USA Reach Regulation for Various Sectors

The United States are involved in the regulation and monitoring of nanomaterials. The two institutions, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA), have the most major role in the regulation and monitoring of nanotechnology goods among the five government agencies listed.

Nanomaterials and nanotechnology products are also subject to five general environmental standards in the United States. Table 2 illustrates where any nanomaterials-containing items fall under the purview of these five Acts. From 2009 to 2014, the EPA conducted a "Nanomaterials Research Strategy" to gather data in preparation for future regulation. It looked at the unique properties of nanoparticles such size, shape, chemical composition, and stability in order to develop prediction models and identify more risky and safe nanomaterials. The programme also investigated things like destiny, transition, interactions with the environment, concentration measurement techniques, and characteristics like shape, surface load, and surface chemistry (EPA,2018c).

Nanomaterials is EPA studying:

 Nano Silver: Because silver nanomaterials have antibacterial, antifungal and antiviral properties, they are used in medical equipment, textiles and cosmetics, fabrics, plastics and other consumer products.

 Carbon Nanotubes: These nanomaterials are one of the most abundant classes of nanomaterials, and come in a variety of shapes and sizes. Carbon materials have a wide range of uses, including composites for vehicles or sports equipment, coatings, textiles, polymers, plastics and integrated circuits for electronic components.

 Cerium dioxide: Nanoscale cerium dioxide is used in electronics, plastics, biomedical supplies, energy, fuel additives, and other consumer products.

 Titanium dioxide: Nano titanium dioxide is used in many products. It can be found in sunscreens, cosmetics, paints and coatings, and electronic devices.

 Iron: One important use of nano zero-valent iron particles is to catalyze the breakdown of chlorinated hydrocarbon compounds that are among the most common toxic contaminants found in hazardous waste sites.

 Micronized Copper: Micro and nanometer sized copper particles are used as preservatives in pressure treated lumber and, in some paints, and coatings.

This research will be used by the EPA to create research methodologies for characterising engineered nanomaterials (ENMs) and assessing exposure and toxicity in complicated biological or environmental systems. This study will allow EPA experts to assess the links between the physical and chemical features of ENMs and their destiny, transit, and impacts, perhaps leading to safer and more sustainable ENMs.

Any chemical that is imported or made in the United States but is not listed by the Environmental Protection Agency (EPA) is a novel chemical that should be added to the list before being sold in the United States. The Toxic Substances Control Act (TSCA) is the primary legislation that governs industrial chemicals in the United States. The Toxic Substances Control Act (TSCA) gives the EPA the ability to examine new compounds and certain new applications of chemicals before they enter the market, impose limits, and then add those new substances to the TSCA Inventory list of existing chemicals.

Nanomaterials should be added to the list as novel substances, and several different nanomaterials have already been added to the list. The EPA has taken steps to control and limit exposure to these materials, such as limiting the use of nanomaterials, requiring the use of personal protective equipment and engineering controls, limiting their release into the environment, and requiring testing to provide required data on health and environmental impacts.

The EPA may also compel the reporting, recording, and testing of chemicals that pose an unjustified danger to human health or the environment, or that reach specific production or exposure thresholds, under TSCA. Pesticides, food, pharmaceuticals, and cosmetics are among the substances that are normally exempt from TSCA.

The Food and Drug Administration (FDA) in the United States is in charge of ensuring the safety of food additives, food contact materials, and feed additives that are put on the market under the Federal Food, Drug, and Cosmetic Act (FFDCA) (US-FDA). Pre-market authorisation by the FDA is usually necessary for food and colour additives, however it is not required for some other food items, such as food components that are generally recognised as safe (GRAS). The FFDCA has no nanotechnology-based product specifications, and the FDA has yet to create a regulatory definition of NMs. When it comes to nanotechnology-based goods, it has taken a very broad and thorough approach.

FDA has issued various guidance documents addressing nanotechnology concerns, such as "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology" to assist industry (US-FDA, 2014a). According to the advice, when determining whether a product contains NMs, FDA considers the material's size (about 1 nm- 100 nm), as well as features or phenomena attributable to the material's exterior dimension(s), even if these dimensions are not in the nanoscale range, but rather up to 1 millimetre. This method is intended to be universally applicable to all FDA-regulated items, including food.

