March #, 2017

Mr. Jarrod Kocin
Emerald Kalama Chemical, LLC
1296 Third Street, NW
Kalama, WA  98625

Re:	Response to Draft Delisting Petitions

Dear Mr. Kocin:

Emerald Kalama Chemical, LLC (Emerald) submitted to the Washington State Department of Ecology (Ecology) and the United States Environmental Protection Agency Region 10 (EPA) the following draft delisting petitions on August 31, 2016:

 "DRAFT Delisting Petition for Mixed Material Stored at Fire Mountain Farms Big Hanaford Facility" (BH Petition)
 "DRAFT Delisting Petition for Mixed Material Stored at Fire Mountain Farms Burnt Ridge Facility" (BR Petition)
 "DRAFT Delisting Petition for Mixed Material Stored at Fire Mountain Farms Newaukum Prairie Facility" (NP Petition)
 "DRAFT Delisting Petition for Emerald Industrial Wastewater Treatment Plant Biological Solids" (IWBS Petition)
According to Emerald, the petitions have not been reviewed by Fire Mountain Farms, Inc. (FMF).

Ecology and EPA noticed several details in the draft petitions that need to be improved.  Ecology and EPA's comments on the draft petitions are shown below.

Please address the comments below and resubmit the draft petitions.  Emerald and FMF may wait to resubmit the draft petitions after all the sample results are finalized according to the Waste Characterization Plan (currently in draft).

Many of the comments apply to all or most of the draft delisting petitions.  Each comment will specify which petition the comment is intended for.

Comment 1:  Applicable to BH, BR, NP, and IWBS Petitions

Define each acronym used in the petition at first use.  For example, but not limited to, "RCRA", "C.F.R.", "TCLP", "LDR", and "°C", should be defined whenever each is first used.

Comment 2:  Applicable to BH, BR, NP, and IWBS Petitions

On page one in the first paragraph, list Ecology as a recipient of the petition.  For example, change the paragraph to read, ". . . jointly petition the U.S. Environmental Protection Agency ("EPA") and the Washington State Department of Ecology ("Ecology") to exclude . . ."  Although the waste is federally listed, Ecology must approve the delisting petition as a separation action.

Comment 3:  Applicable to IWBS Petition

On page two in the second section, add "and Ecology" after EPA so the sentence starts, "Emerald requests EPA and Ecology to send the Kalama IWBS . . ."  Also, on page two in the third section, add "and Ecology" after EPA so the sentence starts, "Emerald is seeking EPA and Ecology approval to delist . . ."

Comment 4:  Applicable to BH, BR, and NP Petitions

On page two in the second section, add a period to the second sentence in paragraph two.

Comment 5:  Applicable to BH, BR, and NP Petitions

On page three in the first full section, add "and Ecology" after EPA so the sentence starts, "Emerald and FMF are seeking EPA and Ecology approval to delist . . ."

Comment 6:   Applicable to BR Petition

On page one in the first paragraph, correctly describe the mixture of material stored at Burnt Ridge.  For example, change the paragraph to read, ". . . to exclude the mixture of industrial wastewater biological solids ("IWBS") generated by Emerald at its Kalama facility, municipal wastewater treatment plant biosolids accepted by FMF, industrial wastewater treatment plant biological solids accepted by FMF, and cow manure barn runoff and currently stored . . ."

Comment 7:   Applicable to NP Petition

On page one in the first paragraph, correctly describe the mixture of material stored at Newaukum Prairie.  For example, change the paragraph to read, ". . . to exclude the mixture of industrial wastewater biological solids ("IWBS") generated by Emerald at its Kalama facility, municipal wastewater treatment plant biosolids accepted by FMF, and industrial wastewater treatment plant biological solids accepted by FMF and currently stored . . ."

Comment 8:   Applicable to BH, BR, and NP Petitions

On page one in the first paragraph, add "from designation as a RCRA hazardous waste" to the end of the sentence to specify what Emerald and FMF are wanting excluded.  See the IWBS Petition for an example.

Comment 9:   Applicable to BH, BR, NP, and IWBS Petitions

On page one in the third paragraph, change the first sentence to ". . . EPA and Ecology approval to send . . ."

Comment 10:   Applicable to BH and NP Petitions

On page one in the third paragraph, the petition says that "the waste meets applicable LDR treatment standards."  According to the Pacific Groundwater Group's (PGG) 2014 sample results, the mixed material is above the LDR treatment standard for toluene.  Update this sentence to correctly say which LDRs are met.

Comment 11:   Applicable to BH, BR, NP, and IWBS Petitions

Throughout the petition, whenever a Code of Federal Regulations (C.F.R.) is cited, include the full reference and corresponding Washington Administrative Code (WAC) citation as well, if applicable.  For example, on page two, the first section stating the name and address of petitioner(s) should be cited as "40 C.F.R. 260.20(b)(1); WAC 173-303-910(1)(b)(i)".

Comment 12:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "A description of the proposed action, including . . ." (page three in BH, BR, and NP Petitions and page two in IWBS Petition), add waste code F003 to the list with U019, U154, and U220.

Comment 13:   Applicable to IWBS Petition

On page two in the fourth section, add an "s" to the word "request" in the second sentence of the first paragraph.

Comment 14:   Applicable to BH, BR, and NP Petitions

On page four in the first full paragraph, remove the word "biosolids" from the second to last sentence.  Also, remove the word "Biosolids" from Table 1's title.  In Table 1, remove the extra "Municipal" from the "Camas Municipal Municipal Wastewater Treatment Plant" line.

Comment 15:  Applicable to BR Petition

On page four in Table 1, the total is given as 126.0 tons but the sum of the individual sources is 125.9 tons.  Change the total to accurately show the sum of the individual sources, or double check the individual sources amounts.  Also on page four, in the first paragraph, the petition says that, ". . . approximately 90 percent of the material in the Burnt Ridge impoundment is municipal biosolids . . ."  This is not correct.  According to Table 1, industrial sources compose 18.2 tons (Emerald and Darigold), municipal sources compose 103.9 tons, and other sources compose 3.8 tons (cow manure).  Out of the total 125.9 tons, municipal sources of 103.9 tons equals 82.5 percent.  Change the "90 percent" to "82.5 percent" or round up to "83 percent."

