The following rules apply to projects using hazardous chemicals, devices and activities. These include substances and devices that are regulated by local, state, country, or international law. Hazardous activities are those that involve a level of risk above and beyond that encountered in the student’s everyday life. The student researcher must minimize the impact of an experiment on the environment.

Index

Prohibited Studies
Rules
Documentation and Approval

Prohibited Studies:

1. A study using prescription drugs is prohibited when the prescription is being used outside of the purpose for which it was prescribed.
2. Students are prohibited from conducting experiments where consumable ethyl alcohol is produced by distillation.
3. Any study using DEA controlled substances is prohibited in a school or home setting.
4. Any study using > 25 kvolts of radiation is prohibited in a school or home setting.
5. All radiation studies may not exceed the dose limits set by the Nuclear Regulatory Commission of 5 mrem/hr or 100 mrem/year of exposure.
6. Underage researchers are prohibited from the following:
   1. Purchasing alcohol, tobacco, and vape products
   2. Purchasing firearms or ammunition, including black powder
   3. Purchasing explosives
7. All projects using chemicals with a GHS safety rating of 1, 2, or 3, or NFPA safety rating of 3 or 4, must be conducted in a school or laboratory setting.

Rules:

1. The student researcher must conduct a risk assessment in collaboration with a Direct Supervisor or Qualified Scientist prior to experimentation. The research must be supervised as appropriate for the hazardous substance, activity or device being used.
2. Students are required to meet all standards and rules imposed by ISEF, school, local, and/or regional fair(s).
3. Student researchers must acquire and use regulated substances in accordance with all local, state, U.S. federal and country laws. This includes:
   1. Regulations regarding DEA-controlled substances,
   2. FDA and state laws regarding prescription drugs,
   3. TTB and state laws regarding alcohol and tobacco,
   4. ATF and state laws regarding firearms and explosives and
   5. FAA and state laws regarding drones.
   6. For further information or classification for these laws and regulations, contact the appropriate regulatory agencies.
4. For all chemicals, devices or activities requiring a federal and/ or state permit, the student/supervisor must obtain the permit prior to the onset of All transportation and acquisition of materials must comply with all Federal and State laws and regulations.
5. Projects using chemicals with a Globally Harmonized System of Classification and Labelling of Chemicals (GHS) safety rating of 1, 2 or 3 or National Fire Protection Association (NFPA) safety rating of 3 or 4 must be conducted in a school or laboratory setting. Projects conducted with chemicals outside these ratings may be conducted in a home setting under the following conditions:
   1. Projects in a home setting must follow standard lab practices for chemical handling, safety, ventilation, and specific disposal procedures used as outlined in the Safety Data Sheets (SDS).
   2. Any cookware, utensils, and/or equipment used during the experimentation cannot be reused for food preparation.
   3. Be conducted with a Direct Supervisor with proper training and knowledge of the chemicals being used.
6. Disposal procedures shall be described in sufficient detail to ensure compliance with EPA Guidelines as outlined in the appropriate Safety Data Sheets. Examples include minimal quantities of chemicals that will require subsequent disposal; ensuring that all disposal is done in an environmentally safe manner. Proper chemical, sharps and other hazardous materials disposal must follow local, state, and federal guidelines.

DEA-Controlled Substances

The U.S. Drug Enforcement Administration (DEA) regulates chemicals that can be diverted from their intended use to make illegal drugs.

1. All studies using DEA-controlled substances must be supervised by a Qualified Scientist at a Regulated Research Institution (RRI) and must be conducted at an RRI who is licensed by the DEA (or other international regulatory body) for use of the controlled substance.
2. All studies using DEA Schedule 1 substances (including marijuana) must have the research protocol approved by DEA before research begins. Schedule 2, 3 and 4 substances do not require protocol approval by DEA.

Prescription Drugs

In the United States, the Food and Drug Administration (FDA) tightly regulates the issuance of prescription drugs including non-controlled medications. It is unlawful to use a prescription for persons or purposes outside of the original intent of the prescription or for the person it was originally prescribed for. All applicable federal, state, and country laws must be followed.

