OPPT 2002 0067 0002 COMMENT AND RESPONSE DOCUMENT FOR REVISED POLICY STATEMENT OF SECTION 8( e) OF TSCA RECEIVED OPPT NCIC 2003 FEB 20 PM 4: 06 1 02/ 2003 GENERAL COMMENTS COMMENT: Once EPA finalizes its new section 8( e) guidance, it should only be applied prospectively. The Agency itself has admitted that the nature and scope of section 8( e) reporting requirements for environmental information have not been clear, and it took the unusual step of suspending its prior guidance. Moreover, many additional Federal and state reporting requirements have been enacted since TSCA became effective in 1976, further muddying the regulatory waters.

The confusion associated with the scope of environmental reporting under section 8( e),

and the absence of Agency attention to the issue, contrasts sharply with the long history of healthrelated section 8( e) guidance and reporting. Given this history, and the continuing questions raised about the Agency's proposal new guidance, it would be inappropriate to apply the guidance retroactively.

RESPONSE: Given the circumstances noted by the commenter, the suspension of the previous guidance, the emphasis on health and environmental effects reporting, the length of time required to propose revised guidance, and the greater specificity of the revised guidance, EPA has concluded that the revised guidance will be enforced prospectively. This means that companies will not have to review preexisting files for information that may be subject to section 8( e)

reporting. These preexisting files would only come into " play" if data obtained by a company after the effective date of the guidance triggered a review of such data and in doing so the combination of data met the section 8( e) reporting criteria.

COMMENT: The draft preamble language will be important because it may contain examples as well as explanations of key terms used in the proposed guidance. In this respect, the preamble 2 language will supplement the revised policy text. Consequently, EPA should make the draft preamble language available for public comment. Additionally, because the July 13, 1993 proposal contained many troubling statements that improperly expanded the potential scope of section 8( e) reporting, EPA should expressly state that the preamble to the July 13, 1993 Federal Register notice has been withdrawn and should be disregarded in its entirety.

RESPONSE: The Agency disagrees. The preamble to the final revised guidance is meant to serve as a broad statement of EPA's policy on the implementation of TSCA section 8( e) as modified in response to public comment. As such the preamble is inherently EPA's official avenue to convey public policy subject to normal EPA administration and OMB review.

However, EPA believes that the joint development of a question and answer document will provide ample opportunity to develop and present the necessary examples and reporting scenarios that will frame industry's reporting responsibilities. Finally, EPA sees no need to withdraw the preamble of the July 13, 1993, notice because the controlling documents will be the final preamble and guidance text, this document, and the question and answer document.

COMMENT: Although the change from 15 working days to 30 calendar days is not a major change ( a net gain of nine calendar days), the change is supported for the submission of health effects data. Longer time frames should be considered for environmental effects data and release and detection data ( environmental contamination).

RESPONSE: EPA agrees for the most part with the comments. The reporting period will be 30 calendar days for health and environmental effects data. Longer time frames ( 90 days) for reporting non emergency contamination data are provided ( see below under non emergency chemical contamination reporting). 3 COMMENT: Part IV of the policy text defines " immediately" to mean " within 30 calendar" days from obtaining information. Does " immediate" in the context of supplementary submissions mean 30 calendar days?

RESPONSE: Yes.

COMMENT: EPA should retain the " if appropriate" language regarding " supplemental information." EPA should confirm that " supplemental information" must be submitted under section 8( e) only if it is new " substantial risk" information that is independently reportable under the statutory standard.

RESPONSE: EPA is retaining the original language regarding the submission of " supplementary information." EPA did not specifically propose a change to this reporting standard. The change was editorial in nature. Only information meeting the section 8( e) statutory requirement must be submitted within the required time frames.

COMMENT: Given the changes to the policy statement, i. e., notices submitted within 30 calendar days and the option to report under state and other Federal requirements with different reporting time frames, it may be more clear to delete " within 30 calendar days" and substitute the following to the Note. At the end of Part II:

" that such information is properly reported to EPA under the provisions of the policy statement."

RESPONSE: EPA agrees. Language has been changed to add " properly" reported.

COMMENT: The date when one " obtains knowledge" under TSCA section 8( e), like the " initiation" of a potentially reportable monitoring or modeling study under TSCA section 8( d) [ 40 CFR 716], is incapable of clear definition. " Knowledge" of contamination occurs when the 4 analytical laboratory reports the results of its first analyses. However, as recognized by the EPA,

the mere presence of a chemical in environmental media is not ( and should not be) per se section 8( e) reportable information. It may take several months after the receipt of analyses before engineering studies can begin to put physical parameters around the " amount, extent and pattern"

of contamination. Because the determination of significant risk can take considerable time, the 90 day clock for reporting environmental contamination should begin once a determination of significance has been made.

RESPONSE: Regarding when the " clock" starts, EPA agrees that this should occur when the company obtains the requisite information to make the section 8( e) determination. This may be many months or even years after the non emergency release occurred.

COMMENT: Because of the vagaries of mail delivery it may be difficult to ensure that a submission is received by EPA not later than 30 calendar days after obtaining the information.

EPA should change the requirement to postmarked by the 30th calendar day.

RESPONSE: EPA disagrees. The reporting obligation is that EPA " receives" the notice within 30 calendar days. A notice " postmarked" within 30 calendar days may not necessarily be " received" by EPA within the time period. Also, postmarking provides no guarantee to the submitter that the notice has actually been received by the Agency in a timely manner as does United States Postal Service registered mail or mail handled by commercial delivery services that guarantee delivery dates. The burden is on the reporting entity to make certain the reporting deadline is met.

COMMENT: In the guidance for reporting information about non emergency incidents of environmental contamination, EPA should clarify whether emissions from facilities which are 5 wholly regulated under FIFRA or FFDCA need be considered for reporting under section 8( e) of TSCA.

RESPONSE: Environmental emissions/ releases from manufacturing facilities are not regulated under FIFRA and FFDCA. Therefore, such release are potentially subject to reporting under section 8( e).

COMMENT: EPA should exempt from section 8( e) reporting field tests conducted on research and development ( R& D) pesticides or clarify that such tests would normally not be reportable because of a) the situation does not represent widespread exposure at the R & D stage of development and b) the contamination is not previously unsuspected ( because it is known,

intentional, and under controlled conditions).

RESPONSE: EPA agrees that they would not normally be reportable because the exposure is not widespread and previously unsuspected. However, if health or environmental effects are seen then reporting should be considered. Also, if the substance has started the regulatory review process under FIFRA it would not be subject to section 8( e) reporting. A chemical substance which is in the process of R& D as a pesticide is subject to TSCA until such time as the manufacturer or importer demonstrates the intent to produce a pesticide by submitting to the Agency an application for an " Experimental Use Permit" or registration under FIFRA.

COMMENT: The inclusion of activities associated with the use of chemicals in the 1978 Policy Statement is inappropriate. Chemical use involves activities that support, promote, or contribute to the person's operations, where the chemical used does not become part of a distributed product. Examples of chemicals that are used and not processed are chemical processing aids such as catalysts, solvents, or reaction terminators. Other examples would be manufacturing aids 6 such as lubricants, refrigerants, or metalworking fluids, or chemicals used for other purposes such as cleaners, degreasers, or fuels. Substantial risk information concerning chemicals that are used by the person receiving the information should not be subject to section 8( e) reporting unless the person also manufactures, processes, or distributes the chemical.

