On March 21, 2019,
EPA published the Initiation of
Prioritization under the Toxic Substances Control Act
(TSCA). In the Federal Register notice, the Agency
announced that it is initiating the prioritization process for 20 chemical
substances as candidates for designation as High Priority Substances for risk
evaluation and 20 chemical substances as candidates for designation as Low
Priority Substances for risk evaluation. Under the amended TSCA High Priority Substance
and Low Priority Substance are defined as follows:
- High Priority
Substance.
A chemical substance that EPA
determines, without consideration of costs or other non-risk factors, may
present an unreasonable risk of injury to health or the environment because of
a potential hazard and a potential route of exposure under the conditions of
use, including an unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant by EPA.
- Low Priority
Substance. A chemical that EPA concludes, based on
information sufficient to establish, without consideration of costs or other
non-risk factors, does not meet the statutory criteria for designation as a
High Priority Substance.
The Agency noted
that the initiation of prioritization for a substance as a High Priority
candidate is not a finding of risk by EPA.
To identify
candidates for designation as High Priority Substances, the Agency primarily considered
the TSCA Work Plan Chemicals. EPA then
collected information from reasonably available sources. The Agency evaluated the information across a
number of data elements including hazard, exposure, uses, and physicochemical,
fate, and transport properties. Substances
were then reviewed for data availability across all data elements. EPA also considered chemical similarity,
similar identified functions (e.g., solvents, phthalates, flame retardants),
existing EPA Office
of Pollution Prevention and Toxics (OPPT) work (e.g., experience gained from
the first ten chemicals to undergo risk evaluation) and other information as
identified in available risk assessments (e.g., IRIS, ECHA), and public literature. In addition, the Agency used information such
as the 2016 CDR reported uses and products to inform prioritization. (EPA noted that the Agency’s working approach to selecting candidates for
designation as High Priority Substances for risk evaluation is outlined in the
document, A Working Approach
for Identifying Potential Candidate Chemicals for Prioritization.)
The Agency has
identified the following substances as candidates for designation as High
Priority Substances candidates:
1. 1,3-Butadiene (CASRN 106-99-0)
2. Butyl benzyl phthalate (BBP) (1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl)
ester) (CAS RN 85-68-7)
3. Dibutyl phthalate (DBP)
(1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester) (CAS RN 84-74-2)
4. 1,1-Dichloroethane
(CASRN 75-34-3)
5. 1,2-Dichloroethane (CASRN 107-06-2)
6. 1,2-Dichloropropane (CASRN 78-87-5)
7. Dicyclohexyl phthalate
(1,2-Benzenedicarboxylic acid, 1,2-dicyclohexyl ester) (CASRN 84-61-7)
8. Di-ethylhexyl phthalate (DEHP) (1,2-Benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl)
ester) (CASRN 117-81-7)
9.
Di-isobutyl phthalate (DIBP) (1,2-Benzenedicarboxylic acid,
1,2-bis(2-methylpropyl) ester) (CASRN 84-69-5)
10.
Ethylene
dibromide (Ethane, 1,2-dibromo-) (CASRN 106-93-4)
11.
Formaldehyde
(CASRN 50-00-0)
12. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]
-2-benzopyran (HHCB) (CASRN 1222-05-5)
13.
4,4′-(1-Methylethylidene)bis[2,
6-dibromophenol] (TBBPA) (CASRN 79-94-7)
14.
o-Dichlorobenzene
(Benzene, 1,2-dichloro-) (CASRN 95-50-1)
15. p-Dichlorobenzene
(Benzene, 1,4-dichloro-) (CASRN 106-46-7)
16.
Phosphoric
acid, triphenyl ester (TPP) (CASRN 115-86-6)
17.
