Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 59523 

EPA-APPROVED LOUISIANA NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES

Name of SIP provision Applicable geographic or nonattainment area 

State submittal 

date/effective 

date 

EPA approval date Explanation 

* * * * * * * 

1997 8-Hour Ozone Section 

110 Maintenance Plan.

Calcasieu Parish (Lake 

Charles Area), LA.

7/20/07 10/09/08 [Insert FR page 

number where document 

begins].

1997 8-Hour Ozone Section 

110 Maintenance Plan.

St. James Parish, LA ............. 8/24/07 10/09/08 [Insert FR page 

number where document 

begins].

■ 3. Section 52.975, entitled, 

‘‘Redesignations and maintenance 

plans; ozone’’, is amended by adding a 

new paragraph (j) as follows: 

§ 52.975 Redesignations and maintenance 

plans; ozone. 

* * * * * 

(j) Approval. The Louisiana 

Department of Environmental Quality 

(LDEQ) submitted 1997 8-hour ozone 

NAAQS maintenance plans for the areas 

of Calcasieu and St. James Parishes on 

July 20, 2007, and August 24, 2007, 

respectively. The two areas are 

designated unclassifiable/attainment for 

the 1997 8-hour ozone standard. EPA 

determined these requests for Calcasieu 

and St. James Parishes were complete 

on October 5, 2007, and October 16, 

2007, respectively. The maintenance 

plans meet the requirements of section 

110(a)(1) of the Clean Air Act, and are 

consistent with EPA’s maintenance plan 

guidance document dated May 20, 2005. 

The EPA therefore approved the 1997 8- 

hour ozone NAAQS maintenance plans 

for the areas of Calcasieu and St. James 

Parishes on October 9, 2008. 

* * * * * 

[FR Doc. E8–23867 Filed 10–8–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 261 

[EPA–R06–RCRA–2008–0418; SW–FRL– 

8727–8] 

Hazardous Waste Management 

System; Identification and Listing of 

Hazardous Waste; Final Exclusion 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: Environmental Protection 

Agency (EPA) is granting a petition 

submitted by Lockheed Martin 

Aeronautics Company to exclude (or 

delist) the sludge from its wastewater 

treatment plant generated by Lockheed 

Martin Aeronautics Company in Fort 

Worth, Texas from the lists of hazardous 

wastes. This final rule responds to the 

petition submitted by Lockheed Martin 

Aeronautics Company to delist F019 

sludge generated from the facility’s 

wastewater treatment plant. 

After careful analysis and use of the 

Delisting Risk Assessment Software 

(DRAS), EPA has concluded the 

petitioned waste is not hazardous waste. 

This exclusion applies to 90 cubic yards 

per year of the F019 sludge. 

Accordingly, this final rule excludes the 

petitioned waste from the requirements 

of hazardous waste regulations under 

the Resource Conservation and 

Recovery Act (RCRA) when it is 

disposed in a Subtitle D Landfill. 

DATES: Effective Date: October 9, 2008. 

ADDRESSES: The public docket for this 

final rule is located at the 

Environmental Protection Agency 

Region 6, 1445 Ross Avenue, Dallas, 

Texas 75202, and is available for 

viewing in EPA Freedom of Information 

Act review room on the 7th floor from 

8 a.m. to 4 p.m., Monday through 

Friday, excluding Federal holidays. Call 

(214) 665–6444 for appointments. The 

reference number for this docket is 

EPA–R06–RCRA–2008–0418. The 

public may copy material from any 

regulatory docket at no cost for the first 

100 pages and at a cost of $0.15 per page 

for additional copies. 

FOR FURTHER INFORMATION CONTACT: Ben 

Banipal, Section Chief of the Corrective 

Action and Waste Minimization 

Section, Multimedia Planning and 

Permitting Division (6PD–C), 

Environmental Protection Agency 

Region 6, 1445 Ross Avenue, Dallas, 

Texas 75202. 

For technical information concerning 

this notice, contact Wendy Jacques, 

Environmental Protection Agency 

Region 6, 1445 Ross Avenue, (6PD–F), 

Dallas, Texas 75202, at (214) 665–7395, 

or jacques.wendy@epa.gov. 