Comment 16:   Applicable to NP Petition

On page four in Table 1, the total is given as 340.0 tons but the sum of the individual sources is 339.9 tons.  Change the total to accurately show the sum of the individual sources, or double check the individual sources amounts.  Also on page four, in the first paragraph, the petition says that, ". . . approximately 93 percent of the material in the Newaukum Prairie impoundment is municipal biosolids . . ."  This is not correct.  According to Table 1, industrial sources compose 46.9 tons (Emerald, Darigold, and Port of Longview) and municipal sources compose 293.0 tons.  Out of the total 339.9 tons, municipal sources of 293.0 tons equals 86.2 percent.  Change the "93 percent" to "86.2 percent" or round down to "86 percent."

Comment 17:   Applicable to BH, BR, NP, and IWBS Petitions

The language in the delisting petitions should be consistent with how Ecology and EPA would approve the delisting.  This means avoiding absolute statements.  For example, in the sentence, "The IWBS do not contain any other chemical constituent that would cause it to be hazardous" (page five in BH, BR, and NP Petitions and page three in IWBS Petition), the "do not contain" has an absolute meaning which is difficult to prove true without continuous monitoring.  An example of how to make this sentence more acceptable could be, "The IWBS likely do not contain any other chemical constituent that would cause it to be hazardous, according to waste sampling."  Review the draft petition and change those sentences/words that suggest an absolute meaning to something that is less absolute (such as conditional on sampling data).

Comment 18:   Applicable to IWBS Petition

On page three, remove the duplicate paragraph starting with, "The IWBS do not contain any other chemical constituent . . ."

Comment 19:   Applicable to BH, BR, and NP Petitions

The petition should focus on the mixed material and not rely solely (or significantly) on Emerald's IWBS.  For example, on page five in the paragraph starting with, "The mixed biosolid material must be acceptable for disposal in a Subtitle D landfill given that the IWBS has never . . .", the petition fails to take into account the other sources that FMF mixed with Emerald's IWBS.  Therefore, the basis for delisting cannot solely rely on information and test results from the IWBS.  According to the Code of Federal Regulations (CFR) in 40 CFR 260.22(b), the basis for delisting "must be made with respect to the waste mixture as a whole."  Ecology and EPA recognize the importance of and support the use of information and test results from the IWBS, but the entire mixture must be the main focus of the delisting analysis.  Throughout the entire petition, include more information about the mixed material and the other sources that FMF mixed with Emerald's IWBS when discussing how each delisting criteria is met.

Comment 20:   Applicable to BH, BR, and NP Petitions

On page five in the paragraph starting with, "The mixed biosolid material must be acceptable for disposal in a Subtitle D landfill given that the IWBS has never . . .", the word "never" is another example of using an absolute as described in Comment 17.  Also, the paragraph says that the IWBS did not exhibit any of the characteristics of the associated waste codes.  The RCRA toxic and state-only wastes should be addressed in this paragraph as well.  For example, the paragraph should be similar to the following:

      The mixed biosolid material should be acceptable for disposal in a Subtitle D landfill given that the IWBS have never contained above detection any of the chemicals that would cause it to be hazardous, exhibited any of the characteristics for which the waste was listed, designated as RCRA toxic waste or Washington State-only wastes, and comprises approximately five percent of the total mass of material in the Big Hanaford impoundment.

More information is needed about the mixed material and the other sources that FMF mixed with Emerald's IWBS in order to make the conclusion that the mixed material should be acceptable for disposal in a Subtitle D landfill as described in Comment 19.  Also, ensure the percent values are accurate according to Comments 15 and 16.  Also, toluene was detected in the IWBS so the statement "that the IWBS have never contained above detection" is not true.  Add a qualifier to the sentence, such as, "that the IWBS have never contained above detection (except for one isolated incident in January 2013)."

Comment 21:   Applicable to BH, BR, and NP Petitions

In the section called, "The waste does not exhibit the characteristic of ignitability . . ." (page five in BH Petition and page six in BR and NP Petitions), add the second and third paragraphs from the IWBS Petition's same section.  These two paragraphs are applicable to the BH, BR, and NP Petitions.

Comment 22:   Applicable to BH, BR, and NP Petitions

On page six, in the section called, "The waste does not exhibit the characteristic of ignitability . . .", the second to last paragraph says that municipal biosolids do not carry any RCRA waste codes.  Include additional explanation on how this was determined.

Comment 23:   Applicable to BH, BR, and NP Petitions

On page six, in the section called, "The waste does not exhibit the characteristic of ignitability . . .", update the percent values in the last paragraph according to Comments 15 and 16.

Comment 24:   Applicable to BH, BR, and NP Petitions

On page six, in the section called, "The waste does not exhibit the characteristic of ignitability . . .", in the last paragraph, preliminary delisting levels (PDLs) should be the standard to meet with respect to the delisting petition, not the LDRs.  Add language to include PDLs.  Also, this paragraph has absolute statements/words and should be changed according to Comment 17.  This paragraph should include more information about the mixed material, not only the sources that make up the mixture according to Comment 19.

Comment 25:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "Demonstration samples must consist . . ." (page six in BH, BR, and NP Petitions and page four in IWBS Petition), in the first paragraph, change the second sentence to begin with, "All of these data are summarized . . ."  Check the petition for other instances where sentences with "data" need to be changed to a plural context.  For example, see the second paragraph of the same section.

Comment 26:   Applicable to BH, BR, and NP Petitions

In the section called, "Demonstration samples must consist . . ." (page six in BH Petition and page seven in BR and NP Petitions), in the third paragraph, change "biosolids" to "mixed material" or something similar.

Comment 27:   Applicable to BH Petition

On page seven in the section called, "Demonstration samples must consist . . .", in the paragraph starting with, "Most analytes and parameters . . .", only include analyses of PGG's results for those LDRs that are associated with the mixed material.  For example, remove 4-methyl phenol and phenol from the discussion since they are not applicable to the waste.

