September 10, 2003 1 RISK SCREEN ON THE USE OF SUBSTITUTES FOR OZONE DEPLETING SUBSTANCES REFRIGERATION AND AIR CONDITIONING End Use: Proposed Replacement for R 13B1 in Very Low Temperature Refrigeration Refrigerant: ISCEON   89 This risk screen contains no Clean Air Act ( CAA) Confidential Business Information ( CBI) and, therefore, can be disclosed to the public.

1. INTRODUCTION Stratospheric ozone depleting substances ( ODS) are being phased out of production in response to a series of diplomatic and legislative efforts, including the Montreal Protocol and the Clean Air Act Amendments of 1990 ( CAAA). The U. S. Environmental Protection Agency ( EPA), as authorized by Section 612 of the CAAA, has developed a program to evaluate the human health and environmental risks posed by alternatives to ODS. The main purpose of EPA's program, called the Significant New Alternatives Policy ( SNAP) program, is to identify acceptable and unacceptable substitutes for ODS in specific end uses.

EPA's decision on the acceptability of a substitute is based largely on the findings of a screening assessment of potential human health and environmental risks posed by the substitute in specific applications. EPA has already screened a large number of substitutes in many enduses within all of the major ODS using sectors, including refrigeration and air conditioning; solvent cleaning; foam blowing; aerosols; fire extinguishing; adhesives, coatings, and inks; and sterilization. The results of these risk screens are presented in a series of background documents that are available in this docket.

The purpose of this report is to supplement EPA's background document on the refrigeration and air conditioning sector1 ( hereinafter referred to as the Background Document) by adding to the list of potential substitutes for specific end uses of R 13B1 in this sector. The reader is referred to this reference for an additional discussion of different methodologies used to conduct risk screens. The specific proposed substitute blend examined in this report is ISCEON ® 89 which may be used in the following applications: environmental test chambers, low temperature freeze dryers, low temperature storage, and process control. The potential risks associated with use of the constituents of this blend in the refrigeration and air conditioning end use have been examined at length in the Background Document.

1 EPA 1994. Significant New Alternatives Policy Technical Background Document: Risk Screen on the Use of Substitutes for Class I Ozone depleting Substances: Refrigeration and Air Conditioning. Stratospheric Protection Division. March, 1994. September 10, 2003 2 Section 2 of this report summarizes the results of the risk screen for the proposed substitute blend listed in Table 1. The remainder of the report is organized similarly to the Background Document: Section 3 presents the toxicity values used for the risk screen, Section 4 presents the results of the atmospheric assessment, Sections 5 and 6 discuss occupational and general population exposures, respectively. Section 7 addresses flammability concerns, and Section 8 discusses potential increases in atmospheric releases of volatile organic compounds ( VOCs).

TABLE 1. PROPOSED SUBSTITUTE BLEND Refrigerant Blend ( Trade Name) Constituents Percent by Weight CAS Number HFC 125 ( also known as pentafluorethane) 86 354 33 6 R 218 ( also known as octafluoropropane) 9 76 19 7 Isceon   89 propane 5 74 98 6 2. SUMMARY OF RESULTS Isceon   89 is recommended for SNAP approval for all the proposed end uses. EPA's risk screen indicates that the use of the proposed substitute will be less harmful to the atmosphere than the continued use of R 13B1 blends. No significant risks to workers are estimated based on occupational exposure modeling. Additionally, general population exposure to the substitute is expected to be below levels of concern for noncancer risks. For applications of this and all other refrigerants, EPA recommends that American Society of Heating, Refrigerating and Air Conditioning Engineers ( ASHRAE) Standards 15 and 34 be followed.

3. TOXICITY REFERENCE VALUES FOR SUBSTITUTES To assess potential health risks from exposure to this substitute for ODS in the refrigeration and air conditioning sector, EPA identified the relevant toxicity threshold values, including available occupational exposure limits ( OELs), for comparison to modeled exposure concentrations for different scenarios. For the occupational exposure analysis provided in this risk screen, potential risks from chronic worker exposure were evaluated by comparing exposure concentrations to values derived by EPA, namely acceptable exposure levels ( AELs). Potential risks from short term occupational exposures were also evaluated through comparison with values derived by EPA, namely short term exposure levels ( STELs). Reference concentrations September 10, 2003 3 ( RfCs) were used to assess risks to the general population from exposure to ambient air releases. The OELs and RfCs used for this assessment are shown in Table 2. EPA's approach for identifying or developing these values is discussed in Chapter 3 of the Background Document.

TABLE 2. TOXICITY THRESHOLD VALUES AEL ( Long term Exposure) STEL ( Short term Exposure) Cardiotoxic LOAEL Cardiotoxic NOAEL Reference Concentration ( RfC) Chemical ppm ppm ppm ppm ppm mg/ m3 HFC 125 1,000a 4,000b 100,000c 75,000c 2 i 10 i R 218 1,000d 3,000e 400,000f 300,000f 0.5 i 4.5 i propane 1,000g 7,500h 100,000 i 50,000 i 0.5 i 0.9 i Source: EPA 1993, EPA 1994, EPA 1995, PAFT 1996, SNAP submission ISCEON ® 98, 2003. a WEEL ( 8 hour time weighted average) established by AIHA ( 1999). b TLV STEL ( Threshold Limit Value Short Term Exposure Limit), a workplace standard sometimes used as a level of concern for emergency response. A chemical's TLV STEL is the maximum time weighted average concentration of that chemical in the air to which workers may be exposed for up to 15 minutes. c Calm 1996 d Rhône Poulenc Chemical Ltd. internal occupational exposure limit ( 1996) as stated in the SNAP submission for ISCEON ® 89 ( 2003). Also, 1000 ppm AEL estimated in Background document ( EPA 1994) by analogy to propane. e STEL was estimated as three times the AEL; this method of estimating a short term exposure limit is commonly done by ACGIH. f Study summerized in the SNAP submission for ISCEON ® 89 ( 2003). g PEL ( 8 hour time weighted average) established by OSHA ( 1998) ( 29 CFR 1910.1000). h Excursion limit Recommendation for 30 minute exposure which can exceed 3 times the 8 hour TLV TWA ( 2500 ppm) established by ACGIH ( 2002). i EPA 1994 ACGIH = American Conference of Governmental Industrial Hygienists; AIHA = American Industrial Hygiene Association; STEL = Short Term Exposure Level; LOAEL = Lowest Observed Adverse Effect Level; NOAEL = No Observed Adverse Effect Level; WEEL= Workplace Environmental Exposure Level; AEL = Acceptable Exposure Level; NA= Not Available 4. ATMOSPHERIC MODELING This section presents an assessment of the potential risks to atmospheric integrity posed by the use of ISCEON ® 89 in the refrigeration and air conditioning sector. The ODP, GWP, and ALT of the proposed substitute are presented in Table 3.