SUPPLEMENTARY INFORMATION: The 

information in this section is organized 

as follows: 

I. Overview Information 

A. What action is EPA finalizing? 

B. Why is EPA approving this action? 

C. What are the limits of this exclusion? 

D. How will Lockheed Martin Aeronautics 

Company manage the waste if it is 

delisted? 

E. When is the final delisting exclusion 

effective? 

F. How does this final rule affect states? 

II. Background 

A. What is a delisting? 

B. What regulations allow facilities to 

delist a waste? 

C. What information must the generator 

supply? 

III. EPA’s Evaluation of the Waste 

Information and Data 

A. What waste did Lockheed Martin 

Aeronautics Company petition EPA to 

delist? 

B. How much waste did Lockheed Martin 

Aeronautics Company propose to delist? 

C. How did Lockheed Martin Aeronautics 

Company sample and analyze the waste 

data in this petition? 

IV. Public Comments Received on the 

proposed exclusion 

Who submitted comments on the proposed 

rule? 

V. Statutory and Executive Order Reviews 

I. Overview Information 

A. What action is EPA finalizing? 

After evaluating the petition, EPA 

proposed, on May 19, 2008, to exclude 

the wastewater treatment plant sludge 

from the lists of hazardous waste under 

40 CFR 261.31 and 261.32 (see 70 FR 

41358). EPA is finalizing the decision to 

grant Lockheed Martin Aeronautics 

Company’s delisting petition to have its 

waste water treatment sludge managed 

and disposed as non-hazardous waste 

provided certain verification and 

monitoring conditions are met. 

B. Why is EPA approving this action? 

Lockheed Martin Aeronautics 

Company’s petition requests a delisting 

from the F019 waste listing under 40 

CFR 260.20 and 260.22. Lockheed 

Martin Aeronautics Company does not 


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59524 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

believe that the petitioned waste meets 

the criteria for which EPA listed it. 

Lockheed Martin Aeronautics Company 

also believes no additional constituents 

or factors could cause the waste to be 

hazardous. EPA’s review of this petition 

included consideration of the original 

listing criteria and the additional factors 

required by the Hazardous and Solid 

Waste Amendments of 1984. See section 

3001(f) of RCRA, 42 U.S.C. 6921(f), and 

40 CFR 260.22 (d)(1)–(4) (hereinafter all 

sectional references are to 40 CFR 

unless otherwise indicated). In making 

the final delisting determination, EPA 

evaluated the petitioned waste against 

the listing criteria and factors cited in 

§ 261.11(a)(2) and (a)(3). Based on this 

review, EPA agrees with the petitioner 

that the waste is non-hazardous with 

respect to the original listing criteria. If 

EPA had found, based on this review, 

that the waste remained hazardous 

based on the factors for which the waste 

as originally listed, EPA would have 

proposed to deny the petition. EPA 

evaluated the waste with respect to 

other factors or criteria to assess 

whether there is a reasonable basis to 

believe that such additional factors 

could cause the waste to be hazardous. 

EPA considered whether the waste is 

acutely toxic, the concentration of the 

constituents in the waste, their tendency 

to migrate and to bioaccumulate, their 

persistence in the environment once 

released from the waste, plausible and 

specific types of management of the 

petitioned waste, the quantities of waste 

generated, and waste variability. EPA 

believes that the petitioned waste does 

not meet the listing criteria and thus 

should not be a listed waste. EPA’s final 

decision to delist waste from Lockheed 

Martin Aeronautics Company’s facility 

is based on the information submitted in 

support of this rule, including 

descriptions of the wastes and analytical 

data from the Fort Worth, Texas facility. 

C. What are the limits of this exclusion? 

This exclusion applies to the waste 

described in the petition only if the 

requirements described in 40 CFR part 

261, Appendix IX, Table 1 and the 

conditions contained herein are 

satisfied. 

D. How will Lockheed Martin 

Aeronautics Company manage the 

waste if it is delisted? 

The sludge from Lockheed Martin 

Aeronautics Company will be disposed 

of in a RCRA Subtitle D landfill. 

E. When is the final delisting exclusion 

effective? 

This rule is effective October 9, 2008. 

