704.25—11-Aminoundecanoic acid.

(a) Definitions. (1) 11-AA means the chemical substance 11-aminoundecanoic acid, CAS Number 2432-99-7.

(2) Enclosed process means a process that is designed and operated so that there is no intentional release of any substance present in the process. A process with fugitive, inadvertent, or emergency pressure relief releases remains an enclosed process so long as measures are taken to prevent worker exposure to an environmental contamination from the releases.

(3) Internal subunit means a subunit that is covalently linked to at least two other subunits. Internal subunits of polymer molecules are chemically derived from monomer molecules that have formed covalent links between two or more other molecules.

(4) Monomer means a chemical substance that has the capacity to form links between two or more other molecules.

(5) Polymer means a chemical substance that consists of at least a simple weight majority of polymer molecules but consists of less than a simple weight majority of molecules with the same molecular weight. Collectively, such polymer molecules must be distributed over a range of molecular weights wherein differences in molecular weight are primarily attributable to differences in the number of internal subunits.

(6) Polymer molecule means a molecule which includes at least four covalently linked subunits, at least two of which are internal subunits.

(7) Small processor means a processor that meets either the standard in paragraph (a)(7)(i) of this section or the standard in paragraph (a)(7)(ii) of this section.

(i) First standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company, if any, are less than $40 million. However, if the annual processing volume of a particular chemical substance at any individual site owned or controlled by the processor is greater than 45,400 kilograms (100,000 pounds), the processor shall not qualify as small for purposes of reporting on the processing of that chemical substance at that site, unless the processor qualifies as small under paragraph (a)(7)(ii) of this section.

(ii) Second standard. A processor of a chemical substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $4 million, regardless of the quantity of the particular chemical substance processed by that company.

(iii) Inflation index. EPA will use the Inflation Index described in the definition of small manufacturer set forth in § 704.3, for purposes of adjusting the total annual sales values of this small processor definition. EPA will provide notice in the Federal Register when changing the total annual sales values of this definition.

(8) Subunit means an atom or group of associated atoms chemically derived from corresponding reactants.

(b) Persons who must report. Except as provided in paragraph (c) of this section, the following persons are subject to this section:

(1) Persons who manufacture or propose to manufacture 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(2) Persons who import or propose to import 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(3) Persons who process or propose to process 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(1) Small manufacturers (includes importers) as described in § 704.3.

(2) Small processors.

(3) Persons described in § 704.5.

(4) Persons who, at any time during the 3-year period ending July 22, 1986, manufactured, imported, or processed 11-AA:

(i) For use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or

(ii) For use as a component in photoprocessing solutions.

(d) What information to report. Persons identified in paragraph (b) of this section must submit a Premanufacture Notice Form (EPA Form 7710-25).

(e) When to report. (1) Persons who intend to manufacture, import, or process 11-AA for use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process or for use as a component in photoprocessing solutions must notify EPA within 30 days after making a firm management decision to commit financial resources for the manufacturing, importing, or processing of 11-AA.

(2) Persons who initiated manufacturing, importing, or processing of 11-AA for use as an intermediate in the manufacture of polymers in an enclosed process when it is expected that the 11-AA will be fully polymerized during the manufacturing process, or for use as a component in photoprocessing solutions during the time period between July 22, 1986 and July 13, 1987 must notify EPA by August 10, 1987.

(f) Recordkeeping. Persons subject to the reporting requirements of this section must retain documentation of information contained in their reports for a period of 5 years from the date of submission of the report.

(g) Where to send reports. Reports must be submitted by certified mail to the Document Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, ATTN: 11-AA Notification.

Code of Federal Regulations

[52 FR 19864, May 28, 1987, as amended at 60 FR 16308, Mar. 29, 1995; 60 FR 34463, July 3, 1995; 71 FR 33641, June 12, 2006]

CFR

704.25—11-Aminoundecanoic acid.

Code of Federal Regulations