Comment 28:   Applicable to NP Petition

On page seven in the section called, "Demonstration samples must consist . . .", in the paragraph starting with, "All analytes and parameters . . .", change this paragraph to be similar to the BH Petition since toluene was detected at a concentration greater than the LDR treatment standard.

Comment 29:   Applicable to BH, BR, and NP Petitions

After the sample results are finalized according to the Waste Characterization Plan (currently in draft), the section called, "Demonstration samples must consist . . ." should be updated to include the new sample results and associated analysis.

Comment 30:   Applicable to BH, BR, NP, and IWBS Petitions

The required information from 40 CFR 260.22(i) is presented in the petition (starting on page eight for BH, BR, and NP Petitions and page five IWBS Petition).  The petition incorrectly uses 40 CFR 260.22(h) as the reference.  Change all the sections' references related to the information from 40 CFR 260.22(i) to the correct citation.  Also, in accordance with Comment 11, add the corresponding WAC reference.

Comment 31:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "Names and qualifications . . ." (page eight in BH, BR, and NP Petitions and page five in IWBS Petition), the petition must include the qualifications of the persons sampling and testing the waste.  Describe the qualifications in the petition.  Also, see the definition of "person" in 40 CFR 260.10.

Comment 32:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "The dates of sampling . . ." (page eight in BH Petition, page nine in BR and NP Petitions, and page five in IWBS Petition), the petition must include the dates of sampling and testing.  Ensure that the sample date and the test date are clearly specified in the tables referenced in the petition.

Comment 33:   Applicable to BH and NP Petitions

On page nine in the section called, "The location of the generating . . .", the business and physical locations should both be listed for the FMF generating facility.  The BH Petition should be listed similar to the following:

Business Location			Physical Location
Fire Mountain Farms, Inc.		Fire Mountain Farms, Inc.
856 Burnt Ridge Road		307 Big Hanaford Road
Onalaska, WA 98570			Centralia, WA 98531

The NP Petition should be listed similar to the following:

Business Location			Physical Location
Fire Mountain Farms, Inc.		Fire Mountain Farms, Inc.
856 Burnt Ridge Road		349 State Route 508
Onalaska, WA 98570			Chehalis, WA 98532

Comment 34:   Applicable to BH, BR, and NP Petitions

On page nine in the section called, "A description of the manufacturing . . .", in the first paragraph, change the beginning of the first sentence to, "There are approximately . . ."  Also, update the percent values according to Comments 15 and 16.

Comment 35:   Applicable to BH, BR, and NP Petitions

On page nine in the section called, "A description of the manufacturing . . .", in the second paragraph, change the second sentence to, "As part of that treatment process, the plant generates IWBS."  This is more clear and consistent with the IWBS Petition.

Comment 36:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "A description of the manufacturing . . .", in the paragraph starting with, "The Kalama facility's biological . . . " (page nine in BH, BR, and NP Petitions and page six in IWBS Petition), do not use an absolute statement in the third sentence according to Comment 17.  Instead, start the sentence similar to, "Emerald's IWBS are basically the same material . . ."

Comment 37:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "A description of the manufacturing . . .", in the paragraph starting with, "The Kalama facility periodically treats . . . " (page ten in BH, BR, and NP Petitions and page six in IWBS Petition), change the word "material" in the second sentence to "IWBS" to clarify what material is being referred to.  Also, clarify the second to last sentence which says LDRs must be met before a hazardous waste can be land applied.  More specifically, LDRs must be met before a hazardous waste can be disposed in a RCRA Subtitle C landfill.  The last sentence says that the, "Kalama facility regularly samples the IWBS for various constituents as previously discussed".  Is Emerald still sampling the IWBS for the various constituents and at the indicated frequencies as previously mentioned in the petition?  For example, does Emerald still test the IWBS for benzene and toluene annually; pH, lead, cadmium, arsenic, selenium, chromium, molybdenum, mercury, and barium quarterly; and total solids percent, copper, nickel, zinc, and cobalt monthly?  According to Table 1 in Appendix A, the last sample results are from March 21, 2014.  Include all sampling done on the IWBS.

Comment 38:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "A description of the manufacturing . . .", in the paragraph starting with, "Emerald understands the nature of all . . ." (page ten in BH, BR, and NP Petitions and page six in IWBS Petition) and through the paragraph starting with, "Stormwater that falls along . . .", include the specific waste codes associated with the waste streams discussed.  Also indicate whether or not the waste code applies to the IWBS.  This clarification will help show how the waste codes discussed in previous sections of the petition are determined.

Comment 39:   Applicable to BH, BR, NP, and IWBS Petitions

In the chemical manufacturing process description section (starting on page ten in BH, BR, and NP Petitions and page seven in IWBS Petition), describe how the byproducts are managed.  For example, are the byproducts sent to through wastewater treatment system or used somehow else?  Separate the products and the byproducts to increase clarity.  Also, for those products and byproducts that go to the treatment system, describe the toxicity of each pollutant.  Discuss the treatment's ability to effectively treat the wastewaters.  Include treatment efficacy discussions for those chemicals sent to the treatment system that are do not have a PDL.  This is critical information for Ecology and EPA to make a delisting determination.

Comment 40:   Applicable to BH, BR, NP, and IWBS Petitions

In the specialty department processes section for hexaldehyde (page 15 in BH, BR, and NP Petitions and page 12 in IWBS Petition), a product or byproduct is listed as, "2-ethyl butanaldehyde  -  impurity ?"  Delete the "?" or explain why it should be retained.

Comment 41:   Applicable to IWBS Petition

On page 16 in the section called, "A description of the waste and an estimate . . .", do not use an absolute statement in the third sentence according to Comment 17.  Instead, start the sentence similar to, "Emerald's IWBS are basically the same material . . ."

Comment 42:   Applicable to BH, BR, and NP Petitions

On page 19 in the section called, "A description of the waste and an estimate . . .", update the percent values according to Comments 15 and 16.

Comment 43:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "Pertinent data on and discussion . . ." (page 19 in BH, BR, and NP Petitions and page 17 in IWBS Petition), remove the extra "(" in the first factor.

