Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for
Comments, identified by docket control number OPPTS–50645, must be received on or before March 11, 2002.
Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the
You may be potentially affected by this action if you manufacture (including import), process, or use products that contain living microorganisms subject to jurisdiction under TSCA, especially if you know that your products contain or may contain Bcc. Potentially affected categories and entities may include, but are not limited to:
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table in this unit could also be affected. To determine whether you or your business is affected by this action, you should carefully examine the list of substances excluded by TSCA section (3)(2)(B), and the applicability provisions at 40 CFR 725.105(c) for SNUR related obligations. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
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You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS–50645 in the subject line on the first page of your response.
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Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person identified under
We invite you to provide your views on the various options we propose, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the proposed rule or collection activity.
7. Make sure to submit your comments by the deadline in this document.
8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
This proposed rule would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of Bcc, a group of naturally occurring microorganisms, for any use other than research and development in the degradation of chemicals via injection into subsurface groundwater.
TSCA section 5(a)(2) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” See also, 40 CFR part 725, Subparts L–M. EPA must make this determination by rule after considering all relevant factors, including those listed in section 5(a)(2) of TSCA. Section 5(a)(2) of TSCA lists the following as potentially relevant factors for EPA to consider: (A) the projected volume of manufacturing and processing of a chemical substance, (B) the extent to which a use changes
Once EPA promulgates a rule designating “significant new uses” for a given chemical substance, section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the substance for that use. The mechanism for reporting under this requirement is established under 40 CFR 725.105(c).
EPA has interpreted the TSCA section 3(2) definition of “chemical substance” as authorizing EPA to regulate microorganisms under TSCA. See the
General provisions for SNURs appear under subpart L of 40 CFR part 725. These provisions describe persons subject to the proposed rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the proposed rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters of Microbial Commercial Activity Notices (MCANs) under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the conditions necessary to qualify for the exemptions under TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), as codified in the regulations at 40 CFR part 725. In contrast to the provisions of 40 CFR part 721, under 40 CFR part 725, EPA has adopted a narrow interpretation of the TSCA section 5(h)(3) exemption for small quantities used in research. Under 40 CFR 725.3, EPA has defined small quantities solely for research and development as “quantities of a microorganism manufactured, imported, or processed or proposed to be manufactured, imported, or processed solely for research and development that meet the requirements of § 725.234.” Any other research and development activity of a microorganism subject to a SNUR must comply with the section 5(a)(1)(A) notification requirements unless that activity has been excluded from coverage under the SNUR. See, 40 CFR 725.3, Subparts E and F of 40 CFR part 725, and the
Once EPA receives an MCAN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the MCAN notice. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the
Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707. Persons who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, which are codified at 19 CFR 12.118 through 12.127 and 127.28. Such persons must certify that they are in compliance with SNUR requirements. The EPA policy addressing the import certification appears at 40 CFR part 707.
On July 31, 2001, The Cystic Fibrosis Foundation submitted a petition under section 21 of TSCA which requested EPA to “establish regulations prohibiting the manufacture, processing, distribution in commerce, use, and improper disposal of bacterial species within the
It is well established that when encountered in sufficient numbers through an appropriate route of exposure by a member of a sensitive population, such as a CF patient, Bcc has the potential to cause a severe infection, resulting in significantly increased rates of mortality. There is also the possibility of increased exposure from several potential commercial uses especially for bioremediation where EPA has identified environmental research and development of Bcc that has already occurred. EPA believes that there is currently no general commercial use of Bcc. Therefore, EPA is proposing to designate any use of Bcc other than research and development in the degradation of chemicals via injection into subsurface groundwater as a significant new use.
This proposed rule, when finalized, would require persons, who intend to manufacture, import, or process Bcc for a significant new use to notify EPA, through submission of an MCAN or TSCA Experimental Release Application (TERA), at least 90 days before commencing the manufacture or importation of any of these microorganisms for any use other than research and development in the degradation of chemicals via injection into subsurface groundwater. The required notice would provide EPA with the opportunity to evaluate the intended use, and, if necessary, to prohibit or limit that use before it occurs.
