(a) Purpose and scope. The Texas Hazardous Substances Act, Health and Safety Code, Chapter 501, requires manufacturers of hazardous substances whose products are distributed in Texas to file a registration statement with the department prior to doing business in the state; establishes a registration fee; and requires the adoption of rules covering the registration statement, the procedures for filing it, and procedures for denying, suspending, or canceling the registration statement. This section is intended to accomplish the statutory purpose.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. In addition, the definitions used in §205.42 of this title (relating to Definitions) apply to this section.
  (1) Distribute.
    (A) dissemination of a hazardous substance to the general public under one's own brand (private label); or
    (B) dissemination of a hazardous substance as a wholly owned subsidiary of the business or establishment that manufactured, imported, or packaged the product.
  (2) Hazardous substance.
    (A) The term "hazardous substance" applies to the following:
      (i) any substance or mixture of substances which is toxic, corrosive, extremely flammable, flammable, combustible, an irritant, or a strong sensitizer, or that generates pressure through decomposition, heat, or other means, if the substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonable foreseeable handling or use, including reasonably foreseeable ingestion by children;
      (ii) any toy or other article other than clothing intended for use by children which presents an electrical, mechanical, or thermal hazard; or
      (iii) any radioactive substance if, with respect to the substance as used in a particular class of article or as packaged, the department finds by rule that the substance is sufficiently hazardous to require labeling in accordance with the provisions of Health and Safety Code, Chapter 501, in order to protect the public health.
    (B) The term "hazardous substance" does not apply to economic pesticides subject to the State or Federal Insecticide, Fungicide, and Rodenticide Act, or to foods, drugs, and cosmetics subject to the Federal Food, Drug and Cosmetic Act, or to beverages complying with or subject to the Federal Alcohol Administration Act or the Texas Food, Drug and Cosmetic Act, or to substances intended for use as fuels when stored in containers and used in the heating, cooking, or refrigeration system of a private residence, or to any source material, special nuclear material, or by-product material as defined in the Federal Atomic Energy Act of 1954, as amended, and regulations issued pursuant thereto by the Atomic Energy Commission.
  (3) Manufacturer--Any person who manufactures, imports, repacks, or distributes a hazardous substance. The term does not include a retailer who distributes a hazardous substance to the general public, except that a retailer who distributes a hazardous substance made to its specifications is considered to be a manufacturer.
  (4) Retailer--The parent corporation, proprietorship, or partnership operating a chain of stores; or if there is only one location, the term shall refer to that location.
(c) Basic requirement. A manufacturer whose products are distributed in the State of Texas or who distributes a hazardous substance in this state under the person's private brand name shall have on file with the department a registration statement accompanied by a registration fee in accordance with this section.
(d) Term of registration statement. Prior to January 1, 2005, the term of a registration statement is one year and expires on the anniversary of the effective date, unless renewed. Effective January 1, 2005, the term of all licenses is two years. Some licenses will be renewed for a one-year term in 2005, in a manner to be determined by the department and two years thereafter.
(e) Registration statement.
  (1) A manufacturer's registration statement shall be signed and verified, shall be made on a registration form furnished by the department, and shall contain the following information:
    (A) the name under which the manufacturing, importing, repacking, or distributing is conducted;
    (B) the address of each place of business or establishment being registered shall be contained on the registration statement;
    (C) if the business is a sole proprietorship, the name of the proprietor shall be included;
    (D) if the business is a partnership, the names of the partners shall be included;
    (E) if the business is a corporation, the names of the officers and directors shall be included;
    (F) if the business is of any other kind than the ones described in subparagraphs (C) - (E) of this paragraph, the names of those persons in a managerial position shall be included.
  (2) Registration forms may be obtained from the Environmental and Sanitation Licensing Group, Regulatory Licensing Unit, Health Care Quality Section, Division for Regulatory Services, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756.
(f) Registration fees.
  (1) Each initial registration statement and each refiling of the registration shall be accompanied by a registration fee of $630 for a two-year term.
  (2) The fee shall be paid by money order, certified check, or personal check and shall be made payable to the Department of State Health Services. Cash payment is not acceptable.
(g) Texas Online Fees. The department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with processing registration statements specified under this section through Texas Online, in accordance with the Texas Government Code, Chapter 2054, §2054.111 (relating to Use of Texas Online Project).
(h) Special provisions. Manufacturers of hazardous substances, whose products are distributed for sale in Texas and whose products might normally be banned, but who meet specific exemption criteria enabling their products to be sold in Texas shall file registration statements accompanied by a registration fee in accordance with this section. Some examples are:
  (1) toy electric trains with special labeling, exempting the products from the ban on toys presenting an electrical hazard; and
  (2) toy caps which are exempt from the classification as a banned hazardous substance by special labeling and peak sound pressure levels.
(i) Refusal to accept, cancel, revoke, or suspend a registration statement.
  (1) After notice and opportunity for a hearing, the department may refuse to accept or may cancel, revoke, or suspend a manufacturer's registration if the manufacturer fails to make payment of the fee required in this section.
  (2) The hearing described in paragraph (1) of this subsection shall be conducted in accordance with the Administrative Procedure Act, Texas Government Code, Chapter 2001 and the department's sections on formal hearings, §§1.21, 1.23, 1.25 and 1.27 of this title (relating to Formal Hearing Procedures).

Source Note: The provisions of this §205.44 adopted to be effective October 11, 1985, 10 TexReg 3767; amended to be effective February 27, 1987, 12 TexReg 503; amended to be effective January 1, 2005, 29 TexReg 11978; amended to be effective February 1, 2006, 31 TexReg 497