Moreover, the Agency should consider exempting from the section 8( e) reporting, the use of paints and coatings in the manufacture of articles where paints, coatings, and other surface treatments are used to apply a film to the article and are not incorporated as a significant component of the article.

RESPONSE: EPA agrees that information obtained on substances that are only " used" as illustrated by the commenter is not subject to reporting. This includes chemical processing aids such as catalysts, reaction solvents, etc. Section 8( e) only applies to information obtained on a substance that is manufactured, processed, or distributed in commerce. However, EPA does not agree that the application of paints and coatings on articles, even if only a minor component,

should be exempted. While a minor component of the article, the application of the substance or mixture may result in significant workplace exposures and as such any information obtained concerning its hazard potential could be cause for section 8( e) reporting. In addition,

the substance or mixture could have many other uses that could lead to significant environmental or human exposure.

COMMENT: This policy mandates the reporting of substantial risk information within specified periods of time. Failure to report can result in a civil penalty and possible criminal prosecution under TSCA section 16. The government, under section 7 of TSCA can seek judicial relief to compel submittal of section 8( e) information and to otherwise restrain any violation of section 7 8( e). In addition, personal liability accrues to all officials responsible and having authority for an organization's execution of section 8( e). Given these considerations, this policy constitutes a rulemaking and should be treated accordingly.

RESPONSE: In proposing and finalizing the revised guidance EPA followed notice and comment procedures that would be followed as if it were a rulemaking. In addition, internal EPA and OMB review of the guidance is similar to the reviews that would be required of a rulemaking. Section 8( e) of TSCA is self implementing, in contrast to other parts of TSCA which involve rulemaking,

and as such is subject to TSCA sections 15 and 16. Specifically section 15( 3) states that " It shall be unlawful for any person to fail or refuse to***( B) submit reports, notices, or other information,*** as required by this Act or a rule***."

COMMENT: Information a company voluntarily self discloses to EPA under a program administered by EPA should not need to be reported.

The regulated community has been encouraged by the Department of Justice Criminal Enforcement Guidelines, U. S. Commission Sentencing Guidelines, and Working Draft Recommendations by the Advisory Working Group on Environmental Sanctions to the United States Sentencing Commission ( March 5, 1993), to self disclose potential violations and information to EPA. Because the goal of TSCA section 8( e) is for EPA to be aware of substantial risk information, self disclosure of information to EPA should also satisfy TSCA section 8( e).

RESPONSE: EPA does not agree that such a blanket exception should apply. Although the CAP allowed numerous companies to self disclose information to EPA, it was not without cost ( although it was substantially reduced). EPA's enforcement policy addresses and allows for 8 mitigated penalties in cases of self disclosure. Such an issue is best handled on a case by case basis.

REPORTING NON EMERGENCY AND EMERGENCY SITUATIONS OF CHEMICAL CONTAMINATION COMMENT: As drafted, the proposal expands the reporting required by the 1978 policy statement by either dropping or adding concepts that define the scope of this part. For instance,

the term " previously unsuspected" is conspicuously absent from the proposed clarification.

Deletion of the phrase will result in unnecessary over reporting as well as duplicative reporting.

The focus of section 8( e) should be on new or previously unsuspected information.

EPA added the term " may seriously threaten" as a factor in determining substantial risk.

This runs counter to the statute which uses the term " presents a substantial risk," implying that a much higher level of certainty is required than a standard that uses " may." No reason was given that supports such a change. Further, in finalizing the 1978 document, EPA rejected using the term " may."

Similarly, EPA states that the toxicity of the detected substance should be considered in conjunction with the magnitude of the contamination. However, instead of allowing companies to rely on the known hazard profile of the substance, EPA introduces the concept of " suspected toxicity" as a reporting threshold. " Suspected toxicity" is analogous to the use of the term " may"

discussed above. The 1978 policy statement indicates that evidence that " reasonably supports the conclusion" of substantial risk should " reliably ascribe the effect to the chemical" and that a serious effect would be reportable if one or more chemicals was " strongly implicated." The 9 criterion of " suspected toxicity" is totally inconsistent with the concepts of " reliably ascribe" and " strongly implicated" in the 1978 guidance. The phrase, " suspected toxicity," should, therefore,

be deleted in the final guidance and only " known toxicity," in conjunction with other factors,

should be considered in determining possible section 8( e) reporting.

RESPONSE: The term " previously unsuspected" was not carried over from the preamble discussion to the policy text. There is no indication in the proposal that the concept was deleted.

Thus, only reporting of environmental/ product contamination that was " previously unsuspected"

by EPA and meets the other criteria should be considered for section 8( e) reporting. Known constituents of products, substances for which companies have permits to discharge, and substances monitored in workplace air, for example, would not be " previously unsuspected."

Contamination by a substance that was " previously unsuspected" is information that is not known to the Agency. For instance, it would include information about the discovery in off site ground water of a substance that had been manufactured at the site for many years. It may not be surprising given the production history of the substance, but it is new information about actual,

measured contamination. Manufacture, processing, and distribution in commerce of substances does not presuppose environmental contamination or knowledge about such contamination by EPA.

As the commenters note, the issue of using " may" as in " may present" and now as " may seriously threaten" was addressed in 1978 when EPA agreed to drop the term. While the proposed text does not address " present" or " may present," the use of the term as in " may seriously threaten" implies that the " presents" standard has been degraded to " may present." EPA agrees that the level of evidence embodied in the 1978 policy statement should be maintained and 10 thus " may" was removed. Similarly, the concept of " suspected" toxicity was removed. While agreeing to these changes EPA must reiterate that the phrase " reasonably supports the conclusion" of substantial risk is not identical to a conclusive demonstration of substantial risk.

COMMENT: The proposed language for Part V( b)( 1) refers to "[ I] nformation that pertains to widespread chemical contamination..." EPA has not specifically defined the term, " widespread,"

in its proposed Notice of Clarification ( July 13, 1993; 58 FR 37735), but rather has given three examples of what would constitute " widespread." EPA states in the preamble that the term,

" widespread," would include, for example, presence in a product that is distributed commercially,

multiple ( e. g., three or more) reports of contamination ( even in a single environmental medium)

involving different sites inside and/ or outside the boundaries of a facility, or presence in more that one environmental medium ( e. g., discovery of a chemical in both soil and groundwater).

These examples of " widespread" are inappropriately broad and will lead to considerable and needless overreporting of environmental release/ contamination information. Presence in a product that is distributed commercially does not necessarily constitute widespread distribution in environmental media. Whether the chemical is ever released to the environment or whether humans are ever exposed to the contamination depends upon the type of product and its intended uses.

Many products distributed commercially are mixtures, which intentionally contain substances ( e. g., solvents) that are known to cause serious health or environmental effects, but which are necessary for the products' performance properties. They may also contain unintentional impurities of a toxic nature. These intentional and unintentional ( but known) toxic substances are addressed on the products's Material Safety Data Sheet ( MSDS) and label. 11 Proper handling and disposal information is included on the MSDS. There is no need to inform EPA of any known product contamination or presence of toxic materials in a product, provided one's customers are adequately informed and instructed in the proper use, handling, and disposal of the product.