Phthalic
anhydride (1,3-Isobenzofurandione) (CASRN 85-44-9)
18.
trans-1,2-
Dichloroethylene (Ethene, 1,2-dichloro-, (1E)-) (CASRN 156-60-5)
19. 1,1,2-Trichloroethane
(CASRN 79-00-5)
20. Tris(2-chloroethyl) phosphate (TCEP) (Ethanol, 2-chloro-, 1,1′,1”-phosphate) (CASRN 115-96-8)
To identify potential Low Priority Substance candidates, EPA started with the over 30,000 chemicals from the April 2018 interim update of the TSCA active inventory. EPA identified potential Low Priority Substance candidates by looking for those that present low-hazard across a range of endpoints. EPA first narrowed the candidate pool to chemicals that had been evaluated by a government body like the US EPA or an Organisation for Economic Co-operation and Development (OECD) member nation. This created a pool of approximately 1,600 potential Low Priority substances. The Agency then filtered the pool of approximately 1,600 chemicals to approximately 200 substances which have discretely defined structures. Substances with discrete structures were selected to increase confidence in the information on hazards. EPA further filtered the chemicals with discrete structures and selected those with the most available data, narrowing the pool to about 75 chemicals with low hazard status among an internationally accepted set of endpoints. The Agency applied a final screen by conducting a literature search to update and verify candidate information for reliability, completeness and consistency. (EPA will make transparent literature search documentation available at the proposal phase for the 20 Low Priority Substance candidates.)
The Agency has
identified the following substances as candidates for designation as Low
Priority Substances candidates:
1.
1-Butanol, 3-methoxy-, 1-acetate (CASRN 4435-53-4)
2.
D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)- (CASRN 31138-65-5)
3. D-Gluconic
acid (CASRN 526-95-4)
4.
D-Gluconic acid, calcium salt (2:1) (CASRN 299-28-5)
5. D-Gluconic
acid, .delta.-lactone (CASRN 90-80-2)
6.
D-Gluconic acid, potassium salt (1:1) (CASRN 299-27-4)
7. D-Gluconic
acid, sodium salt (1:1) (CASRN 527-07-1)
8.
Decanedioic acid, 1,10-dibutyl ester (CASRN 109-43-3
9. 1-Docosanol
(CASRN 661-19-8)
10. 1-Eicosanol
(CASRN 629-96-9)
11.
1,2-Hexanediol
(CASRN 6920-22-5)
12. 1-Octadecanol
(CASRN 112-92-5)
13.
Propanol,
[2-(2-butoxymethylethoxy)methylethoxy]- (CASRN 55934-93-5)
14. Propanedioic
acid, 1,3-diethyl ester (CASRN 105-53-3)
15. Propanedioic
acid, 1,3-dimethyl ester (CASRN 108-59-8)
16. Propanol,
1(or 2)-(2-methoxymethylethoxy)-, acetate (CASRN 88917-22-0)
17. Propanol,
[(1-methyl-1,2-ethanediyl)bis(oxy)]bis- (CASRN 24800-44-0)
18. 2-Propanol,
1,1′-oxybis- (CASRN 110-98-5
19.
Propanol,
oxybis- (CASRN 25265-71-8
20. Tetracosane,
2,6,10,15,19,23-hexamethyl- (CASRN 111-01-3)
EPA is providing a
90-day comment period and requests that interested persons voluntarily submit
relevant information. Relevant information might include, but is not limited
to, information that may inform the screening review (see 40 CFR 702.9(a)).
CAA Permitting and NAAQS Review
/in UncategorizedOn April 9, Verdant attorney Kurt Blase addressed the American Coatings Association Powder Coatings Committee on Powder and PM: Permitting and NAAQS Review. The presentation examined the effect of powder coating lines on facility particulate matter (PM) emissions, and the potential effects of EPA’s current review of the PM national ambient air quality standards (NAAQS) on permitting of powder operations.
It was reported that the addition of powder lines at a facility is likely to increase PM permitting requirements, and that permit conditions are likely to be more stringent for facilities located in airsheds that include other significant PM sources. EPA’s progress to date in the PM NAAQS review was then discussed, including the possibility that the review could result in more stringent standards for PM2.5, PM10 or both. If that were to occur, permitting requirements for powder lines may become more stringent as well. EPA is on a schedule to complete the PM NAAQS review by late 2020.