The environmental impacts resulting from use of ISCEON ® 89 are generally in the range of those predicted for other substitutes examined in the Background Document. EPA believes that the substitute is substantially less harmful to the ozone layer than the continued use of R 13B1. The 100 Year Weighted GWP of ISCEON ® 89 is approximately 3,554 relative to CO2. September 10, 2003 4 However, ISCEON ® 89 is not believed to pose a substantial threat to the environment because its use is restricted to low temperature refrigeration used by medical and research facilities so the production and release of ISCEON ® 89 is expected to be minimal. Additionally, low temperature refrigerators may use more damaging alternatives or higher concentrations of R 218. ISCEON ® 89 has a lower GWP than HFC 23, another alternative substitute for R 13B1 in low temperature refrigeration, with a 100 Year GWP of 12,000 ( IPCC 2000).

TABLE 3. ODP, GWP, AND ALT FOR PROPOSED REFRIGERATION AND AIR CONDITIONING SUBSTITUTES SUBSTITUTE ODP 100 Year GWP ( relative to CO2) 100 Year Weighted GWP ( relative to CO2) ALT ( years)

HFC 125 0 3,400a 2,924 32.6a R 218 0 7,000b 630 2,600b propane 0   < 0.5c a Source: IPCC ( 2000). b Source: Houghton ( 1995). c ALT of propane is 5 21 days ( Wuebbles 2003).  Not applicable 5. OCCUPATIONAL EXPOSURE AND RISK SCREENING ANALYSIS Occupational exposure modeling was performed for the components of the proposed blend to ensure that use of the blend does not pose an unacceptable risk to workers. The highest 8 hour estimated exposure for HFC 125 in all proposed end uses for both manufacture and disposal was 339 ppm. For R 218, the highest 8 hour estimated exposure for all proposed end uses was 93 ppm, and for propane, the highest 8 hour estimated exposure was 54 ppm. All of the 8 hour exposure values fall well below 1,000 ppm, the AEL of all three chemicals, and therefore pose no health risks in occupational settings.

The highest 15 minute estimated exposure for HFC 125 in all proposed end uses for both manufacture and disposal was 1006 ppm. For R 218, the highest 15 minute estimated exposure was 275 ppm, and, the highest 15 minute estimated exposure for propane was 318 ppm. The 15 minute exposure values for the three substitute components are all well below the lowest STEL of 3000 ppm for both manufacture and disposal. ( See Attachment 1 for discussion of R 218 STEL). September 10, 2003 5 The analysis concluded that occupational exposure to any of the constituents in the ISCEON ® 89 blend, HFC 125, R 218, and propane, is not expected to pose unacceptable risks to workers.

6. GENERAL POPULATION EXPOSURE This section screens potential risks to the general population from exposure to ambient air releases of the substitutes examined in this report. The methodology used for refrigerant screening was identical to the one used in the general population exposure analysis described in Chapter 7 of the Refrigeration and Air Conditioning Background Document. A thorough review of HCFC and HFC substitutes by end use is provided including specific data for HFC 125, R 218, and propane ( EPA 1994). Table 4 shows that all three substitutes had exposure concentrations at orders of magnitude below the reference concentrations, even using conservative screening assumptions. Thus, releases of HFC 125, R 218, and propane ( as shown in Table 4) during manufacture, end use, and disposal, are not expected to pose a health risk to the general population.

TABLE 4. RATIO OF HIGHEST EXPOSURE CONCENTRATION TO RfC Chemical Highest Exposure Concentration/ RfC Ratio HFC 125 0.049 R 218 0.071 Propane 0.14 Source: EPA 1994.

7. FLAMMABILITY ANALYSIS It is important to consider the flammability of substances when investigating their acceptability for use as refrigerants since substitutes that are flammable could pose safety concerns to workers. As reported in the submission, ISCEON ® 89 has been tested by Chillworth Research Centre ( Southampton, England) and was considered nonflammable, and thus poses no danger of flame propagation. A Worst Case Fractionation Composition Flammability Test under the guidance of Underwriters Laboratories Inc. Standard 2182 at 25 º C demonstrated a small blue flame that was non propagating in 11 17% ( v/ v) samples.

8. VOLATILE ORGANIC COMPOUND ( VOC) ANALYSIS August 1, 2003 6 HFC 125 and R 218 have been exempted from listing as VOCs under CAA regulations ( 40 CFR § 51.000). With respect to propane, the analysis presented in the Background Document has shown that potential emissions of VOCs from all substitutes for all end uses in the refrigeration and air conditioning sector are likely to be insignificant relative to VOCs from all other sources ( i. e., both anthropogenic and biogenic). Propane has not been exempted as a VOC under the CAA, however, emissions are controlled through existing regulations and industry practices. September 10, 2003 7 REFERENCES American Industrial Hygiene Association. The AIHA 1999 Emergency Response Planning Guidelines and Workplace Environmental Exposure Level Guides Handbook. American Industrial Hygiene Association. Fairfax, VA 1999.

Calm, James M. 1996. The Toxicity of Refrigerants. Presented at the International Refrigeration Conference, Purdue University, July 1996.

EPA. 1994. " SNAP Technical Background Document: Risk Screen on the Use of Substitutes for Class I Ozone depleting Substances: Refrigeration and Air Conditioning." Stratospheric Protection Division. March, 1994.