The FDA also released special advice for food-related nanomaterials/nanotechnology applications. The FDA advises a preliminary safety evaluation of "Food Ingredients and Food Contact Substances Produced at Nanoscale," which should be based on evidence relevant to a food substance's nanometer form. The FDA does not consider all products containing NMs to be intrinsically harmful at the outset, but instead advises using a case-by-case approach when evaluating the completed product's safety and intended use. In terms of the safety of such goods, the FDA also argues that there are currently no food ingredients purposely developed at the nanoscale scale for which there is sufficient safety evidence to evaluate their usage GRAS. FDA asserts in the guideline that it has not received any food or colour additive petitions, or GRAS affirmation petitions, for any applications of food ingredients with a particle size distribution that is entirely in the nanoscale range. FDA also issued "Draft Guidance for Industry on the Use of Nanomaterials in Food for Animals," which includes similar issues (US-FDA, 2014b).

The FDA's existing regulatory framework for nanotechnology-enabled cosmetics is in flux. In 2007, the FDA established a task force to explore the future of nanotechnology goods. The FDA has now issued advice on nano-enabled cosmetics safety (FDA, 2014a) and identifying nano-enabled goods (FDA, 2014b) to give more information to the industry on how the administration views the use of nanoparticles in products that it regulates. As things stand, the FDA will continue to oversee items like cosmetics under the 1938 Federal Food, Drug, and Cosmetic Act's established regulatory structure (FDA, 2014b). Having said that, the FDA has stated that it will continue to evaluate and respond to advances in our understanding of the dangers connected with nanotechnology goods.

In the case of nano-enabled cosmetics, the FDA's strategy is to continue to regulate goods rather than processes. 'The present methodology for safety evaluation is sufficiently strong and adaptable to be applicable for a variety of materials, including nanomaterials,' according to the FDA (2014a). Because the FDA does not accept a single definition of nanotechnology, it will continue to evaluate individual uses of nanotechnology, as well as the safety of the goods that arise, on a case-by-case basis. Manufacturers should apply the FDA's two Points to Consider assessing if their products include nanotechnology. These are some of them:

1. whether at least one exterior dimension, or an internal or surface structure, in the nanoscale range (about 1–100nm) is engineered into a material or finished product, and

2. whether at least one exterior dimension, or an internal or surface structure, in the nanoscale range (about 1–1000nm) is engineered into a material or finished product, and

The FDA usually conducts this study during the pre-market review stage to notify manufacturers whether their product is regulated as containing nanotechnology. Because cosmetics are not subject to FDA pre-market approval, producers must apply these Points to Consider on a voluntary basis. As a result, the FDA has little power to guarantee that the nano-related hazards associated with nano-enabled cosmetics are measured in these substantiation studies because manufacturers undertake their own safety substantiation testing.

For both the medical device sector and the regulatory agency, nanotechnology may be a new and growing subject (Such as the US FDA). Currently, the FDA has not defined nanotechnology-specific criteria to help manufacturers in deciding when a modification to a device that incorporates nanomaterials or otherwise involves the use of nanotechnology becomes significant enough to need a new submission. As a result, the FDA recommends that device makers approach the agency before making any nanotechnology-related changes to see whether and how the change may impair the device's security or efficacy.

In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program. The federal agency responsible for regulating medical devices is the Food and Drug Administration (FDA)—an agency within the Department of Health and Human Services (HHS). FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device premarket review. Another center, the Center for Biologics Evaluation and Research (CBER), regulates devices associated with blood collection and processing procedures, cellular products and tissues.  

FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic Act (FD&C Act). The FD&C Act contains provisions, that is, regulatory requirements, that define FDA's level of control over these products. To fulfil the provisions of the FD&C Act that apply to medical devices and radiation-emitting products, FDA develops, publishes and implements regulations.

• Federal Register (FR) 

• The FR is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. 

• Proposed rules are initially published in the Federal Register for public comment and subsequently published in the Code of Federal Regulations after the rule is final. 

• Final regulations published in the FR are subsequently placed or codified into the printed edition of the Code of Federal Regulations (CFR) on an annual basis. 

• The recently published FR's on the Regulations.gov web page. 