Green Marketing, the FTC’s “Green Guides,” and “Zero VOC”
/in UncategorizedPhil Moffat presented on Green Marketing, the FTC’s “Green Guides,” and “Zero VOC” at the American Coatings Association’s Conference Making Sustainability Ideas Happen: Coatings For the Future on April 10, 2019.
The presentation opened with an overview of green marketing, noting that the number of environmental marketing claims is on the rise, with an attendant increase in the number of claims that are false and/or deceptive, and that DIY building and construction products are being “greened” more quickly than rest of home and consumer products marketplace.
The Green Guides
Mr. Moffat then discussed the FTC Act and the FTC’s Green Guides. He noted that, section 5 of the FTC Act, 15 U.S.C. § 45, authorizes the FTC to take legal action against “unfair or deceptive” practices in commerce, however the statute doesn’t give FTC the authority to set environmental standards (e.g., testing protocols). He also explained that the FTC published the Green Guides to help advertisers avoid making deceptive claims under Section 5, stressing that the Green Guides are non-binding administrative interpretations. The presentation noted that because the Green Guides are non-binding administrative interpretations, they don’t preempt federal, state, or local law; compliance will not necessarily preclude FTC enforcement of Section 5; and that compliance with voluntary standards won’t guarantee Section 5 compliance.
Mr. Moffat explained that the Green Guides apply to claims about the environmental attributes of a product, package, or service in connection with the marketing, offering for sale, or sale of such item or service to individuals, businesses, or other entities; and that Section 5 applies to environmental claims in any marketing medium, whether asserted directly or by implication. He then reported on principles established by the Guides that focus on avoiding deception: “a representation, omission, or practice is deceptive if it is likely to mislead consumers acting reasonably under the circumstances and is material to consumers’ decisions.”
The presentation also discussed the need to substantiate claims. Marketers must identify all express and implied claims that the advertisement reasonably conveys, and ensure that all reasonable interpretations of their claims are truthful, not misleading, and supported by a reasonable basis. For environmental marketing claims, a “reasonable basis” often requires “competent and reliable scientific evidence.”
The presentation then reviewed a type of claim popular with the building products industry – certifications and seals of approval. Certifications and seals of approval are often “endorsements” covered by the FTC’s Endorsement Guides, 16 CFR Part 255. The presentation noted that third-party certifications and seals of approval are appealing, but stressed that companies must exercise due diligence because third-party certifications and seals are not a safe haven from enforcement or lawsuits.
FTC and “Zero VOC”
Mr. Moffat then reported on FTC Enforcement re Zero VOC Claims pre 2017 – 2018 and post 2017-2018 and noted differences between the two.
In 2017 – 2018 the FTC took enforcement actions against four companies for Zero VOC Claims. The companies were making variety of claims, such as:
The consent agreements that FTC entered into with these companies defined “trace” level of emissions as follows:
“Emission” means any compound that is emitted or produced during application, curing, or exposure of a covered product.
Following the 2017-1018 enforcement actions, the FTC’s position is that:
The presentation noted that the FTC has rescinded the 2013 Enforcement Policy and that the industry should now follow the 2018 Consent Orders and accompanying guidance letters. The guidance letters suggest that compliance for a Zero VOC claim can be achieved if a company can substantiate that:
Mr. Moffat closed the program by stressing that claiming Zero-VOC carries risk. He observed that companies considering such claims should first ensure the return is worth the legal, commercial, and reputational risks, and then develop an approach to manage those risks, including their approach to substantiation, disclosures, etc.
EPA Draft Guidance helps Distinguish When Biostimulants are Pesticides under FIFRA
/in UncategorizedOn March 27, 2019, EPA published Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants. The guidance is intended to help companies that produce products that the Agency considers to make claims that are considered plant growth regulator (PGR) claims. This is because making PGR claims subjects the products to regulation under FIFRA as pesticides. According to EPA, “plant biostimulants” (PBS) are a relatively new category of products containing naturally-occurring substances and microbes that are used to stimulate plant growth, enhance resistance to plant pests, and reduce abiotic stress.