One aspect of product contamination that EPA has not addressed, but needs to, is the degree of contamination and whether it presents a significant risk to exposed populations. There are levels of product contamination below which there is no health or environmental concern and,

therefore, would not be section 8( e) reportable, under any circumstances, even if previously unsuspected. Product contamination should be considered for section 8( e) reporting only if it is previously unsuspected and truly presents a substantial risk, because of both significant toxicity at the levels found and actual or high probability of exposure to humans or non human organisms.

EPA's example of multiple ( three or more) reports of contamination ( even in a single environmental medium), involving different sites inside and/ or outside the boundaries of a facility,

does not correspond to or should not be defined as " widespread" in all cases. This example fails to take into account the amount, extent, and pattern of contamination and, if taken literally, could lead to thousands of unnecessary reports under section 8( e).

Presence of contamination in more than one environmental medium is also an inappropriately simplistic example. A spill to soil or water of a liquid or solid chemical with an appreciable vapor pressure will always involve releases to air as well. Land spills near a river or other body of water will almost always involve some releases to the water, particularly if it rains before the spill is contained or cleaned up. Yet, these types of spills may not be widespread at all.

A better and much more narrow definition of " widespread" needs to be developed by 12 EPA. EPA should consider contamination to be " widespread" only if there is a substantial likelihood that widespread or significant exposure of humans or non human organisms to the contaminant will occur.

If EPA, however, has difficulty accepting a definition of " widespread" in terms of actual or likely exposure, then the Agency should define the term based on the following considerations:

a) Containability ( can the distribution in environmental media be controlled?); b) Manageability ( able to be cleaned up with known or available technology); c) Movement off site ( e. g., towards a residential area( s) or body of water that is a drinking water supply or environmental habitat); d)

Any other relevant factors ( e. g., amount, extent, and/ or pattern of contamination, etc.).

The proposed language could be simplified while still emphasizing that all four aspects of a possible scenario for section 8( e) reporting must be present, i. e., widespread, previously unsuspected, known serious effects, and actual or high probability of exposure. Proposed text follows:

" Widespread and previously unsuspected distribution in environmental media of a chemical substance or mixture known to cause serious adverse effects, when coupled with information that widespread or significant exposure to humans or non human organisms has occurred or that there is a substantial likelihood that such exposure will occur."

To illustrate the practical application of the proposed language under Part V( b)( 1), a company should address the following steps:

A. Considerations for Section 8( e) Reportability of Non Emergency Situations of Chemical Contamination Involving Humans and/ or the Environment 13 1. Known Significant Toxicity ( to humans or non human organisms)

2. Previously Unsuspected distribution in environmental media 3. Widespread distribution in environmental media  Amount, extent, and/ or pattern of contamination  Containability ( can the contamination be controlled)

 Manageability ( able to be cleaned up)

 Movement off site ( particularly towards a residential area( s) or body of water that is a drinking water source, etc.)

 Any other relevant or appropriate factors 4. Exposure: Actual or high probability of significant level of exposure to humans or non

human organisms.

B. Section 8( e) Reportability Determination 1. Consideration of all four factors above in their entirety.

2. If one or more of the above four factors are non operative, the information is not section 8( e)

reportable.

3. If all four factors above are operative, the information should be considered for immediate reporting under section 8( e) ( unless the information has or will be reported under an EPA administered statute or EPA approved or delegated state program, within the required time frame for reporting information under such authority.)

The above approach is fairly easy to apply and will result in consistent reporting to EPA of information that truly presents a substantial risk to the environment. 14 RESPONSE: EPA agrees that its discussion of what would constitute " widespread"

contamination and the examples provided are of limited value and could cause overreporting .

One commenter suggested that " widespread" be defined in terms of a number of considerations that when combined with other factors ( toxicity, exposure, previously unsuspected) would determine reportability. In general, EPA supports this approach because it would be impossible to define the myriad combinations of data that would define " widespread." For instance, three or more reports of contamination in an environmental medium may be meaningless if it were three out of a hundred samples taken on the site or nearby area, but it may be significant if contamination was detected in the well water of three nearby homes. While the commenter proposed five elements to consider when determining if contamination is " widespread" ( i. e.,

amount, extent, and/ or pattern of contamination; containability; manageability; movement off site;

other factors), EPA believes that two of the factors, containability and manageability, should not be used because they are more appropriately risk management considerations rather than risk notification elements. Companies should thus consider whether or not contamination is found offsite and if it is, the amount, extent, and or/ pattern of contamination and any other relevant factors.

Similar considerations should be used regarding contamination in products distributed in commerce. While the contamination may be " widespread" because of commercial distribution,

companies need to consider whether the contamination in the product is available to expose users of the product or others during disposal. If the contaminant is tightly bound, such as in a plastic product, there would be no or minimal exposure. Thus, a substantial risk notice would not be required. However, if there was the potential for exposure, companies would still need to 15 consider the contaminant's concentration which bears on the level of exposure, the toxicity of the contaminant, and whether it is unsuspected contamination. Known, toxic constituents, such as may be listed in the MSDS, even if widely commercially distributed would not trigger section 8( e)

reporting.

Workplace exposure would be treated similarly. It would need to be previously unsuspected by EPA, result in contamination to major areas of the work site thus leading to actual or potential exposure, and have known, significant toxicity. Contamination of workplace air or surfaces by substances known to the manufacturer and EPA, such as OSHA regulated substances,

would not need to be examined for section 8( e) reporting under Part V( b)( 1) because they are not " previously unsuspected." However, a sudden release of a large quantity of an OSHA regulated substance, may need to be considered for EIEC reporting depending on the quantity and toxic properties of the substance.

Finally, EPA agrees that the suggested text which embodies the concepts of widespread distribution, previously unsuspected distribution, known significant toxicity, and actual or probable significant exposure, in combination with other unmodified sections of the policy statement, is responsive to the comments.

COMMENT: Additional examples and/ or case studies need to be provided by the Agency to confirm that section 8( e) reporting is not required under the following circumstances:

Groundwater concentrations that are below drinking water standards.

Soil concentrations that are below RCRA action levels, State action levels or State cleanup levels.

Groundwater or soil contamination that is analyzed through customary risk evaluation mechanisms to be below actionable levels. 16 Environmental information generated in the following regulatory contexts:

RCRA closure activities

RCRA corrective action activities

RCRA UST activities

CERCLA cleanup activities

State Superfund cleanup activates

PCB cleanup activities

Clean Air Act Activities RESPONSE: EPA agrees with the general framework of the comment. The comment addresses two aspects of section 8( e) reporting. First, the use of chemical specific quantity benchmarks to determine reporting and, second, the reporting of data under other EPA/ state authorities. EPA requested comment on the use of benchmarks, but did not advance the concept in the proposal.

However, given the fact that the Agency has developed such benchmarks for numerous programs,

and the desire to produce less ambiguous guidance, EPA believes that the use of such benchmarks such as RfD's, MCL's, RCRA action levels, etc., is reasonable in the section 8( e) decision making process. A " Note" to that effect has been added to Part V( b)( 1).

The other part of the comment concerns the submission of data under other EPA/ state authorities. With the exception of the State Superfund activity ( unless specifically known by EPA or as related to an authorized site remediation activity), section 8( e) reporting would not be required if submitted within 90 days of obtaining the information.

