The Texas Department of Health (department) proposes the repeal of §§229.191 - 229.208 and new §§229.541 - 229.554, §§229.571 - 229.584, §§229.601 - 229.614, and §§229.631 - 229.644 concerning the regulation of food, drug, device and cosmetic salvage establishments and brokers. The repeal and proposed new sections are necessary in order to reflect changes in provisions to the statutory authority enacted as a result of Senate Bill 1080, passed during 77th Texas Legislature (2001), which amended the Health and Safety Code, §§431.008, 431.023, 431.048, 431.059, 432.003, 432.005, 432.011, 432.026, and 483.041.

Government Code, §2001.039 requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedures Act). The sections have been reviewed and the department has determined that reasons for adopting the sections continue to exist; however the rules need revisions as described in this preamble.

The department published a Notice of Intention to Review for §229.191 - 229.208 regarding agency review of rules in Government Code §2001.039 in the Texas Register on March 15, 2002 (27 TexReg 2084). No comments were received as a result of the publication of the notice.

Susan Tennyson, Chief of the Bureau of Food and Drug Safety, has determined that for each year of the first five years the new sections and repeals are in effect, there will be no fiscal implications to state or local government as a result of enforcing or administering the sections as proposed. There is no anticipated impact on local employment.

Ms. Tennyson has also determined that for each year of the first five years the new sections and repeals are in effect, the public benefits anticipated as a result of enforcing or administering the sections will be the prevention of serious injury to consumers from the use of adulterated and misbranded food, drugs, devices, and cosmetics. The injury prevention will be achieved through additional clarification and understanding of the salvage requirements provided by this proposal, including revised licensing and enforcement provisions and the reorganization of requirements into separate subchapters based on the type of product salvaged. There will be no effect on micro or small businesses because the new rules are mostly a reorganization of the repealed rules pursuant to the mandate in Senate Bill (SB) 1080 that the standards for salvaged food, drugs, devices, and cosmetics be in separate subchapters. The new requirements are less burdensome to the industry. There are no anticipated economic costs to persons who are required to comply with the new sections and repeals as proposed.

Comments on the proposal may be submitted to Susan Tennyson, Texas Department of Health, Bureau of Food and Drug Safety, 1100 West 49th Street, Austin, Texas 78756, (512) 719-0222, facsimile (512) 719-0202. Comments will be accepted for 30 days following the publication of the proposal in the Texas Register.

The new sections are proposed under Health and Safety Code, §432.011, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 432; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The proposed new sections affect Health and Safety Code, Chapter 432; and Government Code, §2001.039.