(iii) The date the disqualification will be effective;
    (iv) The procedures for requesting a regulatory hearing on the
disqualification under Sec.  1.1173; and
    (v) The procedures for requesting reinstatement after
disqualification under Sec.  1.1142.
    (2) FDA will provide notice of a LAAF-accredited laboratory's
disqualification on the website described in Sec.  1.1109.

Sec.  1.1162  What are the consequences if FDA puts a LAAF-accredited
laboratory on probation or disqualifies a LAAF-accredited laboratory?

    (a) A LAAF-accredited laboratory that FDA has put on probation for
one or more methods is permitted to continue to conduct food testing
under this subpart; however, a LAAF-accredited laboratory that is on
probation for one or more methods is not permitted to submit abridged
analytical reports for the major food testing discipline of which the
probationary methods are part.
    (b) If FDA disqualifies a LAAF-accredited laboratory for all
methods within its scope of LAAF-accreditation, the laboratory is
immediately ineligible to conduct food testing under this subpart. If
FDA disqualifies a LAAF-accredited laboratory for specific methods
within the scope of LAAF-accreditation, the laboratory is immediately
ineligible to use the methods for which the laboratory has been
disqualified to conduct food testing under this subpart.
    (c) With respect to food testing conducted by the laboratory prior
to its disqualification, FDA may refuse to consider results and
associated reports of food testing conducted under this subpart if the
basis for the disqualification of the laboratory indicates that the
specific food testing conducted by the laboratory may not be reliable.
    (d) Within 10 business days of the date of issuance of
disqualification, the laboratory must provide the name and email
address of the custodian who will maintain and make available to FDA
the records required by Sec.  1.1154, and the street address where the
records will be located.
    (e) Within 10 business days of the date of issuance of a notice of
probation or disqualification, the laboratory must notify any owners or
consignees for which it is conducting food testing using methods for
which it is being placed on probation or disqualified under this
subpart, that it is on probation or has been disqualified.

Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions
Under This Subpart

Sec.  1.1171  How does an accreditation body request reconsideration by
FDA of a decision to deny its application for recognition, renewal, or
reinstatement?

    (a) Timing of request. An accreditation body may seek
reconsideration of FDA's decision to deny its application for
recognition or renewal of recognition under Sec.  1.1114, or
reinstatement of recognition under Sec.  1.1117, no later than 10
business days after the date of the issuance of such denial.
    (b) Submission of request. The request to reconsider an application
under paragraph (a) of this section must be signed by the accreditation
body, as appropriate, or by an individual authorized to act on its
behalf. The accreditation body must submit the request, together with
any supporting information, to FDA in accordance with the procedures
described in the notice of denial.
    (c) Notification of FDA's decision. After completing its review and
evaluation of the request for reconsideration and any supporting
information submitted pursuant to paragraph (b) of this section, FDA
will notify the accreditation body of its decision to grant or deny
recognition upon reconsideration.

Sec.  1.1173  How does an accreditation body or laboratory request a
regulatory hearing on FDA's decision to revoke the accreditation body's
recognition or disqualify a LAAF-accredited laboratory?

    (a) Request for hearing. No later than 10 business days after the
date FDA issued a revocation of recognition of an accreditation body
pursuant to Sec.  1.1131 or disqualification of a LAAF-accredited
laboratory under Sec.  1.1161, the accreditation body, laboratory, or
an individual authorized to act on the accreditation body's or
laboratory's behalf, may submit a request for a regulatory hearing,
conducted pursuant to part 16 of this chapter, on the revocation or
disqualification. The notice of revocation issued under Sec.  1.1131 or
notice of disqualification issued under Sec.  1.1161, as applicable,
will contain all the elements required by Sec.  16.22(a) of this
chapter and will thereby constitute the notice of an opportunity for
hearing under part 16 of this chapter.
    (b) Submission of request for regulatory hearing. The request for a
regulatory hearing under this subpart must be submitted with a written
appeal that responds to the bases for the FDA decision described in the
written notice of revocation or disqualification, together with any
supporting information. The request, appeal, and supporting information
must be submitted to FDA in accordance with the procedures described in
the notice of revocation or disqualification.
    (c) Effect of submitting a request for a regulatory hearing on an
FDA decision. The submission of a request for a regulatory hearing
under this subpart will not operate to delay or stay the effect of a
decision by FDA to revoke the recognition of an accreditation body or
disqualify the LAAF-accredited laboratory unless FDA determines that
delay or a stay is in the public interest.
    (d) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
    (e) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec.  16.26(a) of this chapter when no genuine or
substantial issue of fact has been raised.
    (f) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, the hearing will be held
within 10 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the
accreditation body or laboratory, and the presiding officer and FDA.
    (2) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec.  16.5(b) of
this chapter, the procedures for a regulatory hearing apply only to the
extent that such procedures are supplementary and do not conflict with
the procedures specified for regulatory hearings under this subpart.
Accordingly, the following requirements of part 16 of this chapter are
inapplicable to regulatory hearings conducted under this subpart: The
requirements of Sec.  16.22 (Initiation of regulatory hearing); Sec.
16.24(e) (timing) and (f) (contents of notice); Sec.  16.40
(Commissioner); Sec.  16.60(a) (public process); Sec.  16.95(b)
(administrative decision and record for decision); and Sec.  16.119
(Reconsideration and stay of action).
    (3) A decision by the presiding officer to affirm the revocation of
recognition or laboratory disqualification is considered a final agency
action under 5 U.S.C. 702.

Sec.  1.1174  How does an owner or consignee request a regulatory
hearing on a directed food laboratory order?

    (a) Request for hearing. No later than 3 business days after FDA
has issued the directed food laboratory order, an owner or consignee
may submit a request for a regulatory hearing, conducted pursuant to
part 16 of this chapter, on the directed food laboratory order. The
directed food laboratory order will contain all of the elements
required by Sec.  16.22 of this chapter and will thereby constitute the
notice of an opportunity for hearing under part 16 of this chapter.
    (b) Submission of request for regulatory hearing. The request for a
regulatory hearing must be submitted with a written appeal that
responds to the bases, as appropriate, for FDA's determinations
described in the directed food laboratory order, together with any
supporting information. The request, appeal, and supporting information
must be submitted in accordance with the procedures described in the
directed food laboratory order.
    (c) Presiding officer. The presiding officer for a regulatory
hearing under this subpart will be designated after a request for a
regulatory hearing is submitted to FDA.
    (d) Denial of a request for regulatory hearing. The presiding
officer may deny a request for regulatory hearing under this subpart
pursuant to Sec.  16.26(a) of this chapter.
    (e) Conduct of regulatory hearing. (1) If the presiding officer
grants a request for a regulatory hearing, such hearing will be held
within 2 business days after the date the request was filed or, if
applicable, within a timeframe agreed upon in writing by the requestor
and the presiding officer and FDA.
    (2) The presiding officer may require that a hearing conducted
under this subpart be completed within 1 business day, as appropriate.
    (3) The presiding officer must conduct the hearing in accordance
with part 16 of this chapter, except that, pursuant to Sec.  16.5(b) of
this chapter, the procedures for a regulatory hearing described in part
16 of this chapter apply only to the extent that such procedures are
supplementary and not in conflict with the procedures specified for the
conduct of regulatory hearings under this subpart. Accordingly, the
following requirements of part 16 of this chapter are inapplicable to
regulatory hearings conducted under this subpart: Sec.  16.22
(Initiation of regulatory hearing); Sec.  16.24(e) (timing) and (f)
(contents of notice); Sec.  16.40 (Commissioner); Sec.  16.60(a)
(public process); Sec.  16.95(b) (administrative decision and record
for decision); and Sec.  16.119 (Reconsideration and stay of action).
    (4) A decision by the presiding officer to affirm the directed food
laboratory order is considered a final agency action under 5 U.S.C.
702.

Electronic Records and Public Disclosure Requirements

Sec.  1.1199  Are electronic records created under this subpart subject
to the electronic records requirements of part 11 of this chapter?