EPA. 1995. IRIS website. http:// www. epa. gov/ iris/ subst/ 0656. htm.

Houghton, J. T. et al. ( eds), Climate Change 1995; The Science of Climate Change ( New York, NY: Cambridge University Press, 1996). Contribution of Working Group I to the Second Assessment Report of the Intergovernmental Panel on Climate Change.

IPCC ( Intergovernmental Panel on Climate Change), 2000: Emissions Scenarios. N. Nakicenovic, J. Alcamo, G. Davis, B. de Vries, J. Fenhann, S. Gaffin, K. Gregory, A. Grübler, T. Y. Jong, T. Kram, E. Lebre La Rovere, L. Michaelis, S. Mori, T. Morita, W. Pepper, H. Pitcher, L. Price, K. Riahi, A. Roehrl, H H. Rogner, A. Sankovski, M. Schlesinger, P. Shukla, S. Smith, R. Swart, S. van Rooijen, N. Victor, and D. Zhou ( eds.), Special Report of WGIII of the IPCC, Cambridge University Press, Cambridge, UK, ISBN 0 521 80493 0.

ISCEON ® 89, 2003. Application to SNAP for approval of ISCEON ® 89 submitted by Fluorinated Consumer Products.

Programme for Alternative Fluorocarbon Toxicity Testing. ( PAFT). 1996. Website http:// www. afeas. org/ paft/

Wuebbles 2003. Personal communication with Don Wuebbles. E mail. July 21, 2003.


exemption for articles of food that are “low risk” or covered by programs of other agencies, such
as CBP or foreign government regulatory authorities.
(Comments) One comment requests that the final rule exempt foreign-to-foreign transit
mail; i.e., mail shipments that simply transit the United States for delivery in a third country.
The comment reasons that these items are not intended for U.S. consumption (i.e., not intended
for a U.S. recipient); represent the transfer of universal service obligation mail between
sovereign governmental entities; and are items from foreign mailers who would not know when
to submit the required prior notice data as they do not always know whether their mail dispatches
will be transiting the United States.
(Response) As we explained in the IFR and elsewhere in this notice, food that is not
intended for U.S. consumption is still within the scope of “imported or offered for import”  (68
FR 58974 at 58991) and is subject to prior notice requirements.  However, we understand that in

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the case of foreign-to-foreign mail, the sender does not have control over the transportation route
that the foreign-to-foreign shipment will transit. Therefore, we are proposing an enforcement
discretion policy in the Prior Notice Final Rule Draft CPG that would address this situation.
Under that policy, FDA and CBP should typically consider not taking any regulatory action
when an article of food is imported or offered for import via international mail without prior
notice and there is no U.S. recipient.
(Comments) Comments filed by express carriers request that FDA exempt all non-U.S.
destination shipments from the requirement to provide prior notice.  The comments note that the
shipment is in the custody of the express carrier at all times and the risk of diversion from the
highly-controlled environment in which express shipments move, particularly in-bond
shipments, is low.  The comments also reason that foreign shippers and foreign consignees do
not submit the required prior notice data because they are, by design, not aware that their
shipments will transit the United States on their way to a third country because express carriers
do not disclose flight routes of packages either to shippers or consignees due to security
concerns.  If prior notice must be submitted, express carriers will be required to make the
customers aware of routes, nullifying this simple but effective security precaution.
(Response) As described in the previous comment, prior notice applies to food imported
or offered for import notwithstanding that the food is not intended for U.S. consumption.
However, we recognize that, when shipping via express carrier or other private delivery service,
the sender does not have control over the transportation route that the foreign-to-foreign
shipment will transit.  For example, a person in Europe intends to mail an article of food to South
America via an express carrier.  This person has no control over the package entering the United
States if the express carrier, for example, chooses to consolidate shipments going to South

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America in Florida.  The proposed enforcement discretion policy in the Prior Notice Final Rule
Draft CPG states that FDA and CBP should typically consider not taking any regulatory action
when an article of food is imported or offered for import and the carrier is an express
consignment operator or carrier; neither the submitter nor transmitter is the express consignment
operator or carrier; and the importer, owner, or recipient/consignee is not located in the United
States.
(Comments) Several comments request that FDA exempt shipments of food that move
from Canada to Canada under bond by rail through Northern Maine.  These comments note that
such shipments moving by rail in bond cannot be delivered to points within the United States,
must move from Canada to Canada, and that the food products in trailers on rail cars cannot be
diverted to enter the U.S. food supply.  The comments state that having to submit prior notice
puts the U.S. rail carriers at a competitive disadvantage when competing for Canadian rail
business.  Other comments request that FDA exempt shipments of food that move from Canada
to Canada by marine and trucking companies.  The comments reason that their Canada to Canada
in-transit shipments move in sealed containers and that providing detailed information for
products that are never going to enter the U.S. food supply is a hardship to U.S. businesses.
(Response) FDA disagrees.  The Bioterrorism Act does not create any exemptions for this
situation and therefore, there is no basis for excluding such business operations from prior notice
requirements.  The preamble to the IFR provides our rationale for determining that food that
transits the United States falls under the scope of this rule (68 FR 58974 at 58990) and we
continue to hold this view.  Moreover, the comment implies that these shipments should be
exempt from prior notice requirements because they pose a relatively low risk by moving by rail,
in bond, and/or under seal.  Even if such food shipments are a low risk, as discussed elsewhere in