The Hazardous and Solid Waste 

Amendments of 1984 amended section 

3010 of RCRA, 42 U.S.C. 6930(b)(1), 

allows rules to become effective less 

than six months after the rule is 

published when the regulated 

community does not need the six-month 

period to come into compliance. That is 

the case here because this rule reduces, 

rather than increases, the existing 

requirements for persons generating 

hazardous waste. This reduction in 

existing requirements also provides a 

basis for making this rule effective 

immediately, upon publication, under 

the Administrative Procedure Act, 

pursuant to 5 U.S.C. 553(d). 

F. How does this final rule affect states? 

Because EPA is issuing this exclusion 

under the Federal RCRA delisting 

program, only states subject to Federal 

RCRA delisting provisions would be 

affected. This would exclude states 

which have received authorization from 

EPA to make their own delisting 

decisions. 

EPA allows states to impose their own 

non-RCRA regulatory requirements that 

are more stringent than EPA’s, under 

section 3009 of RCRA, 42 U.S.C. 6929. 

These more stringent requirements may 

include a provision that prohibits a 

Federally issued exclusion from taking 

effect in the state. Because a dual system 

(that is, both Federal (RCRA) and State 

(non-RCRA) programs) may regulate a 

petitioner’s waste, EPA urges petitioners 

to contact the State regulatory authority 

to establish the status of their wastes 

under the State law. 

EPA has also authorized some states 

(for example, Louisiana, Oklahoma, 

Georgia, and Illinois) to administer an 

RCRA delisting program in place of the 

Federal program; that is, to make state 

delisting decisions. Therefore, this 

exclusion does not apply in those 

authorized states unless that state makes 

the rule part of its authorized program. 

If Lockheed Martin Aeronautics 

Company transports the petitioned 

waste to or manages the waste in any 

state with delisting authorization, 

Lockheed Martin Aeronautics Company 

must obtain delisting authorization from 

that state before it can manage the waste 

as non-hazardous in the state. 

II. Background 

A. What is a delisting petition? 

A delisting petition is a request from 

a generator to EPA, or another agency 

with jurisdiction, to exclude or delist 

from the RCRA list of hazardous waste, 

certain wastes the generator believes 

should not be considered hazardous 

under RCRA. 

B. What regulations allow facilities to 

delist a waste? 

Under §§ 260.20 and 260.22, facilities 

may petition EPA to remove their 

wastes from hazardous waste regulation 

by excluding them from the lists of 

hazardous wastes contained in 

§§ 261.31 and 261.32. Specifically, 

§ 260.20 allows any person to petition 

the Administrator to modify or revoke 

any provision of 40 CFR parts 260 

through 265 and 268. Section 260.22 

provides generators the opportunity to 

petition the Administrator to exclude a 

waste from a particular generating 

facility from the hazardous waste lists. 

C. What information must the generator 

supply? 

Petitioners must provide sufficient 

information to EPA to allow EPA to 

determine that the waste to be excluded 

does not meet any of the criteria under 

which the waste was listed as a 

hazardous waste. In addition, the 

Administrator must determine, where 

he/she has a reasonable basis to believe 

that factors (including additional 

constituents) other than those for which 

the waste was listed could cause the 

waste to be a hazardous waste and that 

such factors do not warrant retaining the 

waste as a hazardous waste. 

III. EPA’s Evaluation of the Waste 

Information and Data 

A. What waste did Lockheed Martin 

Aeronautics Company petition EPA to 

delist? 

On February 21, 2006, Lockheed 

Martin Aeronautics Company petitioned 

EPA to exclude from the lists of 

hazardous wastes contained in § 261.31, 

sludge (F019) generated from its facility 

located in Forth Worth, Texas. The 

waste falls under the classification of 

listed waste pursuant to § 261.31. 

B. How much waste did Lockheed 

Martin Aeronautics Company propose 

to delist? 

Specifically, in its petition, Lockheed 

Martin Aeronautics Company requested 

that EPA grant a standard exclusion for 

90 cubic yards per year of sludge 

resulting from the treatment of waste 

waters from the manufacturing 

processes at its facility. 

C. How did Lockheed Martin 

Aeronautics Company sample and 

analyze the waste data in this petition? 