    Records that are established or maintained to satisfy the
requirements of this subpart and that meet the definition of electronic
records in Sec.  11.3(b)(6) of this chapter are exempt from the
requirements of part 11 of this chapter. Records that satisfy the
requirements of this subpart, but that also are required under other
applicable statutory provisions or regulations, remain subject to part
11 of this chapter.

Sec.  1.1200  Are the records obtained by FDA under this subpart
subject to public disclosure?

    Records obtained by FDA under this subpart are subject to the
disclosure requirements under part 20 of this chapter.

PART 11--ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

0
4. The authority citation for part 11 continues to read as follows:

    Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

0
5. In Sec.  11.1, add paragraph (p) to read as follows:

Sec.  11.1  Scope.

* * * * *
    (p) This part does not apply to records required to be established
or maintained by subpart R of part 1 of this chapter. Records that
satisfy the requirements of subpart R of part 1 of this chapter, but
that also are required under other applicable statutory provisions or
regulations, remain subject to this part.

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

0
6. The authority citation for part 16 continues to read as follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C.141-149, 321-394, 467f,
679, 821, 1034, 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

0
7. In Sec.  16.1, add entries for Sec. Sec.  1.1173 and 1.1174 in
numerical order to paragraph (b)(2) to read as follows:

Sec.  16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec.  1.1173, relating to the revocation of recognition of an
accreditation body, and the disqualification of a laboratory, with
respect to food testing conducted under part 1, subpart R of this
chapter.
    Sec.  1.1174, relating to the issuance of a directed food
laboratory order by FDA pursuant to Sec.  1.1108.
* * * * *

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

0
8. The authority citation for part 129 is revised to read as follows:

    Authority: 21 U.S.C. 342, 348, 350k, 371, 374, 42 U.S.C. 264.

0
9. Amend Sec.  129.35 by revising paragraph (a)(3)(iii) to read as
follows:

Sec.  129.35  Sanitary facilities.

* * * * *
    (a) * * *
    (3) * * *
    (iii) Analysis of the sample may be performed for the plant by
competent commercial laboratories (e.g., Environmental Protection
Agency (EPA) and State-certified laboratories), except that the
analysis of the five samples from the same sampling site that
originally tested positive for E. coli, as required by paragraph (a)(3)
of this section, must be conducted under part 1, subpart R of this
chapter.
* * * * *

    Dated: November 15, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-25716 Filed 12-1-21; 11:15 am]
BILLING CODE 4164-01-P


QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 120 2.12 ROHM AND HAAS COMPANY This section presents the information and approach used in assigning the Rohm and Haas Company ( Rohm and Haas) to one of the three prioritization groupings based on ( 1) the facilities overall potential for resulting in adverse health impacts and ( 2) an assessment of the protectiveness of current or future MACT standards to determine if additional permit limits may be required to ensure protection of human health and the environment. Section 2.12.1 presents facility specific background information including process descriptions and permit history. Section 2.12.2 describes the process and findings used to assign a facility to one of the three prioritization groupings specific to the risk based facility prioritization strategy. Section 2.12.3 describes the process and findings used to assign a facility to one of the three prioritization groupings following the MACT based facility prioritization strategy. Specific sources of information used to evaluate the Rohm and Haas facility are cited and referenced at the end of this report.

2.12.1 Facility Information The following summarizes the facility specific information provided in Section <IP_ADDRESS> of the Rohm and Haas Qualitative Risk Check Report ( EPA 2001m). This information is intended to provide a general facility overview, including process descriptions and permit history.

The Rohm and Haas Company owns and operates a manufacturing and hazardous waste storage and treatment facility in Jefferson County, Kentucky. Manufacturing consists primarily of acrylic polymers in the form of emulsions, modifiers for plastics, molding resins, and solid and solution grade resins ( Rohm and Haas 1996). The facility is subject to the requirements of RCRA promulgated at Title 40 CFR Part 266 and the equivalent KDEP state regulations at 401 KAR. In addition to manufacturing, Rohm and Haas operates a hazardous waste burning boiler ( Boiler No. 100) for energy recovery.

The facility is located approximately 1.5 kilometers east of the Indiana and Kentucky border across the Ohio River in Louisville, Jefferson County, Kentucky, and occupies approximately 160 acres of land on Campground Road. The facility was first constructed in 1942 by the U. S. Government and was bought by Rohm and Haas in 1960. Constructed features on the property include ( 1) administrative, preparation, receiving, and laboratory buildings; ( 2) a container storage pad; ( 3) three hazardous waste management tanks; ( 4) the incineration building; ( 5) a deluge water basin; and ( 6) two recycle tanks.

Rohm and Haas receives a variety of wastes from on and off site sources. Waste materials generated at the facility are transported directly by pipeline or in containers via fork lift trucks, while off site wastes are transported to the facility by rail car or tank truck. All containerized wastes are characterized before they are accepted at the container storage pad and are managed as if they were filled with free liquid. No waste is accepted from off site for storage or treatment at the facility until a representative sample has been analyzed and it has been determined that the waste can be managed safely in conformance with all applicable permits. Management of the wastes includes design spill calculation, verification that container labels match manifests, and compatibility determination based on process knowledge, testing, and material safety data sheets ( MSDS) ( Rohm and Haas 1996).

Waste streams generated at the facility are generally stored in one of three storage tanks and are treated in QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 121 the facility's boiler. In addition, the facility accepts similar hazardous and nonhazardous wastes from other Rohm and Haas facilities to burn for energy recovery in the boiler. These plants manufacture acrylic monomers, plastics and resins, pesticides, plasticizers, and specialty chemicals. The Rohm and Haas research center in Spring House, Pennsylvania, may also send waste to the Louisville plant ( Rohm and Haas 1996).

After they have been accurately characterized, the wastes are transported to one of three stainless steel tanks (# 64140, # 64141, and # 64250) or the container storage pad on site. The storage pad is located in the north central portion of the facility and stores material that is being held for shipment for off site management or transport to the boiler for incineration. The pad has a concrete berm for spill containment. The enclosed tanks are used to store liquid hazardous wastes before they are burned in the boiler. Tanks # 64140 and # 64141 primarily receive wastes from rail cars and directly by pipeline, while Tank # 64250 primarily receives wastes from tank trucks and directly by pipeline. All three units include sumps and have concrete dikes for secondary containment ( Rohm and Haas 1996). Both the tanks and the container storage pad were constructed to provide an approved location to store of hazardous waste for longer than 90 days. ( Rohm and Haas 1996).

Based on discussions with Pat Moran, Environmental Manager of Rohm and Haas, only two of the original five boilers onsite ( Nos. 100, 200, 300, 400, and 500) are in operation: Boiler No. 100 and Boiler No. 500 ( Tetra Tech 2001a). Boilers 200, 300, and 400 were shut down in the early 1990s. Because Boiler No. 500 is not permitted to treat hazardous wastes, hazardous wastes managed by Rohm and Haas are treated only in Boiler No. 100 ( Tetra Tech 2001a). Specifically, Boiler No. 100 is a forced draft A. B. Combustion Engineering type 35 A 14 packaged water tube boiler designed to provide superheated steam at about 400 pounds per square inch gauge ( psig). The combustion chamber is sealed to prevent fugitive emissions. The flue gases are discharged to the atmosphere through Stack No. 3, which is a 65 foot tall stack. No APCDs are provided for dust abatement to the stack. The production capacity of the packaged boiler is 180,000 pounds per hour ( lbs/ hr) of steam. The schematic for Boiler No. 100 shows waste feed mechanisms, a combustion chamber, and a flue gas stack ( CDM 1999).

