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Assessing and Managing Chemicals under TSCA

TSCA Section 21

Under TSCA section 21, any person may petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule under:

  • Section 4 -- rules requiring chemical testing;
  • Section 6 -- rules imposing regulatory controls on chemicals;
  • Section 8 -- rules requiring information;
  • Section 5(e) -- orders affecting new chemical substances, or
  • Section 6(b) (2) -- orders affecting quality control procedures.

The petition must be filed in EPA's Office of the Administrator, and set forth the facts that are claimed to establish the necessity for the action requested. EPA is required to grant or deny the petition within 90 days from the day the petition is filed with EPA. If EPA grants the petition, EPA must promptly commence an appropriate proceeding. If EPA denies the petition, the reasons for denial must be published in the Federal Register.


Section 21 Petitions Filed with EPA Since September 2007

Asbestos Information Collection for the CDR Rule

On September 27, 2018, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from the Asbestos Disease Awareness Organization (ADAO) and five other non-governmental organizations requesting that EPA initiate rulemaking under section 8(a) of TSCA to amend the Chemical Data Reporting (CDR) rule, 40 C.F.R. Part 711, to increase reporting of asbestos to CDR. Read the petition. EPA will issue its response to the petition on or before December 25, 2018. Read EPA’s letter acknowledging receipt of the petition.

Chlorinated Phosphate Ester Cluster

On January 6, 2017, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from Earthjustice and six other non-governmental organizations requesting that EPA issue an order under TSCA section 4 requiring that exposure and hazard testing be conducted by manufacturers and processors of three chlorinated phosphate ester (CPE) flame retardant chemicals. The three CPE chemicals are: tris(2-chloroethyl) phosphate (TCEP) (CAS 115-96-8), 2-Propanol, 1-chloro-, phosphate (TCPP) (CAS 13674-84-5); and 2-Propanol, 1,3- dichloro-, phosphate (TDCPP) (CAS 13674-87-8). EPA will issue its response to the petition on or before April 6, 2017. Read EPA’s letter acknowledging receipt of the petition. After careful consideration, EPA denied the petition on April 6, 2017 on the grounds that petitioners have not demonstrated there is insufficient data on this chemical, and thus that the specific testing they requested is necessary. Read the Federal Register Notice announcing EPA’s response to the petition.

Tetrabromobisphenol A

On December 13, 2016, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from Earthjustice, the Natural Resources Defense Council and five other non-governmental organizations requesting that EPA issue an order under TSCA section 4 requiring that testing be conducted on the flame retardant Tetrabromobisphenol A (“TBBPA”). The petitioners requested that EPA issue the order to manufacturers and processors of TBBPA to require exposure and hazard testing. Read the petition. EPA sent a letter of receipt to the petitioners on December 20, 2016. Read EPA’s letter acknowledging receipt of the petition. After careful consideration, EPA denied the petition on March 10, 2017, on the grounds that petitioners have not demonstrated there is insufficient data on this chemical, and thus that the specific testing they requested is necessary. Read the Federal Register notice announcing EPA’s response to the petition.

Fluoride Chemicals in Drinking Water

On November 23, 2016, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from the Fluoride Action Network, Food & Water Watch, Organic Consumers Association, American Academy of Environmental Medicine, International Academy of Oral Medicine and Toxicology, and Moms Against Fluoridation, requesting EPA promulgate a rule pursuant to TSCA section 6 to prohibit fluoridation chemicals as drinking water additives. Read the version of the petition with a non-substantive addition. EPA sent a letter of receipt to the petitioners on December 19, 2016. Read EPA’s letter acknowledging receipt of the petition. After careful consideration, EPA denied the petition on February 17, 2017. Read the Federal Register notice announcing EPA’s response to the petition.

Nomenclature System for Natural Sources of Oil and Fat

On October 7, 2015, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from the Biobased and Renewable Products Advocacy Group (BRAG) requesting that EPA “initiate a rulemaking under TSCA section 8 that would establish a process to amend the list of natural sources of oil and fat in the ‘Soap and Detergent Association’ (SDA) nomenclature system by considering the chemical equivalency of additional natural sources.” EPA will issue its response to the petition on or before January 4, 2016. Read EPA’s letter acknowledging receipt of the petition. After careful consideration, EPA denied the petition on December 31, 2015. Read the Federal Register notice announcing EPA’s response to the petition.