To support its petition, Lockheed 

Martin Aeronautics Company 

submitted: 

• Analytical results of the toxicity 

characteristic leaching procedure and 

total constituent analysis for volatile 


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Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 59525 

and semi volatile organics, pesticides, 

herbicides, dioxins/furans, PCBs and 

metals for six sludge samples; 

• Analytical results from multiple pH 

leaching of metals; and 

• Descriptions of the wastewater 

treatment process. 

IV. Public Comments Received on the 

Proposed Exclusion 

Who submitted comments on the 

proposed rule? 

No comments were received on the 

Proposed Rule. 

V. Statutory and Executive Order 

Reviews 

Under Executive Order 12866, 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993), this rule is 

not of general applicability and 

therefore is not a regulatory action 

subject to review by the Office of 

Management and Budget (OMB). This 

rule does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.) because it 

applies to a particular facility only. 

Because this rule is of particular 

applicability relating to a particular 

facility, it is not subject to the regulatory 

flexibility provisions of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.), or 

to sections 202, 204, and 205 of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Pub. L. 104–4). Because this 

rule will affect only a particular facility, 

it will not significantly or uniquely 

affect small governments, as specified in 

section 203 of UMRA. Because this rule 

will affect only a particular facility, this 

final rule does not have federalism 

implications. It will not have substantial 

direct effects 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, as specified in 

Executive Order 13132, ‘‘Federalism’’, 

(64 FR 43255, August 10, 1999). Thus, 

Executive Order 13132 does not apply 

to this rule. Similarly, because this rule 

will affect only a particular facility, this 

final rule does not have tribal 

implications, as specified in Executive 

Order 13175, ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000). Thus, Executive Order 13175 

does not apply to this rule. This rule 

also is not subject to Executive Order 

13045, ‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997), 

because it is not economically 

significant as defined in Executive 

Order 12866, and because the Agency 

does not have reason to believe the 

environmental health or safety risks 

addressed by this action present a 

disproportionate risk to children. The 

basis for this belief is that the Agency 

used the DRAS program, which 

considers health and safety risks to 

infants and children, to calculate the 

maximum allowable concentrations for 

this rule. This rule is not subject to 

Executive Order 13211, ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355 (May 

22, 2001)), because it is not a significant 

regulatory action under Executive Order 

12866. This rule does not involve 

technical standards; thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. As required by 

section 3 of Executive Order 12988, 

‘‘Civil Justice Reform’’, (61 FR 4729, 

February 7, 1996), in issuing this rule, 

EPA has taken the necessary steps to 

eliminate drafting errors and ambiguity, 

minimize potential litigation, and 

provide a clear legal standard for 

affected conduct. The Congressional 

Review Act, 5 U.S.C. 801 et seq., as 

added by the Small Business Regulatory 

Enforcement Fairness Act of 1996, 

generally provides that before a rule 

may take effect, the agency 

promulgating the rule must submit a 

rule report which includes a copy of the 

rule to each House of the Congress and 

to the Comptroller General of the United 

States. Section 804 exempts from 

section 801 the following types of rules: 

(1) Rules of particular applicability; (2) 

rules relating to agency management or 

personnel; and (3) rules of agency 

organization, procedure, or practice that 

do not substantially affect the rights or 

obligations of non-agency parties 5 

U.S.C. 804(3). EPA is not required to 

submit a rule report regarding today’s 

action under section 801 because this is 

a rule of particular applicability. 

Lists of Subjects in 40 CFR Part 261 

Environmental protection, Hazardous 

waste, Recycling, Reporting and 

recordkeeping requirements. 

Authority: Sec. 3001(f) RCRA, 42 U.S.C. 

6921(f) 

Dated: October 1, 2008. 

Bill Luthans, 

Acting Director, Multimedia Planning and 

Permitting Division, Region 6. 

■ For the reasons set out in the 

preamble, 40 CFR part 261 is proposed 

to be amended as follows: 

PART 261—IDENTIFICATION AND 

LISTING OF HAZARDOUS WASTE 

■ 1. The authority citation for part 261 

continues to read as follows: 

Authority: 42 U.S.C. 6905, 6912(a), 6921, 

6922, and 6938. 

