COMMENTS ON PROPOSED AMENDMENTS TO
THE TSCA INVENTORY UPDATE REPORTING RULE

The Society of the Plastics Industry, Inc. ("SPI" or "Society") is pleased to provide the following comments on the U.S. Environmental Protection Agency’s ("EPA" or "Agency") proposal to amend the Toxic Substances Control Act (TSCA) (15 U.S.C. § 2601 et seq.) Inventory Update Rule (IUR). 64 Fed. Reg. 46,772 (August 26, 1999) (OPPTS-82053). Many SPI members are subject to IUR and will be directly or indirectly impacted by the rule as proposed. Thus, SPI and its members have a direct and substantial interest in this rulemaking.

While SPI believes that EPA’s proposal to reduce the burdens of the existing IUR rule is appropriate, the Society has concerns regarding a number of issues associated with the proposal that may significantly impact both SPI and the regulated community as a whole. Many, but not all, SPI members manufacture polymers, which are largely exempt from IUR under the existing rule as well as the proposal. SPI supports this exemption. In addition, many but not all SPI members "process" but do not manufacture or import reportable chemical substances. Neither the existing rule nor the proposal impose any reporting requirements on processors, per se. Thus, many SPI members will not be directly impacted by the rule as proposed.

However, many SPI members do manufacture and import reportable substances and will be subject to the proposal by virtue of such activities. In addition, many SPI members would be indirectly impacted by the rule as proposed due to the requirement that certain manufacturers and importers provide downstream exposure and use information. EPA has failed to adequately consider the logistics of and issues related to the collection of proposed downstream exposure and use information. SPI also believes if the rule were finalized as proposed, the information that would be submitted to EPA would have little or no meaning, and would quickly overwhelm the Agency’s limited resources for processing the information received.

SPI’s principal comments can be summarized as follows:

• Instead of utilizing expanded IUR reporting to obtain information, EPA should better evaluate, manage, and use existing data submitted to it and other federal agencies

• EPA could not effectively process or use the considerable amount of information that would be generated under the rule as amended

• Proposed section 710.32(c)(4)(i) should be revised to clarify the duty of manufacturers and importers to obtain industrial process and use information from processors and users and the reciprocal obligation of processors and users to provide information to reporters

• Proposed section 710.32(c)(4)(i) should be revised to clarify that information regarding industrial processing and use at sites from which reportable substances are indirectly received from manufacturers and importers (other than through brokers and distributors) is not "readily obtainable" for purposes of the rule

• The proposed definition of "reasonably likely to be exposed" and the proposed corresponding requirements to report information on persons reasonably likely to be exposed to reportable substances must be revised to clarify the frequency, duration, and level of exposure required and to reflect the fact that many exposures involve persons wearing personal protective equipment

• The reporting exemption for inorganic substances should be retained

• The proposal fails to meet the standards of section 8 of TSCA and the Paperwork Reduction Act

• The additional CBI substantiation and resubstantiation requirements are overly burdensome and ultra vires

II. COMMENTS

A. Instead of Utilizing Expanded IUR Reporting to Obtain Information, EPA Should Better Evaluate, Manage, and Use Existing Data Submitted to it and Other Federal Agencies

EPA indicates that it is proposing to amend the IUR rule for three primary reasons: (1) to tailor chemical reporting requirements to more closely match the Agency’s overall information needs; (2) to obtain new and updated information relating to potential exposures to a subset of substances listed on the TSCA Inventory; and (3) to improve the utility of the information reported. EPA proposes to achieve these goals by substantially expanding the existing reporting requirement, and, thereby, greatly increasing the amount of industry and Agency resources that must be committed to generating and processing the requested data.

A viable alternative to the proposal is to rely more heavily on existing data sources, including publicly available databases and voluntary arrangements with manufacturers and downstream users. Instead of requiring manufacturers and importers to report use and exposure information (some of which they may not have), EPA can obtain reliable use and exposure related data more efficiently, and at substantially less cost, by using existing data sources.

EPA already has a large body of exposure-related data on many chemicals. Data sources include the TSCA Preliminary Assessment Information Reporting (PAIR), TSCA Comprehensive Assessment Information Reporting (CAIR), the Use and Exposure Information Project (UEIP), the Use Cluster Scoring System (UCSS), the Toxics Release Inventory (TRI), the Biennial Reporting System (BRS), and the Screening Information Data Set (SIDS).