Anthropogenic Emissions of Carbon Dioxide

On June 30, 2015, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from the Center for Biological Diversity and Donn J. Viviani, Ph.D., requesting EPA to promulgate regulations under section 6 of TSCA to protect “public health and the environment from the serious harms associated with anthropogenic emissions of carbon dioxide, including ocean acidification.” The petition alternately requests that EPA “adopt a rule under section 4 of [TSCA] requiring manufacturers and processors responsible for the generation of carbon dioxide to undertake testing to determine toxicity, persistence, and other characteristics which affect health and the environment and are necessary to determine if there is an unreasonable risk of injury to health or the environment.” EPA will issue its response to the petition on or before September 27, 2015. Read EPA’s letter acknowledging receipt of the petition. After careful consideration, EPA denied the petition on September 25, 2015. Read the Federal Register notice announcing EPA’s response to the petition.

Mercury/Recordkeeping and Reporting

On June 24, 2015, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from the Natural Resources Defense Council and the Northeast Waste Management Officials’ Association, requesting EPA “to promulgate a rule pursuant to section 8(a) of the Toxic Substances Control Act requiring recordkeeping and reporting by manufacturers, processors, and importers into the United States of mercury, mercury compounds, or mercury-added products.” More specifically, the petitioners call for the EPA to require electronic reporting every three years and create a national database of entities that engaged in such activities. EPA sent a letter of receipt to the petitioners on July 15, 2015. Read EPA’s letter acknowledging receipt of the petition. EPA will issue its response to the petition on or before September 21, 2015. After careful consideration, EPA denied the petition on September 21, 2015. Read the Federal Register notice announcing EPA’s response to the petition.

Biodiesel Partial Exemption from Chemical Data Reporting (CDR)

March 30, 2015 - EPA published a Federal Register Notice withdrawing the direct final rule that added six chemical substances to the list of chemical substances that are partially exempt from reporting processing and use information under the Chemical Data Reporting (CDR) rule, at 40 CFR 711.6(b)(2)(iv). On February 26, 2015, EPA received an adverse comment pertaining to the addition of the six chemical substances to the list; therefore, in accordance with the procedures specified in the direct final rule, EPA withdrew the rule. EPA intends to publish a notice proposing to add these six chemical substances to the list of chemical substances that are partially exempt from reporting processing and use information under the CDR rule.

Background: On October 21, 2014, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) from the Biobased Renewable Products Advocacy Group requesting that EPA initiate a rulemaking to amend the TSCA section 8 Chemical Data Reporting (CDR) partially exempted chemical list at 40 CFR section 711.6(b)(1) to add “biodiesel” as a chemical category for partial exemption from CDR processing- and use-reporting by adding six chemicals to the list. The petitioner also filed a separate petition, under 40 CFR 711.6(b)(2)(iii)(A), requesting that the same six chemical substances be listed at 40 CFR 711.6(b)(2)(iv), indicating that EPA has determined that information on processing and use is of “low current interest.”

On January 16, 2015, EPA granted the petition to list the chemicals under 40 CFR 711.6(b)(2)(iv) and denied the section 21 petition by letter. EPA determined that, based on the totality of information on the chemical substances, the Agency has low current interest in the CDR processing and use information for these six chemicals and published a direct final rule to amend the list of chemicals at 40 CFR 711.6(b)(2)(iv) to include the six chemicals included in the petition. Because an additional decision to place these six chemical substances on the list at 40 CFR 711.6(b)(1), either individually or as a “biodiesel” category, would afford no further relief to the petitioner, EPA denied the section 21 petition as moot. Read EPA’s letter acknowledging receipt of the petition. EPA’s response, the Federal Register Notice explaining the rationale for denying the section 21 petition, and the Federal Register Notice initiating the direct final rule to amend the list of chemicals at 40 CFR 711.6(b)(2)(iv).