Information on the regulatory history of Rohm and Haas was limited to the Dispersion Modeling Documentation for Compliance Certification of Boiler No. 100 Burning Hazardous Waste Exhausting from Stack No. 3 ( CDM 1999). Rohm and Haas submitted several Precompliance Certification forms in November 1999. Precompliance Certification Form 1 established allowable feed rates before compliance testing began. Precompliance Certification Form 2 calculated the estimated uncontrolled emissions for each feed stream for compliance with standards for particulate matter, metals, hydrogen chloride, and chlorine. Rohm and Haas completed a separate form for each feed stream. Precompliance Certification Form 3 calculated the estimated controlled emissions for compliance with standards for particulate matter, Tier II or III metals, hydrogen chloride, and chlorine. Precompliance Certification Form 4 compared the total allowable emission rates to total emission rates for compliance with the particulate matter, Tier II or III metals, hydrogen chloride, and chlorine standards. Precompliance Certification Form 5 documented the feed rate limits for ash, metals, and chlorine during the precompliance period. Precompliance Certification Form 7 documented the adjusted Tier I feed rate limits for metals and chlorine during the precompliance period. Also in November 1999, Rohm and Haas submitted two Compliance Test Notification forms. Compliance Test Notification Form 3 described the testing planned for Stack 3. The test was intended to QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 122 demonstrate compliance with emission limits for carbon monoxide and particulate matter while feeding hazardous liquid at the maximum rate. Compliance Test Notification Form 4 documented the planned versus allowable feed rate limits. In addition, Rohm and Haas submitted a RCRA Part B permit application in January 2001 that included a Screening Level Ecological Risk Assessment Protocol ( S

F° Risk, LC [ SAF] 2001b), a Human Health Risk Assessment Protocol ( SAF 2001a), and a BIF Trial Burn Plan ( Rohm and Haas 2001). QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 123 Rohm and Haas is operating Boiler No. 100 under interim status pursuant to Hazardous Waste Management Permit No. KYD 006 390 017 in Jefferson County. The facility is also operating under Air Pollution Control Permit No. 449 90 0, which expired March 03, 2001.

2.12.2 Risk Based Facility Prioritization This section describes findings relative to assigning Rohm and Haas to one of the three prioritization groupings using the risk based facility prioritization strategy. Specifically, the following prioritization table presents the results for the individual qualitative guiding factors evaluated in the Rohm and Haas Qualitative Risk Check Report ( EPA 2001m). In addition, the table also identifies which prioritization grouping the overall facility was assigned to using the risk based facility prioritization strategy. The paragraph following the prioritization table provides further justification supporting why the facility was assigned to its specific prioritization grouping. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 124 OVERALL RISK BASED FACILITY PRIORITIZATION QUALITATIVE GUIDING FACTOR PRIORITIZATION GROUPING Low Medium High Section <IP_ADDRESS>   Volumes and Types of Waste Being Burned

Section <IP_ADDRESS>   Emissions Quantification

Section 2.2.2   Other On site and Off site Emission Sources

Section <IP_ADDRESS>   Terrain Characteristics

Section <IP_ADDRESS>   Land Use for Dispersion Coefficients and Surface Roughness

Section <IP_ADDRESS>   Building Wake Effects

Section <IP_ADDRESS>   Particle Size Distribution

Section <IP_ADDRESS>   Meteorological Conditions

Section <IP_ADDRESS>   Physical Source Parameters

Section <IP_ADDRESS>   ( Receptor) Grid Node Array

Section 4.2.1   Type of Receptors and Exposure Scenario( s)

Section 4.2.2   Proximity to Exposure Scenario Location

Section 4.2.3   Presence or Absence and Proximity of Water Bodies and Water Sheds

Section 4.2.4   Proximity to Special Subpopulations

Section 4.2.5   Presence or Absence and Proximity of Ecological Areas

Section 4.2.6   Public Concerns

Rohm and Haas Louisville, Kentucky Risk based Prioritization Grouping: Medium Based on ( 1) a review of the individual qualitative guiding factors and their associated groupings presented in the above table, and ( 2) consideration of how each qualitative guiding factor interrelates collectively,

Rohm and Haas has been assigned to the medium prioritization group utilizing the overall risk based QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 125 prioritization strategy. The medium designation is intended to heighten the awareness of several key factors that indicate an increased potential for adverse impacts to human health and the environment. However,

when compared with facilities assigned to the high prioritization grouping, Rohm and Haas's potential risk impacts are clearly lower than those facilities assigned to the high prioritization grouping. In addition, even though several individual guiding factors were assigned to the high prioritization grouping, there is less additive interaction between the qualitative guiding factors for this facility and increased uncertainty, which limits definitive qualitative conclusions. Specifically, the decision to assign Rohm and Haas to the medium prioritization grouping is supported by the following key factors:

Rohm and Haas treats an estimated 35 million pounds of on and off site hazardous waste annually in Boiler No. 100, which is not fitted with an APCD. These wastes are known or permitted to contain common risk drivers, including mercury, pesticides, and formaldehyde. In comparison, facilities that are grouped in the high prioritization grouping typically have multiple sources and treat larger amounts of waste, and facilities assigned to the low prioritization grouping typically treat well characterized waste generated on site that does not contain common risk drivers.

Rohm and Haas has not performed a trial burn designed to support a site specific risk assessment; therefore, information on actual stack emission is limited.

Presence and proximity of residential, farmer, fisher, and acute exposure scenarios. Specifically, the closest residential exposure scenario is located only 800 meters from the facility boundary.

Presence and proximity and numerous water bodies and their associated watersheds within 3 kilometers from the facility boundary.

Presence of threatened or endangered species ( e. g., six species of mussels) in the study area.

Potentially significant documented public concerns are associated with facility operations. In comparison, facilities assigned to the low prioritization groupings typically do not have significant documented public concerns.

For a detailed discussion on site specific qualitative guiding factors, refer to the Rohm and Haas Qualitative Risk Check Report ( EPA 2001m). Several individual qualitative guiding factors assigned to the medium and high prioritization groupings indicate an increased potential for adverse risk impacts. The decision to assign Rohm and Haas to the medium prioritization grouping is further supported based on a QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 126 comparison with the other 12 facilities included in this report. Rohm and Haas consistently exhibited characteristics similar to those facilities assigned to the medium prioritization grouping. Although the potential for adverse health impacts has been established, Rohm and Haas was not assigned to the high prioritization grouping based on the lack of multiple complicating factors characteristic of the high prioritization grouping. For example, although the closest residential exposure scenarios are located within approximately 800 meters from the facility boundary, when compared to the high grouping facilities, the number of emission sources and volume and type of wastes does not support the allocation of Rohm and Haas into the high prioritization grouping. Therefore, based on a review of site specific characteristics and a comparison to the other facilities in this report, it has been determined that Rohm and Haas is best represented by facilities assigned to the medium priority grouping and lacks commonalities or similar sitespecific conditions associated with facilities assigned to the low and high priority groupings.

As discussed in Section 1.2, placement into the medium prioritization group confirms the need for a sitespecific risk assessment since facilities in this grouping have an increased potential to contribute to adverse impacts to human health and the environment. Further, consistent with the findings presented in the Rohm and Haas Qualitative Risk Check Report ( EPA 2001m), a site specific quantitative risk assessment at the Rohm and Haas facility is recommended to provide the facility and permitting authority with the information necessary to assess potential liabilities and ensure the protection of human health and the environment.

2.12.3 MACT Based Facility Prioritization This section describes the process and findings relative to assigning Rohm and Haas to one of the three prioritization groupings based on the MACT based facility prioritization strategy. The following prioritization table presents the results for the individual qualitative guiding factors evaluated in the Rohm and Haas Qualitative Risk Check Report ( EPA 2001m). In addition, the table also identifies which facility specific prioritization group the Rohm and Haas facility was assigned to. The paragraph following the prioritization table provides the basis for why the facility was assigned to a specific prioritization grouping. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 127 QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 128 MACT BASED FACILITY PRIORITIZATION TABLE QUALITATIVE GUIDING FACTORS PRIORITIZATION GROUPING Low Medium High Section <IP_ADDRESS>   Volumes and Types of Waste Being Burned

Section <IP_ADDRESS>   Emissions Quantification

Section 2.2.2   Other On site and Off site Emission Sources

Section <IP_ADDRESS>   Terrain Characteristics

Section <IP_ADDRESS>   Land Use for Dispersion Coefficients and Surface Roughness