The Chemical Manufacturers Association (CMA) has expended considerable efforts on and has provided EPA with a significant amount of data related to this issue. For example, in 1997, CMA provided EPA with a review of the publicly-available data sources on chemical use and exposure that supplement the data EPA already has collected. In addition, in an attempt to address EPA’s screening requirement data needs, CMA initiated a second study that undertook a structured data search of five chemicals. These studies show that there exist alternatives to an expanded IUR that will satisfy EPA’s perceived data needs.

Consistent with CMA’s findings and recommendations, SPI strongly recommends that EPA reconsider the extent to which better use and management of publicly available data obviates the need for such a significant expansion of the IUR rule. SPI agrees with CMA in that in many cases available data are more extensive than what would be reported under the proposal. Where existing data are found to be inadequate, EPA could use the PAIR rule or other section 8(a) authority to obtain chemical-specific data.

B. EPA Could Not Effectively Process or Use the Considerable Amount of Information That Would Be Generated Under the Rule as Amended

Experience shows that EPA could not begin to make effective and timely use of even a small portion of the processing/use information that the proposed rule would require to be reported in a relatively short timeframe on more than 4,000 chemicals. Yet, as EPA acknowledges, its "ability to utilize [the] information" is critical to realizing any benefits from the proposed Amendments. EPA does not explain how its programs and resources would be able to analyze and use the vast amount of information that would be required to be reported under the rule in a meaningful timeframe.

EPA has not made effective use of the exposure-related data it has already collected under existing or former rules. For example, data collected under two other TSCA rules — the PAIR and CAIR rule — have not been effectively used to support Agency risk assessment or risk management decisions. SPI also notes that under the voluntary Use and Exposure Information Project (UEIP), EPA was furnished exposure-related data on 60 HPV chemicals, but only two made it into the RM-1 process. As another example, although available for over 15 years, National Occupational Exposure Survey (NOES) data on employee exposures have never been used effectively for risk screening or priority setting.

Given this history, EPA would appear to have little chance of making timely use of the volumes of use and exposure data that would have to be reported and collected every four years under the rule as proposed. This would appear to be a legitimate concern given that EPA projects its costs under the reporting program would only be $525,000 in the first reporting year and $275,000 in subsequent reporting years. How EPA plans to utilize this data, given the paltry funds it plans to devote to the program, is far from clear. Also, as discussed below, much of the additional information required to be reported under the proposal would be meaningless.

C. Proposed Section 710.32(c)(4)(i) Should Be Revised to Clarify the Duty of Manufacturers and Importers to Obtain Industrial Process and Use Information from Processors and Users and the Reciprocal Obligation of Processors and Users to Provide Information to Reporters

As EPA indicates in the proposal, companies that "process" or "use" IUR reportable substances are subject to neither the existing nor proposed IUR rule, per se. That is, they are not required to submit Form U’s. However, SPI has significant concern that if finalized as proposed, the rule would indirectly and improperly subject processors and users to the rule and its burdens.

Proposed section 710.32(c)(4) requires that persons who manufacture or import a reportable substance in an amount greater than or equal to 300,000 pounds at any one site during a designated calendar year must report industrial processing and use information both for each reportable substance at sites under their control "and at sites that receive a reportable chemical substance from the submitter directly or indirectly (including through a broker/distributor, from a customer of the submitter, etc.)." The only apparent limitation to this requirement is that "[i]nformation regarding processing or use activities occurring at sites not under the control of the submitter must be reported only to the extent that it is readily obtainable by the submitter." EPA has clarified neither the duty of the manufacturer or importer to contact the downstream customer to obtain such information nor the obligation of the customer to provide such information to the manufacturer or importer. As discussed below, EPA must clarify these issues.

1. Reporter’s duty to obtain information

Although EPA defines the phrase "readily obtainable information" in the proposal, the definition is not useful in the context of the duty to obtain exposure and use information from downstream customers under proposed section 710.32(c)(4). EPA proposes to define the phrase "readily obtainable information" as follows:

information which is known by management and supervisory employees of the submitter company who are associated with research, development, distribution, technical services, or marketing of the reportable chemical substance. Extensive file searches are not required.

