future.

For more information on the proposed rule: http://www.epa.gov/oppt/chemtest/

For more information on OPPT’s increasing transparency efforts: http://www.epa.gov/oppt/existingchemicals/pubs/transparency.html

New SNUR for PBDEs

Posted on April 13, 2012 by Kal

The US Environmental Protection Agency (EPA) is proposing to amend the Toxic Substances Control Act (TSCA) section 5(a). Already California and Washington passed legislations to ban PBDEs. Not to mention others. EPA and OSHA are playing catch-up in many ways with environmental and health issues. This latest news on flame retardants from EPA should be exciting but it has a laggard’s feel to it, rather like the soft “thud” made last week when OSHA published GHS.

Question: Is late better than never? Or are rules best set while momentum is still hot?

What EPA is proposing is a Significant New Use Rule, or SNUR. Also a Test Rule. Formally, this is regarding certain Polybrominated Diphenylethers, which are commonly known as PBDEs. PBDE is pronounced phonetically as an acronymn. To wit: it starts to sound like “Peabody” if you turn the word around in your head too many times in a row. (One of many ah-ha moments achieved while writing this article.)

What you’ll want to know about EPA’s proposal to amend the Toxic Substances Control Act (TSCA) section 5(a).

On the chopping block: polybrominated diphenylethers (PBDEs).

Execution style:

Designating processing of six PBDEs, or any combination of these chemical substances resulting from a chemical reaction, as a significant new use
Designating manufacturing, importing, and processing of a seventh PBDE, decabromodiphenyl ether (decaBDE) for any use which is not ongoing after December 31, 2013, as a significant new use
Making inapplicable the article exemption for SNURs for this action — in other words, no exemptions

A person who intends to import or process any of the seven PBDEs included in the proposed SNUR, as part of an article for a significant new use would be required to notify EPA at least 90 days in advance to ensure that EPA has an opportunity to review and, if necessary, restrict or prohibit a new use before it begins.

EPA is also proposing a test rule under TSCA that would require any entity manufacturing or processing in any articles for any use either:

Commercial pentabromodiphenyl ether (cpentaBDE)
Commercial octabromodiphenyl ether (c-octaBDE), or
Commercial decaBDE (c-decaBDE)

after December 31, 2013 must conduct testing on health and environmental effects.

EPA is proposing to designate all discontinued uses of PBDEs as significant new uses. The test rule would be promulgated if EPA determines that there are persons who intend to manufacture, import, or process c-pentaBDE, c-octaBDE, or cdecaBDE, for any use, including in articles, after December 31, 2013.

DATES: Comments must be received on or before June 1, 2012.

ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2010–1039

FOR MORE on EPA’s plans for PBDEs, HBDEs and related chemicals please refer to the Actio Blog March 20, 2012.

Question: Is late better than never? Or are rules best set while momentum is still hot?

What EPA is proposing is a Significant New Use Rule, or SNUR. Also a Test Rule. Formally, this is regarding certain Polybrominated Diphenylethers, which are commonly known as PBDEs. PBDE is pronounced phonetically as an acronym. To wit: it starts to sound like “Peabody” if you turn the word around in your head too many times in a row. (One of many ah-ha moments achieved while writing this article.)

What you’ll want to know about EPA’s proposal to amend the Toxic Substances Control Act (TSCA) section 5(a).

On the chopping block: polybrominated diphenylethers (PBDEs).

Execution style:

Designating processing of six PBDEs, or any combination of these chemical substances resulting from a chemical reaction, as a significant new use
Designating manufacturing, importing, and processing of a seventh PBDE, decabromodiphenyl ether (decaBDE) for any use which is not ongoing after December 31, 2013, as a significant new use
Making inapplicable the article exemption for SNURs for this action — in other words, no exemptions

EPA is also proposing a test rule under TSCA that would require any entity manufacturing or processing in any articles for any use either:

Commercial pentabromodiphenyl ether (cpentaBDE)
Commercial octabromodiphenyl ether (c-octaBDE), or
Commercial decaBDE (c-decaBDE)

after December 31, 2013 must conduct testing on health and environmental effects.

DATES: Comments must be received on or before June 1, 2012.

ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2010–1039

FOR MORE on EPA’s plans for PBDEs, HBDEs and related chemicals please refer to the Actio Blog March 20, 2012.

EPA Finds More Time for Glymes

Posted on September 9, 2011 by Chris Jellen

There’s now an extension of time allotted for comments on glymes.

In July, the US Environmental Protection Agency (EPA) issued a proposed rule in the Federal Register concerning a proposed significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 14 glymes.

EPA’s list of 14 glymes is here for view or download, in an article written by one of the preeminent Professional Chemical Engineers in the field, Kal Kawar. The article is called “The Worst of Glymes” (who says chemists can’t be funny?). This list is easier to read than anything on the EPA site.