A product makes a PGR claim if, through physiological action, it claims to:
The draft guidance does not provide a definition for “plant biostimulant,” nor does any EPA regulation. The Guidance does provide the following “description” of PBS:
“Generally speaking, a ‘plant biostimulant’ is a naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.”
The Agency is asking for comments on whether EPA should develop a definition for plant biostimulants, noting that the development of a definition would require rulemaking.
At the heart of the issue is whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators by the Agency, and thereby triggering regulation under FIFRA as a pesticide. FIFRA section 2(u) includes plant regulators in its definition of a pesticide.
Based on the plant regulator definition contained in FIFRA section 2(v), EPA believes that many PBS products and substances may be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products.
A key consideration in determining whether or not a product is a pesticide is what claims are being made on product labels. The draft guidance is intended to provide assistance for identifying product label claims that are considered to be plant regulator claims by the Agency, thereby subjecting the products to regulation under FIFRA as pesticides. The guidance provides examples of product label claims generally considered “non-pesticidal:”
The guidance also provides examples of generic product label claims generally considered by the Agency to be “non-pesticidal.” In addition, examples of label claims that are considered by the Agency to be PGR claims that trigger regulation under FIFRA as a pesticide are included. A list of PGR active ingredients contained in EPA-Registered Products is included as well.
The Federal Register notice announcing the guidance notes that as guidance the document is not binding on the Agency or any outside parties, and that the Agency may depart from it where circumstances warrant and without prior notice.
Irene Hantman to Moderate ABA SEER Program — Controversies in Food Contact
/in UncategorizedThe November Safer Chemicals, Healthy Families Food Contact Report Card pointed a spotlight on food contact substances, leaving consumers to wonder whether they should be concerned about the presence of PFAS and other toxic substances in their food packaging. A panel of experts in food contact issues will discuss this issue. The program will also provide background on FDA jurisdiction and key concepts such as TTC (Threshold of Toxicological Concern). Join key stakeholders in this discussion.
This program is presented by thePesticides, Chemical Regulation, and Right-to-Know Committee, ABA Section of Environment, Energy, and Resources; Food, Cosmetics, and Nutrceuticals Committee, ABA Science and Technology Law Section; Food Safety Specialty Section, Society of Toxicology
Date/Time:
Thursday April 25, 2019, 11:30 – 1:00
Panelists:
Paul Honigfort, Director, Division of Food Contact Notifications, Center for Food Safety and Applied Nutrition
Mitch Cheeseman, Steptoe
Tom Neltner, Environmental Defense Fund
Kevin Kenny, Decernis
Moderator:
Irene Hantman, Verdant Law
Location:
Verdant Law, 10 G Street NE, Washington, DC
(Remote participation is also available.)
To register for the program contact Andrew Sitko at admin@verdantlaw.com.
EPA publishes the Initiation of Prioritization under the Toxic Substances Control Act
/in UncategorizedOn March 21, 2019, EPA published the Initiation of Prioritization under the Toxic Substances Control Act (TSCA). In the Federal Register notice, the Agency announced that it is initiating the prioritization process for 20 chemical substances as candidates for designation as High Priority Substances for risk evaluation and 20 chemical substances as candidates for designation as Low Priority Substances for risk evaluation. Under the amended TSCA High Priority Substance and Low Priority Substance are defined as follows:
The Agency noted that the initiation of prioritization for a substance as a High Priority candidate is not a finding of risk by EPA.