COMMENT: Under the recently proposed guidance, it would appear EPA may now be 17 considering that the mere presence of a toxicant in the environment, without any evidence of an effect, is sufficient to trigger substantial risk reporting. For example, the proposed guidance states:

In other words, information regarding a non emergency chemical release or detection event, in and of itself, regardless of whether effects were observed associated with that particular release or detection, may be reportable....

The Agency has failed to recognize that environmental contamination is not an " effect." The actual or potential for harm to human health or ecological systems that may be caused by environmental contamination is the effect for which evidence must reasonably support the conclusion of a substantial risk. The 1978 Policy Statement states that a " substantial risk" is a " risk of considerable concern because of ( a) the seriousness of the effect and ( b) the fact or probability of its occurrence." This clearly led industry to believe there must be a serious effect coupled with the fact or probability of its occurrence before the section 8( e) reporting threshold is reached. The industry requests EPA clarify whether an " effect" is a necessary element of a determination of reportability. The industry believes that EPA should state that, unless actual harm or the significant potential for harm to human health or the environment is shown, there is no duty to report.

In addition, this effect must be unknown to EPA to be reportable. For example, that a common industrial solvent which leaks into groundwater may present a risk to potable water supplies is well known. EPA should clarify that effect scenarios known to EPA are not reportable 18 under section 8( e).

RESPONSE: EPA does not agree with the commenter's interpretation of the proposed guidance and the reporting scenarios presented. Indeed contamination is not an " effect," however Part V( b) is separated into two main parts. Part V( b)( 1) concerns situations of environmental contamination by a substance that because of its toxicity has the potential to cause a serious effect. While Part V( b)( 2 5) concern effects actually observed. For reporting under Part V( b)( 1)

effects do not need to be observed. The observation of health or environmental effects would be reported under Part V( a) and ( b)( 2 5), respectively.

Finally, for Part V( b)( 1) it does not matter whether the potential effect is known. What is unknown, and potentially triggering the reporting, is the new exposure information. The discovery of previously unsuspected contamination of potable water supplies by a wellcharacterized solvent would be reportable even though the characteristics of the hazard are known.

COMMENT: The Agency's incorporation of the withdrawn Part V( c) language to define the term " widespread environmental distribution" is not very helpful because the practical application of the " sliding scale" of exposure/ hazard factors is most formidable ( as proposed in July 1993) .

To use the " sliding scale," it is necessary to engage a multidisciplined team of toxicologists, medical professionals, engineers and lawyers to review scientific literature,

toxicologic information, geologic, hydrogeologic information, and government ( state/ federal)

regulations and standards in order to make judgements about the effect, if any, of the presence of parts per million concentrations of contaminants identified in affected media ( e. g., soil, air, surface water, ground water). 19 At a minimum, the proposed " sliding scale" requires:

( 1) a review of the known toxicity and physical property data of each contaminant ( from a search of toxicity databases) which may include a large number of studies and toxicity endpoints;

( 2) an assessment of the quality of available environmental sampling and sample analysis data;

( 3) an assessment of the potential for environmental migration for the contaminants ( based upon evolving monitoring data);

( 4) a determination of whether the state or federal government ( including EPA, OSHA)

has established an exposure limitation for each chemical and the significance, if any, of that limit to the environmental media being addressed;

( 5) some extrapolation of the toxicity summary effects to the typical parts

permillion parts per billion concentrations of contaminants identified at the site of sampling and/ or modeled media.

Experience with Parts V( b)( 1) and V( c) of the 1978 Statement of Interpretation shows that developing a " sliding scale" assessment is extremely resource intensive. Its application in the context of TSCA section 8( e) requires extraordinary efforts to acquire new information. As a practical matter, the " sliding scale" cannot be used to address environmental contamination involving multiple chemical contaminants, particularly during the early period of an environmental investigation when information about the source, migration or expected concentration of the contaminants in environmental media is not fully known.

RESPONSE: EPA agrees that for situations of environmental contamination a " sliding scale"

approach, i. e., weighing the toxicity or exposure relative to the seriousness of the effect or the 20 magnitude of the exposure is difficult to employ. However, companies would still need to judge the seriousness of the toxicity of the contaminant, the extent of the contamination, and the likelihood of actual exposure. The scheme presented by the commenter regarding the steps required and level effort needed determine if a " substantial risk" notice is needed is far more rigorous than needed. The purpose is not to obtain conclusive evidence but to obtain sufficient information that " reasonably supports" the section 8( e) determination. The exact boundaries of the contamination do not need to be determined, exhaustive database searches for toxicity data need not be performed, nor do quantitative risk assessments need to be undertaken. It is not unreasonable to expect that companies are knowledgeable of the basic toxicological profiles of the substances they manufacture, process, and/ or distribute and are familiar with the surrounding community. This basic knowledge coupled with detection data and other pertinent data should enable a company to make the section 8( e) determination.

COMMENT: Under Part V( c) the term " immediately" is ambiguous and subject to different interpretations. " Immediately" should be clearly defined as a time no later than 24 hours after the person has actual knowledge of the substantial risk. There may be a variety of situations that would not allow the instantaneous reporting of the substantial risk information, including incomplete investigation of an incident or logistical problems, such as the lack of access to a telephone. These situations would not allow for immediate reporting. Therefore, the regulated community should have some leeway in reporting, that still assures that EPA will receive the information expeditiously.

RESPONSE: EPA believes the current language of the Policy Statement is appropriate and offers sufficient flexibility to respondents. The reporting standard is when the person " has knowledge of 21 the incident." This may involve a number of pieces of information such as the toxicity profile of the substance, the amount released, whether the release has been contained in any fashion,

whether the release is ongoing, and other factors. Obtaining the required information could take minutes to hours. An exhaustive data search or risk assessment is not required to determine if the circumstances of the release " reasonably supports" the section 8( e) determination. Thus EPA does not believe a set time frame in this instance is needed. In addition, EPA is not aware that the current reporting structure has caused compliance problems for the regulated community.

INFORMATION WHICH NEED NOT BE REPORTED COMMENT: Documents, reports and studies submitted to EPA for informational purposes only should satisfy the requirements of TSCA Section 8( e) as well.

RESPONSE: EPA does not agree. The purpose of requiring section 8( e) reporting to be identified as such or allowing such information to be submitted under other mandatory reporting requirements is to ensure that it is available in a timely manner to the program office that can best react to the data or refer it to the proper office. Voluntary submission of information could occur in such a way that the receiving office or individual is not aware that it is " substantial risk"

information that may need to be reviewed elsewhere.

COMMENT: In proposed PART VII( a)( 1 6) ( July 13, 1993) the first sentence of paragraph ( a)

differs from the preamble discussion which indicates that information need not be reported if it is " obtained solely from the following sources:." As used, the term " solely" is confusing and unnecessary and should be deleted. This term suggests that information obtained from other nonlisted sources must be reported under section 8( e) even though it also is included in one of the sources identified by EPA. EPA's guidance should indicate that information contained in the 22 identified sources is not reportable under section 8( e) regardless of where else the same information may appear. EPA's intent might be better expressed by indicating in the preamble that the availability of information from any of the listed sources will not excuse a failure to report that information if it was available earlier from another source.