Comment 44:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "Pertinent data on and discussion . . ." (starting on page 19 in BH, BR, and NP Petitions and page 17 in IWBS Petition), the petition lists most of the factors from 40 CFR 261.11(a)(3).  Add the two missing factors from 40 CFR 261.11(a)(3) to the petition.  The petition must provide Ecology and EPA with sufficient information to evaluate the factors in 40 CFR 261.11(a)(3).  Include additional discussion that address the factors from 40 CFR 261.11(a)(3).  Include, but not limited to, a discussion on how the application of nitrogen in the mixed material may relate to factor (ix).

Comment 45:   Applicable to BH, BR, and NP Petitions

On page 20 in the section called, "A description of the methodologies and equipment . . .", in the second paragraph, clarify which appendix will describe the methodology and equipment that will be used.  The petition says Appendix C but that is PGG's 2014 sludge report.  Also, refer to the Waste Characterization Plan (currently in draft) in this section.  Change the "mixed biosolids" in the last sentence to "mixed material."

Comment 46:   Applicable to BH, BR, and NP Petitions

On page 20 in the section called, "A description of the sampling handling . . .", in the second paragraph, change "Biosolid" in the first sentence to "Mixed material."  Also, refer to the Waste Characterization Plan (currently in draft) in this section.  The first paragraph of this section is an exact copy of the first paragraph from the previous section.  Consider revising it to match the corresponding paragraph in the IWBS Petition.

Comment 47:   Applicable to BH, BR, and NP Petitions

The section called, "A description of the tests performed . . ." (starting on page 20 in BH Petition and page 21 in BR and NP Petitions) is very similar to the previous section called, "Demonstration samples must consist . . ." (starting on page six).  Since the earlier comments and discussion are also applicable, add the information to the section called, "A description of the tests performed . . ." (starting on page 20 in BH Petition and page 21 in BR and NP Petitions) or reference the previous section.  Also, check that all sentences have a period at the end of the sentence.

Comment 48:   Applicable to IWBS Petition

On page 18 in the section called, "A description of the tests performed . . .", include a reference back to the section citing 40 CFR 260.22(h) starting on page four since this previous section has more applicable information.  Also, analysis must be done to compare the IWBS test results to PDLs as was done in the Waste Characterization Plan (currently in draft) with the mixed material from each of the three FMF storage locations.  See the letter dated December 7, 2016 Re: Ecology and EPA Clarifications on Comments to the Waste Characterization Plan for more information.  The previous PDLs from the Waste Characterization Plan discussion can't be used to compare with the IWBS.  A new list of PDLs applicable to the IWBS is attached to the email with this letter.  An explanation of what settings and procedures where used for using EPA's Hazardous Waste Delisting Risk Assessment Software (DRAS) are shown in Enclosure 1.

Comment 50:   Applicable to BH, BR, NP, and IWBS Petitions

In the section called, "Certification" (page 22 in BH, BR, and NP Petitions and page 18 in IWBS Petition), the petition should be consistent with previous sections and use a formal section title with references.  The section title should say, "The following statement signed by the generator of the waste or his authorized representative: (40 C.F.R. 260.22(i)(12); WAC 173-303-910(3)(c)(xii))."

Comment 51:   Applicable to BH, BR, and NP Petitions

On page 22 in the section called, "Certification", signature blocks must be used for both Emerald and FMF.  An example of how the signature blocks could look is shown below.  For the final petition, Ecology and EPA must each receive "wet" ink signatures.  "Wet" ink signatures means not a copied signature.  Ecology and EPA prefer that the petition not be signed in counterparts.

______________________________		Date:  ________________________
Robert Thode
Fire Mountain Farms, Inc.
President

______________________________		Date:  ________________________
Edward Gotch
Emerald Kalama Chemical, LLC
Chief Executive Officer

Comment 52:   Applicable to IWBS Petition

On page 18 in the section called, "Certification", a signature block must be used.  An example of how the Emerald signature block could look is shown in Comment 51.  For the final petition, Ecology and EPA must each receive a "wet" ink signature.

Comment 53:   Applicable to BH, BR, NP, and IWBS Petitions

In Appendix A, Table 1, ensure all the test results are included.  In 2014, Emerald submitted a spreadsheet similar to Table 1 that had more test results than what the Appendix A Table 1 is showing.  For example, on January 16, 2013, Emerald sampled the IWBS and the toluene result was 69 parts per billion but this test result is not on the Appendix A Table 1.

Comment 54:   Applicable to BH, BR, NP, and IWBS Petitions

In Appendix A, Table 2, include the non-detect value for the sample results expressed as "ND."  Ecology and EPA must evaluate if low enough detection limits were used.

Comment 55:   Applicable to BH, BR, NP, and IWBS Petitions

In Appendix A, Table 4, include the non-detect value for the sample results expressed as "ND."  Ecology and EPA must evaluate if low enough detection limits were used.

Comment 56:   Applicable to BH, BR, NP, and IWBS Petitions

Ecology and EPA must each receive an original petition with "wet" ink signatures.  Send the petition to the following people:

Dave Bartus				Greg Gould
USEPA Region 10			Washington State Department of Ecology
1200 Sixth Avenue			PO Box 47600
Mail Code: AWT-150			Olympia, WA 98504-7600
Seattle, WA 98101

If you have questions regarding this letter, please contact Greg Gould at<PHONE_NUMBER> or<EMAIL_ADDRESS>
Sincerely,

Laurie G. Davies
Waste 2 Resources Program Manager

By Certified Mail []

cc:	Jonathan Thompson, Attorney General's Office
      Dave Bartus, United States Environmental Protection Agency Region 10

                                  Enclosure 1

Procedures for Determining Preliminary Delisting Levels (PDLs) using EPA's Hazardous Waste Delisting Risk Assessment Software (DRAS)

For more information about DRAS and to download the software, visit https://www.epa.gov/hw/hazardous-waste-delisting-risk-assessment-software-dras.  A user guide is available online to help explain how to run the model.  Also, the website has the Delisting Technical Support Document which presents extensive information delineating all chemical release, exposure and risk assessment algorithms employed by the DRAS program.