For purposes of this proposed rule EPA is defining Bcc as including all nine species. EPA is also proposing to use the provisional name,
Although
CF patients suffer from a variety of health problems including infection, intestinal obstruction, pancreatic insufficiency, reproductive problems, and malnutrition (Ref. 4). These result in symptoms such as gastrointestinal pain, diarrhea, fatigue, weight loss, and wheezing. These problems are the result of mutations in the CFTR gene (Ref. 5). There have been more than 600 different mutations of this gene documented (Ref. 6). Different mutations have resulted in different phenotypes of the disease. Thus, CF is not an “all or none” disease, and the spectrum of CF disease can vary from very mild to very severe (Ref. 7).
Bacterial colonization and associated inflammation are the major causes of morbidity and mortality in patients with CF (Ref. 3). Surprisingly, the spectrum of bacteria that are routinely isolated from CF sputum is narrow (Ref. 3). Characteristically, infant CF patients are infected with
Although
The virulence factors that allow
Ascertaining the virulence factors important for
Ascertaining the virulence factors important for
The therapy for
Studies suggest that Bcc microorganisms may be useful in a variety of TSCA applications, including bioremediation (degradation of toxic chemicals, as well as degradation of grease in drains), turf management, and specialty chemicals production. In order to gauge the scope of commercial use of Bcc, EPA conducted a survey of over
No companies indicated that Bcc was currently used for the degradation of grease (typically in drain cleaners) or for turf management (typically in thatch reduction), although researchers and firms cautioned that even the companies that produce such products may be unaware of the presence of Bcc.
One respondent indicated that lipases harvested from Bcc are used in the production of specialty chemicals. One company web site lists seven lipases derived from Bcc species available for sale under their brand names. However, when this company was contacted, it indicated that it imports the lipases from an overseas firm and does not work with Bcc microorganisms. No more information was available.
Many respondents indicated a knowledge of Bcc and its possible applications, but very few had any knowledge that it was actually being used. Some contacts indicated that Bcc's potential for opportunistic pathogenicity had led them to disregard it for use in their products. Thus, the information available to EPA indicates that the only existing TSCA use of Bcc in the U.S. are the demonstration studies of its effectiveness in degrading chlorinated solvents in groundwater. EPA considers these studies to fall under the description of research and development (Ref. 15).
Bcc is a naturally occurring microorganism which is found in a wide range of habitats but especially in high populations in the soil. While Bcc is not known to be in general commercial use at this time, the potential uses identified could give rise to exposures in different ways. To produce microorganisms on a commercial scale, they first are cultured in large commercial fermentation facilities to obtain adequate amounts for a potential use. If used for specialty chemical manufacture the microorganisms are cultured first then killed after harvesting the chemical substance to be manufactured. EPA has identified potential dermal and inhalation exposures as well as environmental release from manufacture of microorganisms. These exposures could occur for any potential use of microorganisms. Sources of potential environmental release include exhaust gas from the fermentor and wastes from cleanup of equipment. Potential exposures result from laboratory propogation of cells, sampling, equipment cleaning/maintenance, and from cell recovery. Estimates of potential inhalation exposure were derived from area monitoring data in fermentation facilities. Estimates of potential dermal exposure were derived from laboratory experiments involving liquids which measured the retention on the hands for various types of exposures.
In addition to exposure from fermentation, there is also potential for dermal and inhalation exposures as well as environmental release from uses in bioremediation, turf builders, and drain cleaners. The primary source of potential release and dermal exposure is from the intended injection or application of the material. Application of turf builders would be spray applications resulting in increased inhalation exposures. Other release sources include air releases from off-gassing of aerated shipping containers and residue left in the shipping containers. Exposure to bioaerosols may occur from the aerated shipping containers. Although there is no evidence that Bcc specifically is used in the turf building or drain cleaning applications, there are commercially available products that contain microbials. (Ref. 16)
In determining what would constitute a significant new use for the microorganisms that are the subject of this proposed SNUR, EPA considered relevant information on the toxicity of the microorganisms, likely exposures associated with potential uses, information provided by industry sources, and the relevant factors listed in TSCA section 5(a)(2) and Unit II.B. of this document. Based on these considerations, EPA has determined that all uses other than research and development in the degradation of chemicals via injection into subsurface groundwater, are significant new uses.