RESPONSE: While the term " solely" is used in the preamble, it did not appear in the refined policy text. EPA agrees that " solely" should be deleted. The exclusions are not restricted to information that only appears in one of the sources listed. As the commenter notes, the availability of information from any of the listed sources will not excuse a failure to report that information if it was obtained earlier from a non exempt source.

COMMENT: EPA should clarify the phrase " made available to the general public by EPA or another Federal agency." The exemption should incorporate all information in the possession of a Federal agency ( which is available through documents, Freedom of Information Act requests, or other means), whether or not it has been officially published and actively distributed. In practical terms there is no difference between draft and final reports. EPA should consider itself adequately informed of this information. This should extend to State reports if an EPA official is listed on the distribution list or the company has actual knowledge that EPA has received or is aware of the existence of the report.

RESPONSE: EPA disagrees that it should consider itself " adequately informed" of all information in the possession of Federal agencies. Given that the vast majority of information received by the other Federal agencies is not identified to EPA in any systematic manner, it would be impossible for EPA to be assured of an acceptable level of knowledge of this information. For instance, if a company knew that a researcher at NCI was evaluating a potential test substance and 23 sent him a copy of a just completed toxicity study, that study would remain unknown to EPA unless the researcher independently sent the report to EPA. The result would be that the study is in the possession of a Federal agency and, under the commenter's scheme, need not be reported to EPA. Thus, EPA would not have knowledge of the information on a timely basis. A company could avoid a section 8( e) reporting obligation by simply sending data to another agency on an FYI basis.

EPA does agree that information published or made available to the public in final as well as draft reports need not be reported. Further, EPA has added language to Part VII to exempt from reporting information developed by other Federal agencies in which EPA is collaborating in some fashion ( see Part VII( a)( 2)) . Also, companies need not report information contained in state reports if there is actual knowledge that EPA is aware of the information.

COMMENT: In the revised guidance made available on March 29, 1995, EPA provided that information contained in draft or final reports made available to the general public by EPA or other Federal agencies was not subject to reporting. This makes sense for reports from other Federal agencies, but is unclear with respect to EPA reports. If EPA has made a draft or final report available to a person or company, that person or company should not have an obligation to resubmit the information contained in the report under section 8( e). Thus, we assume that, at least with respect to EPA reports, a report is " made available to the general public" when it is made available to any member of the general public ( individual or corporate).

RESPONSE: EPA agrees with the commenter's analysis of the draft guidance. This has been corrected by providing two guidance provisions. One dealing with EPA reports ( Part VII( a)( 1))

and one for other Federal reports ( Part VII( a)( 2)). The EPA exemption is broader in scope 24 because there are greater opportunities for persons to acquire EPA information that has not been made available to the general public, such as cooperative testing efforts, peer review panels,

advisory committees, etc.

COMMENT: EPA has stated that " general information concerning the data bases and publications to which the EPA headquarters libraries subscribe is available from the Environmental Assistance Division." Aside from the fact that this has been demonstrated contrary to fact, such a nebulous ( and potentially changing) list is untenable unless the Agency finds a way to continually publicize these resources. The Agency should add the original language from the 1978 policy statement which lists specific data bases from which information need not be reported to its list of sources. This should be broadened to include all data bases and subscriptions reasonably available to a serious scientific researcher, not merely those to which EPA may from time to time subscribe. Moreover, information in publications or data bases subscribed to by any EPA regional office should be considered available to EPA even if an EPA Headquarters library does not subscribe to the publication or data base.

RESPONSE: The comments regarding EPA's access to data bases and scientific publications are valid. Companies need not report information obtained from well recognized data bases and scientific publications. The limitation in the proposal to only those data bases and publications to which the EPA's Headquarters libraries subscribes has been removed.

COMMENT: Moderate to large size chemical companies receive tens of thousands of documents annually which contain health and safety data. These range from studies conducted by a company or its suppliers, to letters notifying customers of new health effects, to MSDSs. Studies and letters are more frequently directed toward headquarters where health and regulatory management 25 staff are located, while MSDSs are primarily directed to the people who work with the chemical.

Studies and letters highlight new data in some detail, while MSDSs do not. Because MSDSs are required by OSHA to be prepared, updated, and widely distributed, EPA should consider these documents as " published" and " known to the Administrator." Generators of the data, and/ or preparers of the MSDSs, would still be responsible for reporting " new" significant risk information under section 8( e).

RESPONSE: EPA agrees that MSDSs produced as a result of OSHA requirements are generally available on data bases or otherwise known to EPA. Generators of data still have an obligation to report substantial risk information to EPA within 30 days of obtaining the information.

COMMENT: Allowing itself to be informed of a situation of substantial risk from national media sources is supported. The Agency will reduce the burden on the regulated community. However,

EPA should consider expanding the exemption to include all news reports but at a minimum those broadcast regionally. Even the major television and radio networks tailor their news shows to their regional audiences. EPA's organizational division into geographical regions should provide the same level of knowledge of information contained in these regional news reports as for national broadcasts. On a broader level EPA should consider all news reports as allegations.

News reports are usually given by people with little technical training and actual data is rarely provided. This would be especially true for release data. A company has no way of evaluating the validity of information about the release of a substance by another company and would have no way of evaluating the factors that would need to be considered to make a substantial risk " call." Only the company actually releasing the chemical has access to such information and the reporting obligation should be theirs alone. Furthermore, it would be impossible for the EPA to 26 police what information was heard by anyone.

RESPONSE: EPA agrees with the commenters regarding information from written or broadcast news reports. Rarely do these reports provide the range of information that a non generator of the data would need to judge whether or not a substantial risk exists. Generators of the data have an obligation to report to EPA even if they release the study results to the media because there is no assurance that the media report will accurately convey all the pertinent information on the situation to the public and EPA. The reporting exemption is not designed to alleviate generators of test or contamination data of their obligation to report substantial risk notices to EPA, because they do not have any control over when and what will be reported.

COMMENT: The proposed guidance regarding the reportability of information presented at scientific meetings should be revised. Typically, information presented in such forums is not recorded and cited in an abstract or publication within thirty days of the presentation. Thus, little information will be excluded from section 8( e) reporting under the approach proposed by EPA.

EPA should extend the publication period for this category of information to 90 days. EPA's guidance also should explicitly state that, where EPA is either a sponsor, presenter, member or participant of the conference or meeting, the Agency will be deemed to be " adequately informed"

of all information presented. Further, EPA should not include the word " national" or phrase " held within the U. S." Company employees should not be required to consider all information heard at a public scientific conference for section 8( e) reporting simply because the conference might not be considered to be national or is not held in the U. S.

RESPONSE: EPA agrees that information presented at scientific meetings may not be recorded within 30 days, thus offering a minimal reporting burden reduction. Consequently, EPA agrees 27 that a reasonable extension to 90 days is appropriate. Further, as long as the information presented is captured within 90 days and is accessible under PART VII( a)( 1 4,7,8), the location of the meeting is not relevant.

EPA does not fully agree that any information presented at a conference where EPA is a sponsor, presenter, member, or participant need not be considered for reporting under section 8( e). It's not reasonable to assume that EPA attendance at a conference means that EPA is aware of all the information presented. Large conferences have numerous concurrent sessions over a period of days, thus it is not possible to conclude that the Administrator is " adequately informed"

of information based simply on EPA attendance. However, EPA agrees that information presented at conferences sponsored or co sponsored by EPA or presented by EPA employees or EPA contractors need not be reported.

