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Regulatory News

Dec. 26 – Ernst and Young: Regulatory and Compliance Risk Greatest Strategic Challenge in 2008

December 26th, 2007

Electronics News has a terrific article anyone in the electronics industry will want to read: ROHS: It ain’t over. It was this part that caught our eye, though:

Indeed, a recent Ernst and Young report [note: link goes to PDF] stated that regulatory and compliance risk was the greatest strategic challenge facing global businesses in 2008.

“This is being driven by an escalating regulatory burden in many markets, as well as numerous compliance challenges as companies extend their value chains well beyond Europe, North America, and the BRICs (Brazil, Russia, India and China),” the online report states. “As companies become more and more global, compliance becomes a greater challenge, forcing them to manage diverse regulations in different markets. … The importance of understanding local regulations, as well as major global industry regulations is crucial to those companies expanding their global reach.”

For the full article click on the above link.

Dec. 26 – Canada: New and Revised Natural Health Product Monographs

December 26th, 2007

The NHPD Monthly Communiqué – Vol. 3, Issue 4 – December 2007 is out and contains (among other things) new NHP monographs:

Recognizing the important role monographs can play both in facilitating the review and processing of product licence applications and as reliable sources of product information for consumers, the NHPD is committed to developing new monographs as well as revising and updating existing monographs to reflect new research and evidence.

Revised Single Ingredient Monographs

  • Revised Beta-Carotene Monograph
  • Revised Calcium Monograph
  • Revised Copper Monograph
  • Revised Chromium Monograph
  • Revised Folate Monograph
  • Revised Iodine Monograph
  • Revised Iron Monograph
  • Revised Green Tea Monograph
  • Revised Magnesium Monograph
  • Revised Niacin Monograph
  • Revised Vitamin A Monograph
  • Revised Vitamin B6 Monograph
  • Revised Vitamin B12 Monograph
  • Revised Zinc Monograph
  • Revised Product Monographs

    Revised Product Monograph for Antiperspirants

    Click on the above link for the full monthly release.

    Dec. 26 – EPA Authorizes Critical Uses of Methyl Bromide for 2008

    December 26th, 2007

    From the EPA: EPA Authorizes Critical Uses of Methyl Bromide for 2008. It states in part:

    This action is authorizing 4,813,452 kilograms (4,813.5 metric tonnes) of methyl bromide for approved critical uses in 2008, with 3,083,769 kilograms supplied from new production or import. Approved critical uses include strawberry and tomato production, as well as commodity fumigation…

    Critical use exemptions are permitted under the Montreal Protocol for circumstances where there are no technically and economically feasible alternatives to methyl bromide. Further, the Clean Air Act Amendments of 1990 direct the EPA to issue regulations to implement the provisions of the Montreal Protocol within the United States.

    For the full details click on the above link.

    Dec. 26 – OEHHA 60-Day Call in Period for 3 Chemicals For Prop-65 Consideration

    December 26th, 2007

    The OEHHA with their: Announcement of Chemicals Selected by OEHHA for Consideration for Listing by the Carcinogen Identification Committee and Request for Relevant Information on the Carcinogenic Hazards of These Chemicals (available here. It states, in part:

    OEHHA has selected three chemicals for the Committee’s review for possible listing under Proposition 65 and is initiating the development of hazard identification materials on these chemicals…

    N,N-Dimethylformamide (68-12-2)

    Marijuana smoke

    2,4,6-Trinitrotoluene (TNT) (118-96-7)

    These chemicals were selected using the procedure described in the document entitled: “Process for Prioritizing Chemicals for Consideration under Proposition 65 by the Sate’s Qualified Experts,” adopted in 2004, and available on the Internet at www.oehha.ca.gov…

    By this notice, OEHHA is providing the public an opportunity to provide information relevant to the assessment of the evidence of carcinogenicity for any of the chemicals listed in Table 1. Relevant information includes but is not limited to: cancer bioassays, cancer epidemiological studies, genotoxicity testing, and other pertinent data on pharmacokinetics, biomarkers, and effects on biochemical and physiological processes in humans for any of the three chemicals. Interested parties or members of the public wishing to provide such information should send it to the address given below.

    The publication of this notice marks the start of a 60-day data call-in period. This period will end on Tuesday, February 20, 2008. The information received during this data call-in period will be reviewed and considered by OEHHA as it prepares the cancer hazard identification materials on these chemicals. This request for information is the next step in the process described in the 2004 prioritization procedure.

    For more information click on the above link.

    Dec. 26 – Singapore: New MSDS amendment to come into play in 2009

    December 26th, 2007

    From the Singapore Maritime and Port Authority which states in part:

    Resolution MSC.239(83) – Adoption of amendments to the International Convention for the Safety of Life at Sea, 1974, as amended…

    The following amendments to the SOLAS Convention are expected to enter into force on 1 July 2009…

    b) new regulation VI/5-1 on material safety data sheets (MSDS), to require ships carrying MARPOL Annex I cargoes (oil) and marine fuel oils to be provided with a material safety data sheet prior to loading such cargoes.

    For MSDS, the resolution refers to the mandatory application of resolution MSC.150(77), which contains the specifications and format of MSDS. The resolution is expected to be revised at BLG 12 (Feb 08), and any revision should be applicable on the entry into force date of 1 July 2009. MPA will inform the shipping community of further developments regarding MSDS.

    For the full annoucement click on the above link.