■ 2. In Table 1 of Appendix IX of Part 

261 add the following waste stream in 

alphabetical order by facility to read as 

follows: 

Appendix IX to Part 261—Waste 

Excluded Under §§ 260.20 and 260.22 

TABLE 1—WASTE EXCLUDED FROM NON-SPECIFIC SOURCES

Facility Address Waste description 

* * * * * * * 

Lockheed Martin Aeronautics Company.Fort Worth, TX ............ Sludge (EPA Hazardous Waste Number F019) generated at a maximum rate of 90 cubic 

yards per calendar year after October 9, 2008. 

For the exclusion to be valid, Lockheed Martin Aeronautics Company must implement a 

verification testing program that meets the following Paragraphs: 

(1) Delisting Levels: All concentrations for those constituents must not exceed the maximum 

allowable concentrations in mg/l specified in this paragraph. 

Sludge Leachable Concentrations (mg/l): Antimony—8.45; Arsenic—0.657; Barium—100.0; 

Cadmium—1.00; Chromium—5.0; Chromium, Hexavalent—5.0; Cobalt—1040; Copper— 

1810; Cyanide—240; Lead—5.0; Mercury—0.20; Nickel—1040; Selenium—1.0; Silver— 

5.0; Vanadium—51.5; Zinc—15800; Acetone—40600; Acetonitrile—766; Carbon Disulfide—4400; Ethylbenzene—846; Methyl Ethyl Ketone—200.0; Methyl Isobutyl Ketone— 

3610; Methylene Chloride—6.16; Toluene—1180; Xylenes—745. 

(2) Waste Holding and Handling: 


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59526 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 

TABLE 1—WASTE EXCLUDED FROM NON-SPECIFIC SOURCES—Continued 

Facility Address Waste description 

(A) Waste classification as non-hazardous can not begin until compliance with the limits set 

in paragraph (1) for sludge has occurred for two consecutive quarterly sampling events. 

(B) If constituent levels in any sample taken by Lockheed Martin Aeronautics Company exceed any of the delisting levels set in paragraph (1) for the sludge, Lockheed Martin Aeronautics Company must do the following: 

(i) notify EPA in accordance with paragraph (6) and 

(ii) manage and dispose the sludge as hazardous waste generated under Subtitle C of 

RCRA. 

(3) Testing Requirements: 

Upon this exclusion becoming final, Lockheed Martin Aeronautics Company may perform 

quarterly analytical testing by sampling and analyzing the sludge as follows: 

(A) Quarterly Testing: 

(i) Collect two representative composite samples of the sludge at quarterly intervals after 

EPA grants the final exclusion. The first composite samples may be taken at any time after 

EPA grants the final approval. Sampling should be performed in accordance with the sampling plan approved by EPA in support of the exclusion. 

(ii) Analyze the samples for all constituents listed in paragraph (1). Any composite sample 

taken that exceeds the delisting levels listed in paragraph (1) for the sludge must be disposed as hazardous waste in accordance with the applicable hazardous waste requirements. 

(iii) Within thirty (30) days after taking each quarterly sample, Lockheed Martin Aeronautics 

Company will report its quarterly analytical test data to EPA. If levels of constituents measured in the samples of the sludge do not exceed the levels set forth in paragraph (1) of this 

exclusion for two consecutive quarters or sampling events, Lockheed Martin Aeronautics 

Company can manage and dispose the non-hazardous sludge according to all applicable 

solid waste regulations. 

(B) Annual Testing: 

(i) If Lockheed Martin Aeronautics Company completes the quarterly testing specified in paragraph (3) above and no sample contains a constituent at a level which exceeds the limits 

set forth in paragraph (1), Lockheed Martin Aeronautics Company may begin annual testing as follows: Lockheed Martin Aeronautics Company must test two representative composite samples of the sludge for all constituents listed in paragraph (1) at least once per 

calendar year. 