Polyvinyl Chloride (PVC)

August 21, 2014 – On July 29, 2014, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA) and section 7004(a) of the Resource Conservation and Recovery Act (RCRA) from the Center for Biological Diversity tasking EPA to promulgate regulations governing the safe treatment, storage and disposal of polyvinyl chloride (PVC), vinyl chloride and associated dialkyl- and alkylarylesters of 1,2-benzenedicarboxylic acid, commonly known as phthalate plasticizers. On October 31, EPA denied the TSCA section 21 portion of the petition by letter. After careful consideration, EPA denied the petitioner's request to initiate a TSCA section 6 rulemaking, because the TSCA section 21 petition does not specify what risk management action it is requesting; set forth sufficient facts to establish that the disposal of PVC, vinyl chloride, or phthalates used as plasticizers presents or will present an unreasonable risk; or explain why action under TSCA would be preferable to action under other statutory authorities. EPA also denied the petitioner's request to initiate a TSCA section 4 rulemaking to require further toxicity testing of PVC, vinyl chloride, or phthalates used as plasticizers, because the TSCA section 21 petition does not set forth sufficient facts for EPA to find that the toxicity information available to the Agency is insufficient to permit a reasoned evaluation of the health or environmental effects of these PVC constituents, or for EPA to conclude that toxicity testing is necessary to develop any missing data. The TSCA section 21 petition was accompanied by an independent petition for EPA to take action under the authority of the Resource Conservation and Recovery Act (RCRA). EPA continues to review the petitioner's requests for action under RCRA; it is under review by the Office of Resource Conservation and Recovery, which is responsible for programs under RCRA. Read EPA’s letter acknowledging the request of the petitioner, EPA’s response, and the Federal Register Notice.

Lead in Paint - Public and Commercial Buildings

March 12, 2014 -- On October 31, 2013, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA), from the National Center for Healthy Housing, the International Union of Painters and Allied Trades, the Lead and Environmental Hazards Association, and the National Association of Lead and Healthy Homes Grantees, requesting that EPA promulgate a rule pursuant to TSCA section 8(d) requiring property managers, building owners, and contractors disturbing paint on public and commercial buildings to submit to EPA certain records related to the Occupational Safety and Health Administration’s construction standard for lead. On January 28, 2014, EPA denied the TSCA section 21 petition by letter. After careful consideration, EPA found that the petition did not demonstrate that a TSCA section 8(d) reporting rule is necessary and that, while the records requested by the petitioners are potentially useful, they are not necessary to carry out the purposes of TSCA or to support the rulemaking analysis. Read EPA's letter acknowledging receipt of the petition, EPA's response, and the Federal Register notice.

Hydrofluorosilicic acid (HFSA) as a Water Fluoridation Agent

August 6, 2013 -- On May 9, 2013, EPA received a petition from J. William Hirzy, Ph.D., Chemist in Residence, with American University, requesting that EPA take action under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the use of hydrofluorosilicic acid (HFSA) as a water fluoridation agent. Read the petition and EPA’s acknowledgement letter. On August 6, 2013, EPA notified the petitioners that after careful consideration, the Agency denied the TSCA section 21 petition because the evidence presented by the petitioners does not adequately support a conclusion that HFSA, when used as a fluoridation agent, presents or will present an unreasonable risk to health or the environment and that a TSCA section 6 rulemaking is necessary to protect adequately against such risk. See the Agency’s response and the Federal Register Notice.

PCBs - Navy SINKEX

July 12, 2012 -- On April 11, 2012, EPA received a request from the Basel Action Network, the Sierra Club, and the Center for Biological Diversity asking that EPA take certain actions to protect human health and the marine environment from PCBs that leach from ships sunk through the U.S. Navy's sinking exercises (SINKEX) program. The petitioners requested that EPA amend the existing general permit issued to the Navy under the Marine Protection, Research, and Sanctuaries Act (MPRSA) or, in the alternative, enact rules under the Toxic Substances Control Act (TSCA). In requesting actions under TSCA, the petitioners have invoked the citizen petition provisions of section 21 of TSCA. In a letter dated July 10, 2012, EPA denied the request for actions under TSCA because the petitioners did not demonstrate that the TSCA rules they requested are necessary. Among other things, EPA determined that TSCA is not the appropriate vehicle for the regulation of PCBs on ships used in Navy’s SINKEX program, because the Administrator in 1999 determined under section 9(b) of TSCA that such regulation should be under the MPRSA, not TSCA. See the Agency’s response to the requests for action under TSCA and the Federal Register Notice. EPA will respond separately to the petitioners’ request for revisions to the general permit for the transport of target vessels under SINKEX issued by EPA under the MPRSA.