To identify candidates for designation as High Priority Substances, the Agency primarily considered the TSCA Work Plan Chemicals. EPA then collected information from reasonably available sources. The Agency evaluated the information across a number of data elements including hazard, exposure, uses, and physicochemical, fate, and transport properties. Substances were then reviewed for data availability across all data elements. EPA also considered chemical similarity, similar identified functions (e.g., solvents, phthalates, flame retardants), existing EPA Office of Pollution Prevention and Toxics (OPPT) work (e.g., experience gained from the first ten chemicals to undergo risk evaluation) and other information as identified in available risk assessments (e.g., IRIS, ECHA), and public literature. In addition, the Agency used information such as the 2016 CDR reported uses and products to inform prioritization. (EPA noted that the Agency’s working approach to selecting candidates for designation as High Priority Substances for risk evaluation is outlined in the document, A Working Approach for Identifying Potential Candidate Chemicals for Prioritization.)
The Agency has identified the following substances as candidates for designation as High Priority Substances candidates:
1. 1,3-Butadiene (CASRN 106-99-0)
2. Butyl benzyl phthalate (BBP) (1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester) (CAS RN 85-68-7)
3. Dibutyl phthalate (DBP) (1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester) (CAS RN 84-74-2)
4. 1,1-Dichloroethane (CASRN 75-34-3)
5. 1,2-Dichloroethane (CASRN 107-06-2)
6. 1,2-Dichloropropane (CASRN 78-87-5)
7. Dicyclohexyl phthalate (1,2-Benzenedicarboxylic acid, 1,2-dicyclohexyl ester) (CASRN 84-61-7)
8. Di-ethylhexyl phthalate (DEHP) (1,2-Benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl) ester) (CASRN 117-81-7)
9. Di-isobutyl phthalate (DIBP) (1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester) (CASRN 84-69-5)
10. Ethylene dibromide (Ethane, 1,2-dibromo-) (CASRN 106-93-4)
11. Formaldehyde (CASRN 50-00-0)
12. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]
-2-benzopyran (HHCB) (CASRN 1222-05-5)
13. 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CASRN 79-94-7)
14. o-Dichlorobenzene (Benzene, 1,2-dichloro-) (CASRN 95-50-1)
15. p-Dichlorobenzene (Benzene, 1,4-dichloro-) (CASRN 106-46-7)
16. Phosphoric acid, triphenyl ester (TPP) (CASRN 115-86-6)
17. Phthalic anhydride (1,3-Isobenzofurandione) (CASRN 85-44-9)
18. trans-1,2- Dichloroethylene (Ethene, 1,2-dichloro-, (1E)-) (CASRN 156-60-5)
19. 1,1,2-Trichloroethane (CASRN 79-00-5)
20. Tris(2-chloroethyl) phosphate (TCEP) (Ethanol, 2-chloro-, 1,1′,1”-phosphate) (CASRN 115-96-8)
To identify potential Low Priority Substance candidates, EPA started with the over 30,000 chemicals from the April 2018 interim update of the TSCA active inventory. EPA identified potential Low Priority Substance candidates by looking for those that present low-hazard across a range of endpoints. EPA first narrowed the candidate pool to chemicals that had been evaluated by a government body like the US EPA or an Organisation for Economic Co-operation and Development (OECD) member nation. This created a pool of approximately 1,600 potential Low Priority substances. The Agency then filtered the pool of approximately 1,600 chemicals to approximately 200 substances which have discretely defined structures. Substances with discrete structures were selected to increase confidence in the information on hazards. EPA further filtered the chemicals with discrete structures and selected those with the most available data, narrowing the pool to about 75 chemicals with low hazard status among an internationally accepted set of endpoints. The Agency applied a final screen by conducting a literature search to update and verify candidate information for reliability, completeness and consistency. (EPA will make transparent literature search documentation available at the proposal phase for the 20 Low Priority Substance candidates.)