64 Fed. Reg. at 46,803 (proposed section 710.2(d)).

This definition may be helpful in clarifying the duty of a manufacturer or importer to obtain information regarding the reporter’s own site, but provides no guidance whatsoever as to the scope of the obligation to obtain information regarding downstream customer exposure and use information. For example, if no process/use information regarding the downstream customer site(s) is known "by management and supervisory employees" of the submitter, would the submitter be correct in concluding that no information about the site(s) is "readily obtainable"?

EPA must describe in specific terms the actions a manufacturer or importer must or need not take in order to satisfy the proposed "readily obtainable" standard. For example, consistent with the proposed definition of "readily obtainable information," in the context of obtaining information from customers, EPA should make clear that only such information that is already known to the management and supervisory employees of the manufacturer or importer about customer sites must be reported.

Moreover, SPI is concerned that under the proposal the submitter is required to provide estimates for information that is not readily obtainable. Specifically, under proposed section 710.32(c)(4)(i), EPA specifies that if the required information is not readily obtainable, the submitter

shall provide estimates, using the submitter’s best professional judgment, based upon the submitter’s past experience for similar chemical substances in the same or similar markets, and/or any reasonable projections of likely processing and use scenarios for the chemical substance.

64 Fed. Reg. at 46,809.

Although SPI agrees that in many instances providing such estimates would obviate the need for EPA to make overly conservative worst-case assumptions about exposure and use of reportable chemicals at processing and use sites, SPI is troubled by the fact that reporters are required to provide estimates in the absence of readily obtainable information and are required to certify that to the best of the reporter’s knowledge and belief the information provided in the Form U is complete and accurate. If it is later discovered that the estimates were far from accurate, there is an implicit data burden to document the basis for believing that the reported data were reasonable estimates at the time they were made.

Other statutes require estimates in the absence of data. For example, section 313 of the Emergency Planning and Community Right-To-Know Act (EPCRA) specifies that where release data are not readily available, "reasonable estimates" must be made. However, these "reasonable estimates" relate to activities under the control of the reporter. Here, EPA proposes that estimates be made regarding activities occurring at other sites. These data would be of limited accuracy, at best. It is in the best interests of all concerned to limit the data reported under the IUR to data that is known, accurate, and which can be substantiated.

2. Customer’s duty to provide information

As is the case with respect to the duty of a manufacturer or importer to obtain information from downstream customers, the duty of customers to provide data to manufacturers and importers is unclear and, for a number of reasons, problematic.

EPA should first clarify the legal duty of a customer/processor to provide such information. SPI does not dispute EPA’s authority under section 8 to require manufacturers, importers and processors of chemical substances to report a wide variety of data, including the exposure-related information that would be reported under the proposal. In addition, SPI recognizes that many companies may have no objection to providing such information to assist EPA in administering TSCA and as a matter of good product stewardship and corporate environmental citizenship. However, EPA should make clear in the rule that a processor has no legal duty to provide such information to manufacturers and importers under this rule, particularly because to do so may involve additional resources and costs.

Although SPI suspects that some processors would voluntarily provide processing and use information to their suppliers upon request, SPI suspects that most would not. Even if this information is not proprietary to the processor company, per se, disclosure of this information to a supplier may allow a supplier to obtain sensitive information about the customer’s business, other customers’ businesses, and the relationship between the two. Furthermore, armed with such knowledge, it is in the supplier’s interest to induce others to purchase the substance for the same purpose, thereby assisting others to compete against the original data submitter. EPA proposes safeguards for the protection of confidential business information (CBI) submitted under the rule, but no safeguards are provided for information contained in these types of communications, which occur between suppliers and customers and not between the submitter and EPA. Indeed, if the rule were finalized as proposed SPI believes that confidentiality issues would be the principal reason that customers would be reluctant to provide information to suppliers.

Some of the issues discussed in this section of these comments may have been considered by EPA in the developing the proposal. Indeed, it is interesting to note that EPA considered some of these types of issues some twenty years ago, when it proposed to require that persons submitting premanufacture notices (PMN) under section 5 of TSCA submit a "Processing and Consumer Use Form" to certain persons prior to submitting a PMN. With respect to this proposal, EPA noted that

the persons contacted would have no legal obligation to respond to these requests for information . . . however, EPA . . . could make worst-case assumptions about possible exposures associated with processing and use, and initiate control actions based on such assumptions. Therefore those contacted may decide that it is in their best interest to provide the information . . . because much of the information requested may be confidential, the proposed rules authorize persons contacted to respond directly to EPA and to make claims of confidentiality for any information submitted. Further, the rules and forms would require [the PMN submitter] to tell all persons whom [the PMN submitter] contacts that they are not legally obligated to respond, and that they may report either to the submitter or directly to EPA.

