From the OEHHA:

The Office of Environmental Health Hazard Assessment (OEHHA) of the California Environmental Protection Agency is adding gallium arsenide to the list of chemicals known to the state to cause cancer and hexafluoroacetone, nitrous oxide and vinyl cyclohexene dioxide to the list of chemicals known to the state to cause reproductive toxicity for the purposes of Proposition 65. The listing of gallium arsenide, hexafluoroacetone, nitrous oxide and vinyl cyclohexene dioxide is effective August 1, 2008…

Cancer:

Gallium arsenide - CAS No. 1303-00-0

Reproductive Toxicity:

Hexafluoroacetone - CAS No. 684-16-2 - Male reproductive toxicity

Nitrous oxide - CAS No. 10024-97-2 - Developmental toxicity

Vinyl cyclohexene dioxide - CAS No. 106-87-6 - Female and male reproductive toxicity

Click on the above link for more information.

From the EPA: ” an extension of the public comment period on the Draft Risk and Exposure Assessment Reports for Nitrogen Dioxide (NO2) (73 FR 20045; April 14, 2008)”:

The EPA is extending the comment period that originally ends on May 1, 2008. The extended comment period will close on May 30, 2008. The EPA is extending the comment period to provide stakeholders and the public with adequate time to conduct appropriate analysis and prepare meaningful comments.

Under section 108(a) of the Clean Air Act (CAA), the Administrator identifies and lists certain pollutants which “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare.'’ The EPA then issues air quality criteria for listed pollutants, which are commonly referred to as “criteria pollutants.’… Air quality criteria have been established for the nitrogen oxides (NOX) and NAAQS have been established for nitrogen dioxide (NO2), an indicator for NOX. Presently, EPA is reviewing the air quality criteria for NOX and the NAAQS for NO2.

The full release is available here.

We posted a few days ago about Restricted Components Regulations. One question that kept coming up was “We have a product that is a mixture and one of the components is listed in the regulations. Does this apply to us?” The answer: Unless specifically mentioned in the regulations, the act only covers the pure form not mixtures. The Ministry of Natural Resources sent us this clarification:

Except for the H2O2, the Nitric Acid and the Ammonium nitrate, the other 6 restricted components (including Nitromethane) are currently regulated under their pure form (i.e. 100%).

The exemptions are as follows:

(a) ammonium nitrate in solid form at a concentration between 28 and 34% nitrogen;

(b) hydrogen peroxide at a concentration of at least 30%, UN numbers: 2015 and 3149;

(g) nitric acid at a concentration of at least 68%, UN numbers: 2031 and 2032;

I hope this clears things up. If you have any additional questions, please feel free to contact us at info@nexreg.com

From Canada’s Ministry of Natural Resources, and recently printed in the Canada Gazette. The full text of the regulations is available here. A few key details:

What it covers:

The following components of an explosive are prescribed for the purpose of the definition “restricted component” in section 2 of the Act:

(a) ammonium nitrate in solid form at a concentration between 28 and 34% nitrogen;

(b) hydrogen peroxide at a concentration of at least 30%, UN numbers: 2015 and 3149;

(c) nitromethane, UN number: 1261;

(d) potassium chlorate, UN number: 1485;

(e) potassium perchlorate, UN number: 1489;

(f) sodium chlorate in solid form, UN number: 1495;

(g) nitric acid at a concentration of at least 68%, UN numbers: 2031 and 2032;

(h) potassium nitrate, UN numbers: 1486 and 1499; and

(i) sodium nitrate in solid form, UN numbers: 1498 and 1499.

[Section 3 of the Act]

These components will no longer be available for sale in Canada:

No person shall sell a restricted component except in accordance with these Regulations.

[Section 4 of the Act]

Unless the seller is on the list of sellers of restricted components:

Only persons who are enrolled on the list of sellers of restricted components may sell a restricted component.

A person may be enrolled on the list of sellers by applying to the Chief Inspector using the form provided by the Minister. The application must include

(a) the applicant’s name, address, telephone number, facsimile number and e-mail address;

(b) the restricted components that the applicant intends to sell;

(c) the locations where restricted components are to be stored or sold, and the storage capacity at each location for each component; and

(d) the name, telephone number, facsimile number and e-mail address of a contact person for each location where the restricted component is to be stored or sold.

[Sections 5 and 6 of the Act]

There are some exceptions:

These Regulations do not apply to the sale of restricted components to laboratories that are a part of or affiliated with a

(a) post-secondary educational institution recognized by a province;

(b) hospital or health clinic; or

(c) federal or provincial government or government agency.

[Section 2 of the Act]

The restrictions on Ammonium Nitrate come into effect on June 1, 2008 and the restrictions on all other chemicals come into effect on March 1, 2009:

(1) These Regulations, other than Part 1, come into force on June 1, 2008.

(2) Part 1 comes into force on March 1, 2009.