COMMENT: In proposed PART VII( b) ( July 13, 1993) EPA states that it maintains its position under Part VII( c) of the 1978 Policy Statement that information which corroborates well established, serious adverse effects that are already documented need not be reported. EPA should revisit its 1978 position on the issue of what is meant by " corroborate." Further, EPA should provide examples illustrating its definition of " corroborate" as applied to incidents of nonemergency contamination or occupational exposure information.

According to Webster's Seventh New Collegiate Dictionary, corroborate means " to support with evidence or authority; make more certain." It is clear that this definition does not agree with EPA's which, in practice, has equated " corroborate" to " duplicate." EPA should make it clear that reporting is not required for information which, in the judgement of a competent scientific investigator, confirms existing, well documented serious effects without necessarily 28 duplicating the existing information.

RESPONSE: EPA notes the comment on what constitutes corroborative data but believes that the scope of what does not constitute corroborative data is adequately stated in the July 13, 1993,

preamble ( thus defining the range of corroborative data). The exclusion applies only to health and environmental effects data.

COMMENT: Regarding proposed PART VII( c d) ( July 13, 1993), EPA correctly notes that many environmental laws and regulations have been promulgated since 1978 requiring the submission of a wide range of environmental monitoring data. EPA's proposal to exclude from section 8( e) reporting information submitted under these other statutes is supported. However,

little if any benefit is seen if such reporting must be done within 30 calendar days. The 30 day requirement will be a major reporting burden to industry and will result in considerable duplication of reports to the government, while achieving no real benefit. Such reporting also runs counter to the Paperwork Reduction Act. Reporting requirements and time frames for each program are chosen so as to permit awareness and management of risk by those agencies that have primary responsibility for each of the regulated areas. Of the non emergency reporting requirements studied, only 27 percent have a reporting period of 30 days. For example, the reporting of environmental contamination information generated during an ongoing Superfund remediation investigation to EPA under section 8( e) within 30 days is unnecessary and a wasteful duplication of effort if, for example, the remedial investigation protocol requires reporting of such information to EPA every three or six months.

All environmental release/ contamination data reported under existing EPA statutes and EPA administered state programs, within the time frames required by those programs, should be 29 considered " known to the Administrator" and be excluded entirely from reporting under section 8( e).

RESPONSE: EPA agrees that a significant expansion of environmental contamination reporting has occurred at the Federal level since 1978. In response, EPA, in the proposed revisions,

expanded the scope of the information which need not be reported by updating the EPA statutes and adding state programs authorized or delegated by EPA. The proposed 30 day reporting time frame would apply. However, the commenters raise a valid issue of the utility of requiring separate reporting of information to EPA under TSCA within 30 days if the other EPA requirements allow 60 or 90 days. A company could advance their reporting under the other requirements to within 30 days to avoid TSCA reporting, but the net effect is to either unilaterally reduce some reporting periods to 30 days or to force duplicative reporting because a company would still have a continuing reporting obligation under the other requirements. Thus, any reduction in reporting burdens may be illusionary.

In the proposal, EPA rejected allowing longer time frames because substantial risk information must be reported " immediately" and longer time frames would conflict with this statutory requirement. However, on reflection, the more appropriate standard to use is whether the Administrator is " adequately informed of such information." As a general rule, it would appear reasonable that the Administrator is " adequately informed" if substantial risk information concerning environmental contamination is submitted to the Agency under the varying time frames of the non TSCA requirements. However, it is also reasonable to assume that being " adequately informed" includes a timeliness component. Otherwise it is difficult to support the basis of section 8( e) which is to force the submittal of substantial risk information in a time frame 30 that allows the Agency to evaluate the risk and if necessary take appropriate action. Time frames longer than a few months quickly erode the basic purpose of section 8( e). Therefore, allowing reporting under other EPA/ EPA state requirements up to 90 days is a reasonable accommodation that avoids significant duplicative reporting while assuring that important environmental contamination data is submitted on a timely basis. Based on an analysis by a commenter, nearly 70 percent of non emergency reporting requirements have time frames of up to 90 days and this includes most of the information types most likely to constitute substantial risk data. Health and environmental effects data would still be subject to the 30 day time frame.

COMMENT: The inclusion of the Comprehensive Environmental Response, Compensation and Liability Act ( CERCLA) and the Resource Conservation and Recovery Act ( RCRA) under section 8( e) reporting is nonsensical. EPA already administers these programs and will receive all required filings. Further, the agency must ask itself whether the mere listing of a site on the NPL automatically triggers a finding of substantial risk for the site and consequently section 8( e)

reporting. Additional questions the agency must address include whether an individual company would have reporting requirements for CERCLA sites when that company is contesting the accuracy of being named a potentially responsible party ( PRP) for the site? Could a PRP group or contractor report for a CERCLA site and remove responsibility from the individual companies or must all ( often several hundreds of companies) PRPs report?

RESPONSE: The only reason CERCLA and RCRA are listed is to avoid duplicative reporting of information that may meet both section 8( e) and another EPA statute's requirements. The passage of these other statutes did not negate the statutory requirement under section 8( e) of TSCA. 31 The listing of a site on the NPL would not trigger section 8( e). What could trigger reporting is if a current manufacturer, processor, or distributor of a substance( s) obtains information about contamination by that substance( s) of a site owned or controlled by the company. Under Part VII( g) only the person controlling the site is responsible for reporting.

COMMENT: We strongly recommend that EPA include in this category [ information that does not need to be reported] reporting of emergency releases to local emergency response committees as created under EPCRA. Although these committees may not meet the formal definition of delegated or authorized by EPA, they were created by Congressional action with the clear mandate of managing risks associated with emergency releases.

RESPONSE: EPA agrees. Because local emergency response committees were created under the rubric of EPCRA, there is a strong enough nexus to EPA.

COMMENT: Because EPA is a member of the National Response Center, persons reporting EIEC's should be considered to have met their section 8( e) obligations if they report incidents to the National Response Center instead of to the regional EPA contacts.

RESPONSE: EPA agrees. The National Response Center telephone number has been added to Part IX.

COMMENT: EPA should expand the exemption for information " required" to be submitted in connection with an authorized site remediation program because information generated during a site remediation may often exceed what is expressly required by statute or consent agreement.

This " voluntarily" developed data should not be separately subject to section 8( e) reporting when the main data generated are not. 32 RESPONSE: The commenter is correct in pointing out that much information generated at these sites that may not be strictly " required." EPA agrees that differentiating between the two is counterproductive in the context of an authorized site remediation. Consequently, the guidance language has been modified accordingly. However, the intent of the change is to include " like information" such as additional monitoring data that are site specific. It does not include voluntarily generated data such as toxicological studies of chemicals that have broader applicability.

COMMENT: Many companies generate environmental information in regulatory contexts in which there is no " substantial risk" associated with the information. For example, companies engaged in remedial activities routinely will identify groundwater and/ or soil readings above cleanup or " action" levels. By definition, however, the sites typically represent situations that are being supervised and/ or controlled and that therefore are unlikely to pose a " substantial risk"

that triggers section 8( e) reporting requirements.

RESPONSE: In revising Part VII, EPA added paragraph ( f) which would exempt from reporting data developed and required to be submitted as a result of an authorized site remediation program.