• Code of Federal Regulations (CFR) 

• The CFR is a codification of the general and permanent rules that were published in the FR by the Executive departments and agencies of the Federal Government.  

• It is divided into 50 titles that represent broad areas subject to Federal regulation. 

• The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA. 

• FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers of medical devices. Medical devices are regulated under the Federal Food Drug & Cosmetic Act (FD&C Act) Part 800-1299. 

• Manufacturers importing medical devices into the USA must designate a United States agent, register the establishment, list the device, manufacture according to the quality system requirements and file a Premarket Notification 510 (k) or a Premarket Approval. 

• A post marketing surveillance system is required (21 CFR Part 803). Medical devices are divided into Class I, Class II and Class III where class I devices represent the lowest risk and class III devices represent the highest risk. Most Class I devices and some Class II devices are exempted from a Premarket Notification 510 (k).

• The FDA does not “certify" devices, and the FDA logo is for the official use of the FDA and not for use on private sector materials. The FDA does not issue registration certificates to medical device facilities nor does the FDA certify information for facilities that have registered their establishments and listed their medical devices. 

• All device establishments required to register must complete their annual registration for each Fiscal Year between October 1 and December 31. 

• FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process. 

• In completing product listings for facilities, bear in mind that you are required to identify any that are combination products.

How can GPC help you? 

• Identification of compliance requirements under various guidelines including all data requirements.​ 

• Data gap analysis and pre-assessment support​ 

• Technical documentation support​ 

• Pre and post submission support and technical liaison with authorities. 

The Environmental Protection Agency regulates pesticides on a national level in the United States (EPA). The Federal Insecticide, Fungicide, and Rodenticide Act, as well as the Federal Food, Drug, and Cosmetic Act, give pesticides broad regulatory jurisdiction. The Food Quality Protection Act and the Pesticide Registration Improvement Act have both altered these laws. 

1. US Environmental Protection Agency (USEPA): It established maximum residue levels for the reregistration and reassessment process. When exemption is found to be a safe candidate then tolerance exemptions are granted exceptionally. 

2. US Food and Drug Administration (FDA): Implementation of tolerance values that is specified for other foods  

3. US Department of Agriculture (DOA): Enforcement of maximum tolerances values for certain egg and meat  

4. BLM and US Fish and Wildlife Services: regulation of risks from agrochemicals to the aquatic system, wildlife and environment  

5. Food and Agriculture Organization (FAO): Enhancement of nutritional value and food security  

6. The United States Environmental Protection Agency (USEPA) and California Department of Pesticide Regulation (CDPR) : Regulation of agrochemicals in US and the state of California  

Note: The USEPA and CDPR regulate the use of agrochemicals in California where placement of any additional restrictions is allowed by CDPR beyond the guidelines given by USEPA concerning the climatic conditions of the respective place  

Companies involved in the manufacturing, formulation, repackaging, exportation, importation, marketing, and application service of pesticides shall file the registration application.

The registration of a pesticide is a scientific, legal, and administrative process consist of examination of pesticide's ingredients, the specific site or crop where it will be used, the amount, frequency, and timing of its application, as well as storage and disposal policies. 

There is a wide range of potential human health and environmental impacts connected with pesticide use while evaluating a pesticide registration application. The company that wants to make the pesticide must submit evidence from studies that meet testing requirements. 

• The risk assessments analyze the potential for harm.  

• Humans, wildlife, fish, and plants, including endangered species and non-target organisms, are all negatively affected. 

• Surface and ground water contamination due to leaching, runoff, and spray drift. Short-term toxicity to long-term impacts like cancer and reproductive system abnormalities are all possible human dangers. 

The language on each pesticide label to verify that the usage instructions and safety precautions are acceptable for any potential risk. Following the guidelines on the label is required by law and is essential for safe use. 

Companies file a registration action application, such as registering a new pesticide active ingredient, a new product for an existing pesticide, or adding a new use to an existing pesticide. 

The following items are usually included in a company's application: 

• The Pesticide Registration Improvement Act mandates the payment of a service charge (PRIA). 

• Forms that describe the action that has been requested. 

• All compounds in the product's identification and quantity. 

• Data about potential threats to human health and the environment, including pesticide residues on food (if applicable). 

• Evidence of the product's production process's dependability. 