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this notice, section 801(m) of the act does not authorize a "low risk" exemption.  However, the
proposed guidance in the Prior Notice Final Rule Draft CPG (which would continue the policy
established in the March 2005 revision to the Prior Notice Interim Final Rule CPG) addresses
imported food arriving from and exiting to the same country.  It describes the situations and
conditions under which FDA and CBP should typically consider not taking regulatory action
when prior notice is not submitted.
(Comments) Another comment suggests that that the FDA work cooperatively with CBP
such that transshipments that follow the CBP transshipment procedures are not required to enter
additional information for FDA prior notice purposes, and that shipments that may pose a risk
are identified through the CBP process.   The comment also states that the current requirements
in the agreement for secure in-transit procedures could be modified to meet the objective of the
prior notice IFR to prevent the entry of products that have been intentionally adulterated.
Shipments that follow the proposed secure in-transit procedures would not be distributed in the
United States and would be of minimal risk to human or animal security and safety.  The
comment also suggests that FDA can achieve certainty of safety of overseas shipments that are
transiting to the United States through Canada by conducting examinations at the first point of
arrival in North America and through the expansion of existing bilateral harmonized risk
screening and lockout sharing systems to accommodate additional high-risk commodities.
(Response) CBP's secure in-transit procedures cannot substitute for the submission of
prior notice for in-transit shipments because they do not meet the requirements of the
Bioterrorism Act, such as providing FDA with certain specified information.  The information in
a prior notice is necessary for FDA to determine whether it should examine the food at the U.S.
port of arrival.  In addition, section 801(m) of the act does not authorize an exemption for articles

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of food that are covered by programs of other agencies, such as CBP, even if those programs
would "prevent the entry of products that have been intentionally adulterated."
(Comments) One comment notes that there are many ocean containers crossing into the
United States for transshipment purposes and prior notice is not being submitted.  The comment
asks how to ensure that ocean containers that arrive in Canada or Mexico and cross into the
United States by rail have prior notice submitted in a timely fashion, or submitted at all, when
shippers are not always aware of when the containers are due to cross or on which train.
(Response) FDA addressed this issue in the IFR when it allowed any person with
knowledge of the required information to submit prior notice.  In § 1.285 of the proposed prior
notice rule (68 FR 5428; February 3, 2003), FDA provided that a purchaser or importer of an
article of food who resides or maintains a place of business in the United States or an agent
thereof was authorized to submit prior notice. FDA further proposed that if the article of food is
imported for in-bond movement through the United States for export, the prior notice must be
submitted by the arriving carrier or, if known, the carrier making the in-bond entry.  Many
comments to the proposed rule objected to the limitation that only a person who resides or
maintains a place of business in the United States can submit the prior notice. In addition,
comments pointed out that under some circumstances, the U.S. importer or purchaser or carrier
would not have all the information required by prior notice, but that other entities, e.g., the
foreign manufacturer/ processor, shipper, or exporter, would have the required information.
Many comments stated that entities other than U.S. firms or carriers should be allowed to submit
prior notice.
In response, FDA modified this provision in the IFR and removed the restriction on who
can submit prior notice. Accordingly, § 1.278 of the IFR provides that any person with

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knowledge of the required information may submit prior notice to FDA. FDA has retained this
provision in the final rule.
17. Additional Exclusions Requested--Diplomatic Pouch
We have determined that prior notice does not apply to food in diplomatic pouches
because Art. 27(3) of The Vienna Convention on Diplomatic Relations (1961) states that:  “The
diplomatic bag shall not be opened or detained.”
(Final Rule) Section 1.277(b)(7) of the final rule adds a new exclusion to the rule:
“Articles of food subject to Art. 27(3) of The Vienna Convention on Diplomatic Relations
(1961), i.e., shipped as baggage or cargo constituting the diplomatic bag.”
18. Additional Exclusions Requested--Seeds for Planting
(Comments) One comment requests that FDA exempt imported seed that is destined
solely for planting purposes, even if small amounts found unsuitable for planting will end up in
the food supply.  The comment also requests that the FD3 flags be removed from HTS codes that
cover seed for sowing or planting or, alternatively, to clarify that FD3 flagged HTS codes may be
"disclaimed" at entry.
(Response) Whether seeds are subject to prior notice depends on whether the seeds meet
the definition of food.  Some seeds, such as sesame seeds for baking or as a garnish, are food for
which prior notice must be submitted to FDA before the seed is imported or offered for import
into the United States.  Some seeds are capable of both food and non-food uses, such as seeds
that are sometimes processed into cooking oil and other times processed into industrial-use oil.
As discussed elsewhere in this document, FDA considers such seed to be food for the purpose of
prior notice if the seed is reasonably likely to be directed to a food use.  Even when seed is for a
non-food use, such as seeds for growing flowers, if a small portion of that seed is reasonably

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likely to be directed for use in animal feed, prior notice would be required.  Because seeds,
including seeds for planting, may be subject to prior notice under section 801(m) of the act, we
believe they are properly flagged as FD3.
Nonetheless, we note that the draft Prior Notice Final Rule CPG, announced elsewhere in
this issue of the FEDERAL REGISTER, proposes an enforcement policy regarding seeds for
planting.  Under the draft policy, FDA and CBP should typically consider not taking any
regulatory action regarding seeds that will be used for cultivation if they are imported or offered
for import without prior notice.  The policy would apply when no more than a small portion of
that seed is diverted from cultivation to animal feed or other food use. It would not apply,
however, where the seed is used for the production of edible sprouts, such as alfalfa seeds for the
production of alfalfa sprouts.
E. Who is Authorized to Submit Prior Notice? (§ 1.278)
Section 1.278 of the IFR states that prior notice may be submitted by any person with
knowledge of the required information and identifies this person as the submitter.  The IFR also
states that the submitter also may use another person to transmit the required information on
his/her behalf and identifies the person who transmits the information as the transmitter.  The
IFR also states that the submitter and transmitter may be the same person.
(Comments) Several comments note that carriers often do not have access to the
information required to classify articles in the FDA system (the commercial invoice and packing
list) because it is proprietary information that the owners of the goods will not want to give to
intermediaries in the transportation chain.  Also, there is confusion regarding who is responsible
for submitting prior notice.  This causes particular problems for carriers of in-bond cargo
transiting the United States.  The comment suggests that exempting in-bond shipments from