Lead in Shot and Bullets

April 9, 2012 -- On March 13, 2012, EPA received a petition from the Center for Biological Diversity and a number of other groups requesting that EPA take action to regulate bullets and shot containing lead for use in hunting and shooting sports. In August 2010, EPA denied a similar request on lead bullets and shot after concluding that the Agency does not have the legal authority to regulate this type of product under TSCA. On April 9, 2012 EPA notified the petitioners that the March 2012 submission provides no new information that would lead EPA to consider the 2012 submission to be a new petition under section 21, nor does it include information not previously considered by EPA that would warrant reconsideration of EPA’s conclusion that it does not have authority under TSCA to regulate shot and bullets. See the Agency's response.

Lead in Fishing Tackle

February 14, 2012 -- On November 17, 2011, EPA received a petition under section 21 of the Toxic Substances Control Act (TSCA), from the Center for Biological Diversity, the Loon Lake Loon Association, and Project Gutpile, requesting that EPA “evaluate the unreasonable risk of injury to the environment from fishing tackle containing lead (including fishing weights, sinkers, lures, jigs, and/or other tackle) of various sizes and uses that are ingested by wildlife, resulting in lead exposure.” The petition also requests that EPA “initiate a proceeding for the issuance of a rulemaking under section 6 of TSCA to adequately protect against such risks.” Read EPA's letter acknowledging receipt of the petition. On February 14, 2012, EPA notified the petitioners that Agency denied the petition. After careful consideration, EPA found that the petition did not demonstrate federal action is necessary, based in part on the fact that in many of the places where lead exposure among birds may be a problem, states have taken action to regulate the use of fishing tackle containing lead or initiated programs to reduce its use. See the Agency’s response and the Federal Register Notice.

Oil and Gas Exploration and Production Chemicals and Mixtures

Nov. 23, 2011 -- EPA received a petition from Earthjustice and 114 other groups on Aug. 4, 2011, requesting that EPA issue TSCA section 4 and 8 rules requiring toxicity testing and reporting of health and safety studies on oil and gas exploration and production chemicals. Read the petition and EPA's acknowledgement. In responses dated Nov. 2 and Nov. 23, 2011, EPA informed the petitioners that the Agency is not granting the request to require toxicity testing because the petition does not satisfy the required TSCA statutory requirements for additional testing. EPA also notified the petitioners that the Agency is partially granting the TSCA section 8(a) and 8(d) requests and will initiate a dialogue process to seek public input on the design and scope of TSCA reporting requirements. See the Agency's November 2, 2011 response. On Nov 23, 2011, EPA notified the petitioners that the Agency is partially granting the TSCA section 8(a) and 8(d) requests and will initiate a dialogue process to seek public input on the design and scope of TSCA reporting requirements. See the Agency's response. Read the July 11, 2013, Federal Register notice explaining the Agency’s 2011 partial denial of the petition.

On May 9, 2014, EPA issued an Advance Notice of Proposed Rulemaking under section 8 of TSCA which will begin the public participation process and seek public comment on the types of chemical information that could be reported and disclosed under TSCA and the approaches to obtain this information on chemicals and mixtures used in hydraulic fracturing activities. EPA is requesting public comments on the ANPR. The comment period (initially scheduled to close on August 18, 2014) has been extended by Federal Register Notice to September 18, 2014. Read the Federal Register notice.  Read the press release. Learn more about EPA’s efforts related to Natural Gas Extraction and Hydraulic Fracturing.

