Manufacturing and Processing Changes

New Chemicals Upon enactment of this rule, the EPA must keep an inventory list of all chemicals manufactured or processed in the United States. New chemicals may not be manufactured on or after the 30^th day after the publication of the list. There is one exception, however. A person may manufacture a new chemical 30 days or more after the publication of the inventory if the following steps are taken:

• At least 90 days prior to the manufacture or process of the chemical, a notice of intention to manufacture or process must be sent to the EPA.
• The Agency must review the notice and make a determination on the use of the chemical. If sufficient information is available and the chemical is found not to present an unreasonable risk to health or the environment, then the submitter may commence manufacture of the chemical substance. The Agency must then submit a public statement on their findings.
• If the Agency fails to make a determination within the applicable review period, and submitter has provided all necessary information, then the submitter will be refunded all fees associated with submitting the notice. The Agency will still be responsible for making a determination in this case.

In some cases, the submitter of the notice may be required to submit more information to guide EPA in making a determination. Prior to the changes in the rulemaking, submitters of information were granted the chance to orally present information. This option is no longer available. Information must be submitted in writing to be considered. If the EPA has requested information from the submitter, the submitter must comply. However, even if the submitter does not receive a request for information, they may choose to voluntarily submit new information. Information submitted to the agency should show that the chemical in question does not present an unreasonable risk of injury to health or the environment. Upon making a determination, the Agency may issue a proposed rule to limit the amount of a certain substance may be manufactured, processed, or distributed in the United States, or to prohibit the use of the chemical altogether. In promulgating this rule, the Agency must consult with the Assistant Secretary of Labor for Occupational Safety and Health to address workplace exposure issues. If a rule or order is issued, no later than 90 days after issuance the EPA must consider whether to also promulgate a rule that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance not included in the restrictions imposed by the action or order. Then the Agency must either initiate such a rulemaking or publish a statement describing the reasons for not doing so.   Reporting Requirements Under the old rule, the agency was authorized to require anyone who manufactured, processed, or proposed to manufacture or process, to maintain records of such actions. This excluded small manufacturers and processors, and the agency was required to consult with the Administrator of the Small Business Administration and prescribe standards for determining who would qualify as small manufacturers and processors. These provisions still apply, with some key additions. No later than 180 days after the enactment of the new TSCA legislation, and once every ten years thereafter, the agency must review these standards for determining small manufacturers and processors, provide public notice and an opportunity for comment, and determine whether revision is needed. The new legislation also clarifies that reporting and recordkeeping requirements may be different depending on the manufacturer or processor. However, the EPA is not authorized to require unnecessary or duplicative reporting. This part of the legislation also has an added section on negotiated rulemaking for inorganic byproducts. No later than three years after the enactment of this legislation, the EPA must enter into a negotiated rulemaking to develop a proposed rule for limiting reporting requirements for manufacturers of inorganic byproducts that are recycled, reused, or reprocessed.