Section <IP_ADDRESS>   Building Wake Effects

Section <IP_ADDRESS>   Particle Size Distribution

Section <IP_ADDRESS>   Meteorological Conditions

Section <IP_ADDRESS>   Physical Source Parameters

Section <IP_ADDRESS>   ( Receptor) Grid Node Array

Section 4.2.1   Type of Receptors and Exposure Scenario( s)

Section 4.2.2   Proximity to Exposure Scenario Location

Section 4.2.3   Presence or Absence and Proximity of Water Bodies and Water Sheds

Section 4.2.4   Proximity to Special Subpopulations

Section 4.2.5   Presence or Absence and Proximity of Ecological Areas

Section 4.2.6   Public Concerns

Rohm and Haas Louisville, Kentucky MACT Based Prioritization Grouping: High As discussed in Section 1.1, while Phase I MACT standards do not apply to facilities operating hazardous waste fueled boilers, it is believed that the development of future Phase II MACT standards, which will apply to facilities operating boilers, will also include a national MACT risk assessment. With this QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 129 assumption in mind, it is also believed that the qualitative guiding factors listed in section 1.0 and the known limitations of the Phase I national MACT risk assessment will also apply to boilers. As a result, the same criteria for evaluating and assigning facilities that are subject to Phase I MACT standards to one of the three prioritization groupings utilizing the MACT based facility prioritization strategy are also applied to facilities with boilers. Based on ( 1) a review of the individual qualitative guiding factors and their associated groupings presented in the table above, and ( 2) consideration of how each qualitative guiding factor interrelates collectively, Rohm and Haas has been assigned to the high prioritization group utilizing the MACT based prioritization strategy. In addition, when compared with the 12 other facilities included in this summary report, Rohm and Haas clearly exhibits multiple complicating factors that individually or collectively support its designation in the high prioritization grouping. This designation is intended to heighten the awareness of several key factors that indicate the potential for remaining adverse risk impacts even after compliance with future MACT Standards. Specifically, the decision to assign Rohm and Haas to the high prioritization grouping is supported by the following key factors:

Presence of 35 million pounds per year of highly variable hazardous waste received from both on and off site sources known or permitted to contain chemicals not expected to be covered under future MACT standards ( e. g., non dioxin PICs, 10 of the 12 PBTs). Since future MACT limits are not expected to apply to all stack emissions, the potential for adverse health impacts from these emissions exists. In comparison with the lower prioritization groupings, Rohm and Haas exhibits multiple site specific characteristics and complex individual and additive qualitative guiding factors which indicate an increased potential from those facilities in the low and medium groupings.

Presence of other significant on site fugitive emission sources ( e. g., 133,900 pounds of emissions from fugitive sources as reported in 1999 TRI inventory). Fugitive emission sources were not evaluated in the national MACT risk assessment conducted to support development of current Phase I MACT Standards, nor are they expected to be considered in the national MACT risk assessment conducted during the development of future Phase II MACT Standards. The presence of potentially significant amounts of fugitive emissions indicates a clear increased potential for adverse impacts. In addition, when compared with facilities assigned to the lower prioritization groupings, Rohm and Haas is capable of emitting more known risk drivers as fugitive emissions due to its highly variable waste feed than the facilities in the low and medium groupings.

Utilizing the same modeling methodologies presented in the national MACT risk assessment for selecting the appropriate terrain option would result in the misclassification of terrain in the Rohm and Haas assessment area. This mis classification QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 130 increases the potential that the concentration and deposition will be underestimated in areas with increased terrain. Since areas with increased terrain elevation are present in the assessment area and many of them are known or capable of supporting the default exposure pathways, there is an increased potential that the national MACT risk assessment that is expected to support Phase II MACT limits underestimated risk in these areas. As a result, there is an increased potential that the Phase II MACT limits will result in higher risk estimates than originally predicted. Therefore, protection to human health and the environment under the Phase II MACT standards cannot be confirmed without the introduction of additional site specific information and a sitespecific refinement to air dispersion modeling methodologies, which were not included in the national MACT risk assessment to support Phase I MACT standards.

Particle size distributions utilized in the national MACT risk assessment to support Phase I MACT standards were not source specific, but were generalized based on combustion unit type. As stated above, it is assumed that the national MACT risk assessment to support Phase II MACT standards will utilize the same methodologies as those used in the national MACT risk assessment to support Phase I MACT standards. Defining particle size distribution by combustion unit type introduces significant uncertainty, thereby resulting in the inability to accurately quantify risk impacts. Due to this potentially significant uncertainty, protection based on compliance with future Phase II MACT Limits cannot be inferred based on this methodology, but will require additional site specific risk assessment activities, including introduction of representative particle size distribution data collected as part of a trial burn designed to support a site specific risk assessment.

The national MACT risk assessment conducted to support Phase I MACT limits did not include an evaluation of acute exposure, and it is assumed that the national MACT risk assessment to support Phase II MACT standards will utilize the same methodologies. Since actual and potential acute exposure scenario locations are located in close proximity to the facility, no definitive conclusions regarding the protectiveness of MACT standards can be made without additional risk assessment activities.

Residential exposure scenario locations are located in close proximity ( i. e., within 800 meters) to the Rohm and Haas facility. The Phase I national MACT risk assessment utilized 16 sector based grid averaging. Based on the assumption that the same approach will be utilized in future MACT risk assessments, this approach, when applied on a site specific basis, may result in the averaging of locally elevated media concentrations ( hotspots), resulting in the potential underestimation of upper bound risk estimates for those exposure scenario located in close proximity to Rohm and Haas. Due to this potential underestimation, protection based on compliance with future Phase II MACT limits alone cannot be inferred, which further establishes the need for additional risk assessment activities.

The selection of representative water bodies in the national MACT risk assessment to support Phase I MACT limits may have been biased to meet multiple selection criteria, QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 131 resulting in the potential for overlooking more heavily impacted water bodies and their associated watersheds, which may result in the underestimation of risk to receptors. Assuming that the national MACT risk assessment expected to be conducted to support Phase II MACT limits will follow the same methodology, protection based on compliance with Phase II MACT limits alone cannot be inferred, which further establishes the need for additional risk assessment activities.

Established presence of significant ecological habitats in close proximity to the Rohm and Haas facility and ecological receptors, including threatened or endangered species ( e. g., six species of mussels). The national MACT Risk Assessment did not include a separate analysis or consideration of threatened or endangered species. Based on the assumption that future MACT risk assessment will also not include an evaluation of threatened or endangered species, there is an increased potential that future MACT standards may not ensure protection of human health and the environment.

For a detailed discussion on site specific qualitative guiding factors, refer to the Rohm and Haas Qualitative Risk Check Report ( EPA 2001m). Further justification for assigning Rohm and Haas to the high prioritization group is based on the fact that while some of the qualitative guiding factors evaluated for this facility have been individually assigned to the medium or low group, these individual guiding factors alone do not justify demoting the facility to a lower prioritization grouping. Additionally, the site specific characteristics at the Rohm and Haas facility exhibits the complex interplay or additive relationships between guiding factors typically found in the facilities assigned to the high prioritization group.

Therefore, based on a review of site specific characteristics and a comparison to the other facilities in this report, it has been determined that, for the MACT based prioritization grouping, Rohm and Haas is best represented by facilities assigned to the high priority grouping and exhibits multiple site specific characteristics that clearly indicate an increased potential for adverse health impacts.

As discussed in Section 1.2, placement into the high prioritization group confirms the need for conducting additional site specific risk assessment activities at the Rohm and Haas facility in order to quantify risk impacts to human health and the environment, since facilities in this grouping have the largest potential for contributing to adverse health impacts. Therefore, consistent with the Rohm and Haas Qualitative Risk Check Report ( EPA 2001m), additional site specific risk assessment activities are warranted and will help both the facility and permitting authority demonstrate that compliance with future MACT standards meet the requirements of the RCRA omnibus provisions.