COMMENT: EPA should clarify that information about releases and detections outside the United States need not be considered for section 8( e) reporting. EPA's position that if domestic companies' employees come into possession of health effects information ( e. g., a toxicology study conducted overseas), it does not matter that the information was not initially generated in the 33 United States is understandable. However, the situation of releases and detections outside the United States is definitely not analogous. Information that a chemical substance has been released or detected in another country is not directly relevant to assessment of chemical risks posed to the U. S. public or environment.

RESPONSE: As opposed to information a company may receive from a source outside the United States about the effects of a substance, EPA believes that in the case of contamination at sites outside the United States companies have no obligation to consider these data for reporting under section 8( e). Further, because companies, other than the one controlling a United States site where contamination is discovered, would not have access to the range of data needed to make a section 8( e) " call," EPA is including this as a type of information under PART VII( h) that need not be reported, except as noted in the caveat.

CONFIDENTIAL BUSINESS INFORMATION COMMENT: TSCA section 14 does not obligate, and may not even permit EPA to disseminate health and safety studies. EPA has discretion to disclose health and safety studies which contain CBI only where they are subject to a FOIA request. Otherwise, the broad CBI protections of section 14( a) apply.

RESPONSE: EPA disagrees with this comment. Section 14( b) confers the authority to release health and safety data from health and safety studies which are not restricted from release by the second sentence of section 14( b)( 1).

COMMENT: TSCA section 14( b) does not apply to chemicals not offered for commercial distribution and not subject to section 4 testing or section 5 PMN requirements. Research and 34 development chemicals are excepted from this disclosure.

RESPONSE: EPA disagrees with the comment that research and development chemicals are somehow excepted from the section 14( b) disclosure requirements.

EPA's long held position is that research and development activities are specifically included in the definition of commercial distribution for purposes of complying with sections 8( e)

and 14( b). 43 Fed. Reg. 11115 ( March 16, 1978) ( Response to Comment 31). See also 40 CFR § § 716.55( a)( 1) and 717.3( e)( 1).

COMMENT: Even for substances distributed in commerce, TSCA section 14( b) permits CBI treatment of the identity of the test substance where the submitter provides EPA with a generic chemical name and the study's methodology and the conclusions are available for public review.

RESPONSE: EPA disagrees with this comment. EPA has consistently found that chemical identity is an integral part of, or underlying data to a health and safety study. As such, chemical identity may be properly claimed as CBI only in the limited circumstances found in section 14( b)( 1)( a).

The utility of a health and safety study, especially for chemicals in commercial distribution,

is greatly enhanced by connection to a specific chemical identity. The connection the specific chemical and an identified hazard allows for risk analysis and management by all segments of the interested public, including the chemical industry. For example, there have been a number of instances where an entire industry has taken immediate voluntary protective actions when new,

readily identifiable hazards are reported by one submitter to EPA under section 8( e). Such actions cannot take place when a hazard cannot be associated with a specific chemical. 35 COMMENT: Reporting requirements under TSCA sections 8( d) and 8( e) create an increased need for CBI protection for chemical identity. In particular, research and development and site limited intermediates and catalysts not in distribution should receive CBI protection for chemical identity.

RESPONSE: EPA disagrees with this comment. Both of the examples in the comment can receive, in the appropriate circumstances, CBI protection under the current CBI system. It can be proper to assert a CBI claim for chemical identity for a new chemical compound undergoing research and development activities. Likewise, it can be appropriate to claim as confidential the specific identity of a site limited intermediate or catalyst whose disclosure would compromise process information.

COMMENT: EPA misinterprets what portion of a mixture means in section 14( b). Disclosure of information greater than percentages is prohibited.

RESPONSE: EPA disagrees with this comment. The language " disclosing the portion of the mixture comprised by any of the chemicals in the mixture" in the second sentence of section 14( b)( 2) was taken verbatim from the House of Representatives version of TSCA. The House Report accompanying H. R. 14032 clearly explains what this phrase is intended to mean. The report explains that;

[ i] n referring to data " disclosing the portion of the mixture comprised by any of the chemicals in the mixture," the Committee intends to protect confidential trade secret information respecting the specific formulation of a mixture. However, the Committee does not intend to prohibit the Administrator from disclosing the chemical substances comprising the mixture by their order of quantity in the 36 mixture. H. R. Rep. No. 94 1341, 94th Cong., 2nd Sess. at 51 ( 1976).

Given this guidance in the legislative history, EPA believes that it is consistent with the statute to identify all chemicals, by either non confidential name or generic name, in a mixture formulation and that such identification can be made in order of quantity in the mixture.

COMMENT: TSCA sections 14( a) and 14( c) provide sufficient information about confidential chemical identities in emergencies that chemical identities should be afforded CBI status.

RESPONSE: In a very limited sense, EPA agrees with this comment. However, reacting to emergencies is not the only Agency activity supported by the data collected by section 8( e). EPA is increasingly seeking to manage and mitigate the risks identified in section 8( e) submissions before the occurrence of an emergency. Indeed, the existence of an emergency can sometimes be attributed to a failure of EPA, industry and the marketplace the properly manage risks.

Disclosure of specific chemical identities enhances the ability of the Agency, Industry and the marketplace to proactively address hazards and risk.

COMMENT: Submitter identity should be permitted CBI status.

RESPONSE: EPA agrees with this comment in the appropriate circumstances. However, there will be occasions, such as when a site limited chemical release occurs, where submitter identity or location will be health and safety data and subject to section 14( b).


[Federal Register Volume 84, Number 78 (Tuesday, April 23, 2019)]
[Rules and Regulations]
[Pages 16767-16770]
[FR Doc No: 2019-08095]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0965; Product Identifier 2018-NM-124-AD; Amendment
39-19617; AD 2019-07-06]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc., Model BD-100-1A10 airplanes. This AD was prompted by
a report that certain split ball bearings used in main landing gear
(MLG) side brace actuator assemblies are manufactured from material
that does not meet the required material properties. This AD requires
an inspection of the left and right MLG side brace actuator assemblies
and, if necessary, replacement of the split ball bearings. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective May 28, 2019.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 28, 2019.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., 200 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 2A3, Canada; North America toll-free telephone 1-866-
538-1247 or direct-dial telephone 1-514-855-2999; email
[email protected]; internet http://www.bombardier.com. You may
view this service information at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2018-0965.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0965; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Darren Gassetto, Aerospace Engineer,
Mechanical Systems and Admin Services Section, FAA, New York ACO
Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone
516-228-7323; fax<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.,
Model BD-100-1A10 airplanes. The NPRM published in the Federal Register
on November 29, 2018 (83 FR 61336). The NPRM was prompted by a report
that certain split ball bearings used in MLG side brace actuator
assemblies are manufactured from material that does not meet the
required material properties. The NPRM proposed to require an
inspection of the left and right MLG side brace actuator assemblies
and, if necessary, replacement of the split ball bearings.
    We are issuing this AD to address the non-conforming split ball
bearings, which, if not corrected, could result in potentially
asymmetric MLG extension or retraction and consequent collapse of the
MLG during landing.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2018-20, dated July 27,
2018 (referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for
certain Bombardier, Inc., Model BD-100-1A10 airplanes. The MCAI states:

    The landing gear supplier has informed Bombardier Aerospace
about a quality escape involving Main Landing Gear (MLG) side brace
actuators that have been assembled using non-conforming split ball
bearings. The affected bearings are manufactured from material that
does not meet the required material properties. If not corrected,
this condition can result in potentially asymmetric MLG gear
extension or retraction and subsequent gear collapse during landing.
    This [Canadian] AD mandates verification of the installed MLG
side brace actuator assemblies and replacement of the affected
parts.