EPA's considerations under each of the relevant factors are discussed below:
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EPA expects only limited exposures from the identified field studies of Bcc as only technically qualified individuals are growing and injecting Bcc directly into groundwater. The potential uses identified in Unit IV.C. of this document, which include bioremediation (degradation of toxic chemicals, as well as degradation of grease in drains), turf management, and specialty chemicals production, could significantly increase dermal and inhalation exposures of Bcc to humans. In some cases these exposures could be higher than typically found in nature and more likely to be encountered by a member of a sensitive population. These exposures would significantly increase the type, form, magnitude, and duration of exposures to human beings from known uses of Bcc.
EPA wants to achieve the following objectives with regard to the significant new uses that are designated in this proposed rule. EPA wants to ensure that:
1. EPA will receive notice of any company's intent to manufacture, import, or process Bcc for a significant new use before that activity begins.
2. EPA will have an opportunity to review and evaluate data submitted in an MCAN before the notice submitter begins manufacturing, importing, or processing Bcc for a significant new use.
3. EPA would be able to regulate prospective manufacturers, importers, or processors of Bcc before a significant new use occurs, provided such regulation is warranted pursuant to TSCA section 5(e) or section (f).
Before proposing this SNUR, EPA considered the following alternative regulatory actions for Bcc. In addition, EPA determined that Bcc is currently not subject to Federal notification requirements.
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EPA recognizes that section 5 of TSCA does not require the development of any particular test data before submission of a MCAN or TERA. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 725.160).
However, in view of the potential health risks posed by the significant new uses of Bcc, EPA requests that potential MCAN or TERA submitters include data that would permit a reasoned evaluation of risks posed by Bcc when used for an intended significant new use. EPA also requests that potential MCAN or TERA submitters include data that demonstrate that the bacteria which would be the subject of the MCAN or TERA are in fact in the Bcc. EPA encourages persons to consult with the Agency before submitting an MCAN or TERA for Bcc. As part of this optional pre-notice consultation, EPA will discuss specific data it believes are necessary to evaluate a significant new use of Bcc. EPA urges MCAN or TERA submitters to provide detailed information on human and environmental exposures that would result or could reasonably be anticipated to result from the significant new uses of Bcc. In addition, EPA encourages persons to submit information on risks posed by Bcc compared to risks posed by possible substitutes. An MCAN or TERA submitted without sufficient data to reasonably evaluate risks posed by a significant new use of Bcc may increase the likelihood that EPA will take action under TSCA section 5(e).
EPA believes that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the proposal date of the SNUR, rather than as of the effective date of the final rule. If uses begun after publication of the proposed SNUR were considered to be ongoing, rather than new, it would be difficult for EPA to establish notification requirements, because any person could defeat the SNUR by initiating the proposed significant new use before the proposed rule became final, and then argue that the use was ongoing.
Persons who begin commercial manufacture, import, or processing of Bcc, for the significant new use in this proposed SNUR, after the proposal has been published must stop that activity before the effective date of the final rule. To resume commercial manufacture, import or processing of Bcc, those persons will have to meet all applicable MCAN or TERA requirements and wait until the notice review period, including all extensions, expires before engaging in any commercial manufacture, import, or processing of Bcc for a significant new use. If, however, persons who begin commercial manufacture or import of Bcc for a significant new use between the proposal and the effective date of the final SNUR meet the conditions of advance compliance as codified at 40 CFR 725.912, those persons would be considered to have met the requirements of the final SNUR for those activities.
EPA has evaluated the potential costs of establishing a SNUR for potential manufacturers, importers, and processors of Bcc. These potential costs are related to the submission of MCANs, TERAs, and the export notification requirements of TSCA section 12(b). EPA notes that, the costs of submission of MCANs or TERAs will not be incurred by any company unless that company decides to pursue a significant new use as defined in this proposed SNUR.
Because of uncertainties related to predicting the number of MCANs or TERAs that will be submitted as a result of this proposed SNUR, EPA is unable to calculate the total annual cost of compliance with the final rule. However, EPA estimates that the cost for preparation and submission of an MCAN ranges from approximately $7,582 to $42,736, which includes the $2,500 user fee required by the Agency. EPA notes that small businesses with annual sales of less than $40 million are subject to a reduced user fee of $100. The cost of a TERA is estimated to range from $6,905 to $73,562 (Ref. 17).