2.13 TENNESSEE EASTMAN QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 132 This section presents the information and approach used in assigning Tennessee Eastman ( Eastman) to one of the three prioritization groupings based on ( 1) the facility's overall potential for resulting in adverse health impacts and ( 2) an assessment of the protectiveness of current or future MACT standards to determine if additional permit limits may be required to ensure protection of human health and the environment. Section 2.13.1 presents facility specific background information including process descriptions and permit history. Section 2.13.2 describes the process and findings used to assign a facility to one of the three prioritization groupings specific to the risk based facility prioritization strategy. Section 2.13.3 describes the process and findings used to assign a facility to one of the three prioritization groupings following the MACT based facility prioritization strategy. Specific sources of information used to evaluate the Eastman facility are cited and referenced at the end of this report.

2.13.1 Facility Information The following summarizes the facility specific information provided in Section <IP_ADDRESS> of the Eastman Qualitative Risk Check Report ( EPA 2001g). This information is intended to provide a general facility overview, including process descriptions and permit history.

Eastman is a privately owned facility that manufactures chemicals, fibers, and plastics. The Eastman facility is located on Eastman Road, about 3 kilometers southeast of Kingsport in Sullivan County,

Tennessee. The facility is situated at the foothills of the Appalachian mountains in a region known as the Tri Cities Tennessee/ Virginia region. The property consists of approximately 1,000 acres and was first established in 1920 to produce methanol for use in Kodak's photographic film base ( Eastman 2000). The facility operates an on site industrial wastewater treatment system ( IWWTS) to treat wastewater from its operations. Eastman also operates three hazardous waste combustion areas consisting of eight Boiler and Industrial Furnace ( BIF) boilers, two rotary kiln incinerators ( RKI), and one liquid chemical destructor ( LCD) under a permit issued by the Tennessee Hazardous Waste Management Act and RCRA ( Eastman 1999b). Constructed features on the facility property include ( 1) the manufacturing facility, which includes the boilers and incinerators; ( 2) industrial landfills; ( 3) a wastewater treatment plant; and ( 4) several administrative buildings. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 133 The facility's two RKIs and its LCD are subject to the requirements of RCRA promulgated at 40 CFR 260 through 263, 265, 268, and 270, and the equivalent Tennessee Department of the Environment and Conservation ( TDEC) state regulations. The facility's boilers are subject to the BIF Rule requirements of RCRA promulgated at 40 CFR 266 Subpart H and Part 268 Subpart D and the equivalent TDEC state regulations.

Most of the materials managed in these units are generated on site. However, small quantities of hazardous and nonhazardous wastes may be received from off site facilities owned or operated by Eastman,

subsidiaries of Eastman, or product distribution sites under contract to Eastman ( Eastman 1999b). Waste treated in the RKIs and the LCD is stored in one of four storage tanks or in one of nine container storage areas prior to treatment. The container storage areas include four trailer pads and two warehouse areas ( Eastman 1999b). Waste treated in the boilers is not stored in tanks, but in containers ( tank trailers and dumpster tanks) designed to hold waste chemicals ( Eastman 1998a). These trailers and dumpster tanks are unloaded on one of two unloading pads prior to treatment.

Eastman operates a total of eight on site hazardous waste boilers ( Eastman 1998a). Boilers 18 through 24 are stoker fed, coal fired boilers with a steam rating of 196 to 476 million British thermal units per hour ( MMBtu/ hr) ( Eastman 1998b, c, d). Boilers 18 through 22 are used for thermal treatment of biosludge from the on site industrial wastewater treatment system ( IWWTS) and solid wastes ( in pellet and powder form).

The biosludge stream consists of de watered biological solids from the belt filters and solids from the grit dewatering system of the IWWTS. Boilers 23 and 24 are used for thermal treatment of biosludge, solid waste, and other pumpable liquid waste chemicals. Flue gas from all seven boilers exhaust through three interconnected, 225 foot tall stacks ( Eastman 1998 b, c, d). Boiler 30 is a pulverized coal, suspension fired boiler with a steam rating of 780 MMBtu/ hr ( Eastman 1998e). Boiler 30 is used for thermal treatment of pumpable liquid waste chemicals and nonhazardous process gas and exhausts through a dedicated, 375

foot tall stack. Based on information provided by EPA Region 4, Boiler 30 is in the process of being shut down ( EPA 2000a).

Eastman also operates two RKIs and one LCD ( Eastman 1999a). The RKIs are horizontal, cylindrical,

refractory lined chambers with a " nameplate" design capacity of 40 to 50 MMBtu/ hr. Both hazardous and QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 134 nonhazardous liquid and solid wastes are treated in the RKIs at temperatures ranging from 1,450 to 1,850 oF. Uncombusted kiln gas and relatively high Btu (> 5000 Btu/ pound) waste liquids are further treated in the combustion system at temperatures ranging from 1,700 to 2,100 oF. The RKIs are equipped with an induced draft ( ID) fan, which exhausts directly to a shared, 200 foot tall by 10 foot inside diameter stack.

The LCD is a horizontal, rectangular, refractory lined chamber with a " nameplate" design capacity of 50 MM Btu/ hr. Both hazardous and nonhazardous wastes are treated in the LCD at temperatures ranging from 1,650 to 2,100 oF. The LCD is equipped with an ID fan, which exhausts directly to a 50 foot tall by 42.5 inch inside diameter stack.

Since 1980, Eastman has been operating its boilers under interim status as defined by federal regulations governing BIF facilities and air quality operating permits issued by EPA Region 4. The two RKIs and the LCD were originally permitted in September 1989 ( Permit No. TNHW 025). Eastman submitted a RCRA Part A permit application in August 1991. In September 1991, Eastman submitted a Certification of Compliance for Boilers 21 and 22. Eastman submitted a revised Certification of Precompliance for Boilers 18, 19, 20, 23, 24, and 30 in December 1991. In March 1992, Eastman submitted a revised Certification of Precompliance for Boilers 18, 19, 20, 23, 24, and 30. In August 1992, Eastman submitted a Certification of Compliance for Boilers 18, 19, 20, 23, 24, and 30. In December 1998, Eastman submitted a RCRA Part A and Part B permit application, a trial burn plan, and a risk assessment work plan to EPA.

The Part B permit application is currently under review by EPA Region 4 and the TDEC.

2.13.2 Risk Based Facility Prioritization This section describes findings relative to assigning Eastman to one of the three prioritization groupings using the risk based facility prioritization strategy. Specifically, the following prioritization table presents results for the individual qualitative guiding factors evaluated in the Eastman Qualitative Risk Check Report ( EPA 2001g). In addition, the table also identifies which prioritization grouping the overall facility was assigned to using the risk based facility prioritization strategy. The paragraph following the prioritization table provides further justification supporting why the facility was assigned to a specific prioritization grouping. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 135 OVERALL RISK BASED FACILITY PRIORITIZATION QUALITATIVE GUIDING FACTOR PRIORITIZATION GROUPING Low Medium High Section <IP_ADDRESS>   Volumes and Types of Waste Being Burned

Section <IP_ADDRESS>   Emissions Quantification

Section 2.2.2   Other On site and Off site Emission Sources

Section <IP_ADDRESS>   Terrain Characteristics

Section <IP_ADDRESS>   Land Use for Dispersion Coefficients and Surface Roughness

Section <IP_ADDRESS>   Building Wake Effects

Section <IP_ADDRESS>   Particle Size Distribution

Section <IP_ADDRESS>   Meteorological Conditions

Section <IP_ADDRESS>   Physical Source Parameters

Section <IP_ADDRESS>   ( Receptor) Grid Node Array

Section 4.2.1   Type of Receptors and Exposure Scenario( s)

Section 4.2.2   Proximity to Exposure Scenario Location

Section 4.2.3   Presence or Absence and Proximity of Water Bodies and Water Sheds

Section 4.2.4   Proximity to Special Subpopulations

Section 4.2.5   Presence or Absence and Proximity of Ecological Areas

Section 4.2.6   Public Concerns

Eastman Kingsport, Tennessee Risk based Prioritization Grouping: High Based on ( 1) a review of the individual qualitative guiding factors and their associated groupings presented in the above table, and ( 2) consideration of how each qualitative guiding factor interrelates collectively,

Eastman has been assigned to the high prioritization grouping utilizing the overall risk based prioritization strategy. The high designation is intended to heighten the awareness of several key factors that indicate an QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 136 increased potential for adverse impacts to human health and the environment. In addition, when compared with the 12 other facilities included in this summary report, Eastman clearly exhibits multiple complicating factors that individually or collectively support its designation to the high prioritization grouping.