[Section 36 of the Act

Note: Part 1 has the title SECURITY — RESTRICTED COMPONENTS OTHER THAN AMMONIUM NITRATE]

The above is just a few of the key points of the Regulations. Please refer to the full text - available here.

NUTRA Ingredients Europe on new EU flavouring regulations:

Flavourings currently fall under directive 88/388. However the regulatory situation is set to change next year, with the anticipated adoption of FIAP (Food Improvement Agent Package), Joy Hardinge of AJH Consulting told attendees at the SAFC symposium in Grasse, France, last week.

Whereas directive 88/388 covered flavourings, under FIAP (which also relates to additives, enzymes, and the common authorisation procedure) the scope is extended to cover “certain food ingredients with flavouring properties”.

Directive 88/388 covers flavouring preparations, process flavourings, smoke flavourings, and three categories of flavouring substances - natural, nature identical (NI) and artificial.

But with the proposed regulation the scope is set to change.

Firstly, it looks to replace process flavours with ‘thermal process flavours’ - that is flavourings obtained after a heat treatment from a mixture of ingredients that do not necessarily have flavouring properties themselves. One ingredient must contain an amino nitrogen, and one be a reducing sugar.

It also does away with the NI and artificial categories of flavouring substances - a big change, since the claim that a food “contains no artificial flavourings” currently holds much marketing sway.

Click on the above link for more information.

A recent news release from the EPA includes the following:

The proposal recommends an ozone standard within a range of 0.070 to 0.075 parts per million (ppm). EPA also is taking comments on alternative standards within a range from 0.060 ppm up to the level of the current 8-hour ozone standard, which is 0.08 ppm…

Ground-level ozone is not emitted directly into the air, but is created through a reaction of nitrogen oxides and volatile organic compound emissions in the presence of sunlight. Emissions from industrial facilities, electric utilities, motor vehicle exhaust, gasoline vapors, and chemical solvents are the major man-made sources of these ozone precursors.

EPA also is proposing to revise the “secondary” standard for ozone to improve protection for plants, trees and crops during the growing season. The secondary standard is based on scientific evidence indicating that exposure to even low levels of ozone can damage vegetation. EPA is proposing two alternatives for this standard: a standard that would be identical to the “primary” standard to protect public health; and a cumulative standard aimed at protecting vegetation during the growing season…

The agency will take public comment for 90 days following publication of the proposal in the Federal Register and will hold four public hearings. The hearings will be held in Los Angeles and Philadelphia on Aug. 30, and in Chicago and Houston on Sept. 5.

Information about the EPA’s ground-level ozone proposal is available at: http://epa.gov/groundlevelozone/.

The Food and Drug Administration (FDA) is issuing a proposed rule designed to make the contents of medical gas containers more readily identifiable, in order to prevent deaths and injuries from inadvertent use of incorrect medical gas or from use of contaminated medical gas.

Medical gases such as oxygen, nitrous oxide, and nitrogen, are administered to patients in healthcare facilities and the home, for a variety of purposes. For example, oxygen is often administered to patients suffering from various respiratory conditions, such as emphysema.

In some cases, injury or death has resulted from a medical gas mix-up caused by one of several factors, including mistaken administration of industrial gas to patients, improper connection of industrial gases to medical oxygen supply systems, and contamination of medical gas cylinders with residues of industrial cleaning solvents. Between 1996 and 2006, the agency received reports of medical gas mix-ups that resulted in at least 8 deaths and 18 serious injuries.

“By issuing this proposal, FDA is heightening consumer and industry awareness about this specialty area of regulated products. Greater understanding of the possible problems associated with the use of medical gases and the steps we can take to eliminate them will only lead to safer use of these products,” said Steven Galson, MD, Director, Center for Drug Evaluation and Research.

This regulation would apply to medical gas manufacturers and distributors and will require that certain portable medical gas containers comply with the following requirements:

• have gas use outlet connections (used to connect these containers to gas supply systems) that cannot be readily removed;
• be identified by labels that wrap all the way around the tops of these containers;
• have high-pressure medical gas cylinders painted according to a standard color-coding system that corresponds to the gases stored in them; and
• be dedicated to medical use and not converted from industrial use.

FDA has undertaken a careful evaluation of the operations and processes required to produce suitable medical gases. Since 2000, the agency has conducted several public meetings to elicit comments from the medical gas industry as well as patients, professional associations, and manufacturers.

In addition to agency efforts, the medical gas industry and other bodies, including the Joint Commission on Accreditation of Healthcare Organizations and the National Fire Protection Association have taken steps to help prevent medical gas mix-ups and ensure the safe use of medical gases.

The proposed rule is intended to supplement existing FDA regulations and guidance regarding the safe use of medical gases by adding requirements — based largely on current, recommended, industry practice — to minimize the incidence of medical gas mix-ups and contamination. It is intended to ensure that health care facilities and patients receive only appropriate, safe, effective, and high-quality medical gases.

There is a 90-day public comment period on the proposed regulation before FDA develops the final rule.
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