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prior notice would allow carriers to move the shipment without having to submit prior notice and
permit the broker at the port of entry, who does get the necessary documents, to properly submit
the prior notice.
(Response) FDA disagrees that there is confusion regarding who is responsible for
submitting prior notice.  The IFR and this final rule expressly state in § 1.278 that any person
with knowledge of the required information may submit the prior notice.  FDA provided this
flexibility as to who could submit prior notice in response to comments that FDA received on the
proposed rule, which urged FDA not to limit who could file prior notice to either a purchaser or
importer of an article of food who resides or maintains a place of business in the United States or
an agent thereof, or to the arriving carrier or the carrier making the in-bond entry if the article of
food is imported for in-bond movement through the United States for export.  (See 68 FR 58974
at 58994.) Comments to the proposed rule also pointed out that under some circumstances, the
U.S. importer or purchaser or carrier would not have all the information required by prior notice,
but that other entities, e.g., the foreign manufacturer/ processor, shipper, or exporter, would have
the required information.  Many comments stated that entities other than U.S. firms or carriers
should be allowed to submit prior notice.  In response, FDA modified this provision in the IFR
and removed the limitation on who can submit prior notice.
Accordingly, § 1.278 of the IFR provides that any person with knowledge of the required
information may submit prior notice to FDA.  FDA noted in the preamble to the IFR that any
person may now take responsibility for submitting prior notice for a particular article of food, as
long as that person can provide all the required information.  This person is referred to as the
submitter in the IFR.  The IFR also states that the submitter may use another person to transmit
the required information to FDA.  For ease of reference, the person who transmits the prior

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notice is referred to as the transmitter in the IFR. FDA has retained these provisions in the final
rule.  FDA further notes that to the extent that there is confusion, the parties to the transaction
may want to consider a means for identifying which party is responsible for submitting prior
notice as part of their business arrangements (e.g., within their contract).
(Comments) Several comments note that problems arise because the IFR creates no
particular obligation on any particular party within the distribution system to submit prior notice.
One comment states that because prior notice can be submitted by any person who has the
information, there are many cases of duplicate prior notices filed by different parties for the same
shipment.  Another comment suggests that FDA select one party to be responsible, suggesting
the appropriate party would be either the exporter or the importer-broker.
(Response) Please see the response to the previous comments. FDA’s proposed rule did
specify a limited class of individuals who could provide prior notice and this limitation received
significant adverse comment.  Accordingly, both the IFR and this final rule provide that any
person with knowledge of the required information may submit the prior notice (§ 1.278).  FDA
notes that the parties to a transaction can elect to take steps among them to identify which party
should submit the prior notice and ensure that the party submitting prior notice has the
appropriate and correct information.
(Comments) One comment suggests that it is improper for a carrier to require the shipper
to submit prior notice when the shipper is not shipping goods into the United States, but the
carrier unilaterally moves the goods through their hub in the United States, thereby causing the
shipment to enter the United States.  Another comment notes that the data elements required in a
prior notice are not available to the shipper, inferring that it is not possible for a shipper to
submit prior notice.

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(Response) Neither the IFR nor this final rule specifies who must file prior notice.
Rather, the rule provides that any person with knowledge of the required information may submit
prior notice to FDA. Accordingly, it is not for FDA to say whether it is proper for a carrier to
require a shipper to submit prior notice as a condition of shipment, as that is a matter between
two contracting parties.  We note that the Prior Notice Final Rule Draft CPG proposes an
enforcement policy for foreign-to-foreign mail.  Under the proposed policy, if there is no prior
notice FDA and CBP should typically consider not taking any regulatory action in the case of
international mail where the recipient is not in the United States since the sender does not have
control over the transportation route that the foreign-to-foreign mail will transit.
(Comments) One comment asks whether there are any prior notice obligations to fulfill if
the exporter is not required to register with the FDA under the Bioterrorism Act (21 CFR part 1,
subpart H).
(Response) Prior notice and registration are separate obligations under different
regulations and with differing applicability.  For example, registration applies to facilities that
manufacture, process, pack or hold food that will be consumed by humans or animals in the
United States.  By comparison, prior notice generally applies to FDA-regulated food being
imported or offered for import into the United States, regardless of whether it will be consumed
in the United States and regardless of whether the exporter must register.
(Comments) One comment asks for clarification of the legal responsibility of the
submitter.
(Response) Among the requirements of the final rule, the prior notice information must
be accurate and timely.  As described in § 1.283, if an article of food is imported or offered for
import and the notice is inaccurate or untimely, the food is subject to refusal of admission.  Other

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consequences under the act for those who fail to comply with the prior notice requirements, such
as by submitting inaccurate or untimely notice, are described in § 1.284.
(Final rule) Section 1.278 of the final rule states that prior notice may be submitted by
any person with knowledge of the required information and identifies this person as the
submitter.  The final rule also states that the submitter may use another person to transmit the
required information on his/her behalf and identifies the person who transmits the information as
the transmitter.  The final rule also states that the submitter and transmitter may be the same
person.
F. When Must Prior Notice Be Submitted to FDA? (§ 1.279)
Section 801(m)(2)(A) of the act states that FDA shall by regulation prescribe the time of
submission of the notification in advance of importation or the offering of the food for import,
which period shall be no less than the minimum amount of time necessary for the Secretary to
receive, review, and appropriately respond to such notification, and any timeframe FDA adopts
in the final rule must be justified under this standard.  Section 1.279(a) of the IFR requires FDA
to receive prior notice and confirm it for review no less than 2 hours before arriving at the port of
arrival by land via road, no less than 4 hours before arriving at the port of arrival by air and land
via rail, and no less than 8 hours before arriving at the port of arrival by water.  We explained in
the preamble to the IFR that the “interim final rule provides for greatly reduced timeframes for
foods [from what we had proposed] based on mode of transportation. These timeframes are what
FDA has determined are the minimum timeframes necessary to allow it to satisfy the statutory
mandate that the timeframes give the agency the time it needs to ‘receive, review, and respond’
to prior notices.”  (68 FR 58974 at 58995)