44 Fed. Reg. at 2,251.

In the final PMN rule, however, EPA declined to adopt this requirement. EPA also eliminated the proposed requirement that submitters report the number of customers intending to use the new chemical substance in ways not known to the submitter and to report the percentage of production volume allocated to those customers during the first three years of production. EPA eliminated mandatory customer contact because "information from processors and other customers often is not necessary for substances that do not undergo detailed review." It would seem that the same rationale should hold true today, viz., if needed or desired by EPA, detailed chemical processing information should only be required for a targeted set of substances.

D. Proposed Section 710.32(c)(4)(i) Should Be Revised to Clarify That Information Regarding Industrial Processing and Use at Sites from Which Reportable Substances Are Indirectly Received from Manufacturers and Importers Is Not "Readily Obtainable" for Purposes of the Rule

EPA recognizes that under the proposal there is a possibility of "double-counting" processing and use sites and the numbers of workers at these sites. EPA provides an example in which two or more submitters manufacture the same reportable substance and each ships the chemical substance to the same processing or use site. EPA, however, believes that these issues are not significant, and, for example, with respect to double counting the number of workers, states:

Because EPA is proposing that the number of workers be reported through the use of broad ranges, EPA believes the impact of double-counting workers will not significantly affect the use of the estimates for risk screening purposes. In addition, it will be possible to estimate the maximum potential magnitude of double counted workers at processing and use sites because the total number of manufacturers (including importers) will be known to EPA.

64 Fed. Reg. at 46,791.

SPI disagrees with EPA and believes that the potential multiple counting issue is significant. SPI also fails to understand how knowing the total number of manufacturers and importers will allow EPA to estimate the magnitude of double-counting of process and use sites or the number of exposed employees at these sites.

A simple hypothetical illustrates this point. Assume that 10 manufacturers produce a reportable substance at three sites each. Each site manufactures over 300,000 pounds per year, and all 30 of these sites supply a single processor (admittedly an unlikely situation) who has 50 "exposed" workers.

Under this hypothetical, EPA would receive 30 Form U’s for the substance. Each of the Form U’s would indicate that "less than 10" sites receive the substance from the reporter and that 100% of the site’s production volume of the substance is being supplied to the indicated NAICS code and industrial function category for that single site. Given EPA’s proposed ranges for reporting number of sites and number of exposed workers per site, upon review of the 30 Form U’s for this substance, EPA could reasonably conclude that 30 {30 x 1} to 270 {30 x 9} sites processed the substance, when, in fact, the substance was processed at only one site. This "double counting" is further exaggerated because EPA could also reasonably conclude that the number of exposed workers was between 1,500 {30 sites x 50 workers} and 26,730 {270 sites x 99 workers}, when, in fact, 50 workers were exposed. Thus, under this hypothetical, the "double counting" problem could exaggerate the number of exposed workers by a factor of over 500.

This problem is exacerbated by the fact that under the proposal reporting would be required for sites that indirectly receive the substance from the submitter. EPA specifically contemplates submitters reporting information relating to sites who receive the substance from customers of the submitter. In other words, under the proposal, EPA appears to be requiring submission of processing and use data from sites that exist at any distance down the supply chain. To avoid at least some of the multiple-counting issues described above, and to avoid confusion and burden to both industry and EPA, if EPA wishes to require process and use information regarding customer sites, this requirement should extend only to the immediate customer(s) of the reporter. Requiring data from customers further downstream will only further reduce the quality of the obtained data and promote confusion.

E. The Proposed Definition of "Reasonably Likely to Be Exposed" and the Proposed Corresponding Requirements to Report Information on Persons Reasonably Likely to Be Exposed to Reportable Substances Must Be Revised

1. EPA Must Clarify the Frequency, Duration, and Level of Exposure Needed to Fall Within this Definition

SPI agrees, in part, with EPA’s proposed definition of "reasonably likely to be exposed." Under the proposal, this phrase is defined to mean

an exposure to a chemical substance which, under foreseeable conditions of manufacture (including import), processing, distribution in commerce, or use of the chemical substance, is more likely to occur than not to occur. Such exposures would normally include, but not be limited to, activities such as charging reactor vessels, drumming, bulk loading, cleaning equipment, maintenance operations, materials handling, and transfers, and analytical operations. Covered exposures include exposures through any route of entry (inhalation, ingestion, skin contact, absorption, etc.), but excludes accidental or theoretical exposures.