• Directions for usage, contents, and applicable warnings are all included on the labelling. 

• Evidence that you've met all of your legal and financial commitments. 

Each application for registration of a new product that contains a new pesticide active ingredient or proposes a new use for an existing pesticide receives a notice of receipt in the Federal Register. 

The appropriate pesticide division receives the application, which is processed and tracked. After that, a project manager is assigned to: 

• Complete a thorough examination of the application. 

• Assign and coordinate a scientific review that is appropriate. 

• PRIA's priorities and timeframe should be followed. 

• Organize administrative activities. 

• Inform the applicant (also known as the registrant) of the review. 

1. Human Health risk 

a. Risks in the aggregate–from food, water, and residential uses 

b. Risks accumulated over time from several pesticides with similar effects 

c. Occupational hazards for people who use the product at work 

2. Environmental risks 

a. Contamination of groundwater is possible. 

b. Endangered and threatened species are at risk. 

c. Endocrine disruption is a possibility. 

3. Risk assessment and peer review 

a. the scientific facts on the pesticide product and generate complete risk assessments that look at the product's or ingredient's possible effects on people and the environment. 

b. The risk assessments for health and the environment are subjected to peer review by scientific experts. 

4. Risk management and regulatory decisions 

a. Consider the findings of the risk assessments and peer reviews. 

b. Examine any procedures required to mitigate any detected concerns by researching alternative pesticides that have already been approved. 

c. Discuss with the applicant whether any changes to the product or labelling are required to reduce risk. 

d. After posting notices for comment in the Federal Register, establish new food tolerances if necessary. 

e. If no adjustments are required, or if the applicant accepts the necessary revisions, registration will be granted. 

f. Publish a notice of registration issue in the Federal Register.

Before a pesticide can be sold or disseminated in the United States, the FDA must approve all label text as part of the licensing/registration procedure. The label's overarching goal is to provide clear instructions for efficient product performance while reducing dangers to human health and the environment. Using a pesticide in a way that contradicts its labelling is illegal under federal law. A label is considered a legal document by the courts. Furthermore, to ensure safe and effective use, it is vital to follow the labelling directions carefully and precisely. 

https://www.epa.gov/pesticide-registration/about-pesticide-registration#:~:text=Federal%20Insecticide%2C%20Fungicide%2C%20and%20Rodenticide%20Act%20(FIFRA)%20%2D,benefits%20of%20a%20product's%20use

Persistent Organic Pollutants (POPs), also referred to as “emerging contaminants”, include a range of chemical substances from diverse applications, ranging from medicines, personal care, household cleaning products, lawn care, agricultural products, among others.

The toxicity of POPs has been long investigated, and researchers found that these chemicals may have long-range mobility and long-lasting duration, leading to environmental contamination and pollution. POPs are often classified as Substance of Very High Concern (SVHC) with hormone disruption consequences, bioaccumulation and biomagnification through the food chain. The presence of POPs in the environment and in human health can lead to several complications, from mild effects to more serious consequences, for example, reproductive disruptions and immunological disorders.

Since POPs are not easily broken down, a characteristic that guarantees its continuation in the environment, the contaminant consequences are still being investigated. In other words, the emerging contaminants are mainly not from new pollutants that recently entered the environment. Instead, there is a good understanding of contaminants, but the consequences to their exposure are still being discovered.

Countries have created a set of rules and regulations to regulate, control, and mitigate POPs use and its effects on the environment and on human health. The essence of these legislations is to eliminate the production, trading, and use of such chemicals, including storage and waste management.

International effort in addressing POPs starts in the late 1990s. The initial protocol to address POPs was implemented in 1998, signing 16 chemicals to phase out according to previously established risk criteria. The Aarhus Protocol also impose parties to reduce their emissions below 1990 levels.

The Stockholm Convention is an international conference specifically for POPs proposed in May 2001 in Sweden (complementing the Aarhus Protocol), entering into force in 2004. Among the objectives, the Stockholm Convention aims to:

• Prohibit, eliminate, and restrict several POPs in the production, use, import, and export.
• Ensure that waste containing POPs is managed safely and in an environmentally sound manner.
• Promote tools for information exchange, public access, awareness and education, research, development and monitoring, reporting, and implementation of plans to fight POPs pollution.