1. A study involving prescription drugs must obtain the prescription drug through the authority of a practitioner or researcher that has obtained the non- controlled medication with appropriate approvals or be using a prescription drug that is a research or education research-grade product and therefore not for human consumption.
2. Research involving prescription drugs being administered to vertebrate animals, may only be done under a veterinarian’s supervision and with prescriptions provided for this specified purpose.

Alcohol and Tobacco

The U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates the production of alcohol and distribution of alcohol and tobacco products. Many such products are restricted by age for purchase, possession and consumption.

1. Fermentation studies in which minute quantities of ethyl alcohol are produced are permitted.
2. The Direct Supervisor is responsible for the acquisition, usage and appropriate disposal of the alcohol, tobacco, or vape products used in the study.
3. Production of wine or beer by adults is allowable in the home and must meet TTB home production regulations. Students are allowed to design and conduct a research project, under direct parental supervision, involving the legal production of the wine or beer.
4. Students may distill alcohol for fuel or other non- consumable products, but the work must be conducted at school or a Regulated Research Institution and follow all local and country laws.

Firearms and Explosives

The U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), along with state agencies, regulates the purchase and use of firearms and explosives. Explosives include, but are not limited to, dynamite, black powder, pellet powder, detonators, and igniters. The purchase of a firearm by a minor is generally unlawful. The use of a firearm, without proper state certification, is illegal.

Students should check the training and certification requirements of individual states and countries.

1. Projects involving firearms and explosives are allowable when conducted with the direct supervision of a Direct Supervisor and when in compliance with all federal, state and local Any use of a firearm must be conducted with the proper state certification and training.
2. A fully assembled rocket motor, reload kit or propellant modules containing more than 62.5 grams of propellant are subject to the permitting, storage, transportation, and other requirements of federal explosive laws and regulations.
3. Potato guns and paintball guns are not considered firearms unless they are intended to be used as weapons. However, they must be treated as hazardous devices.

Regulated Drones

1. Projects involving unmanned aircraft systems (UAS)/ drones must follow all state, federal and country laws. See the Federal Aviation Administration (FAA) for more details (https://faa.gov/uas/).
2. Current U.S. law requires all forms of drones to be registered with the FAA.

Radiation

Projects involving radionuclides (radioisotopes) and X-rays must involve a careful examination of the risks associated with the study and appropriate safety precautions must be taken.

1. If the voltage needed in the study is <10 kvolts, a risk assessment must be conducted. The study may be done at home or school, and SRC preapproval is not required.
2. A study using 10–25 kvolts must have a risk assessment conducted and must be preapproved by the SRC to assess Such a study must be conducted in a metal-lined chamber using a camera only, not direct view through glass. A dosimeter or radiation survey meter is required to measure radiation exposure.
3. All studies using > 25 kvolts must be conducted at an institution with a Licensed Radiation Program and must be preapproved by the Institutions’ Radiation Safety Officer or the Committee which oversees the use of ionizing radiation to ensure compliance with state and federal regulations.

Documentation and Approval:

1. Student researchers must have a Research Plan that includes all of the standard elements as well as a thorough risk assessment that discusses:
   1.  process,
   2. supervision,
   3. usage,
   4. safety precautions and
   5. methods of disposal
2. The student researcher must conduct a risk assessment in collaboration with a Direct Supervisor or Qualified Scientist prior to experimentation. The result of this review is also documented on Risk Assessment Form 3.
3. Any permits and/or licenses collected as a requirement of the project must be included with the project paperwork and must be available for review by adults supervising the project and the local, affiliated, and ISEF SRCs in their review prior to competition.
4. The following forms are required:
   1. Checklist for Adult Sponsor (1)
   2. Student Checklist (1A)
   3. Research Plan/Project Summary
   4. Approval Form (1B)
   5. Regulated Research Institution Form (1C), when applicable
   6. Qualified Scientist (2), when applicable
   7. Risk Assessment (3)

The International Rules & Guidelines use several terms to describe individuals involved in the research and the review committees that support the pre-approval and competition review to ensure the safety of the student researchers and all involved in the research.