64 Fed. Reg. at 46,803 (proposed section 710.2(d)).

SPI agrees with EPA’s decision to reject the OSHA hazard communication standard’s (29 C.F.R. § 1910.1200) definition of exposed worker, which SPI agrees is overly broad. However, SPI believes several aspects of this definition require clarification.

First, while under the proposed definition the exposure must be more likely to occur than not, the rule is silent as to the level of exposure to a substance (e.g., workplace air concentration) that would cause a worker to be "reasonably likely to be exposed." EPA provides examples of operations that would give rise to exposure (e.g., drumming), but provides no examples of activities that do not. At some level, all persons are exposed to all chemicals present in the ambient and workplace environment, most, if not all, of the time. EPA should establish a de minimis concentration or other criteria under which a person is not deemed to be reasonably likely to be exposed.

Second, some minimum frequency and duration of exposure should be included in the definition. Current Agency risk assessment procedures are typically based on overall daily exposure levels and tend to emphasize effects resulting from continuous exposure over a person’s or worker’s lifetime or workplace lifetime. EPA recognizes that exposures are more likely to be experienced as bursts or spikes, or intermittent exposures of varying levels. Indeed, EPA recently made a report on this topic available to the public. These concepts should be incorporated into the proposed definition of "reasonably likely to be exposed."

2. The Reporting Requirement Should Reflect the Fact That Many Exposures Involve Persons Routinely Required To Wear Personal Protective Equipment

EPA states that the use of protective equipment or engineering controls to minimize worker exposures cannot be used by submitters as a rationale for lowering their estimates of the total number of exposed workers. In contrast, the TSCA PMN Form requests information on the number of workers exposed to the reported substance but also requests information regarding personal protective equipment and engineering controls to reduce exposure to the substance. While SPI does not advocate requiring that such information be requested in the Form U, it believes that the number of workers "reasonably likely to be exposed" should reflect the fact that many exposures involve persons routinely required to wear personal protective equipment.

F. The Reporting Exemption for Inorganic Substances Should Be Retained

Beyond reiterating its assertion that exposure information is needed for every chemical regardless of hazard potential, EPA provides almost no support for its proposal to require reporting for inorganics. As EPA itself states, the hazard potential of most inorganic chemicals is "relatively well-established." The only stated basis for eliminating the inorganics exclusion is reference to a report that some new materials containing asbestos have "unknowingly" been incorporated into buildings.

As with organic chemicals, use information and exposure-related data are also available for most inorganic chemicals through publicly-available means. Thus, SPI believes that available data on inorganic chemicals should be adequate to perform risk screening and priority setting.

For many inorganic substances, information on the average and maximum concentration as the substance leaves the manufacturing/importing site or as present in a consumer or commercial end-use product would be meaningless in assessing potential exposures. Some inorganics are manufactured or imported in solid, monolithic, form and are shipped in this form from the site of manufacture or import. In such cases, although the concentration of the inorganic substance will be close to 100 percent, the information is of little use in assessing potential exposures. Eliminating the existing inorganic exemption will simply add to the burden of the IUR rule with little benefit.

G. The Proposal Fails to Meet the Standards of Section 8 of TSCA and the Paperwork Reduction Act

As discussed above, SPI strongly believes that EPA would be unable to effectively use the data reported under the rule as proposed. For this reason, and because exposure-related information on existing chemicals can be obtained without such a dramatic expansion of the rule, the proposed amendments are not "necessary for the effective enforcement" of TSCA, and cannot "reasonably [be] require[d]" by the Administrator, as required by section 8.

While EPA is empowered to obtain use and exposure information for risk screening and priority setting under TSCA, EPA indicates in the preamble that the proposed amendments are also intended to provide "right-to-know" information to non-governmental entities and private organizations. Such a broad "right to know" objective is not within EPA’s information-gathering authority under TSCA, but instead falls solely within EPA’s jurisdiction under Emergency Planning and Community Right to Know Act (EPCRA).