The Stockholm Convention is considered the main international instrument to address POPs. Most countries adhere to the Stockholm Convention.

The United States has not yet ratified the Stockholm Convention. The main reason for the delay is that the United States does not have the authority to implement all the Convention’s provisions, and currently, the country participates as an observer in the meetings and working groups. Yet, the Stockholm Convention contributed to the development of similar frameworks across the United States; for example, the Environmental Protection Agency (EPA) reduced amounts of dioxins and furans sources and banned agrochemicals such as Dichlorodiphenyltrichloroethane (DDT).

Today, 12 chemicals listed in the Stockholm Convention original list cannot be registered and distributed in the United States – the implementation of amendments still have to be addressed.

The United States does not have a specific regulation addressing POPs. According to the Toxic Substances Control Act (TSCA), Chemicals must undergo the general registration steps to be marketable.

It is The part of the States Department of Health and Human Services and is one of the United States federal execuve departments. New drugs, including biologics, Food addives for people and animals, Color addives in food, drugs, and cosmecs for people and animals, Medical devices, Food and beverages, Cosmecs, Radiaon –eming- electronic devices, Tobacco products. What is U. S FDA?

The FDA evaluates and approves many different things, including: If the management does not convincingly address the Form 483 observaons within the specified me period, the FDA issues a warning leer. Somemes, if the observaons are of a severe nature, the FDA may issue a warning leer even without issuing Form 483. Unsasfactory response to the warning leer could lead to further acon including import alert for products or the facility, withholding of product approval, and suspension or cancellaon of manufacturing license.

The FDA calls for a response to the Form 483 observaons within 15 working days. Though a wrien response is not mandatory, it is preferred so that a warning leer can be avoided. The company has to respond to the observaons in detail with reasons for the shortcomings and correcve acon plans. Each observaon should be addressed individually

The FDA exercises authority for inspecons of facilies in foreign countries which supply pharma and food products to the US. So, pharma and food plants in countries that export to the USA must adhere to the CGMP (current good manufacturing pracces) as per FDA guidelines. FDA officials visit the facilies to check compliance with the rules.FDA issues form 483 at the compleon of inspecon. If it finds deviaons from CGMP, it is menoned in the form 483. The form specifies areas in which the facility fell short of regulatory expectaons. It is then presented and discussed with the management of the company, Along with the form 483, the FDA also issues an Establishment Inspecon Report (EIR) which specifies whether acon is required to be taken.

The appointment of a US Agent is a mandatory requirement for foreign companies who wish to sell drugs or pharmaceuticals, medical devices, food and dietary supplements, in United States.

• AS. agent may be an individual, partnership, corporation, or association.
• AS. agent must have a place of business or residence in the United States and be physically present in the United States. For example, a foreign facility may use its U.S. importer as its U.S. agent. As established in 21 CFR 1.227,
• TheS. agent acts as a communications link between FDA and a foreign facility for both routine and emergency communications.
• The U.S. agent will be the person FDA contacts when an emergency occurs, unless the registration specifies another emergency contact. In functioning as the communications link with FDA, a U.S. agent may choose to initiate communications with FDA, and FDA may likewise choose to initiate communicationswith the S. agent.

Section415(a)(3) of the FD & C Act requires facilities that are required to register with FDA to renew their registrations every other year, during the period beginning on October 1 and ending Contains

(Nonbinding Recommendations 37) on December 31 of each even-numbered year.

FDA’s prior notice for imported foods system is the agency’s primary tool for ensuring that foreign facilities that offer food for import into the United States are registered under section 415 of the FD&C Act. (See 21 CFR 1.285 and CPG Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness Response Act of 2002). If FDA determines that a foreign food facility is not registered in accordance with section 415 and 21 CFR part 1, subpart H, the food being imported or offered for import into the United States from the foreign facility is subject to being held at the port of entry (as defined in 19 CFR 101.1), in accordance with section 801(l) of the FD&C Act, unless

U.S. Customs Border Protection (CBP) concurrence is obtained for the export of the food and the food is immediately exported from the port of arrival (as defined in 21 CFR 1.276(b)(11) (see 21 CFR 1.285(b)). Food held in this circumstance shall not be entered and shall not be delivered to the importer, owner, or ultimate consignee until the foreign facility is registered in accordance with section 415 and 21 CFR part 1, subpart H, and the appropriate registration number is provided in prior notice as specified in 21 CFR 1.285(i).