Lead for Shot, Bullets, and Fishing Sinkers

November 4, 2010 -- EPA has denied the portion of a petition (PDF) requesting a ban on lead in fishing sinkers because the petitioners have not demonstrated that the requested rule is necessary to protect against an unreasonable risk of injury to health or the environment, in light of state regulations and other on-going state and localized activities designed to address the risk concerns identified in the petition. Read the press release.

On August 3, 2010, the American Bird Conservancy, the Association of Avian Veterinarians, and a number of other groups submitted a petition (PDF) to EPA under section 21 of the Toxic Substances Control Act (TSCA) asking EPA to "prohibit the manufacture, processing, and distribution in commerce of lead for shot, bullets, and fishing sinkers." Read EPA's letter acknowledging receipt of the petition (PDF). On August 27, 2010, EPA denied the portion of the petition (PDF) relating to lead in ammunition because the Agency does not have the legal authority to regulate this type of product under TSCA. Read the Federal Register notice.

Cadmium in Consumer Products, Especially Toy Metal Jewelry

January 3, 2013 -- A notice withdrawing the immediate final health and safety data reporting rule was published in the Federal Register on December 28, 2012.

On December 14, 2012, EPA informed the regulated community that the Agency is withdrawing the immediate final health and safety data reporting rule for cadmium due to questions and concerns raised about the scope and extent of the rule that indicate that there is significant confusion and uncertainty within certain industrial sectors concerning the rule. EPA will be considering the questions and concerns raised in response to the immediate final and next steps with regard to this rule. EPA will also continue to work with the Consumer Product Safety Commission (CPSC) to reduce exposure to cadmium in consumer products generally, and especially those consumer products used by or around children, such as children's metal jewelry.

Prior to this, on December 3, 2012, EPA issued an immediate final rule requiring manufacturers and importers of cadmium or cadmium compounds that have been, or are reasonably likely to be, incorporated into consumer products to report unpublished health and safety data to the Agency. Read the rule. The rule was in response to a citizens' petition received in August 2010. On August 30, 2010, EPA granted a petition to use its authority under TSCA section 8(d) to require producers, importers, and processors of cadmium and cadmium compounds that are reasonably likely to be incorporated into consumer products to provide EPA with lists and/or copies of ongoing and completed unpublished health and safety studies relevant to a Consumer Product Safety Commission (CPSC) determination on whether a potential hazard exists and whether a product may be a banned hazardous substance. Petitioners are the Empire State Consumer Project, the Sierra Club, the Center for Environmental Health, and Rochesterians Against the Misuse of Pesticides. They also requested that, working with the CPSC, EPA use its authority under TSCA section 6 to adopt a rule setting limits on cadmium and cadmium compounds in toy metal jewelry. Read  EPA’s response.

Natural Rubber in Tires

On November 19, 2009, EPA received a citizen’s petition that asked it to “establish regulations prohibiting the use and distribution in commerce of Hevea brasiliensis baled natural-rubber for the manufacture of tires. The petition said rubber fails to satisfy The American Society for Testing Materials method ASTM D1076-06 (Category 5),” because: "Implementation of an EPA regulation that guides tire manufacturers to use Hevea brasiliensis baled natural-rubber that satisfies ASTM D1076-06 (Category 5) may affect the incidence of Hevea brasiliensis natural-rubber allergies and allergy induced autism." Read the petition. EPA denied the petitioner’s request on February 16, 2010, as described in a Federal Register notice published on February 22, 2010, (75 FR 7586), for a variety of reasons, including that ASTM D1076-06 (Category 5) did not exist, that it had not been established that natural rubber antigens caused autism, that other federal agencies had evaluated the health risks from Hevea natural rubber latex without prohibiting its use, and that the requirements for a issuing a regulation had not been met. Read EPA’s response.

Lead Dust Hazard Standard and Definition of Lead-based Paint

On August 10, 2009, EPA received a petition requesting the Agency to lower lead dust hazard standards and modify the definition of lead-based paint in its regulations promulgated under sections 401 and 403 of the Toxic Substances Control Act (TSCA). Specifically, petitioners are requesting that EPA:

  • Lower dust lead hazard standards at 40 CFR 745.65(b), 40 CFR 745.227(e)(8)(viii), and 40 CFR 745.227(h)(3)(i) from 40 micrograms of lead per square foot of surface area (µg/ft2) to 10 µg/ft2 or less for floors and from 250 µg/ft2 to 100 µg /ft2 or less for window sills.