After installing DRAS on a computer, open the DRAS model file provided called "PrelimDelistingLevels.DRS".  Alternatively, open DRAS and start with a new model file.  The chemicals and values have already been populated into the model file provided, which will save time later.

Ecology and EPA adjusted the main inputs in the Step 2 - Waste Management Unit and Risk/HQ Information section on the first screen (see Figure 1).  The inputs Ecology and EPA used are as follows:

Waste Management Unit Type
 Selected the `Landfill' option (indicates the final disposal unit type).
 Entered the Waste Volume as 2,000 cubic yards (this is approximately equivalent to 1,601 tons referenced in the IWBS Petition on page 16).
 1,601 tons/year equals 3,202,000 pounds/year
 IWBS are approximately 90% and water density is around 62.4 pounds/cubic feet
  3,202,000 pounds/year divided by 62.4 pounds/cubic feet equals 51,314 cubic feet/year
 51,314 cubic feet/year equals 1900 cubic yards/year
 Incorporate a factor of safety and use 2,000 cubic yards/year
Risk/HQ Values
 Set the Cancer Risk Level at 1E-6.
 Set the Hazard Quotient (HQ) at 0.1.
Waste Management Unit Active Life
 Selected the `Multiple Year Batch' option.
 Entered 20 for the Active Life (this is the default value for landfills according to the DRAS user guide).
Figure 1.  User-adjusted inputs to the DRAS model.

After setting the inputs to the correct options and values, click the `Update Information' button in Step 3 on in the main screen.  Next click the `Calculate Delisting Levels' button.  DRAS will automatically show a few new screens which can be ignored.  Click the maximization button on the minimized window (bottom left of screen) to open the main screen again.  Then click the `To Steps 4-5>>' button.

Now at Step 4 - Select Chemicals of Concern and Enter Concentrations, if the provided model file is opened, all of the available chemicals in the model should be populated.  If a new model file is started, the chemicals may need to be entered one at a time.  Also, fake values for the TCLP Concentration (mg/L) and Total Concentration (mg/kg) columns need to be entered for the model to work.  A value of 0.00001 should be low enough not to affect the model results.  Again, if the provided model file is used, the chemicals and values are already populated.

If the `Update Site COCs' button is available to select, click this first then select `Run DRAS'.  The model will generate a series of screens.  Find the screen called `Limiting Pathways'.  The values in this screen are the PDLs.  To export the table, make sure the Limiting Pathways screen is selected (at the forefront).  Go to `File' and select `Export to Table'.  When saving, use the `MS Excel Tab Delimited Text File' option.  This text file can be opened in Excel.

Ecology and EPA generated the site specific PDLs for the IWBS.  The PDLs are provided in the Excel file called "PrelimDelistingLevelsIWBS.xlsx".


[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Proposed Rules]
[Page 58352]
[FR Doc No: 2012-23133]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2012-0596; FRL 9731-2]

Approval and Promulgation of Implementation Plans; State of
Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the state of Missouri on September 21, 2010. This
revision proposes to amend the ambient air quality standards table to
reflect revised National Ambient Air Quality Standards (NAAQS), update
reference methods associated with the revised NAAQS, and update the
breakpoint values for the Air Quality Index. These revisions would make
Missouri's rules consistent with Federal regulations and improve the
clarity of the rules.

DATES: Comments on this proposed action must be received in writing by
October 22, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2012-0596, by mail to Amy Bhesania, Environmental Protection
Agency, Air Planning and Development Branch, 901 North 5th Street,
Kansas City, Kansas 66101. Comments may also be submitted
electronically or through hand delivery/courier by following the
detailed instructions in the ADDRESSES section of the direct final rule
located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Amy Bhesania at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the rules
section of this Federal Register.

    Dated: September 11, 2012.
Karl Brooks,
Regional Administrator, Region 7.
[FR Doc. 2012-23133 Filed 9-19-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40417-40419]
[FR Doc No: 2019-17436]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2374]

Drugs Intended for Human Use That Are Improperly Listed Due to
Lack of Annual Certification or Identification of a Manufacturing
Establishment Not Duly Registered With the Food and Drug
Administration; Action Dates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
its intention to begin inactivating drug listing records that are
improperly listed in accordance with FDA requirements because these
drug listings are not certified as being active and up to date or are
associated with a manufacturing establishment that is not currently
registered with FDA. FDA's regulations governing drug establishment
registration and drug listing require registrants to notify FDA if
commercial distribution of a listed drug is discontinued. They also
require firms to submit drug listing updates if any material changes
are made to information previously submitted, including a change in
manufacturing establishment(s). FDA has found that listings for many
drug products do not comply with these regulations because they have
not been updated in over a year, they have not been certified as being
up to date, or they identify within the listing information at least
one manufacturing establishment that is not currently registered with
FDA. Many of the drugs that are the subject of these listings appear to
no longer be in commercial distribution. The purpose of this notice is
to remind registrants of their legal obligations and announce that, if
drug listings are not appropriately updated, certified, or associated
with a registered establishment, they will be marked by FDA as
``inactive,'' and the date of inactivation will be added to the listing
record. This process will result in the closure of drug records in all
public drug listing databases maintained by FDA, including the National
Drug Code (NDC) Directory and the NDC SPL Data Elements (NSDE) file,
until corrections to the relevant listings are made.

DATES: This notice is applicable September 13, 2019.