Specifically, the decision to assign Eastman to the medium prioritization grouping is supported by the following key factors:

Presence of three on site incinerators and eight boilers. In comparison, facilities assigned to the low prioritization grouping typically only operate a single hazardous waste combustor.

Presence of highly variable hazardous waste received mainly from off site sources. In comparison, facilities assigned to the lower prioritization groupings typically treat well or moderately characterized waste.

Eastman treats an estimated 40,000 tons of hazardous wastes in its boilers, RKIs, and LCD annually. These wastes are known or permitted to contain toxic and bioaccumulative compounds, including known PBTs and common risk drivers. In comparison, facilities assigned to the lower prioritization groupings typically treat significantly less waste, which does not contain known PBTs or common risk drivers.

Eastman has not performed a trial burn designed to support a site specific risk assessment; therefore, information on actual stack emission is limited.

Presence and proximity of residential, farmer, fisher, and acute exposure scenarios. Specifically, the closest residential exposure scenario is located within 1 kilometer from the facility boundary.

The risk assessment work plan indicates that no on site modeling will be performed. Due to the large size of the Eastman Facility property ( i. e., over 1,000 acres) this issue may be significant, since potential on site receptors ( e. g., ecological, grazing, etc.) would be overlooked due to a lack of air dispersion modeling data. In addition, due to the size of the Eastman property, there is an increased likelihood that maximum concentration and deposition will occur within the facility boundary.

Presence and proximity of numerous water bodies and their associated watersheds within 3 kilometers from the facility boundary.

Presence of over 60 threatened or endangered species. It should be noted; however, that their presence within close proximity or within the facility boundary has not been confirmed.

Potentially significant public concerns are documented in association with the facility. In comparison, facilities assigned to the low prioritization grouping typically do not have QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 137 documented, significant public concerns. For a detailed discussion on site specific qualitative guiding factors, refer to the Eastman Qualitative Risk Check Report ( EPA 2001g). Further justification for assigning Eastman to the high prioritization grouping is based on the relationship or complex interplay associated with many of the qualitative guiding factors individually assigned to the medium and high prioritization grouping. For example, Eastman treats a large quantity of highly variable wastes in one of three on site incinerators and eight boilers. The waste feed is also known or permitted to contain RCRA D, F, and U listed wastes, which may include toxic and bioaccumulative compounds including known PBTs. The potential for adverse health impacts is further increased by the close proximity ( i. e., within 1 kilometer) of existing exposure scenario locations. Other complicating factors include the presence of ecological areas known or anticipated to support threatened or endangered species and documented public concerns. When these factors are considered collectively, the potential for adverse health impacts associated with Eastman emissions is increased, especially when compared with the 12 other facilities included in this summary report. For these reasons, Eastman was assigned to the high prioritization grouping to increase the awareness of the issues discussed above and to help the facility and permitting authority allocate and prioritize their resources in order to efficiently address any potential liabilities and provide quantitative results supporting conclusions regarding potential impacts, if any, to human health and the environment. Therefore, based on a review of site specific characteristics and a comparison to the other facilities in this report, it has been determined that Eastman is best represented by facilities assigned to the high priority grouping and lacks commonalities or similar sitespecific conditions associated with facilities assigned to the low and high priority groupings.

As discussed in Section 1.2, placement into the high prioritization group confirms the need for conducting additional site specific risk assessment activities at the Eastman facility in order to quantify risk impacts to human health and the environment, since facilities in this grouping have the largest potential for contributing to adverse health impacts. Therefore, consistent with the Eastman Qualitative Risk Check Report ( EPA 2001g), additional site specific risk assessment activities are warranted and will help both the facility and permitting authority demonstrate that the Eastman facility meets the requirements of the RCRA omnibus provisions. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 138 2.13.3 MACT Based Facility Prioritization This section describes the process and findings relative to assigning Eastman to one of the three prioritization groupings based on the MACT based facility prioritization strategy. The following prioritization table presents the results for the individual qualitative guiding factors evaluated in the Eastman Qualitative Risk Check Report ( EPA 2001g). In addition, the table also identifies which facilityspecific prioritization group the Eastman facility was assigned to. The paragraph following the prioritization table provides the basis for why the facility was assigned to its specific prioritization grouping. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 139 MACT BASED FACILITY PRIORITIZATION TABLE QUALITATIVE GUIDING FACTORS PRIORITIZATION GROUPING Low Medium High Section <IP_ADDRESS>   Volumes and Types of Waste Being Burned

Section <IP_ADDRESS>   Emissions Quantification

Section 2.2.2   Other On site and Off site Emission Sources

Section <IP_ADDRESS>   Terrain Characteristics

Section <IP_ADDRESS>   Land Use for Dispersion Coefficients and Surface Roughness

Section <IP_ADDRESS>   Building Wake Effects

Section <IP_ADDRESS>   Particle Size Distribution

Section <IP_ADDRESS>   Meteorological Conditions

Section <IP_ADDRESS>   Physical Source Parameters

Section <IP_ADDRESS>   ( Receptor) Grid Node Array

Section 4.2.1   Type of Receptors and Exposure Scenario( s)

Section 4.2.2   Proximity to Exposure Scenario Location

Section 4.2.3   Presence or Absence and Proximity of Water Bodies and Water Sheds

Section 4.2.4   Proximity to Special Subpopulations

Section 4.2.5   Presence or Absence and Proximity of Ecological Areas

Section 4.2.6   Public Concerns

Eastman Kingsport, Tennessee MACT based Prioritization Grouping: High As discussed in Section 1.1, while Phase I MACT standards do not apply to facilities operating hazardous waste fueled boilers, it is believed that development of future Phase II MACT standards, which will apply to facilities operating boilers, will also include a national MACT risk assessment. With this assumption in mind, it is also believed that the qualitative guiding factors listed in section 1.0 and the known limitations of QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 140 the Phase I national MACT risk assessment will also apply to boilers. As a result, the same criteria for evaluating and assigning facilities that are subject to Phase I MACT standards to one of the three prioritization groupings utilizing the MACT based facility prioritization strategy are also applied to facilities with boilers. Based on ( 1) a review of the individual qualitative guiding factors and their associated groupings presented in the table above, and ( 2) consideration of how each qualitative guiding factor interrelates collectively, Eastman has been assigned to the high prioritization grouping utilizing the MACT based prioritization strategy. In addition, when compared with the 12 other facilities included in this summary report, Eastman clearly exhibits multiple complicating factors that individually and collectively support its designation in the high prioritization grouping. This designation is intended to heighten the awareness of several key factors that indicate the potential for remaining adverse risk impacts even after compliance with future MACT Standards. Specifically, the decision to assign Eastman into the high prioritization grouping is supported by the following key factors:

Presence of 80 million pounds per year of highly variable hazardous waste received primarily from off site sources that are known or permitted to contain chemicals not expected to be covered under MACT standards ( e. g., non dioxin PICs, 10 of the 12 PBTs, and other toxic metals). Since current MACT limits do not apply to all stack emissions ( and future MACT limits are not expected to apply), the potential for adverse health impacts from these emissions exists. In comparison with the lower prioritization groupings, Eastman exhibits multiple site specific characteristics and complex individual and additive qualitative guiding factors that indicate an increased potential from those facilities in the low and medium groupings.

Presence of other significant on site fugitive emission sources ( e. g., 980,000 pounds of emissions from fugitive sources as reported in 1999 TRI inventory). Fugitive emission sources were not evaluated in the national MACT risk assessment conducted to support development of current Phase I MACT Standards, nor are they expected to be considered during in the national MACT risk assessment conducted during development of future Phase II MACT Standards. The presence of potentially significant amounts of fugitive emissions indicates a clear increased potential for adverse impacts. In addition, when compared with facilities ed to the lower prioritization groupings, Eastman is capable of emitting more known risk drivers as fugitive emissions due to its highly variable waste feed than the facilities in the low and medium groupings.