(ii) The samples for the annual testing shall be a representative composite sample according 

to appropriate methods. As applicable to the method-defined parameters of concern, analyses requiring the use of SW–846 methods incorporated by reference in 40 CFR 260.11 

must be used without substitution. As applicable, the SW–846 methods might include 

Methods 0010, 0011, 0020, 0023A, 0030, 0031, 0040, 0050, 0051, 0060, 0061, 1010A, 

1020B, 1110A, 1310B, 1311, 1312, 1320, 1330A, 9010C, 9012B, 9040C, 9045D, 9060A, 

9070A (uses EPA Method 1664, Rev. A), 9071B, and 9095B. Methods must meet Performance Based Measurement System Criteria in which the Data Quality Objectives are to 

demonstrate that samples of the Lockheed Martin Aeronautics Company sludge are representative for all constituents listed in paragraph (1). 

(iii) The samples for the annual testing taken for the second and subsequent annual testing 

events shall be taken within the same calendar month as the first annual sample taken. 

(iv) The annual testing report should include the total amount of waste in cubic yards disposed during the calendar year. 

(4) Changes in Operating Conditions: If Lockheed Martin Aeronautics Company significantly 

changes the process described in its petition or starts any processes that generate(s) the 

waste that may or could affect the composition or type of waste generated (by illustration, 

but not limitation, changes in equipment or operating conditions of the treatment process), 

it must notify EPA in writing and it may no longer handle the wastes generated from the 

new process as non-hazardous until the wastes meet the delisting levels set in paragraph 

(1) and it has received written approval to do so from EPA. 

Lockheed Martin Aeronautics Company must submit a modification to the petition complete 

with full sampling and analysis for circumstances where the waste volume changes and/or 

additional waste codes are added to the waste stream. 

(5) Data Submittals: 

Lockheed Martin Aeronautics Company must submit the information described below. If Lockheed Martin Aeronautics Company fails to submit the required data within the specified 

time or maintain the required records on-site for the specified time, EPA, at its discretion, 

will consider this sufficient basis to reopen the exclusion as described in paragraph (6). 

Lockheed Martin Aeronautics Company must: 

(A) Submit the data obtained through paragraph (3) to the Chief, Corrective Action and 

Waste Minimization Section, Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency Region 6, 1445 Ross Ave., Dallas, Texas, 75202, within the time 

specified. All supporting data can be submitted on CD–ROM or some comparable electronic media. 

(B) Compile records of analytical data from paragraph (3), summarized, and maintained onsite for a minimum of five years. 

(C) Furnish these records and data when either EPA or the State of Texas requests them for 

inspection. 


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Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Rules and Regulations 59527 

TABLE 1—WASTE EXCLUDED FROM NON-SPECIFIC SOURCES—Continued 

Facility Address Waste description 

(D) Send along with all data a signed copy of the following certification statement, to attest to 

the truth and accuracy of the data submitted: 

‘‘Under civil and criminal penalty of law for the making or submission of false or fraudulent 

statements or representations (pursuant to the applicable provisions of the Federal Code, 

which include, but may not be limited to, 18 U.S.C. 1001 and 42 U.S.C. 6928), I certify that 

the information contained in or accompanying this document is true, accurate and complete. 

As to the (those) identified section(s) of this document for which I cannot personally verify its 

(their) truth and accuracy, I certify as the company official having supervisory responsibility 

for the persons who, acting under my direct instructions, made the verification that this information is true, accurate and complete. 

If any of this information is determined by EPA in its sole discretion to be false, inaccurate or 

incomplete, and upon conveyance of this fact to the company, I recognize and agree that 

this exclusion of waste will be void as if it never had effect or to the extent directed by EPA 

and that the company will be liable for any actions taken in contravention of the company’s 

RCRA and CERCLA obligations premised upon the company’s reliance on the void exclusion.’’ 

(6) Reopener: 

(A) If, anytime after disposal of the delisted waste Lockheed Martin Aeronautics Company 

possesses or is otherwise made aware of any environmental data (including but not limited 

to leachate data or ground water monitoring data) or any other data relevant to the delisted 

waste indicating that any constituent identified for the delisting verification testing is at level 

higher than the delisting level allowed by the Division Director in granting the petition, then 

the facility must report the data, in writing, to the Division Director within 10 days of first 

possessing or being made aware of that data. 