FOR FURTHER INFORMATION CONTACT: Paul Loebach, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2262, Silver Spring, MD 20993-0002, 301-
796-2173<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360) and part 207 (21 CFR part 207) of FDA's regulations
have long required owners or operators of drug manufacturing
establishments to register their establishments with FDA. In this
notice, the term ``manufacture'' refers to all activities that trigger
the drug establishment registration obligation under part 207,
including repacking, relabeling, and salvaging as defined in part 207.
Registrants are also required by section 510 and part 207 to ``list''
each drug manufactured at their establishments for commercial
distribution and submit updated drug listing information to FDA twice
yearly, in June and December, notifying FDA if this information has
changed. Specifically, section 510(i)(2) and (j) of the FD&C Act
require registered establishments to report and periodically update,
among other information, listing information for each drug
manufactured, prepared, propagated, compounded, or processed by them
for commercial distribution in the United States. Under 21 CFR 207.49,
207.53, and 207.54, registrants must provide listing information that
corresponds to the activity or activities they engage in for that drug.
    As part of the drug listing information they submit to FDA,
registrants must identify all establishments where a ``listed drug''
(as the term used in the context of section 510 of the FD&C Act and
part 207) is manufactured or provide a source NDC that enables FDA to
identify such establishments. Registered establishments must also
report to FDA the discontinuation of commercial distribution of a
listed drug (section 510(j)(2)(B) of the FD&C Act) and any material
change in drug listing information previously submitted, which includes
any changes in the establishment(s) where the drug is manufactured
(section 510(j)(2)(D) of the FD&C Act and 21 CFR 207.1). On August 31,
2016, FDA amended part 207 to require drug manufacturers and other
registrants, at the time of registration renewal, to certify that no
changes have occurred to their listings that were not submitted or
updated during the current calendar year (81 FR 60170 and Sec.  207.57
(21 CFR 207.57)). The first certifications under this new requirement
were due during the registration renewal period from October 1 to
December 31, 2017 (81 FR 60170 at 60201 and Sec.  207.57).
Establishments and labeler code holders are also required to update
contact information (name, telephone number, and email) submitted to
FDA within 30 calendar days of any changes (21 CFR 207.25(g),
207.29(a)(3), and 207.33(c)(2)).
    Complete, accurate, and up-to-date establishment registration and
drug listing information is essential to FDA's mission. FDA relies on
establishment registration and drug listing information in
administering several key programs, including drug establishment
inspections, postmarketing surveillance, counterterrorism, recalls,
drug quality reports, adverse event reports, monitoring of drug
shortages and availability, supply chain security, and identification
of products that are marketed without an approved application. If
registration and listing information is outdated or otherwise
unreliable (such as inaccurate, superfluous, incomplete, or missing),
the integrity of the drug establishment registration and listing
database--and FDA's ability to rely on the reported information for
these programs--is compromised. Drug registration and listing
information is also widely used outside FDA for several purposes,
including electronic drug prescribing, prescription drug reimbursement,
and patient education. A review of our data shows that the types of
errors discussed in this notice affect tens of thousands of records.
Therefore, the inclusion of such incorrect or outdated information in
FDA's NDC Directory, the NSDE file, or other public drug listing
databases can negatively affect public health.

II. Circumstances Under Which Certain Drug Listing Information Becomes
Inaccurate

    Each registrant must list all drugs it manufactures for commercial
distribution within 3 days of initial

registration (21 CFR 207.45). Establishment registration must be
renewed annually between October 1 and December 31 (21 CFR 207.29).
Each registrant must in June and December each year: (1) Update its
drug listing information to provide FDA with information about any
drugs introduced for U.S. commercial distribution not previously
listed, (2) report the discontinuation of any listed drug, and (3)
report any material changes in drug listing information submitted
previously (including any updates in the manufacturing establishments)
(Sec.  207.57). If there are no changes to listing information to
report in June or December, then the registrant must certify that there
have been no changes to the listing information previously submitted,
during the October 1 and December 31 registration renewal and listing
certification period (Sec.  207.57). By December 31 of each calendar
year, registrants should review their current files of listed human
drugs to determine whether any data elements in their drug listing
records are no longer accurate and submit updated listing files or
listing certifications.
    While a new drug listing submission transmitted to FDA
electronically will not be accepted if the listing information
identifies a manufacturing establishment that is not registered in
accordance with FDA's requirements, previously submitted establishment
and listing information may become outdated for a variety of reasons.
In some cases, establishments that have discontinued manufacturing let
their registration expire by not renewing their annual establishment
registration at the end of the year but fail to update their drug
listing information to report discontinuation of their listed drug(s).
The result is that listing information for certain drugs may be
certified to be current but potentially identifies one or more
establishments that are not currently registered with FDA in accordance
with FDA's requirements.
    In other cases, registrants may incorrectly include additional
establishments in their drug listing submissions (for example, in
anticipation of a future business relationship with a contract
manufacturer). Consistent with the applicable regulatory requirements
in part 207, FDA expects all establishments identified in a drug
listing submission to reflect current manufacturing facilities for the
listed drug at the time of the listing submission or at the time of the
update so that the Agency can rely on the information when submitted as
an accurate picture of the supply chain. There are also cases in which
a registrant fails to review and update its previously reported drug
listing information as required in June and December of each year.
Similarly, a registrant may neglect to certify to FDA that its listings
are still up to date and accurate. (See section IV of this document for
links to FDA's NDC Directory and other resources that may help
registrants determine whether any data elements in their drug listing
records are no longer accurate and correct inaccurate drug listings.)