The Agency has identified the following substances as candidates for designation as Low Priority Substances candidates:
1. 1-Butanol, 3-methoxy-, 1-acetate (CASRN 4435-53-4)
2. D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)- (CASRN 31138-65-5)
3. D-Gluconic acid (CASRN 526-95-4)
4. D-Gluconic acid, calcium salt (2:1) (CASRN 299-28-5)
5. D-Gluconic acid, .delta.-lactone (CASRN 90-80-2)
6. D-Gluconic acid, potassium salt (1:1) (CASRN 299-27-4)
7. D-Gluconic acid, sodium salt (1:1) (CASRN 527-07-1)
8. Decanedioic acid, 1,10-dibutyl ester (CASRN 109-43-3
9. 1-Docosanol (CASRN 661-19-8)
10. 1-Eicosanol (CASRN 629-96-9)
11. 1,2-Hexanediol (CASRN 6920-22-5)
12. 1-Octadecanol (CASRN 112-92-5)
13. Propanol, [2-(2-butoxymethylethoxy)methylethoxy]- (CASRN 55934-93-5)
14. Propanedioic acid, 1,3-diethyl ester (CASRN 105-53-3)
15. Propanedioic acid, 1,3-dimethyl ester (CASRN 108-59-8)
16. Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate (CASRN 88917-22-0)
17. Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis- (CASRN 24800-44-0)
18. 2-Propanol, 1,1′-oxybis- (CASRN 110-98-5
19. Propanol, oxybis- (CASRN 25265-71-8
20. Tetracosane, 2,6,10,15,19,23-hexamethyl- (CASRN 111-01-3)
EPA is providing a 90-day comment period and requests that interested persons voluntarily submit relevant information. Relevant information might include, but is not limited to, information that may inform the screening review (see 40 CFR 702.9(a)).
EPA Cites Chemours for TSCA Violations
/in UncategorizedOn February 14, 2019, EPA sent a Notice of Violation (NOV) to Chemours identifying TSCA violations at the company’s Fayetteville Works facility in Fayetteville, NC and at the company’s Washington Works facility near Parkersburg, WV. The NOV identifies a number of section 5 violations, including a violation of the TSCA Section 5(e) Consent Order for the manufacture of GenX, a perfluorinated chemical. The violations include:
Chemours was also cited for CDR violations.
The NOV references the July 31, 2018 Compliance Monitoring Inspection Report for Washington Works Facility and the April 24, 2018 Compliance Monitoring Inspection Report for Fayetteville Facility. Those reports explain that EPA became aware of community concerns about the alleged release of potentially harmful chemicals into the Cape Fear River by Chemours’ Fayetteville Works Facility in June 2017. The Agency inspected the Fayetteville facility later that month. The Washington Works facility was inspected as a follow up in October 2017. Both reports discuss the Consent Order. In the Consent Order EPA expressed concerns that the GenX substances (perfluorinated alphatic carboxylic acid and perfluorinated alphatic carboxylic acid, ammonium salt) would persist in the environment, could bioaccumulate, and be toxic (“PBT”) to people, wild mammals and birds.
The Agency’s concerns were based both on data on the GenX substances and on their similarity to perfluorooctanoic acid (“PFOA”) and perfluorooctane sulfonate (“PFOS”). In addition to discharge restrictions, the Consent Order imposed significant worker personnel protective equipment requirements, including that workers who may be exposed via inhalation must wear respirators with a NIOSH Assigned Protection Factor of 3000, and that Chemours must distribute the substances to only those customers that agree to require those respirators. The Consent Order also limited the levels of the GenX substances as residuals in polymers to below 200 ppb.
The NOV noted that EPA continues to investigate and review information concerning the compliance status of these facilities. It reminded the company that the Agency had requested information from Chemours, that it had not yet received, documenting when the company first learned about the GenX-related contamination around the facilities, including GenX contamination in drinking water. The NOV also reminded the company that submission of that information is significant to Chemours’ compliance with the reporting requirements under TSCA Section 8(e) regarding substantial risk information. EPA asked the company to, within 30 days, submit an outline of its action plan and time-frame for coming into compliance with TSCA.
