Bulk Chemicals List

[Crystle Rike]

Commoditychemicals (or bulk commodities or bulk chemicals) are a group of chemicals that are made on a very large scale to satisfy global markets. The average prices of commodity chemicals are regularly published in the chemical trade magazines and web sites such as Chemical Week and ICIS. There have been several studies of the scale and complexity of this market for example in the USA.[1][2]

Commodity chemicals are a sub-sector of the chemical industry (other sub sectors are fine chemicals, specialty chemicals, inorganic chemicals, petrochemicals, pharmaceuticals, renewable energy (e.g. biofuels) and materials (e.g. biopolymers)). Commodity chemicals are differentiated primarily by the bulk of their manufacture.

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These bulk drug substances were determined to meet the criteria for inclusion on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. FDA does not generally intend to take enforcement action against a state-licensed pharmacy or state-licensed veterinarian using these bulk drug substances to compound the below drug preparations for office stock for the corresponding species and disease indications, as described in Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.

FDA will accept nominations of additional bulk drug substances or additional indications for these bulk drug substances at any time and will continue to review nominations and update lists. For information on how to submit a bulk drug substance nomination, see the appendix to Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.

People who do not follow standard safety practices are killed or injured every year while closing or removing tanks. For a safe closure, you need qualified professionals who will use standard safety practices.

For more information on standard safety practices, underground storage tank owners and closure contractors should refer to "Closure of Underground Petroleum Storage Tanks," API Recommended Practice 1604 (1996), which is available from the American Petroleum Institute (API), 1220 L Street, Washington, DC 20005, or call (202) 682-8000 for assistance. You can also visit API's website.

The video and companion booklet called "Tank Closure Without Tears: An Inspector's Safety Guide" are available from the New England Interstate Environmental Training Center at (978) 323-7929. You can also visit NEIWPCC's website.

The video and companion booklet called "Tank Closure Without Tears: An Inspector's Safety Guide" are available from the New England Interstate Environmental Training Center at (978) 323-7929. You can also visit NEIWPCC's website.

Improper handling and storage of petroleum, hazardous substances/chemicals or liquefied natural gas (LNG) can result in spills that threaten the environment or pose health and safety risks to nearby persons. Across the state, there have been instances of spills of petroleum or chemicals that have caused groundwater contamination including some public water supplies. Storage and handling of LNG poses primarily fire safety concerns and risks from handling a cryogenic (extremely cold) material.

Based on several federal and state laws, regulations, and guidance documents, DEC has developed the following programs to establish requirements for the safe storage and handling of these materials, inspection programs to verify that these requirements are being met, and enforcement procedures to require that violations be corrected and deter future non-compliance:

Certain underground storage tanks (USTs) storing petroleum or hazardous substances/chemicals are also subject to federal regulations (40 CFR Part 280) from the United States Environmental Protection Agency (EPA).

Under federal and state regulations, certain underground storage tank (UST) systems must have Operators who are trained in tank-specific knowledge. The revision of New York State's petroleum bulk storage (PBS) regulations, 6 NYCRR Part 613, went into effect on October 11, 2015 and required facilities with such tanks to designate the names of their authorized Class A and Class B Operators with DEC by October 11, 2016. To become authorized, Operators must be trained and must pass a DEC-administered exam that demonstrates their competence to operate these tank systems.

The MOSF program applies to facilities that store a total of 400,000 gallons or more of petroleum in aboveground and underground storage tanks. Facilities must be licensed by DEC and managed in compliance with applicable regulations for the storage and handling of petroleum. Vessels that transfer petroleum to another vessel while operating in the waters of New York State must also obtain an MOSF license prior to these transfers. As applicable, both on-shore MOSFs and MOSF vessels must submit monthly license fees and surcharges to DEC. These fees apply to each barrel of petroleum the first time that the petroleum is imported into New York State (see Navigation Law Section 174).

The LNG program applies to facilities that store LNG or convert it back into a gas, with some exceptions. Facilities must be permitted by DEC and managed in compliance with applicable regulations for the storage and handling of LNG.

Bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with FDA under section 510 of the FD&C Act. In addition, if an applicable United States Pharmacopeia (USP) or National Formulary monograph exists, bulk drug substances must comply with the monograph.

FDA issued a revised final guidance in January 2017, Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, which is in place while the FDA develops the 503B bulks list. The guidance describes conditions under which the agency does not intend to take action against outsourcing facilities that compound drug products from bulk drug substances that cannot otherwise be used in compounding under section 503B. FDA issued this guidance document to avoid unnecessary disruption to patient treatment while FDA evaluates the bulk drug substances nominated for use in compounding under section 503B of the FD&C Act.

Bulk drug substances that appear in category 1, as described in the draft guidance document, before the guidance is finalized would not be affected by this change. These bulk drug substances may continue to be within the scope of the interim enforcement policy until the agency decides on inclusion of these substances on the 503B list or unless the agency removes the substances from category 1 based on, for example, information about safety risks.

Chemicals to be transported in bulk must be listed in Chapter 17 or 18 (or chapter 19) of the IBC Code or contained in the Provisional Categorization of Liquid Substances in accordance with MARPOL Annex II and the IBC Code (MEPC.2/Circular), which sets out the carriage requirements under which it may be transported.

If a product or substance has not yet been assessed and is therefore not included in either of these lists, then an assessment of the chemical must be carried out through two bodies. Firstly, a product or the components of a mixture must first be assessed by the GESAMP/EHS Working Group and assigned a GESAMP Hazard Profile, which establishes the environmental hazard profile for the substance or component. Once a substance or component of a mixture has been assessed and a hazard profile assigned, it is included in what is known as the GESAMP/EHS Composite List, which is issued once a year.

With respect to the information provided for Tripartite Agreements concluded under Lists 1, 3 and 4 of the MEPC.2/Circular, the name of the product, the submitting country and the list number are given, while for those assessments concluded under List 2, the product trade name, the contains name, the n.o.s. entry number and the reporting country are presented.

Following the establishment of a Tripartite Agreement, the manufacturer is required to then have their substance or components of a mixture assessed by the GESAMP/EHS Working Group for the establishment of a GESAMP Hazard Profile and inclusion in the GESAMP/EHS Composite List. The information required for submission to GESAMP/EHS is set out in the GESAMP/EHS Product Reporting Form. Once completed, the form together with all supporting documentation should be forwarded to:

Electronic submissions of the GESAMP/EHS Product Reporting Form and supporting data are acceptable. Submissions to GESAMP-EHS are fee based, at the rate of US$ 6500 per assessment (i.e. per substance or component assessed).

The full description of the GESAMP Hazard Evaluation Procedure for Chemical Substances carried by Ships, including advice to manufacturers on how to submit data to GESAMP/EHS can be found in the GESAMP Reports and Studies No 102.

Following the establishment of a GESAMP Hazard Profile and the addition of the substance (or component(s)) to the GESAMP/EHS Composite List, the manufacturer shall then make a request through its national Administration to submit the product for evaluation by IMO. To do so, the manufacturer must submit a completed PPR Product Data Reporting Form to the Administration, proposing, where possible, the Pollution Category, Ship Type and carriage requirements, in accordance with the provisions set out in MARPOL Annex II and the IBC Code. The Administration in turn, will submit a proposal, including the form, to IMO for evaluation. Evaluations are undertaken by the ESPH Working Group of the PPR Sub-Committee.

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