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Under § 1.279(b) of the IFR, prior notice may not be submitted more than 5 calendar
days before arrival, except in the case of food imported or offered for import by international
mail.  Under § 1.279(c) of the IFR, if the article of food is arriving by international mail, the
prior notice must be submitted before the food is sent to the United States.
Section 1.279(d) of the IFR provides that the time of submission is fixed and the prior
notice time will start for purposes of determining if prior notice is timely when the prior notice
submission is confirmed by FDA for review.  FDA will confirm a prior notice once all required
information has been submitted and confirmed as facially complete.  For example, if the
information submitted failed to include an FDA Product Code, the system will not provide a
confirmation for that prior notice.  The transmitter has an opportunity to correct the rejected
information.  When the information is corrected, transmitted, and determined to be facially valid,
the system will then notify the transmitter and provide the prior notice confirmation number.
Under § 1.279(e) of the IFR, the prior notice confirmation number must accompany any
article of food arriving by international mail.  Under § 1.279(f), a copy of the confirmation (with
the prior notice confirmation number) must accompany any article of food carried by or
otherwise accompanying an individual (unless excluded under § 1.277(b)(1)), and be provided to
CBP or FDA upon arrival.  Additionally, under § 1.279(g) the prior notice confirmation number
must accompany any article of food for which the prior notice was submitted through the FDA
PNSI when arriving in the United States and must be provided to CBP and FDA upon arrival.
We further stated in the IFR’s preamble that we also were interested in exploring flexible
alternatives for submission of prior notice for foods or firms covered by programs of other
agencies, such as C-TPAT, or imported by other agencies.  We explained that FDA and CBP
would publish a plan, including an implementation schedule, to achieve the goal of a uniform,

116
integrated system, and to coordinate timeframes for import prior notice information while
fulfilling the Bioterrorism Act mandates for air and truck modes of transportation with
timeframes finalized by CBP when they finalize their rule entitled “Required Advance Electronic
Presentation of Cargo Information” (the Advance Electronic Information Rule). (68 FR at
58995)  On December 5, 2003, CBP issued the Advance Electronic Information Rule (68 FR
68140), which requires CBP to receive, by way of a CBP-approved electronic data interchange
system, information pertaining to cargo before the cargo is either brought into or sent from the
United States by any mode of commercial transportation (water, air, rail, or truck). The cargo
information required is that which is reasonably necessary to enable high-risk shipments to be
identified for purposes of ensuring cargo safety and security and preventing smuggling under the
laws enforced and administered by CBP.  The Advance Electronic Information Rule implements
the provisions of section 343(a) of the Trade Act of 2002, as amended by the Maritime
Transportation Security Act of 2002.  The relevant timeframes provided in the Advance
Electronic Information Rule are as follows:
•
For arrival by land via road at ports that are fully equipped to accommodate CBP's
Advance Electronic Information Rule, no later than 1 hour prior to the arrival of the
truck at the border, or for Free and Secure Trade (FAST) participants, 30 minutes;
•
For arrival by land via rail at ports that are fully equipped to accommodate CBP's
Advance Electronic Information Rule, no later than 2 hours prior to the arrival of the
train at the border;  For arrival by air, no later than the departure time (“wheels up”)
of the aircraft from any foreign port or place in North America, including locations in
Mexico, Central America, South America (from north of the Equator only), the
Caribbean, and Bermuda, and from other areas into ports that are fully equipped to

117
accommodate CBP's Advance Electronic Information Rule no later than 4 hours prior
to the arrival of the aircraft in the United States.
On April 14, 2004, FDA and CBP announced their “Joint FDA-CBP Plan for Increasing
Integration and Assessing the Coordination of Prior Notice Timeframes” (69 FR 19765), which
the agencies amended in August 2004 (http://www.cfsan.fda.gov/~pn/pnplan2.html).  As stated
in the plan regarding the agencies’ assessment of reduced timeframes “FDA and CBP
continuously are assessing the completeness of prior notice submissions received as well as the
amount of time necessary to receive, review, and respond to those submissions requiring a
human review. However, that process is not yet complete, as we are currently operating under
the enforcement policies outlined in the Prior Notice Compliance Policy Guide (CPG). See
Compliance Policy Guide Sec. 110.310--Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002. (Issued December 15, 2003,
and revised June and August 2004; http://www.fda.gov/ora under Compliance References.) We
currently do not receive prior notice for all shipments.”
In our plan, we also stated that we would assess existing procedures and staffing
needed to receive, review, and respond to the prior notices submitted in accordance with
the Prior Notice IFR; identify what changes to work practices and staffing would be
necessary to determine if FDA could continue to receive, review, and respond to all prior
notice submissions with reduced timeframes for land and air consistent with CBP’s rule;
and implement necessary changes and make appropriate adjustments to ensure we could
receive, review, and respond to all prior notice submissions with reduced timeframes
before issuing the final rule, consistent with our obligation to ensure that any timeframe
selected is sufficient to receive, review, and respond to prior notice submissions, as set

118
out in section 801(m)(2)(A) of the act. We also emphasized that “the evaluation of
whether to reduce the timeframes for prior notice review will depend on the level of
compliance industry achieves during the assessment. If we are unable to make such an
assessment, our intended timeframe for issuing a prior notice final rule may be delayed.”
Comments received on the prior notice IFR addressed the timeframes required in the IFR,
as well as integration of those timeframes with the timeframes covered by CBP’s advance
electronic information rule.  Comments also covered the IFR’s requirement that prior notice must
be submitted at least 5 days prior to arrival. We respond to the issue of timeframes for
submitting prior notice here, and respond to the other questions raised in our Joint
Implementation Plan and April 14, 2004, reopening of the comment period later in this preamble.
1. IFR Timeframes (2, 4, and 8 hours)
(Comments) One comment asks FDA to permit prior notice to be submitted at the port of
entry, instead of at the port of arrival, in order to align the prior notice process with long-
standing, existing CBP clearance processes and infrastructures at the port of entry.   The
comment reasons that since according to FDA’s own estimates, 80 to 90 percent of prior notice
data will be filed by the ABI filer, it is logical that prior notice should be filed at the same port
where clearance entry is filed.  The comment also suggests that FDA may want to consider a
two-step process for submitting prior notice, under which the CBP “ACI data” is accepted as the
first step, filed at port of arrival as part of the “ACI data,” followed by complete prior notice in
its current form, filed as a second step at the port of entry, i.e., concurrent with the clearance
entry.  Another comment suggests that to ensure consistency with ACE, the prior notice should
be required and calculated from the port of entry and not the first point of arrival, as is currently
the case.