III. FDA's Intended Response

    To address the above registration and listing problems, FDA is
encouraging firms that are required to register drug establishments and
list human drugs under part 207 to review their currently listed human
drugs and determine whether any information in their drug listings,
including drug establishments identified, is no longer accurate. Any
active drug listing submissions that are inaccurate should be updated
as soon as possible.
    Thirty days after publication of this notice, and every January
thereafter, FDA will begin to inactivate human drug listings that
remain uncertified from the previous renewal period of October 1 to
December 31. In addition, every July thereafter, FDA will begin to
inactivate human drug listings that remain active and certified after
the June listing update, but still contain at least one establishment
that is not currently registered in accordance with FDA's requirements.
This action taken by FDA will include listings for finished drug
products, as well as for active pharmaceutical ingredients and other
unfinished drugs. These listing records, including their NDCs, will be
inactivated and subject to immediate removal from FDA's NDC Directory
and notification of each NDC's inactivation date will be included in
FDA's NSDE file. NDCs that are inactivated by FDA may be reactivated
with an updated and compliant drug listing submission as soon as the
next business day. If activated again, the listing will again be
included in the NDC Directory and the reactivation date will be
included in the NSDE file. If a drug remains in commercial distribution
after it has been inactivated and removed from the NDC Directory, the
drug may be deemed misbranded for failure to fulfill registration or
listing obligations under section 502(o) of the FD&C Act (21 U.S.C.
352(o)), and persons marketing the drug in the United States or
offering it for import into the United States may be subject to
enforcement.
    Manufacturers and repackagers of products subject to the new
product identification requirement (see section 582(b)(2) and (e)(2) of
the FD&C Act, respectively (21 U.S.C. 360eee-1(b)(2) and (e)(2))), and
who have incorporated the new product identifier (serialization) into
their labeling, must submit such updated labeling with listing updates
(Sec.  207.57) and not merely certify that affected listings are up to
date via ``no changes'' certifications during the registration renewal
period. Such a change requires that a new and representative sample of
labeling incorporating the new product identifier requirements be
submitted as an update to listing (Sec.  207.57). Note that such an
update would satisfy the annual certification requirement for the drug
listing and not require an additional ``blanket no changes'' submission
to maintain the listing's active status.
    Firms are required by law to update their drug listings when they
discontinue marketing their listed drugs (Sec.  207.57). To properly
discontinue a listed drug, the listing record must be updated to
include an accurate marketing end date that corresponds with the last
lot expiration date of the drug (Sec.  207.57(b)(ii)). If the listing
record expires without an update, certification, or discontinuance
submitted, the process described above will assign an inactivation date
that is different from the actual date of discontinuance and may have
unintended consequences for dispensing and reimbursement. Rather than
explicitly discontinuing certain listings, some firms have notified FDA
that they do not intend to certify or update those listings. However,
listing certification is a separate requirement and should not be
treated as a mechanism to discontinue the drug listing record.

IV. Resources Available To Assist With Updating or Certifying Drug
Listings

    The NDC Directory (available at: https://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm) currently identifies all active, but
uncertified, listings. The online search marks uncertified listings
with a ``(U)'' in red font. The online search also marks active but
otherwise deficient or erroneous listing records with an ``(E)''.
Listing records marked with an ``(E)'' have been identified by FDA as
having an error or deficiency associated with the submission. These
include, but are not limited to, records with at least one
establishment that is not registered in accordance with FDA's
requirements. All listing records should be reviewed for accuracy at
least biannually,

regardless of whether they have been marked as deficient or not. Within
the download files for the NDC Directory, uncertified listings may be
identified using the LISTING CERTIFIED THROUGH DATE column. Any value
that appears in this date field occurring in the past identifies a
product listing that has not been certified. Erroneous or deficient
listings are identified by a value of ``E'' in the EXCLUDE FLAG column.
    Updates and certifications to listing information must be provided
electronically in Structured Product Labeling (SPL) format. Anyone
seeking information on how to update listing information may visit
www.fda.gov/edrls or contact<EMAIL_ADDRESS>Additionally, FDA
offers two SPL authoring tools for use in the creation and submission
of SPL: Xforms and CDER Direct. Xforms is available from FDA's SPL web
page at: https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. CDER Direct is available at:
https://direct.fda.gov.

    Dated: August 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17436 Filed 8-13-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Notices]
[Page 26635]
[FR Doc No: 2013-10733]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP13-819-000.
    Applicants: ANR Pipeline Company.
    Description: Maps Update to be effective 6/1/2013.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5098.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: RP13-820-000.
    Applicants: TC Offshore LLC.
    Description: Map Update to be effective 6/1/2013.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5099.
    Comments Due: 5 p.m. ET 5/8/13.

    Docket Numbers: RP13-821-000.
    Applicants: Alliance Pipeline L.P.
    Description: May 1--31 2013 Auction to be effective 5/1/2013.
    Filed Date: 4/26/13.
    Accession Number: 20130426-5174.
    Comments Due: 5 p.m. ET 5/8/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated April 29, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-10733 Filed 5-6-13; 8:45 am]
BILLING CODE 6717-01-P


Ms. Drusilla Hufford

Environmental Protection Agency

1200 Pennsylvania Avenue, NW

MC  6205J

Washington, DC  20460

June 22, 2011

Subject:  SNAP EPA-HQ-OAR 2008-0664 HFO-1234yf LGWP MAC Refrigerant
Industrial Transfer

Dear Drusilla

It was nice to meet your team last week, thanks to all for taking time
to discuss commercial introduction of HFO-1234yf refrigerant for mobile
air conditioning.  The pace towards full production is rapidly
accelerating as we look to support our MAC customers around the globe.
Expedient movement of the refrigerant to the various global regions is
critical the operation of our business and the successful implementation
of this new lower global warming refrigerant.

We need to move HFO-1234yf today for industrial transfers but vitally
need EPA non-objection to allow use of other than the SAE J2844 service
cylinder fitting. We would appreciate your agreement with our
interpretation that such shipments would not conflict with the intent of
the SNAP ruling. Honeywell needs to move material immediately both
internal inventory transfers and to support customer production
activities.  These shipments are not for “professional service or
service for consideration” usage.

During our discussion we briefly addressed HFO-1234yf SNAP Final Rule
EPA-HQ-OAR-2008-0664 and the SAE J2844 quick connect fitting standard
referencing professional service cylinder fittings.  From our
discussion, it is our understanding that the SNAP reference relates to
“professional service or service for consideration” when identifying
a specific fitting.  Therefore, any industrial transfer either internal
to Honeywell or to a non-professional service usage would be excluded
from the fitting requirement. It is this last point that we need
immediate clarification to allow movement of refrigerant.

Please provide a response indicating your agreement with our desire to
utilize standard industry fillings for  material transfers for
industrial usage.

Thank you for your assistance, I look forward to your feedback.  As we
discussed at the meeting, please communicate directly with me at
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>or<PHONE_NUMBER>.

