CFR > Title 40 > Chapter I > Part 790 > § 790.62. Submission of study plans and conduct of testing
Current as of: July 2009
(a) Timing of submission. The principal sponsor of testing conducted pursuant to a consent agreement shall submit a study plan no later than 45 days prior to the initiation of testing.
(b) Content of study plans. All study plans are required to contain the following information:
(1) Identity of the consent agreement under which testing will be performed.
(2) The specific test requirements to be covered by the study plan.
(3) The name and address of the principal test sponsor.
(4) The names, addresses, and telephone numbers of the responsible administrative official[s] and project manager[s] in the principal sponsor's organization.
(5) The names, addresses, and telephone numbers of the technical contacts at each manufacturer and/or processor subject to the agreement.
(6) The names and addresses of the testing facilities responsible for the testing and the names, addresses, and telephone numbers of the administrative officials[s] and project manager[s] assigned to oversee the testing program at these facilities.
(7) Brief summaries of the training and experience of each professional involved in the study, including study director, veterinarian[s], toxicologist[s], pathologist[s], chemist[s], microbiologist[s], and laboratory assistants.
(8) Identity and supporting data on the chemical substance[s] being tested, including physical constants, spectral data, chemical analysis, and stability under test and storage conditions, as appropriate.
(9) Study protocol, including the rationale for any combination of test protocols; the rationale for species/strain selection; dose selection (and supporting data); route(s) or method(s) of exposure; description of diet to be used and its source, including nutrients and contaminants and their concentrations; for in vitro test systems, a description of culture medium and its source; and a summary of expected spontaneous chronic diseases (including tumors), genealogy, and life span.
(10) A schedule, with reasonable timeables and deadlines, for initiation and completion of each short-term test and of each major phases of long-term tests, and submission of interim progress and/or final reports to EPA.
(c) Review and modification. (1) Upon receipt of a study plan, EPA will review it to determine whether it complies with paragraph (b) of this section. If EPA determines that the study plan does not comply with paragraph (b) of this section, EPA will notify the submitter that the plan is incomplete and will identify the deficiencies and the steps necessary to complete the plan. It is the responsibility of the test sponsor to review the study protocols to determine if they comply with all the mandatory testing conditions and requirements in the test standards (i.e., ``shall statements'').
(2) The submitter will have 15 days after the day it receives a notice under paragraph (c)(1) of this section to submit appropriate information to make the study plan complete.
(3) If the submitter fails to provide appropriate information to complete a study plan within 15 days after having received a notice under paragraph (c)(1) of this section, the submitter will be considered to be in violation of the consent agreement and subject to enforcement proceedings pursuant to Sec. 790.65 (c) and (d).
(4) The test sponsor shall submit any amendments to study plans to EPA at the address specified in Sec. 790.5(b).
(d) Functions of the principal test sponsor. When testing is being conducted pursuant to a consent agreement, the principal test sponsor will be responsible for submitting interim progress and final reports to EPA, informing the Agency of any proposed changes in standards for the development of data, study plans or testing schedules, and communicating with the Agency about laboratory inspections and other matters affecting the progress of testing.
[51 FR 23715, June 30, 1986, as amended at 54 FR 36314, Sept. 1, 1989; 60 FR 34466, July 3, 1995]________________________________________________________________________
Questions & Answers: Hazardous Products and Materials
CFR Provisions: Hazardous Products and Materials