119
Another comment recommends that to fully achieve the FDA-CBP goal of coordinating
timeframes, FDA should adopt the "point of entry," rather than the "point of arrival" in the
United States to measure the timeliness of the prior notice filing.  CBP's "point of entry" is well
known to importers and its use for purposes of the Bioterrorism Act not only will alleviate
unnecessary confusion, but also will facilitate the stream of U.S. commerce without
compromising food safety.
The comment also states that with the growing partnership between FDA and CBP,
FDA's concern regarding limited personnel should no longer be an issue now that FDA and CBP
collectively are using their respective enforcement officials for this joint endeavor.
(Response) FDA discussed the “port of entry/port of arrival” issue extensively in the
preamble to the IFR and is not persuaded by the comments that its initial position should be
changed.  (See 68 FR 58974 at 58988.)  The Bioterrorism Act established that prior notice be
provided by a specified period of time in advance of the time of the importation of the article of
food involved or the offering of the food for import, which period shall be no less than the
minimum amount of time necessary for the Secretary to receive, review, and appropriately
respond to such notification, but may not exceed 5 days.  That means that prior notice must be
submitted before the article of food arrives in the United States.  Moreover, we explained in the
IFR that the overall purpose of the Bioterrorism Act is to improve the ability of the United States
to prevent, prepare for, and respond to bioterrorism and other public health emergencies, thereby
making essential the ability to examine or hold a suspect article of food when it first arrives at a
port of entry in the United States, rather than later at the port where CBP will process the entry.
Thus, the final rule uses the term “port of arrival” rather than “port of entry” as the food may not
arrive at the port of entry until long after it has arrived in the United States.  In addition, CBP’s

120
advance electronic information rule also requires notice in advance of “arrival” in the United
States, and not at “entry.”
The IFR and final rule define “port of arrival” and “port of entry.”  Neither, however, use
the terms “point of arrival” or “point of entry.”  FDA could not find reference to “point of entry”
in CBP rules or regulations.
FDA does agree that FDA’s staffing at certain U.S. ports is much less of an issue.
Under an MOU between FDA and CBP signed by the respective commissioners of both agencies
on December 3, 2003, FDA has commissioned thousands of CBP officers in ports and other
locations to conduct, on FDA's behalf, investigations and examinations of imported foods. This
unprecedented FDA-CBP collaboration significantly strengthens the implementation of the
Bioterrorism Act to ensure the security of imported foods, particularly with respect to
implementing the prior notice rule.  Building on FDA's and CBP's long history of close
cooperation, the MOU upgrades the two agencies' teamwork in training, day-to-day operations,
and information sharing. As part of the MOU, FDA and CBP have provided specialized training
for the commissioned CBP employees who carry out this work, and both agencies have
expanded their existing cooperative arrangements to directly share information affecting the
safety and security of imported foods, including co-locating FDA’s PNC with CBP staff.
Although the FDA and CBP partnership benefits the prior notice process in many ways, this
partnership does not mean that the PNC no longer would have staffing concerns such that the
prior notice timeframes could be reduced, as the comment implies.  Please see the discussion
later in this document regarding “Integration of FDA and CBP timeframes” for further
discussion on reducing timeframes.

121
(Comments) One comment noted that the time difference between their country and the
United States makes it difficult for the agent to start submitting prior notice immediately upon
the receipt of necessary information.  Therefore, some food transported by air, as well as by
water, has actually missed the appointed timeframe.  The comment requests that prior notice be
accepted until immediately before the arrival of the food.
(Response) FDA disagrees.  FDA’s PNSI is available 24 hours a day to submit prior
notice.  The timeframes established in the final rule are the minimum amount of time that FDA
needs to receive, review, and respond to prior notice submissions.
2. Integration of FDA and CBP Timeframes
(Comments) One comment states that “no shorter timeframes should be allowed.”
However, the remainder of the comments addressing consistency of timeframes between FDA


[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Proposed Rules]
[Pages 43115-43116]
[FR Doc No: 2010-17779]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-R03-SFUND-2010-0436; FRL-9177-9]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Intent to Partially Delete the Letterkenny
Army Depot Southeastern (SE) Area and Letterkenny Army Depot Property
Disposal Office (PDO) Area Superfund Sites

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) Region III is
issuing a Notice of Intent to Delete portions of the Letterkenny Army
Depot Southeastern (SE) Area and Letterkenny Army Depot Property
Disposal Office (PDO) Area (Sites), located in Chambersburg, Franklin
County, Pennsylvania, from the National Priorities List (NPL) and
requests public comments on this proposed action. The NPL, promulgated
pursuant to section 105 of the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA) of 1980, as amended, is an
appendix of the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). The EPA and the Commonwealth of Pennsylvania,
through the Pennsylvania Department of Environmental Protection
(PADEP), have determined that all appropriate response actions at these
identified parcels under CERCLA, other than operation, maintenance, and
five-year reviews, have been completed. However, this deletion does not
preclude future actions under Superfund.
    This partial deletion pertains to the soil and groundwater of
parcels 24, 27, 28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90,
and 3-91. All other parcels within the site boundaries of the
Letterkenny Army Depot SE and PDO Areas will remain on the NPL and are
not being considered for deletion as part of this action.

DATES: Comments must be received by August 23, 2010.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-R03-
SFUND-2010-0436, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>, Attn: Gerald Hoover.
     Mail or Hand Delivery: U.S. Environmental Protection
Agency, Region III, Attn: Gerald Hoover (3HS11), 1650 Arch Street,
Philadelphia, PA 19103-2029, Phone:<PHONE_NUMBER>. Business Hours:
Mon. thru Fri.--9 a.m. to 4 p.m.

Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-R03-SFUND-
2010-0436. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you

consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.