Since publication of the proposed rule, EPA has received a request for additional time to submit comments. Now, EPA will extend the comment period for 30 days, from September 12, 2011 to October 12, 2011.

Deadlines for comment: Comments, identified by docket identification (ID) number EPA–HQ–OPPT–2009–0767, must be received on or before October 12, 2011.

In the Federal Register of July 12, 2011 (76 FR 40850) (FRL–8877–8), EPA proposed a SNUR for 14 glymes, designated proposed significant new uses for the 14 glymes, and asked for public comment on several topics. EPA requested comment on whether any of the chemical substances included in the identified glyme category are sufficiently dissimilar from the rest such that they should be removed from the category, or whether any additional chemical substances are sufficiently similar such that they should be added to the category. Comments were also requested on whether any of the additional unconfirmed uses listed in the proposed rule are actual ongoing uses in a consumer product, and whether there are any other ongoing uses in a consumer product of the other chemicals listed in the SNUR.

For further information, see the contact names in the Federal Register here.

EPA Denies Requests for Chemical Confidentiality

Posted on February 14, 2011 by Kal

Last summer, the Environmental Protection Agency (EPA) stated it would reject confidentiality claims for chemical identity in health and safety studies (see our previous post: EPA to reject confidentiality claims).

EPA says it already notified five companies that the identities of 14 chemicals associated with a number of health and safety studies submitted under the Toxic Substances Control Act (TSCA) and claimed as confidential are not eligible for confidential treatment. The chemicals were unnamed.

More chemical names connected with health and safety studies will be released in the future.

This newsflash is of particular interest for those that manufacture (defined by statute to include import) and/or process chemical substances and mixtures subject to TSCA (15 U.S.C. 2601 et seq.).

“The public deserves access to critical health and safety information on chemicals, but if the name of the chemical is kept secret in the health and safety report, the information is of no real value to people,” said Steve Owens, EPA’s assistant administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP).

Owens said the agency is committed to increasing the American people’s access to this important information.

And the caveat is…The agency plans to deny confidentiality claims for chemical identity in health and safety studies provided to the agency under TSCA. The only caveat comes if and when your chemical identity contains process or mixture information that is expressly protected by law. That will take some convincing. And some research and legal expertise.

Timeframe: 31 days. So how long do companies have to pursue the caveat or, if not, to watch their data go public? The last paragraph of the EPA letter sent to companies states:

“EPA will make the information available to the public on the thirty-first (31st) calendar day after the date of your receipt of this determination…”

For more information on chemical transparency initiatives in U.S. manufacturing, go to: http://www.epa.gov/oppt/existingchemicals/pubs/transparency.html

For information on technology to manage chemical transparency initiatives in US manufacturing, try the products page on the Actio website or try: http://www.materialdisclosure.com.

http://www.actio.net/default/index.cfm/actio-blog/

EPA Requires 19 Chemicals Tested For EHS

Posted on January 6, 2011 by Chris Jellen

In breaking manufacturing news from Washington, D.C., the US Environmental Protection Agency (EPA) is issuing a final rule under the modern TSCA or Toxic Substances Control Act.

The new final rule requires that manufacturers of 19 high production volume (HPV) chemicals test the effects, in terms of environment, health, and safety (EHS) of the named 19 chemicals. Companies must then submit the data to the EPA.

“This chemical data reporting will provide EPA with critical information to better evaluate any potential risks from these chemicals that are being produced in large quantities in this country,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention.

“Having this information is essential to improve chemical safety and protect the health of the American people and the environment,” Owens said.

HPVIS Data

EPA already hosts the High Production Volume Information System (HPVIS), an online database populated with HPV chemical data. HPVIS allows users to search and query chemical data tailored to their specific needs.

We checked out the database. A search for “toxic” or “triclosan” yielded nothing — zero search results. Not everyone has chemical CAS numbers at their fingertips. This is where these types of databases often fail. Even compliance managers have to dig up CAS numbers.

Anyway, the CAS number for triclosan is 9012-63-9. We tried that and still got zero (0) search results. Maybe we needed something with a higher production value? So we tried BPA and got one (1) result. What comes up is pretty neat data — see if you can see this link — and if not, do the search yourself. It’s worth being familiar with the database, especially if you’re a journalist reading this blog.

New Rule of 19 High Production Chemicals

The chemicals in the new rule show up in many consumer and industrial uses and products. For instance:

9, 10-anthracenedione is used to manufacture dyes
leuco sulfur black is a fingerprinting agent
diphenylmethanone is used in consumer products and may be found in personal-care products
C12-C24 chloroalkenes are used as metalworking fluids
pentaerythritol tetranitrate (PETN) is a blasting and demolition agent

Ironically, these were hard to find — zero (0) — in the HPV database. Hence the rule…?