You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0965.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment.

Support for the NPRM

    One commenter, Andy Ingwersen, and Flexjet indicated support for
the NPRM.

Request for Records Check To Determine MLG Side Brace Actuator Assembly
Serial Number as an Alternative Method of Compliance

    Flexjet requested that an additional means of verification be
allowed for determining the serial number of the left and right MLG
side brace actuator assembly part number 40310-103. Flexjet suggested
that we add language to paragraph (g) of the proposed AD stating ``A
review of airplane maintenance records is acceptable in lieu of this
inspection if the serial number can be conclusively determined from
that review.'' Flexjet justified this request by pointing out that
similar language is used in other ADs. Flexjet explained that 20 MLG
side brace actuator assembly serial numbers are affected by Bombardier
Service Bulletin 100-32-30, dated December 18, 2017, and 217 MLG side
brace actuator

assembly serial numbers are affected by Bombardier Service Bulletin
350-32-006, dated December 18, 2017, and reasoned that a logbook review
would save time and present less of a financial burden on operators.
    We agree with the commenter for the reasons provided. We have
determined that a review of maintenance records is acceptable for
complying with the actions specified in paragraph (g) of this AD,
provided the serial number can be conclusively determined from that
review. We have revised paragraph (g) of this AD accordingly.

Request To Shorten Compliance Time

    One commenter, Ty Smith, made a request to change the compliance
time to verify the MLG side brace actuator assembly serial number and
perform applicable on-condition actions, and we infer from the request
that the commenter wishes the compliance time to be shortened. The
commenter asserted that a compliance time of 48 months leaves a large
window of opportunity for the unsafe condition to potentially lead to a
malfunction. The commenter conceded that a certain amount of time is
needed to address the unsafe condition, but presumed that operators
have the means to address the unsafe condition sooner than the 48 month
compliance time allows.
    We agree to clarify. As noted in figure 1 to paragraphs (g) and (h)
of this AD, the compliance time varies depending on the total number of
flight cycles accumulated on an airplane, with 48 months being the
longest possible compliance time. In consideration of the average
utilization rate by the affected U.S. operators, the practical aspects
of an orderly modification of the U.S. fleet during regular maintenance
periods, and the availability of required modification parts, we have
determined that the compliance times specified in figure 1 to
paragraphs (g) and (h) of this AD are appropriate. We have not changed
this AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule with the changes described previously and minor
editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., has issued Service Bulletin 100-32-30, dated
December 18, 2017; and Service Bulletin 350-32-006, dated December 18,
2017. This service information describes procedures for inspecting the
left and right MLG side brace actuator assemblies to verify the serial
number and replace the split ball bearings. These documents are
distinct since they apply to airplanes in different configurations.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 468 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85          $39,780
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary on-condition
actions that would be required based on the results of the required
inspection. We have no way of determining the number of aircraft that
might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
8 work-hours x $85 per hour = $680 per          $1,820           $2,500
 airplane.............................
------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all known costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to

the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2019-07-06 Bombardier, Inc.: Amendment 39-19617; Docket No. FAA-
2018-0965; Product Identifier 2018-NM-124-AD.

(a) Effective Date

    This AD is effective May 28, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Bombardier, Inc., Model BD-100-1A10
airplanes, certificated in any category, serial numbers 20003
through 20500 and 20501 through 20665 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Reason

    This AD was prompted by a report that certain split ball
bearings used in main landing gear (MLG) side brace actuator
assemblies are manufactured from material that does not meet the
required material properties. We are issuing this AD to address
these non-conforming split ball bearings, which, if not corrected,
can result in potentially asymmetric MLG extension or retraction and
consequent collapse of the MLG during landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection To Verify Serial Number

    At the applicable time specified in figure 1 to paragraphs (g)
and (h) of this AD: Perform an inspection to verify the serial
number of the left and right MLG side brace actuator assemblies
having part number (P/N) 40310-103, in accordance with paragraphs
2.A. and 2.B. of the Accomplishment Instructions of Bombardier
Service Bulletin 100-32-30, dated December 18, 2017; or perform an
inspection to verify the serial number of the left and right MLG
side brace actuator assemblies having P/N 2-8554-2, in accordance
with paragraphs 2.A. and 2.B. of the Accomplishment Instructions of
Bombardier Service Bulletin 350-32-006, dated December 18, 2017; as
applicable. A review of airplane maintenance records is acceptable
in lieu of this inspection if the serial number can be conclusively
determined from that review.
[GRAPHIC] [TIFF OMITTED] TR23AP19.022

(h) Replacement

    If, during the inspection specified in paragraph (g) of this AD,
the serial number of the part installed is listed in table 1 of
paragraph 2.B. of the Accomplishment Instructions of Bombardier
Service Bulletin 100-32-30, dated December 18, 2017; or table 1 of
paragraph 2.B. of the Accomplishment Instructions of Bombardier
Service Bulletin 350-32-006, dated December 18, 2017; as applicable:
at the applicable time specified in figure 1 to paragraphs (g) and
(h) of this AD, replace the split ball bearing having P/N 104467672,
in accordance with paragraph 2.C. of the Accomplishment Instructions
of Bombardier Service Bulletin 100-32-30, dated December 18, 2017;
or paragraph 2.C. of the Accomplishment Instructions of Bombardier
Service Bulletin 350-32-006, dated December 18, 2017; as applicable.
If the serial number of the installed part is not listed in table 1
of paragraph 2.B. of the Accomplishment Instructions of Bombardier
Service Bulletin 100-32-30, dated December 18, 2017; or table 1 of
paragraph 2.B. of the Accomplishment Instructions of Bombardier
Service Bulletin 350-32-006, dated December 18, 2017; as applicable;
no further action is required by this paragraph.

(i) Parts Installation Limitation

    As of the effective date of this AD, no person may install on
any Bombardier, Inc., Model BD-100-1A10 airplane any MLG side brace
actuator assembly having a serial number listed in table 1 of
paragraph 2.B. of the Accomplishment Instructions of Bombardier
Service Bulletin 100-32-30, dated December 18, 2017; or table 1 of
paragraph 2.B. of the Accomplishment Instructions of Bombardier
Service Bulletin 350-32-006, dated December 18, 2017; as applicable;
unless the split ball bearing having P/N 104467672 has been
previously replaced as specified in paragraph (h) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2018-20, dated July 27, 2018, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0965.
    (2) For more information about this AD, contact Darren Gassetto,
Aerospace Engineer, Mechanical Systems and Admin Services Section,
FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 100-32-30, dated December 18,
2017.
    (ii) Bombardier Service Bulletin 350-32-006, dated December 18,
2017.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 200 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 2A3, Canada; North America toll-free telephone 1-
866-538-1247 or direct-dial telephone 1-514-855-2999; email
[email protected]; internet http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on April 8, 2019.
Michael J. Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-08095 Filed 4-22-19; 8:45 am]
BILLING CODE 4910-13-P