U.S. Code Provisions: Hazardous Products and MaterialsState Laws: Hazardous Products and Materials| Alaska | Alaska Statutes Chapter 18.63 - Hazardous Painting Certification | | Arizona | Arizona Laws > Title 36 > Chapter 9 - Regulation Of Alkalies, Acids, Human Blood And Its Derivatives And Poisons | | Arizona Laws > Title 36 > Chapter 13 > Article 5 - Injurious Drugs and Substances | | Arizona Laws > Title 36 > Chapter 13 > Article 8 - Environmental Exposure Risk Assessment | | California | California Business and Professions Code > Division 8 > Chapter 6 - Paints | | California Health and Safety Code > Division 11 > Part 3 - Flamethrowing Devices | | California Health and Safety Code > Division 20 > Chapter 6.8 - Hazardous Substance Account | | California Health and Safety Code > Division 20 > Chapter 6.82 - California Land Reuse And Revitalization Act Of 2004 | | California Health and Safety Code > Division 20 > Chapter 6.85 - California Expedited Remedial Action Reform Act Of 1994 | | California Health and Safety Code > Division 20 > Chapter 6.91 - Hazardous Materials Data | | California Health and Safety Code > Division 20 > Chapter 6.95 - Hazardous Materials Release Response Plans And Inventory | | California Health and Safety Code > Division 20 > Chapter 6.96 - Hazardous Materials Liability Of Lenders And Fiduciaries | | California Health and Safety Code > Division 20 > Chapter 6.97 - Hazardous Materials Information And Consulting Services | | California Health and Safety Code > Division 20 > Chapter 15 - Safety Glazing Materials | | California Health and Safety Code > Division 104 > Part 3 - Product Safety | | California Public Resources Code > Division 12.2 - Products Containing Toxic Metals | | California Vehicle Code > Division 14.1 - Transportation Of Hazardous Material | | California Vehicle Code > Division 14.3 - Transportation Of Inhalation Hazards | | Connecticut | Connecticut General Statutes > Title 19a > Chapter 368l - Carcinogenic Substances | | Connecticut General Statutes > Title 21a > Chapter 419c - Illuminating Oils, Burning Fluids and Kerosene | | Delaware | Delaware Code Title 7 > Chapter 77 - Extremely Hazardous Substances Risk Management Act | | Delaware Code Title 7 > Chapter 92 - Transfer Or Closure Of Chemical Or Hazardous Substance Establishments [Effective Upon Promulgation Of Regulations By The Secretary Pursuant To § 9203(C) Of This Title] | | Delaware Code Title 16 > Chapter 23 - Caustic Alkali, Acids Or Corrosive Substances | | Delaware Code Title 16 > Chapter 24 - Hazardous Chemical Information | | Delaware Code Title 16 > Chapter 74 - Radiation Control | | Delaware Code Title 16 > Chapter 86 - Glass And Safety Glazed Materials | | Florida | Florida Statutes > Chapter 404 - Radiation | | Florida Regulations Chapter 5F-10 - Antifreeze Standards | | Florida Regulations Chapter 9G-14 - Hazardous Materials | | Florida Regulations Chapter 9G-21 - Hazardous Materials Risk Management Planning Fee Schedule | | Florida Regulations Chapter 62-150 - Hazardous Substance Release Notification | | Florida Regulations Chapter 64E-4 - Control of Nonionizing Radiation Hazards | | Florida Regulations Chapter 64E-5 - Control of Radiation Hazards | | Idaho | Idaho Code Title 39 > Chapter 71 - Hazardous Substance Emergency Response Act | | Idaho Code Title 49 > Chapter 22 - Hazardous Materials/Hazardous Waste Transportation Enforcement | | Illinois | Illinois Compiled Statutes > 415 ILCS 70 - Hazardous Substances Construction Disclosure Act | | Illinois Compiled Statutes > 430 ILCS 30 - Illinois Hazardous Materials Transportation Act | | Illinois Compiled Statutes > 430 ILCS 35 - Uniform Hazardous Substances Act of Illinois | | Illinois Compiled Statutes > 430 ILCS 50 - Hazardous Materials Emergency Act | | Illinois Compiled Statutes > 430 ILCS 55 - Hazardous Material Emergency Response Reimbursement Act | | Illinois Compiled Statutes > 430 ILCS 60 - Safety Glazing Materials Act | | Illinois Compiled Statutes > 430 ILCS 140 - Cadmium-Safe Kids Act | | Indiana | Indiana Code > Title 13 > Article 25 - Hazardous Substances | | Indiana Code > Title 16 > Article 43 - Hazardous Products | | Iowa | Iowa Code Chapter 89B - Hazardous chemicals risks -- right to know | | Iowa Code Chapter 208A - Motor vehicle antifreeze | | Kansas | Kansas Statutes > Chapter 65 > Article 27 - Hazardous Household Articles | | Louisiana | Louisiana Revised Statutes > Title 30 > Chapter 16 - Hazardous Material Information Development, Preparedness, And Response Act | | Louisiana