Based on past experience with SNURs and the low number of Significant New Use Notices (SNUNs) which are submitted on an annual basis, EPA believes that there would be few, if any, MCANs or TERAs submitted as a result of this SNUR. Furthermore, no company is required to submit an MCAN or TERA for Bcc unless the company decides to
As noted in Unit II.C. of this document, persons who intend to export a microorganism identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)). These provisions require that a company notify EPA of the first shipment to a particular country of an affected microorganism. The estimated cost of the TSCA section 12(b)(1) export notification, which would be required for the first export to a particular country of a microorganism subject to this proposed rule, is estimated to be $158.35 for the first time that an exporter must comply with TSCA section 12(b)(1) export notification requirements, and $14.43 for each subsequent export notification submitted by that exporter (Ref. 17).
EPA is unable to estimate the total number of TSCA section 12(b) notifications that will be received as a result of this proposed SNUR, or the total number of companies that will file these notices. However, EPA expects that the total cost of complying with the export notification provisions of TSCA section 12(b) will be limited based on historical experience with TSCA section 12(b) notifications and the fact that no companies have currently been identified that currently market Bcc commercially. If companies were to manufacture the microorganisms covered by this proposed SNUR for export only, these companies would incur costs associated with export notification even if these companies decided to forgo any domestic significant new use. EPA is not aware of any companies in this situation, and expects that any potential impact would be limited to the small burden of export notification.
These references have been placed in the official record that was established under docket control number OPPTS–50645 for this document as indicated in Unit I.B.2. of this document.
1. Risk Assessment for TSCA Section 21 Petition on Bacteria in the
2. Mohr, C.D., Tomich, M., and Herfst, C.A., Microbes and Infection, 3, 2001, 425.
3. Hutchison, M. L., and Govan, J. R. W, Microbes and Infection, 1, 1999, 1005.
4. Buchwald, M.., Clin Invest Med 1996; 19 (5): 304.
5. Mickle, JE.and Cutting, G.G., Clin.Chest Med. 19, 1998, 443.
6. do Pico, Guillermo A., http://www.chestnet.org/education/pccu/vol12/lesson20.html
7. Bush, A., and Wallis, C., Ped. Pulmonology 30, 2000, 139.
8. Davies, S.S., Advanced Drug Delivery Reviews 51, 2001, 21.
9. FIFRA SAP Report # 99–04, Sept. 30, 1999.
10. Geiszt, M., Kapus, A., and Legeti, E., J. Leukocyte Biology 69, 2001, 191.
11. Parke, J. L., Gurian-Sherman, D., Ann. Rev. Phytopath. 39, 2001, 225.
12. FIFRA SAP report (1999). Risk Assessment of
13. Speert, D. P., Infect. Med., 18, 2001,49.
14. Parke, J.J., The Plant Health Instructor, 10, 2000, 1094.
15. Commercial Uses of
16. Assessment of Potential Worker Exposure and Environmental Releases From Commercial Uses of
17. Economic Analysis to Support the Proposed SNUR for
Under Executive Order 12866, entitled
Based on EPA's experience with proposing and finalizing SNURs, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As such, EPA has determined that this regulatory action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4).
This proposed rule does not have tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled
In issuing this proposed rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled
EPA has complied with Executive Order 12630, entitled
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled
This action is not subject to Executive Order 13045, entitled
In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. 104–113, section
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070–0012 (EPA ICR No. 1188.06). This action does not impose any burden requiring additional OMB approval. If an entity were to submit an MCAN or TERA to the Agency, the annual burden is estimated to average between 98.96 and 118.92 hours per response at an estimated reporting cost between $5,957 and $7,192 per MCAN. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review and submit the required MCAN or TERA. This burden estimate does not include the $2,500 user fee submission of an MCAN ($100 for businesses with less than $40 million in annual sales).
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, OP Regulatory Information Division (2137), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
This proposed rule is not subject to Executive Order 13211, “
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
15 U.S.C. 2604, 2607, 2613, and 2625.
(a)
(2) The significant new use is any use other than research and development in the degradation of chemicals via injection into subsurface groundwater.
(b) [Reserved]