Thanks,

Steven H. Bernhardt, PhD

Global Director Regulatory Affairs

Honeywell International

101 Columbia Road, NIC-5

Morristown, NJ  07962

cc. Cindy Newberg

      Margaret Sheppard

      Yaidi Cancel

Honeywell

101 Columbia Road

Morristown, NJ  07962


[Federal Register Volume 88, Number 45 (Wednesday, March 8, 2023)]
[Proposed Rules]
[Pages 14301-14303]
[FR Doc No: 2023-04620]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0425; Project Identifier MCAI-2022-00980-A]
RIN 2120-AA64

Airworthiness Directives; DAHER AEROSPACE (Type Certificate
Previously Held by SOCATA) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain DAHER AEROSPACE (type certificate previously held by
SOCATA) Model TBM 700 airplanes. This proposed AD was prompted by
mandatory continuing airworthiness information (MCAI) issued by the
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI identifies the unsafe
condition as interference between the emergency exit trim panel and the
upholstery panel, which could result in additional effort required to
open the emergency exit door. This proposed AD would require
modification of the gripping strap, which maintains the upholstery
panel on the emergency exit trim panel. The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this NPRM by April 24, 2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0425; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the MCAI, any comments received, and other
information. The street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For service information identified in this NPRM, contact
DAHER AEROSPACE, Customer Support, Airplane Business Unit, Tarbes Cedex
9, France 65921; phone:<PHONE_NUMBER>; email: daher.com">[email protected]daher.com;
website: daher.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Fred Guerin, Aviation Safety Engineer,
General Aviation & Rotorcraft Section, International Validation Branch,
FAA, 2300 S 216th Street, Des Moines, WA 98198; phone:<PHONE_NUMBER>;
email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-0425; Project Identifier
MCAI-2022-00980-A'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI

as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Fred
Guerin, Aviation Safety Engineer, General Aviation & Rotorcraft
Section, International Validation Branch, FAA, 2300 S. 216th Street,
Des Moines, WA 98198. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union, has issued
EASA AD 2022-0149, dated July 21, 2022 (referred to after this as ``the
MCAI''), to correct an unsafe condition on certain serial-numbered
DAHER AEROSPACE (type certificate previously held by SOCATA) Model TBM
700 airplanes.
    The MCAI was prompted by a report that, due to interference between
the emergency exit trim panel and the upholstery panel, additional
effort may be required to open the emergency exit door. An
investigation revealed that the gripping strap, which maintains the
upholstery panel on the emergency exit trim panel, is not properly
sized. The MCAI requires inserting a temporary revision (TR) into the
emergency procedures section of the applicable pilot's operating
handbook (POH), informing all flight crews, operating the airplane
accordingly, and modifying the gripping strap, at which time the TR can
be removed from the POH. The unsafe condition, if not addressed, could
lead to failure of the emergency exit door to perform its intended
function during an emergency opening, possibly resulting in reduced
evacuation capacity from the airplane and injury to occupants.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0425.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Daher Aerospace Service Bulletin SB 70-304-25,
dated July 2022, which specifies procedures for modifying the gripping
strap on the emergency exit trim panel.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

FAA's Determination

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI and service information described above. The FAA is issuing
this NPRM after determining that the unsafe condition described
previously is likely to exist or develop on other products of the same
type design.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in the MCAI, except as discussed under ``Differences Between this
Proposed AD and the MCAI.''

Differences Between This Proposed AD and the MCAI

    The MCAI requires inserting a TR into the emergency procedures
section of the applicable POH, informing all flight crews, and
thereafter, operating the airplane accordingly until the modification
of the gripping strap, at which time the TR can be removed from the
POH. This proposed AD would only require modifying the gripping strap
because FAA regulations mandate compliance with only the operating
limitations section of the POH and not the emergency procedures
section.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 841 airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Modification of the gripping strap....  1 work-hour x $85 per               $300            $385        $323,785
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

DAHER AEROSPACE (Type Certificate Previously Held by SOCATA): Docket
No. FAA-2023-0425; Project Identifier MCAI-2022-00980-A.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by April 24, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to DAHER AEROSPACE (type certificate previously
held by SOCATA) Model TBM 700 airplanes, serial numbers 434 through
1424 inclusive, except serial numbers 1408 and 1420, certificated in
any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 5220, Emergency
Exits.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI identifies the unsafe condition as interference
between the emergency exit trim panel and the upholstery panel,
which could result in additional effort required to open the
emergency exit door. The FAA is issuing this AD to address this
condition. The unsafe condition, if not addressed, could lead to
failure of the emergency exit door to perform its intended function
during an emergency opening, resulting in reduced evacuation
capacity from the airplane and injury to occupants.

(f) Compliance

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

(g) Required Actions

    Within 12 months after the effective date of this AD, modify the
gripping strap on the emergency exit trim panel by following, as
applicable for your serial-numbered airplane, sections A, B, and C
in the Description of Accomplishment Instructions in Daher Aerospace
Service Bulletin SB 70-304-25, dated July 2022 (Daher SB 70-304-25),
except where Daher SB 70-304-25 specifies to discard certain parts,
this AD requires removing those parts from service. If the
operational check of the emergency exit fails, before further
flight, re-modify the gripping strap on the emergency exit trim
panel by following, as applicable for your serial-numbered airplane,
sections A, B, and C in the Description of Accomplishment
Instructions in Daher SB 70-304-25 until it passes this operational
check, except where Daher SB 70-304-25 specifies to discard certain
parts, this AD requires removing those parts from service.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in Sec.  39.19. In accordance with Sec.  39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, mail
it to the address identified in paragraph (i)(2) of this AD or email
to: [email protected]. If mailing information, also submit
information by email. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.

(i) Additional Information

    (1) Refer to European Union Aviation Safety Agency (EASA) AD
2022-0149, dated July 21, 2022, for related information. This EASA
AD may be found in the AD docket at regulations.gov under Docket No.
FAA-2023-0425.
    (2) For more information about this AD, contact Fred Guerin,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 2300 S 216th Street, Des
Moines, WA 98198; phone:<PHONE_NUMBER>; email: [email protected].

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Daher Aerospace Service Bulletin SB 70-304-25, dated July
2022.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact DAHER
AEROSPACE, Customer Support, Airplane Business Unit, Tarbes Cedex 9,
France 65921; phone:<PHONE_NUMBER>; email: daher.com">[email protected]daher.com;
website: daher.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 2, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-04620 Filed 3-7-23; 8:45 am]
BILLING CODE 4910-13-P