Beginning January 4, 2020, registrants must submit their registration or registration renewal to FDA electronically; unless FDA has granted a waiver under 21 CFR 1.245 (see 21 CFR 1.231). If FDA has granted a waiver under 21 CFR 1.245, the registrant may register or renew by mail or by fax. If you submit a registration or registration renewal by mail or fax, you must use the paper version of Form FDA 3537. That version is available for download at

https://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm.

You can request the paper form and submit the completed form by fax to 301-436-2804 or by mail to:

U.S. Food and Drug Administration Food Facility Registration (HFS-681) 5001 Campus Dr. College Park, MD 20740.

FDA office in India:

FDA opened the India Office in New Delhi in 2008, to ensure that food and medical products exported from India to the U.S. are safe, are of good quality, and are effective.

FDA’s goals in India are to obtain information to help make better regulatory decisions about the products from India that are being developed and exported for the U.S. market. This includes medical products being reviewed for marketing authorization in the U.S., and the safety assessment of products that are already on the U.S. market. In addition, the India Office helps verify that foods being imported into the U.S. are safe.

As outlined in 21 CFR 1.232, the following information is required for domestic and foreign food facility registrations:

• The facility name, address, phone number, and emergency contact phone number; • Preferred mailing address, if different from that of the facility;
• Parent company name, address, and phone number (if the facility is a subsidiary of the parent company);
• Alltrade names the facility uses;
• Name, address, and phone number of the owner, operator, or agent in charge;
• The email address of the owner, operator, or agent in charge, unless FDA has granted a waiver under 21 CFR 245;
• Applicable food product categories of any food manufactured/processed, packed, or held at the facility, as identified on Form FDA 3537;
• The type (s) of activity at the facility for each food product category, as provided in 21 CFR 232(a)(8);
  • A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manne

The Toxic Substances Control Act (TSCA) regulates the manufacture, import, and use of chemical substances in the US. The Act was originally enacted in 1976. The purpose of TSCA is to regulate the manufacture, importation, processing, distribution, and use of chemicals and chemical substances in order to protect human health and the environment from unreasonable risks. TSCA addresses the production, implementation, use, and disposal of specific chemicals including polychlorinated biphenyls (PCBs), asbestos, radon, and lead-based paint. TSCA applies to all chemical substances produced or imported into the United States.

In June 2016, the Frank R. Lautenberg Chemical Safety for the 21^st Century Act (Lautenberg Chemical Safety Act, LSCA) was signed into law and TSCA was thereby amended. The LSCA is more commonly known as New TSCA. New TSCA include several changes impacting companies that manufacture, import, or process substances in the USA, including review of Pre-Manufacture Notices (PMNs) for new chemicals, review of existing chemicals, testing, confidentiality claims, fees, and relationship between TSCA and other US federal and state law.

New TSCA revised Section 4 to grant additional authority to the EPA to require the development of new information relating to a chemical substance. Additionally, New TSCA expanded the situations under which the EPA is required to take action against chemicals presenting significant risks. Importantly, under New TSCA, the EPA may not consider non-risk factors (such as cost) in determining whether a risk is unreasonable.

Regulation of New Chemicals

New TSCA strengthened the existing Section 5 process. The law now requires manufacturers and processers to submit Pre-Manufacture Notices (PMNs) to EPA at least 90 days before beginning to manufacture or process a new chemical substance.

The following substances are excluded from PMN reporting under certain conditions:

• Naturally occurring materials

• Products of incidental reactions

• Products of end-use reactions

• Mixtures (but not mixture components)

• Impurities

• By-products

• Substances manufactured solely for export

• Non-isolated intermediates

• Substances formed during the manufacture of an article

For chemical substances that have been subject to a PMN Significant New Use Rules (SNURs) are issued by the EPA under TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to submit a Significant New Use Notice (SNUN) to the EPA at least 90 days before commencing that activity. The EPA must then review all new chemicals and significant new uses, decide, and take required action during that 90-day window. During its review process, the EPA is prohibited from considering costs or other non-risk factors.