Utilizing the same modeling methodologies presented in the national MACT risk assessment for selecting the appropriate terrain option would result in the misclassification of terrain in the Eastman assessment area. This mis classification increases the potential that concentration and deposition will be underestimated in QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 141 areas with increased terrain. This issue is especially important in the Eastman assessment area since many exposure scenario locations are located in areas of increased terrain. Since areas with increased terrain elevation are present in the assessment area, and many of them are known or capable of supporting the default exposure pathways, there is an increased potential that the national MACT risk assessment that supported Phase I MACT limits underestimated risk in these areas. As a result, there is an increased potential that the Phase I and Phase II MACT limits will result in higher risk estimates than originally predicted. Therefore, protection of human health and the environment under the Phase I and Phase II MACT standards cannot be confirmed without introducing of additional site specific information and a site specific refinement to air dispersion modeling methodologies.

Particle size distributions utilized in the national MACT risk assessment to support Phase I MACT standards were not source specific, but were generalized based on combustion unit type. As stated above, it is assumed that the national MACT risk assessment to support Phase II MACT standards will utilize the same methodologies as those used in the national MACT risk assessment to support Phase I MACT standards. Defining particle size distribution by combustion unit type introduces significant uncertainty, thereby resulting in the inability to accurately quantify risk impacts. Due to this potentially significant uncertainty, protection based on compliance with current and future MACT Limits cannot be inferred based on this methodology, but will require additional site specific risk assessment activities, including introduction of representative particle size distribution data collected as part of a trial burn designed to support a site specific risk assessment.

The national MACT risk assessment conducted to support Phase I MACT limits did not include an evaluation of acute exposure, and it is assumed that the national MACT risk assessment to support Phase II MACT standards will utilize the same methodologies. Since actual and potential acute exposure scenario locations are located in close proximity to the facility, no definitive conclusions regarding the protectiveness of MACT standards can be made without additional risk assessment activities.

Residential exposure scenario locations are located in close proximity ( i. e., within 1 kilometer) to the Eastman facility. The Phase I national MACT risk assessment utilized 16 sector based grid averaging. Based on the assumption that the same approach will be utilized in future MACT risk assessments, this approach ( when applied on a sitespecific basis) may result in the averaging of locally elevated media concentrations ( hotspots), resulting in the potential underestimation of upper bound risk estimates for those exposure scenarios located in close proximity to Eastman. Due to this potential underestimation, protection based on compliance with current and future MACT limits alone cannot be inferred, which further establishes the need for additional risk assessment activities. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 142

The selection of representative water bodies in the national MACT risk assessment to support Phase I MACT limits may have been biased to meet multiple selection criteria, resulting in the potential to overlook more heavily impacted water bodies and their associated watersheds, which may result in the underestimation of risk to receptors. Assuming that the national MACT risk assessment expected to be conducted to support Phase II MACT limits will follow the same methodology, protection based on compliance with current and future MACT limits alone cannot be inferred, which further establishes the need for additional risk assessment activities.

Established presence of significant ecological habitats in close proximity to the Eastman facility and ecological receptors, including over 60 threatened or endangered species. The national MACT risk assessment did not include a separate analysis or consideration of threatened or endangered species. Based on the assumption that future MACT risk assessment will also not include an evaluation of threatened or endangered species, there is an increased potential that current and future MACT standards may not ensure protection of human health and the environment.

For a detailed discussion on site specific qualitative guiding factors, refer to the Eastman Qualitative Risk Check Report ( EPA 2001g). Further justification for assigning Eastman to the high prioritization group is based on the fact that while some of the qualitative guiding factors evaluated for this facility have been individually assigned to the medium or low group, these individual guiding factors alone do not justify demoting the facility to a lower prioritization grouping. Additionally, the site specific characteristics at the Eastman facility exhibits the complex interplay or additive relationships between guiding factors typically found in the facilities assigned to the high prioritization group. Therefore, based on a review of sitespecific characteristics and a comparison to the other facilities in this report, it has been determined that,

for the MACT based prioritization grouping, Eastman is best represented by facilities assigned to the high priority grouping and exhibits multiple site specific characteristics that clearly indicate an increased potential for adverse health impacts.

As discussed in Section 1.2, placement into the high prioritization group confirms the need for conducting additional site specific risk assessment activities at the Eastman facility in order to quantify risk impacts to human health and the environment since facilities in this grouping have the largest potential for contributing to adverse health impacts. Therefore, consistent with the Eastman Qualitative Risk Check Report ( EPA 2001g), additional site specific risk assessment activities are warranted and will help both the facility and permitting authority demonstrate that compliance with current and future MACT standards meet the requirements of the RCRA omnibus provisions. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 143 REFERENCES Camp Dresser & McKee Inc. ( CDM). 1999. Dispersion Modeling Documentation for Compliance Certification of Boiler No. 100 Burning Hazardous Waste Exhausting from Stack No. 3. September.

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Tetra Tech EM Inc. ( Tetra Tech). 2001a. Record of Telephone Conversation Regarding Facility Operations at Rohm and Haas. Between Diana Harris, Environmental Scientist, and Pat Moran, Environmental Manager, Rohm and Haas. February 1.

Tetra Tech. 2001b. Record of Telephone Conversation Regarding Catalytica Facility Permitting and Trial Burn History. Between Kaitlin Boyce, Environmental Engineer, and Carl Utterback, North Carolina Department of the Environment and Natural Resources, RCRA Permit Writer. March 6.

Tetra Tech. 2001c. Record of Telephone Conversation Regarding Permit Status of First Chemical Facility. Between Kaitlin Boyce, Environmental Engineer, and Jay Bassett, EPA Region 4. March 26.

Tetra Tech. 2001d. Record of Telephone Conversation Regarding Mallinckrodt Permitting Status. Between Kaitlin Boyce, Environmental Engineer, and Hugh Hazen, EPA Region 4. April.

Tetra Tech. 2001e. Personal Communication Between Mr. Hugh Hazen, EPA Region 4, and Amanda Pryor, Environmental Scientist. May 9. QUALITATIVE RISK CHECK SUMMARY REPORT SEPTEMBER 2001 FACILITY PRIORITIZATION GROUPING 146 TRC. 1993. " RCRA Part B Permit Application for Operation of a Hazardous Waste Storage and Boiler/ Industrial Furnace Facility Volume I." July 15.

Triangle Environmental Group ( TEI). 1995. " Air Quality Modeling for Boiler and Industrial Furnace Regulations." August.

U. S. Environmental Protection Agency ( EPA). 1999. " Evaluation of Albemarle's Status Under the RCRIS Corrective Action Environmental Indicator Codes." Memorandum from Denise Housley, EPA Region 4 to John Litton, Division of Solid and Infectious Waste Management, South Carolina Department of Health and Environmental Control. October.

EPA. 2000. Personal correspondence between Tim Jarosch, Project Manager, Tetra Tech EM Inc. and EPA Region 4. November 28.

EPA. 2001a. LWD, Inc. Qualitative Risk Check Report. February 21.

EPA. 2001b. Catalytica Pharmaceuticals, Inc. Qualitative Risk Check Report. April 2.

EPA. 2001c. First Chemical Corporation Qualitative Risk Check Report. April 17.

EPA. 2001d. Giant Cement Company Qualitative Risk Check Report. May 22.

EPA. 2001e. Monsanto Company Qualitative Risk Check Report. June 5.

EPA. 2001f. Mallinckrodt Chemical Company Qualitative Risk Check Report. June 14.

EPA. 2001g. Tennessee Eastman Qualitative Risk Check Report. June 15.

EPA. 2001h. Diversified Scientific Services, Inc. Qualitative Risk Check Report. June 21.

EPA. 2001i. Albemarle Corporation Qualitative Risk Check Report. June 22.

EPA. 2001j. DSM Chemicals North America, Inc. Qualitative Risk Check Report. June 25.

EPA. 2001k. 3V, Inc. Qualitative Risk Check Report. June 27.

EPA. 2001l. GlaxoSmithKline, Inc. Qualitative Risk Check Report. June 27.