Section 8(a) provides EPA authority to require reporting by manufacturers or processors of such information as the Agency "may reasonably require." This provision further directs EPA not to require "any reporting which is unnecessary or duplicative." These requirements necessarily limit reporting under section 8(a) to information that EPA needs to perform its specified responsibilities under TSCA.

In addition, because the Paperwork Reduction Act (PRA) mandates that federal agencies become more responsible and be held publicly accountable for the burden of federal paperwork on the public, the proposed IUR amendments fail to meet the requirements of the PRA. EPA’s proposal assumes that the current IUR reporting requirements of 11 items of information per reportable CASRN will explode to more than 200 information items per CASRN under the amended rule. In addition, the current IUR requirement requires a separate "line item" or report for each manufacturing activity, non-site limited volume, and import volume. Thus, the proposed amendment would result in over 600 information items potentially being reported, compared to 33 information items under the current rule.

By fiscal year 2000, EPA is supposed to have reduced paperwork burdens to 40 percent of fiscal year 1995 levels. In the period since fiscal year 1995, however, EPA’s paperwork burdens have increased nearly 120 percent. SPI cannot see how such a dramatic increase in reporting burden can be consistent with the Agency’s obligations under the PRA and believes that if finalized as proposed the IUR rule will further ensure that EPA will not meet this statutory mandate.

H. The Additional CBI Substantiation and Resubstantiation Requirements Are Overly Burdensome and Ultra Vires

The proposed CBI substantiation requirement is not authorized by TSCA. Moreover, even if authorized by the Act, they make little practical sense. SPI strongly recommends that EPA abandon its proposed changes to the handling of CBI under the IUR.

Under the existing rule, EPA requires submitters to provide commercially sensitive data such as production volume and chemical identity. Under section 14 of TSCA, EPA has a statutory obligation to protect from improper disclosure information that is properly claimed as CBI. In every instance in which EPA proposes to disclose CBI, the Agency must provide prior notice of the intended disclosure. EPA’s proposed CBI substantiation and resubstantiation requirements under the proposal ignore these statutory duties. Instead of EPA providing advance notice of public disclosure of properly-claimed CBI, the Agency would disclose CBI on the submitter’s failure to reclaim CBI status. The plain language of TSCA does not permit such a process. Even if EPA correctly assumes it has the legal authority to institute the proposed changes to the handling of CBI under the IUR, the Agency has failed to demonstrate that its proposed changes will, as the Agency asserts, make more site-specific data available for disclosure.

EPA also has not considered the considerable effort that would be required to comply with the proposed CBI provisions. In addition to completing a current report, submitters would have to analyze CBI claims made in past reports, declassify any claims as necessary, and prepare a newly reclassified report. The newly reclassified report, moreover, would be based on data that is at least five years old. This data reassertion scheme could be repeated several times. Reassertion would also be difficult where a site changes ownership.

SPI notes that the burden of asserting-reasserting-resubmitting IUR reports has not been analyzed in EPA’s estimates of the burden of the IUR amendments. At a minimum, EPA should analyze the burden associated with the data reassertion implications of the proposal.

III. CONCLUSIONS

Instead of utilizing expanded IUR reporting to obtain information, EPA should better evaluate, manage, and use existing data submitted to it and other federal agencies. If finalized as proposed, not only would the information provided to EPA be misleading, experience shows that EPA would be unable to process the considerable amount of information it would receive in a reasonable timeframe. For these reasons, the proposal fails to meet the standards of section 8 and the Paperwork Reduction Act.

If, however, EPA proceeds with amending the IUR rule, the duty of manufacturers and importers to obtain industrial process and use information from processors and users and the reciprocal obligation of processors and users to provide information to reporters must be clarified. Further, information regarding industrial processing and use at sites from which reportable substances are indirectly received from manufacturers and importers (other than through brokers and distributors) should be deemed to be not "readily obtainable." The proposed definition of "reasonably likely to be exposed" and the proposed corresponding requirements to report information on persons reasonably likely to be exposed to reportable substances should also be revised. The reporting exemption for inorganics should be retained. Finally, the additional CBI substantiation and resubstantiation requirements are overly burdensome and ultra vires, and should be abandoned.

* * *

We thank the Agency in advance for its consideration of these comments.

Respectively submitted,

/s/

Peter L. de la Cruz

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