Revised Statutes > Title 32 > Chapter 12 - Hazardous Materials Transportation And Motor Carrier Safety | | Maine | Maine Revised Statutes > Title 22 > Chapter 267 - Exposure To Diethylstilbestrol | | Maine Revised Statutes > Title 25 > Chapter 255 - Safety Glazing | | Maine Revised Statutes > Title 25 > Chapter 256 - Hazardous Materials Control | | Maine Revised Statutes > Title 32 > Chapter 26-A - Reduction Of Toxics In Packaging | | Maine Revised Statutes > Title 38 > Chapter 13-B - Uncontrolled Hazardous Substance Sites | | Maine Revised Statutes > Title 38 > Chapter 14 - Liability Of Persons Mitigating The Effects Of Discharge Of Hazardous Materials | | Maine Revised Statutes > Title 38 > Chapter 16-C - Arsenic-Treated Wood Products | | Maine Revised Statutes > Title 38 > Chapter 16-D - Toxic Chemicals In Children's Products | | Massachusetts | Massachusetts General Laws > Part I > Title II > Chapter 21E - Massachusetts Oil And Hazardous Material Release Prevention And Response Act | | Massachusetts General Laws > Part I > Title II > Chapter 21I - Massachusetts Toxics Use Reduction Act | | Massachusetts General Laws > Part I > Title II > Chapter 21K - Mitigation Of Hazardous Materials | | Massachusetts General Laws > Part I > Title XV > Chapter 94B - Hazardous Substances | | Michigan | Michigan Laws > Chapter 29 > Act 138 of 1998 - Hazardous Materials Transportation Act | | Michigan Laws > Chapter 125 > Act 311 of 1972 - Safety Glazing Materials | | Michigan Laws > Chapter 286 > Act 116 of 1978 - The John C. Hertel Toxic Substance Control Commission Act | | Michigan Laws > Chapter 286 > Act 188 of 1965 - Hazardous Substances Act | | Michigan Laws > Chapter 325 > Act 459 of 1982 - Toxic Substance Loan Repayment | | Michigan Laws > Chapter 752 > Act 231 of 1931 - Liquid Fuels, Lubricating Oils, Or Similar Products | | Michigan Laws > Chapter 752 > Act 119 of 1967 - Chemical Agents | | Montana | Montana Code Title 50 > Chapter 78 - Employee And Community Hazardous Chemical Information Act | | Nevada | Nevada Revised Statutes > Chapter 459 - Hazardous Materials | | New Hampshire | New Hampshire Revised Statutes > Chapter 339-A - Labeling Of Hazardous Substances | | New Jersey | New Jersey Statutes > Title 13 > Chapter 1K - Harmful and Destructive Substances | | New Jersey Statutes > Title 13 > Chapter 8 - Solid Fuel | | New Jersey Statutes > Title 13 > Chapter 9 - Liquid Fuel | | New Jersey Statutes > Title 13 > Chapter 12 - Safety Glazing Material | | New Jersey Statutes > Title 13 > Chapter 13 - Lighters | | New Mexico | New Mexico Statutes Chapter 12 > Article 12 - Hazardous Materials Emergency Response Act | | New Mexico Statutes Chapter 74 > Article 4E - Hazardous Chemicals Information Act | | New York | New York Laws - Agriculture & Markets > Article 14-A - Sale and Distribution of Lye and Other Caustic Substances | | New York Laws - Environmental Conservation > Article 35 - Detergents and Other Household Cleansing Products | | New York Laws - Environmental Conservation > Article 37 - Substances Hazardous Or Acutely Hazardous To Public Health, Safety Or the Environment | | New York Laws - Environmental Conservation > Article 38 - Chlorofluorocarbon Compounds | | New York Laws - Environmental Conservation > Article 39 - Sewage System Cleaners and Additives Used In Restricted Geographical Areas | | New York Laws - Environmental Conservation > Article 40 - Hazardous Substances Bulk Storage Act | | New York Laws - General Business > Article 25-B - Use of Safety Glazing Materials | | New York Laws - Labor > Article 28 - Toxic Substances | | New York Public Health Law > Article 13 > Title 12 - Toxic Substances | | New York Laws - Public Health > Article 48 - Toxic Substances | | New York | New York Laws > Agriculture & Markets > Article 14-A - Sale And Distribution Of Lye And Other Caustic Substances | | New York Laws > Environmental Conservation > Article 35 - Detergents And Other Household Cleansing Products | | New York Laws > Environmental Conservation > Article 37 - Substances Hazardous Or Acutely Hazardous To Public Health, Safety Or The Environment | | New York Laws > Environmental Conservation > Article 38 - Chlorofluorocarbon Compounds | | New York Laws > Environmental Conservation > Article 39 - Sewage System Cleaners And Additives Used In Restricted Geographical Areas | | New York Laws > Environmental Conservation > Article 40 - Hazardous Substances Bulk Storage Act | | New York Laws > General Business > Article 25-B - Use Of Safety Glazing Materials | | New York Laws > Labor > Article 28 - Toxic Substances | | New York Laws > Public Health > Article 13 > Title 12 - Toxic Substances | | New York Laws > Public Health > Article 48 - Toxic Substances | | North Carolina | North Carolina General Statutes Chapter 66 > Article 2 - Manufacture and Sale of Matches and Lighters | | North Carolina General Statutes Chapter 66 > Article 18 - Labeling of Household Cleaners | | North Carolina General Statutes Chapter 90 > Article 5A - North Carolina Toxic Vapors Act | | North Carolina General Statutes Chapter 143 > Article 21A - Oil Pollution and Hazardous Substances Control | | North Dakota | North Dakota Code > Chapter 19-16.1 - Antifreeze Regulation | | North Dakota Code > Chapter 19-21 - Labeling of Hazardous Substances | | Ohio | Ohio Code > Title 37 > Chapter 3713 - Bedding And Stuffed Toys | | Ohio Code > Title 37 > Chapter 3714 - Construction And Demolition Debris | | Ohio Code > Title 37 > Chapter 3716 - Labeling Of Hazardous Substances | | Ohio Code > Title 37 > Chapter 3751 - Hazardous Substances | | Oregon | Oregon Statutes > Chapter 453 - Hazardous Substances; Radiation Sources | | Oregon Statutes > Chapter 465 - Hazardous Waste and Hazardous Materials I | | Oregon Statutes > Chapter 466 - Hazardous Waste and Hazardous Materials II | | Rhode Island | Rhode Island General Laws > Chapter 11-48. Substances Releasing Toxic Vapors | | Rhode Island General Laws > Chapter 23-13.4. Hazardous Chemicals – Contamination of Breast Milk and Environment | | Rhode Island General Laws > Chapter 23-18.10. Prohibition of Products Containing Chlorofluorocarbons Products | | Rhode Island General Laws > Chapter 23-18.13. Toxic Packaging Reduction Act | | Rhode Island General Laws > Chapter 23-24. Hazardous Substances | | Rhode Island General Laws > Chapter 23-24.3. Substances or Compounds Used as Sewerage System Cleaners | | Rhode Island General Laws > Chapter 23-24.4. Hazardous Substances Community Right to Know Act | | Rhode Island General Laws > Chapter 23-25.3. Marine Tributyltin Antifoulant Paints | | Rhode Island General Laws > Chapter 23-25.4. Utilization of Unused Prescription Drugs Act | | Rhode Island General Laws > Chapter 23-73. Latex Gloves Safety Act | | South Carolina | South Carolina Code > Title 23 > Chapter 33 - Missiles | | South Carolina Code > Title 23 > Chapter 37 - Safety Glazing Materials | | South Carolina Code > Title 23 > Chapter 39 - Hazardous Substances Act | | South Carolina Code > Title 44 > Chapter 53 - Poisons, Drugs And Other Controlled Substances | | South Carolina Code > Title 44 > Chapter 54 - Drug Dealer Liability Act | | South Dakota | South Dakota Laws > Title 34 > Chapter 21 - Radiation And Uranium Resources Exposure Control | | South Dakota Laws > Title 34 > Chapter 38 - Flammable And Combustible Liquids | | South Dakota Laws > Title 34 > Chapter 40 - Subcutaneous Injection Devices | | South Dakota Laws > Title 34 > Chapter 42 - Portable Oil-Fueled Heaters | | South Dakota Laws > Title 49 > Chapter 28A - Hazardous Material Transportation Safety | | Tennessee | Tennessee Code Title 68 > Safety > Chapter 131 - Hazardous Substances | | Texas | Texas Agriculture Code > Title 5 > Subtitle G - Workplace Chemicals | | Texas Health And Safety Code > Title 6 > Subtitle D - Hazardous Substances | | Utah | Utah Code > Title 19 > Chapter 6 - Hazardous Substances | | Vermont | Vermont Statutes > Title 5 > Chapter 28 - Transportation of Hazardous Materials | | Virginia | Virginia Code Title 44 > Chapter 3.3 - Transportation of Hazardous Radioactive Materials | | Virginia Code Title 44 > Chapter 3.5 - Virginia Hazardous Materials Emergency Response Program | | Virginia Code Title 56 > Chapter 21 - Hazardous Liquid Pipeline Safety Act | | Virginia Code Title 59.1 > Chapter 15 - Storage Batteries | | West Virginia | West Virginia Code > Chapter 16 > Article 3A - Repository Of Information On Medical Treatment For Certain Hazardous Materials; Request For Information; Penalties; Enforcement | | West Virginia Code > Chapter 47 > Article 5 - Safety Glazing Materials | | Wisconsin | Wisconsin Laws Chapter 254 > Subchapter II - Toxic Substances |
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