EPA Announces Changes to PMN Review – Clearer Policy on “Possible Future Uses”
/in UncategorizedAt the 2019 GlobalChem conference, Greg Schweer, the EPA Chief of the New Chemicals Management Branch said that the Agency now has a clearer policy to identify possible future uses of new chemical substances in its Premanufacture Notification (PMN) evaluations, reports Bloomberg Environment. The Lautenberg amendments to the Toxic Substances Control Act (TSCA) require EPA to consider “conditions of use” in the review and determination of PMNs The amendments defined conditions of use as “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” Possible future uses is part of the “conditions of use” review.
According to Bloomberg Environment, Schweer also stated that “EPA also may be able to allow more new chemicals [to] enter commerce without placing unwarranted manufacturing or use restrictions on the company that originally requested to produce the new compound.”
When it becomes available, we will post a copy EPA’s new policy on reasonably foreseen uses. In the interim, information about the EPA PMN process is available here.
EPA Releases PFAS Action Plan
/in UncategorizedOn February 14, 2019, EPA released a Per- and Polyfluoroalkyl Substances (PFAS) Action Plan. The Plan identifies both short- and long-term action items the Agency will take to address current PFAS contamination, preventing future contamination, and effectively communicating with the public about PFAS. These action items include:
EPA Proposes Non-Consent-Order SNURs for 13 Chemical Substances
/in TSCAOn October 16, 2018, the Environmental Protection Agency (EPA) issued a proposed rule that would establish Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances for which premanufacture notices (PMNs) have been approved during the two years since the statute was amended. A total of 6 SNURs were proposed for these 13 substances. Unlike other recent SNURs enacted after TSCA was amended, the 13 chemical substances are not also subject to consent orders. Indeed, all previously proposed and final SNURs for PMNs under amended TSCA were for substances for which EPA had previously negotiated orders under TSCA Section 5(e).
The proposed SNURs would require that persons who intend to manufacture (including import) or process any of the 13 chemical substances for an activity that is designated as a significant new use submit a “Significant New Use Notice” to EPA at least 90 days before commencing that activity. And, consistent with the SNUR regulations at 40 CFR § 721.25, the proposed rule states that persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice and decided on the notice, and the person has taken any actions as are required as a result of that determination. Comments on the proposed SNURs are due November 15, 2018.
EPA Announces New CASAC Members, Begins Ozone and PM NAAQS Reviews
/in UncategorizedOn October 10, 2018, EPA issued a press release announcing the new members of the Clean Air Scientific Advisory Committee (CASAC) who will participate in the current reviews of the national ambient air quality standards (NAAQS) for ozone and PM. The press release also expands the description of the Committee’s charge, as previewed in the prior NAAQS reform materials issued by the Administration, to include examination of the relative contribution of background to current ambient concentrations and consideration of the potential social, economic and energy effects of various NAAQS implementation strategies.
The press release also announced the first draft of the Integrated Science Assessment (ISA) for PM, which was released a few days later. The ISA is the comprehensive scientific document on which EPA’s decision whether to revise the current standards must be based. The new draft ISA was announced in the Federal Register on October 23, with a comment deadline of December 11. A CASAC meeting to review the draft ISA has not yet been announced, but the Committee reportedly is considering a meeting to review the draft on December 12-13.
With respect to ozone, the press release announced a series of webinar workshops the agency currently is holding to consider new studies that should be included in the new ISA. Following those a draft integrated review plan will be released for public and CASAC review. (These steps have long been completed for the PM review.) EPA is attempting, on a very short time frame compared to past reviews, to complete both the ozone and PM reviews by the end of 2020.
Separately, EPA announced that the expanded scientific review panels that have assisted CASAC in recent ozone and PM reviews have been disbanded. These review panels, which grew over time to include 12-15 members, acted as consultants to CASAC, but only the seven formal Committee members voted on the final language in advice letters to the Administrators. The large CASAC consultant panels were one of the reasons that reviews in recent years have stretched far beyond the statutorily mandated 5-year period. One principle of the Administration’s NAAQS reform policy is to stay on the review schedule and finish both the PM and ozone reviews by the end of 2020.