EPA. 2001m. Rohm and Haas Company Qualitative Risk Check Report. June 29.


[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Notices]
[Pages 18619-18620]
[FR Doc No: 2016-07241]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-48-000]

NextEra Energy Power Marketing, LLC and Northeast Energy
Associates, a Limited Partnership v. ISO New England Inc.; Notice of
Amendment to the Complaint

    Take notice that on March 21, 2016, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e (2012), and Rule
206 of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206 (2015), NextEra Energy Power
Marketing, LLC and Northeast Energy Associates, a Limited Partnership
(collectively, Complainants) filed an amendment to revise a number of
sentences in the text of the original complaint filed on March 18, 2016
against ISO New England Inc. (Respondent), alleging that Respondent
violated its Transmission, Markets and Services Tariff in preventing
the Significant Increase at NEA's Bellingham Energy Center (Bellingham)
from being added to Bellingham's summer Qualified Capacity in the tenth
Forward Capacity Auction that was held on February 8, 2016.
    Complainants certify that copies of the complaint were serve on
contacts for Respondent as listed on the Commission's list of Corporate
Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and

Procedure (18 CFR 385.211 and 385.214). Protests will be considered by
the Commission in determining the appropriate action to be taken, but
will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. The Respondent's answer and all
interventions, or protests must be filed on or before the comment date.
The Respondent's answer, motions to intervene, and protests must be
served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on April 7, 2016.

    Dated: March 22, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-07241 Filed 3-30-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34879-34880]
[FR Doc No: 2022-12361]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1425]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Mitigation Strategies
To Protect Food Against Intentional Adulteration

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 8, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0812. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Mitigation Strategies To Protect Food Against Intentional
Adulteration--21 CFR Part 121

OMB Control Number 0910-0812--Extension

    Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) certain
provisions protect against the intentional adulteration of food.
Section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional
adulteration in the context of facilities that manufacture, process,
pack, or hold food and are required to register under section 415 of
the FD&C Act (21 U.S.C. 350d). Section 419 of the FD&C Act (21 U.S.C.
350h) addresses intentional adulteration in the context of fruits and
vegetables that are raw agricultural commodities. Section 420 of the
FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the
context of high-risk foods and exempts farms except for farms that
produce milk. These provisions are codified at 21 CFR part 121 (part
121) and include requirements that an owner, operator, or agent in
charge of a facility must:
     Prepare and implement a written food defense plan that
includes a vulnerability assessment to identify significant
vulnerabilities and actionable process steps, mitigation strategies,
and procedures for food defense monitoring, corrective actions, and
verification (Sec.  121.126);
     identify any significant vulnerabilities and actionable
process steps by conducting a vulnerability assessment for each type of
food manufactured, processed, packed, or held at the facility using
appropriate methods to evaluate each point, step, or procedure in a
food operation (Sec.  121.130);
     identify and implement mitigation strategies at each
actionable process step to provide assurances that the significant
vulnerability at each step will be significantly minimized or prevented
and the food manufactured, processed, packed, or held by the facility
will not be adulterated. For each mitigation strategy implemented at
each actionable process step, include a written explanation of how the
mitigation strategy sufficiently minimizes or prevents the significant
vulnerability associated with the actionable process step (Sec.
121.135);
     establish and implement mitigation strategies management
components, as appropriate to ensure the proper implementation of each
such mitigation strategy, taking into account the nature of the
mitigation strategy and its role in the facility's food defense system
(Sec.  121.138);
     establish and implement food defense monitoring
procedures, for monitoring the mitigation strategies, as appropriate to
the nature of the mitigation strategy and its role in the facility's
food defense system (Sec.  121.140);
     establish and implement food defense corrective action
procedures that must be taken if mitigation strategies are not properly
implemented, as appropriate to the nature of the actionable process
step and the nature of the mitigation strategy (Sec.  121.145);
     establish and implement specified food defense
verification activities, as appropriate to the nature of the mitigation
strategy and its role in the facility's food defense system (Sec.
121.150);
     conduct a reanalysis of the food defense plan (Sec.
121.157);
     ensure that all individuals who perform required food
defense activities are qualified to perform their assigned duties
(Sec.  121.4); and
     establish and maintain certain records, including the
written food defense plan (vulnerability assessment, mitigation
strategies and procedures for food defense monitoring, corrective
actions, and verification) and documentation related to training of
personnel. All records are subject to certain general recordkeeping and
record retention requirements (Sec. Sec.  121.301 through 121.330).
    Under the regulations, an owner, operator, or agent in charge of a
facility must prepare, or have prepared, and implement a written food
defense plan, including written identification of actionable process
steps, written mitigation strategies, written procedures for defense
monitoring, written food defense corrective actions, and written food
defense verification procedures.
    The purpose of the information collection is to ensure compliance
with the provisions under part 121 related to protecting food from
intentional adulteration. The regulations are intended to address
hazards that may be intentionally introduced to foods, including by
acts of terrorism, with the intent to cause widespread harm to public
health. Under the regulations,

domestic and foreign food facilities that are required to register
under the FD&C Act are required to identify and implement mitigation
strategies to significantly minimize or prevent significant
vulnerabilities identified at actionable process steps in a food
operation.
    In an effort to reduce burden and assist respondents, FDA offers
tools and educational materials related to protecting food from
intentional adulteration, including FDA's Food Defense Plan Builder, a
user-friendly tool designed to help owners and operators of food
facilities develop a personalized food defense plan, and the Mitigation
Strategies Database, a database for the food industry providing a range
of preventative measures that firms may choose to implement. These and
other informational resources are available at https://www.fda.gov/food/food-defense/food-defense-tools-educational-materials. FDA also
offers a small entity compliance guide entitled ``Mitigation Strategies
to Protect Food Against Intentional Adulteration'' (August 2017) to
inform domestic and foreign food facilities about compliance with
regulations to protect against intentional adulteration. Further, FDA
developed two draft guidance documents entitled ``Mitigation Strategies
to Protect Food Against Intentional Adulteration: Draft Guidance for
Industry'' (March 2019) and ``Supplemental Draft Guidance for Industry:
Mitigation Strategies to Protect Food Against Intentional
Adulteration'' (February 2020). Once finalized, the draft guidance
documents would assist the food industry in developing and implementing
the elements of a food defense plan. These guidance documents are
available at https://www.fda.gov/food/food-defense. All Agency guidance
documents are issued in accordance with our good guidance practice
regulations in 21 CFR 10.115, which provide for public comment at any
time.
    Description of Respondents: The respondents to this information
collection are manufacturers, processors, packers, and holders of
retail food products marketed in the United States.
    In the Federal Register of December 17, 2021 (86 FR 71646), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           Activity; 21 CFR Section               Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food from very small                     18,080               1          18,080  0.5 (30 minutes).........................           9,040
 businesses; Sec.   121.5.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Certain facilities may qualify for an exemption under the
regulations. Because these facilities must provide documentation upon
request to verify their exempt status, we have characterized this as a
reporting burden.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Number of        No. of records      Total annual
        Activity; 21 CFR Section           recordkeepers     per recordkeeper       records         Average burden per recordkeeping      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Defense Plan; Sec.   121.126......              3,247                  1              3,247  23.................................             74,681
Actionable Process Steps; Sec.                       9,759                  1              9,759  20.................................            195,180
 121.130.
Mitigation Strategies; Sec.                          9,759                  1              9,759  20.................................            195,180
 121.135(b).
Monitoring Corrective Actions,                       9,759                  1              9,759  175................................          1,707,825
 Verification; Sec.  Sec.   121.140(a),
 121.145(a)(1), and 121.150(c).
Training;Sec.   121.160................            367,203                  1            367,203  0.67 (40 minutes)..................            246,026
Records; Sec.  Sec.   121.305 and                    9,759                  1              9,759  10.................................             97,590
 121.310.
                                        ----------------------------------------------------------------------------------------------------------------
    Total..............................  .................  .................  .................  ...................................          2,516,482
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments other than to
increase the burden estimate by 1,224 hours due to a corrected
calculation for the estimate related to training (Sec.  121.160).

    Dated: June 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12361 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P