(B) If either the quarterly or annual testing of the waste does not meet the delisting requirements in paragraph 1, Lockheed Martin Aeronautics Company must report the data, in writing, to the Division Director within 10 days of first possessing or being made aware of that 

data. 

(C) If Lockheed Martin Aeronautics Company fails to submit the information described in 

paragraphs (5), (6)(A) or (6)(B) or if any other information is received from any source, the 

Division Director will make a preliminary determination as to whether the reported information requires EPA action to protect human health and/or the environment. Further action 

may include suspending, or revoking the exclusion, or other appropriate response necessary to protect human health and the environment. 

(D) If the Division Director determines that the reported information requires action by EPA, 

the Division Director will notify the facility in writing of the actions the Division Director believes are necessary to protect human health and the environment. The notice shall include 

a statement of the proposed action and a statement providing the facility with an opportunity to present information as to why the proposed EPA action is not necessary. The facility shall have 10 days from the date of the Division Director’s notice to present such information. 

(E) Following the receipt of information from the facility described in paragraph (6)(D) or (if no 

information is presented under paragraph (6)(D)) the initial receipt of information described 

in paragraphs (5), (6)(A) or (6)(B), the Division Director will issue a final written determination describing EPA actions that are necessary to protect human health and/or the environment. Any required action described in the Division Director’s determination shall become 

effective immediately, unless the Division Director provides otherwise. 

(7) Notification Requirements: Lockheed Martin Aeronautics Company must do the following 

before transporting the delisted waste. Failure to provide this notification will result in a violation of the delisting petition and a possible revocation of the decision. 

(A) Provide a one-time written notification to any state Regulatory Agency to which or through 

which it will transport the delisted waste described above for disposal, 60 days before beginning such activities. 

(B) Update one-time written notification, if it ships the delisted waste into a different disposal 

facility. 

(C) Failure to provide this notification will result in a violation of the delisting variance and a 

possible revocation of the decision. 

* * * * * * * 


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[FR Doc. E8–24009 Filed 10–8–08; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

42 CFR Part 100 

RIN 0906–AA55 

National Vaccine Injury Compensation 

Program: Removal of Separate 

Category for Vaccines Containing Live, 

Oral, Rhesus-Based Rotavirus From 

the Vaccine Injury Table 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Interim final rule. 

SUMMARY: Through this interim final 

rule, the Secretary removes the category 

of vaccines containing live, oral, rhesusbased rotavirus, Category XII, from the 

Vaccine Injury Table (Table). The Table 

includes a list of covered vaccines 

under the National Vaccine Injury 

Compensation Program (VICP). The 

VICP provides a system of no-fault 

compensation for certain individuals 

who have been injured by covered 

childhood vaccines. This interim final 

rule is technical in nature. Even prior to 

the publication of this final rule, 

Category XII, the category that is being 

removed from the Table, only applied to 

vaccines that were administered on or 

before August 26, 2002. Given the 

applicable statute of limitations and the 

fact that Category XII limited its 

application to vaccines administered on 

or before August 26, 2002, the Secretary 

believes that no persons have claims 

that could be pursued under that 

category. Petitioners may still be able to 

file petitions relating to rotavirus 

vaccines under Category XI of the Table, 

the category of ‘‘rotavirus vaccines,’’ 

which does not include any associated 

injuries. Although the Secretary believes 

that the changes made in this interim 

final rule are noncontroversial as they 

do not affect the rights of any potential 

petitioners with the VICP, the 

Department is seeking public comment 

on this interim final rule. Written 

comments must be submitted on or 

before November 10, 2008. The 

Department will consider the comments 

received and will decide whether to 

amend the Table based on such 

comments. 

DATES: This regulation is effective 

November 10, 2008. 

ADDRESSES: You may submit written 

comments, identified by the Regulatory 

Information Number (RIN) 0906–AA55 

by an any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: gevans@hrsa.gov. Include 

RIN 0906–AA55 in the subject line of 

the message. 

• Mail: Geoffrey Evans, M.D., 

Director, Division of Vaccine Injury 

Compensation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration (HRSA), Room 11C–26, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857. 