The Challenge and the Rule

The rule on the 19 chemicals requiring testing follows on 2010’s voluntary HPV Challenge Program Chemical List launched by EPA that included chemicals used in household products such as hobby/craft glues, personal-care products, home cleaning products, home maintenance products, and automotive products.

The program challenged companies to make health and environmental effects data publicly available for HPV chemicals.

Companies voluntarily supplied data on more than 2,200 HPV chemicals. But apparently no health and environmental effects data was provided on the 19 chemicals in today’s rule. Thus EPA found it necessary to require testing.

In the coming year, EPA intends to require testing of other chemicals for which the agency has not received data. So really, this is a warning flag from EPA that it’s not messing around. Nor should it be, with dangerous chemicals in everything from food coloring to jewelry, public pressure on EPA is at an all time high.

You’d expect consumer protests would be the next thing. And hand it to Dow Chemical for stepping away from the pack and toward greener chemicals and products last year.

For Industry

As a reminder, in 2008, the OECD produced Guidelines for Chemicals Testing. These may help. Or not! But a key reference for the back pocket of companies pursuing the chemical testing in an action sense of the word:

OECD Test Guidelines are harmonized test methods included in the OECD Council Decision on Mutual Acceptance of Data. This means that “data generated in the testing of chemicals in an OECD Member country (or some non member economies ) in accordance with OECD Test Guidelines and OECD principles of Good Laboratory Practice2 shall be accepted in other Member countries (or non member economies) for purposes of assessment and other uses relating to the protection of man and the environment.”

6 Principles of US Import Protocol

Posted on October 29, 2010 by Kal

Unsafe imports can mean many different things. Just ask my colleague Chris, who purchased a set of inexpensive deck-chairs made in a foreign country. Those were unsafe. You can imagine the rest.

Unsafe imports were on the minds of US Agency heads last week, and they weren’t talking deck chairs per se but about the larger safety issues associated with import/export. Senior leaders from 10 federal agencies met in Washington, D.C. on Oct. 21 . There, they addressed past, current, and future efforts to protect the health & safety of both the American consumer and the environment from unsafe imports. Participating agencies are listed at bottom of this post.

Import / export of chemical substance. Risk Managers have a tough time of it. Consider import and export laws regarding chemical management. In 2008, EPA published the Compliance Guide for Chemical Import Requirements under the Toxic Substances Control Act or TSCA. Short version is that EPA regulates certain chemical substances and mixtures under the Toxic Substances Control Act (TSCA), including chemical import and export.

The United States Customs and Border Protection monitors chemical imports regulated under TSCA section 13. Custom and Border Protection rules (19 CFR 12.118 to 12.128 and 127.28) (also: 40 CFR 707.20) require certification from the importer such as:

positive certification — the shipment complies with TSCA and all applicable rules and orders
negative certification — the shipment is not subject to TSCA

TSCA section 13 certification applies to TSCA sections 5, 6, and 7. In addition, importers may have obligations under TSCA section 4, which covers testing, and/or section 8 which covers reporting and record-keeping. In terms of exporting chemicals, TSCA Section 12(b) and 40 CFR Part 707 requires EPA to notify importing countries of the export of chemicals or mixtures if they are subject to certain rules and orders; also requiring notification are certain products containing PCBs or asbestos.
Six general principles of import safety in America. The agency leaders affirmed their commitment to import safety by agreeing to six key principles thereof. These six principles provide a foundation for further collaboration between participating agencies.

EPA pointed out that all participating agencies are in some way charged with protecting American consumers from unsafe imports.

The six principles of import safety — as agreed to by 10 U.S. federal agencies — are:

1. The creation of an interagency forum of senior representatives dedicated to import safety cooperation

2. Continued commitment to information sharing across federal agencies involved in import safety concerns

3. Enhanced efforts to help the private sector comply with import safety requirements

4. Development of common systems to exchange information

5. Strong, consistent enforcement measures to deter imports of unsafe products

6. The use of risk-management strategies to streamline lawful trade

Goal: to achieve the common mission of protecting American consumers from unsafe imports.

Participating agencies. The new group includes executives from:

The U.S. Environmental Protection Agency
Department of Homeland Security
U.S. Customs and Border Protection
Immigration and Customs Enforcement
Bureau of Alcohol, Tobacco, Firearms and Explosives (BATFE?)
Animal and Plant Health Inspection Service
Consumer Product Safety Commission
Food and Drug Administration or FDA
Food Safety and Inspection Service
National Highway Traffic Safety Administration
National Marine Fisheries Service

It’s quite a lineup. Will be interesting to see what comes of it.