  • Modify the definition of lead-based paint in 40 CFR 745.103 and 745.223 for previously applied paint or other surface coatings in housing, child-occupied facilities, public building and commercial buildings to reduce the lead levels from 0.5 percent by weight (5,000 parts per million (ppm)) to 0.06 percent by weight (600 ppm) with a corresponding reduction in the 1.0 milligram per square centimeter standard.

  • The petition was filed by the National Center for Healthy Housing, the Alliance for Healthy Homes, the Sierra Club and others. Read the petition. Read the Federal Register Notice on EPA's receipt of the petition.

On October 22, 2009, EPA responded to the petition, and agreed to revisit the current lead dust hazards standard and to work with the U.S. Department of Housing and Urban Development (HUD) to modify the definition of lead-based paint in its regulations. Read the Agency's response.

Lead Wheel Weights

The Sierra Club, the Ecology Center and others filed the petition on May 29, 2009.

On August 26, 2009, EPA announced that it will grant a petition to initiate regulatory action to address lead hazards associated with the manufacture, processing, and distribution in commerce of lead wheel balancing weights ("wheel weights").

Read the petition. The petition incorporates by reference a similar 2005 petition by the Ecology Center, which was denied. Read EPA's response to the petitioners.

Formaldehyde

On March 24, 2008, EPA received a petition from numerous organizations and individuals asking EPA to regulate formaldehyde in pressed wood products. In response to the review of the petition. EPA has launched a broad effort to gain a greater scientific understanding of the potential health risks of formaldehyde's use in pressed wood products.

Read the petition and the decision in the June 27, 2008, Federal Register (73 FR 36504). Exhibits to the petition and decision can be viewed in the docket (EPA-HQ-OPPT-2008-0267).

Natural Rubber Latex Adhesives

On March 6, 2008, an individual filed a petition with EPA requesting that the Agency "establish regulations prohibiting the use and distribution in commerce of Hevea brasiliensis natural rubber latex adhesives with a total protein content greater than 200 micrograms per [gram] dry weight of latex based on the American Society for Testing Materials method ASTM D1076-06 (Category 4)" in order to reduce "the incidence and prevalence of latex allergy and allergy-induced autism in neonates." EPA denied the petitioner's request in June 2008 as unsupported and unnecessary.

Read the petition. And read the decision in the June 9, 2008, Federal Register. Exhibits can be viewed in the docket (EPA-OPPT-2008-0273).

Air Fresheners

On September 20, 2007, the Sierra Club, the National Center for Healthy Housing, the Alliance for Healthy Homes, and the Natural Resources Defense Council filed a petition with EPA requesting that EPA:

  • Require manufacturers to submit to EPA allegations of adverse reactions related to air freshener products recorded by manufacturers and processors pursuant to TSCA section 8(c) and 40 CFR Part 717;
  • Adopt a rule pursuant to TSCA section 8(d) to require submittal of health and safety studies related to air fresheners;
  • Adopt a rule pursuant to TSCA section 4 to require manufacturers to conduct acute and chronic studies to evaluate the impact of air fresheners on human health; and
  • Adopt a rule pursuant to TSCA section 6 to require that air fresheners be labeled to identify their ingredients.

Read the petition.

On December 18, 2007, in letters to the petitioners, EPA dismissed the petitioners' first request under TSCA section 8(c) because it did not involve a proceeding for a rule, and denied the petitioners' other three requests as unsupported and unnecessary.

Read the decision in the December 21, 2007, Federal Register.

Additional Action Related to Air Fresheners

EPA sent letters to seven companies that produce air fresheners asking them to voluntarily submit certain production and ingredient information to EPA by March 31, 2008. On March 24, 2008, EPA granted the companies a 45 day extension until May 15, 2008. The following responses, submitted by the manufacturers to EPA, are available to the public.