    Dec. 15 – OSHA Fall Agenda Only to List Significant Items (GHS)

    December 15th, 2007

    An article on Occupational Hazards disscusses OSHA and GHS. It says in part:

    In the new agenda, OSHA said the agency would submit a complete peer review of economic analysis on OSHA’s Hazard Communication standard by November 2007, but evidently this action has been delayed. The issue of implementing a Globally Harmonized System of Classification and Labeling of Chemicals (GHS) has been of importance to both large global companies and to OSHA, as it admitted, “U.S. manufacturers, employers and employees will be at a disadvantage in the event that our system of hazard communication is not compliant with the GHS.”

    Click on the above link for the full article.

    Dec. 15 – Meeting Synopsis and Slide Presentations from the Carcinogen Identification Committee (OEHHA)

    December 15th, 2007

    A notice from the OEHHA:

    Meeting Synopsis and Slide Presentations from the Carcinogen Identification Committee Meeting Held on November 19, 2007

    A meeting of the Carcinogen Identification Committee (CIC) was held on November 19, 2007, at the California Environmental Protection Agency Headquarters Building in Sacramento, California. Below are links to the slide presentations made by staff of the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA). The segments of the agenda covered by this material include the “Prioritization of Chemicals for Carcinogen Identification Committee Review” and “Discussion of Next Prioritization Data Screen.”

    The CIC met to consider three chemicals, N,N-dimethylformamide, marijuana smoke, and 2,4,6-trinitrotoluene, for possible preparation of hazard identification materials. By majority vote, the CIC advised OEHHA to proceed with preparing hazard identification materials for each of the three chemicals. On the advice of the CIC and considering input from the public, OEHHA will prepare cancer hazard identification materials for all three chemicals. A public notice announcing the data call-in period will be published in the California Regulatory Notice Register and posted on the OEHHA web site at www.oehha.ca.gov on December 21, 2007.

    More information can be found by clicking the above link.

    Dec. 15 – Chemical buyers and suppliers work Green from different angles (REACH)

    December 15th, 2007

    Not news, per se, but the article Chemical buyers and suppliers work Green from different angles has a section on how North American companies are impacted by the EU’S REACH regulation:

    Clearly, the regulation that has had the largest impact on the global chemicals industry has been the European Union’s REACH regulation, which went into effect in June. It requires all manufacturers and importers in Europe to register and to disclose the chemical substances in their products before they can be sold in the EU.

    Shondra Garrigus, vice president of purchasing at Seattle-based chemicals distributor TRI, says in some ways the regulation has changed the way TRI does business.

    “For example, although we have always considered our relationships with suppliers of the utmost importance, we find the maintenance of lasting, open relationships with our suppliers increasingly vital to the success of our business under REACH,” she says. “When you have to identify the end-user and provide application information, there really isn’t anything you can do to avoid being cut out of the business so now, more than ever, you need to thoroughly trust your suppliers as well as your customers.”

    Most chemical buyers and suppliers say REACH should not be thought of as a European regulation, because in today’s global economy, a marketplace the size of the European Union cannot be avoided. So for the time being, REACH has set the bar for environmental regulation in the chemicals industry, as RoHS did for the electronics industry.

    Garrigus believes “we are at least a few years away from enacting laws that regulate the U.S. chemical industry in the same way that REACH currently regulates the European chemical industry. However, any wise U.S. chemical company is going to start looking into these matters now in order to prepare themselves for that eventuality.”

    But while a U.S. standard may be on the horizon, there are some immediate concerns to buyers.

    “Certain materials I used to buy have been discontinued due to government regulations and as a result we’ve had to reformulate some of our blends,” says Jeff Marcella, corporate senior buyer at Canadian General Tower in Cambridge, Ont. Specifically, he says in April of this year, the State of California’s Office of Environmental Health Hazard Assessment elected to list di-isodecyl phthalate as a hazardous substance. And because his company does business in California, Marcella has had to find a substitute material.

    For the full article, click on the above link.

    Dec. 7 – Prop 65: Reproductive Toxicity for Di(n-butyl)phthalate (DBP)

    December 7th, 2007

    A recent release by the OEHHA on Di(n-butyl)phthalate (DBP):

    Pursuant to the requirements of Government Code sections 11346.8(d), 11346.9(a)(1), and 11347.1, the Office of Environmental Health Hazard Assessment (OEHHA) is providing notice that documents and other information which the agency has relied upon in proposing amendments to Title 22, California Code of Regulations, section 12805*, have been added to the rulemaking file and are available for public inspection and comment.

    On June 29, 2007, OEHHA published a Notice of Proposed Rulemaking (California Regulatory Notice Register, 2007, No. 26-Z, pages 1123-1125; Notice File No. Z-07-0619-02) to adopt regulatory levels for DBP pursuant to Title 22, California Code of Regulations, section 12805. The Initial Statement of Reasons set forth the grounds for the proposed regulation. Pursuant to the Notice of Proposed Rulemaking, a public comment period of 45 days was provided from the publication of the Notice until August 13, 2007. A total of three sets of written comments were received. These comments cited a number of publications that had not been previously included in the proposed rulemaking file (OAL Notice File No. Z-07-0619-02). In addition, a number of research or review papers became available to OEHHA after the draft MADL document was completed.

    The purpose of this notice is to enter all relevant documents into the proposed rulemaking file (OAL Notice File No. Z-07-0619-02). All of the documents on the list below have been reviewed by OEHHA. None of these documents contributed directly to the development of the MADLs and were thus not cited in the main text of the document supporting the MADL (OEHHA, 2007). However, these papers have been reviewed by OEHHA and are sources of relevant information.

    Click on the above link for the full release.