• Instructions: All submissions 

received must include the agency name 

and RIN for this rulemaking. All 

comments received will be available for 

public inspection and copying without 

charge, including any personal 

information provided, at Parklawn 

Building, 5600 Fishers Lane Room 11C– 

26, Rockville, Maryland 20857, 

weekdays (Federal holidays excepted) 

between the hours of 8:30 a.m. and 5 

p.m. 

FOR FURTHER INFORMATION CONTACT: 

Geoffrey Evans, M.D., Director, Division 

of Vaccine Injury Compensation, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

Parklawn Building, Room 11C–26, 5600 

Fishers Lane, Rockville, Maryland 

20857; telephone number (301) 443– 

6593. 

SUPPLEMENTARY INFORMATION: 

The National Childhood Vaccine 

Injury Act of 1986, title III of Public Law 

99–660 (42 U.S.C. 300aa–10 et seq.) 

established the National Vaccine Injury 

Compensation Program (VICP) for 

persons found to be injured by vaccines. 

Under this Federal program, petitions 

for compensation are filed with the 

United States Court of Federal Claims 

(Court). The Court, acting through 

special masters, makes findings as to 

eligibility for, and amount of, 

compensation. In order to gain 

entitlement to compensation under title 

XXI of the Public Health Service (PHS) 

Act for a covered vaccine, a petitioner 

must establish a vaccine-related injury 

or death, either by proving that the first 

symptom of an injury/condition, as 

defined by the Qualifications and Aids 

to Interpretation, occurred within the 

time period listed on the Vaccine Injury 

Table (Table), and therefore presumed 

to be caused by a vaccine (unless 

another cause is found), or by proof of 

vaccine causation, if the injury/ 

condition is not on the Table or did not 

occur within the time period specified 

on the Table. 

The statute authorizing the VICP 

provides for the inclusion of additional 

vaccines in the VICP when they are 

recommended by the Centers for Disease 

Control and Prevention (CDC) for 

routine administration to children. See 

section 2114(e)(2) of the PHS Act, 42 

U.S.C. 300aa–14(e)(2). Consistent with 

section 13632(a)(3) of Public Law 103– 

66, the regulations governing the VICP 

provide that such vaccines will be 

included in the Table as of the effective 

date of an excise tax to provide funds 

for the payment of compensation with 

respect to such vaccines. (42 CFR 

100.3(c)(5)). The statute authorizing the 

VICP also authorizes the Secretary to 

create and modify a list of injuries, 

disabilities, illnesses, conditions, and 

deaths (and their associated time 

frames) associated with each category of 

vaccines included on the Table. See 

sections 2114(c)(3) and 2114(e)(2) of the 

PHS Act, 42 U.S.C. 300aa–14(c)(3) and 

300aa–14(e)(2). 

Because the prerequisites for adding 

rotavirus vaccines to the VICP occurred, 

the Secretary published a final rule in 

the Federal Register (FR) on July 27, 

1999, adding vaccines against rotavirus 

to the Table (64 FR 40517). Because the 

Secretary had not identified any illness, 

disease, injury or condition caused by 

vaccines against rotavirus, the category 

of vaccines was added to the Table with 

‘‘[n]o condition specified.’’ The 

Secretary made clear that if he learned 

of any such illness, disease, injury or 

condition, he would consider amending 

the Table. 

In a notice of proposed rulemaking 

published on July 13, 2001, the 

Secretary announced his findings that 

the condition of intussusception could 

reasonably be determined in some 

circumstances to be caused by vaccines 

containing live, oral, rhesus-based 

rotavirus (66 FR 36735). Based on those 

findings, the Secretary proposed 

amending the Table by adding to the 

Table vaccines containing live, oral, 

rhesus-based rotavirus (trade name 

Rotashield) as a distinct category, with 

intussusception listed as a covered 

Table injury. This proposal was based 

upon the recommendation by the CDC 

that Rotashield, the only rotavirus 

vaccine licensed in the United States 

(U.S.) at the time, no longer be 

administered to infants in the U.S. 

based on review of data indicating a 

strong association between Rotashield 

and intussusception in the 1 to 2 weeks 

following vaccination. 

In a final rule published July 25, 2002, 

the Secretary made the changes 

proposed in the earlier rule (67 FR 

48558). After these amendments, the 

Table included two categories of 


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