Docket

    All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at:

U.S. EPA Region III, Library, 2nd Floor, 1650 Arch Street,
Philadelphia, Pennsylvania, 19103-2029, Phone:<PHONE_NUMBER>, Business
Hours: Mon. thru Fri.--8 am to 5 pm
Letterkenny Army Depot, Building 14, Chambersburg, PA 17201-4150, POC
Bryan Hoke,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Gerald Hoover, Remedial Project
Manager, U.S. Environmental Protection Agency, Region III, (3HS11) 1650
Arch St., Philadelphia, PA 19103-2029,<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' Section of
today's Federal Register, we are publishing a direct final Notice of
Partial Deletion for portions of the Letterkenny Army Depot SE and PDO
Areas without prior Notice of Intent for Partial Deletion because EPA
views this as a noncontroversial revision and anticipates no adverse
comment. We have explained our reasons for this partial deletion in the
preamble to the direct final Notice of Partial Deletion, and those
reasons are incorporated herein. If we receive no adverse comment(s) on
this partial deletion action, we will not take further action on this
Notice of Intent for Partial Deletion. If we receive adverse
comment(s), we will withdraw the direct final Notice of Partial
Deletion and it will not take effect. We will, as appropriate, address
all public comments in a subsequent final Notice of Partial Deletion
based on this Notice of Intent for Partial Deletion. We will not
institute a second comment period on this Notice of Intent for Partial
Deletion. Any parties interested in commenting must do so at this time.
    For additional information, see the direct final Notice of Partial
Deletion which is located in the Rules section of this Federal
Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority:  33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923; 3 CFR, 1987 Comp., p. 193.

    Dated: July 12, 2010.
William C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2010-17779 Filed 7-22-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 5, 2009 (Volume 74, Number 42)]
[Notices]
[Page 9609]
[DOCID:fr05mr09-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OA09-22-000]

Florida Power & Light Company; Notice of Filing

February 26, 2009.
    Take notice that on February 17, 2009, Florida Power & Light
Company submitted their methodology for distribution of revenues for
operational penalties for unreserved use and operational penalties for
late studies in compliance with Order Nos. 890 and 890-A. Preventing
Undue Discrimination and Preference in Transmission Service, 118 FERC
61, 119 (Order No. 890), Order on Rehearing, 121 FERC 61, 297 (Order
890-A) (2007).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 10, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-4715 Filed 3-4-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: December 12, 2005 (Volume 70, Number 237)]
[Notices]
[Page 73488]
[DOCID:fr12de05-93]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

Federal Register Citation of Previous Announcement: 70 FR 72318,
December 2, 2005.

Status: Closed meeting.

Place: 100 F Street, NE., Washington, DC.

Announcement of Additional Meeting: Additional meeting.
    An additional closed meeting has been scheduled for Thursday,
December 8, 2005 at 11 a.m.
    Commissioners and certain staff members who have an interest in the
matter will attend the closed meeting.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(5), (7), (9)(B) and (10) and 17 CFR 200.402(a)(5),
(7), 9(ii) and (10) permit consideration of the scheduled matter at the
closed meeting.
    Commissioner Nazareth, as duty officer, voted to consider the item
listed for the closed meeting in closed session and that no earlier
notice thereof was possible.
    The subject matter of the closed meeting scheduled for Thursday,
December 8, 2005 will be:

Institution and settlement of injunctive actions.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact: The Office of the Secretary at<PHONE_NUMBER>.

    Dated: December 8, 2005.
J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 05-23964 Filed 12-8-05; 11:30 am]

BILLING CODE 8010-01-P


Contractor 0.00 6.00 38.00 19.00 63.00 $ 3,109.00 $ 0.00 $ 0.00 1,567 98,721 $ 4,871,803 Prepare and submit report 0.50 1.00 0.00 0.00 1.50 $ 124.00 $ 0.00 $ 125.50 1,567 2,351 $ 390,967 Investigations for Soil and Groundwater Cleanup ( 280.65)

Gather information for investigation report  Facility 0.00 2.00 0.00 0.00 2.00 $ 146.00 $ 0.00 $ 2,859.36 3,133 6,266 $ 9,415,793 Gather information for investigation report  Contractor 0.00 10.00 61.00 31.00 102.00 $ 5,037.00 $ 0.00 $ 0.00 3,133 319,566 $ 15,780,921 Submit collected information 0.50 0.75 0.00 0.00 1.25 $ 105.75 $ 0.00 $ 371.11 3,133 3,916 $ 1,494,002 Corrective Action Plan ( 280.66)

Prepare and submit corrective action plan or additional information  Facility 2.00 2.25 0.00 0.00 4.25 $ 368.25 $ 0.00 $ 922.00 2,350 9,988 $ 3,032,088 Prepare and submit corrective action plan or additional information  Contractor 0.00 13.00 78.00 39.00 130.00 $ 6,435.00 $ 0.00 $ 0.00 2,350 305,500 $ 15,122,250 Notify implementing agency of early cleanup 0.00 0.50 0.00 0.00 0.50 $ 36.50 $ 0.00 $ 3.00 235 118 $ 9,283 Report results of implementing plan  Facility 2.00 2.75 0.00 0.00 4.75 $ 404.75 $ 0.00 $ 667.00 2,350 11,163 $ 2,518,613 Report results of implementing plan  Contractor 0.00 6.00 37.00 19.00 62.00 $ 3,057.00 $ 0.00 $ 0.00 2,350 145,700 $ 7,183,950 Subtotal varies varies varies varies varies varies varies varies varies 2,110,743 $ 158,607,278 OUT OF SERVICE UST SYSTEMS AND CLOSURE Reading the Regulations Read the regulations 0.25 0.25 0.50 0.00 1.00 $ 70.25 $ 0.00 $ 0.00 4,698 4,698 $ 330,035 Permanent Closure and Change In Service Notification ( 280.71( a))

Notify the implementing agency of permanent closure or change in service 0.00 0.25 0.00 0.00 0.25 $ 18.25 $ 0.00 $ 3.00 35,000 8,750 $ 743,750 Conduct site assessment of excavation zone  Facility 0.00 2.75 0.00 0.00 2.75 $ 200.75 $ 0.00 $ 2,333.00 35,000 96,250 $ 88,681,250 Conduct site assessment of excavation zone  Contr. 0.00 6.00 37.00 18.00 61.00 $ 3,022.00 $ 0.00 $ 0.00 35,000 2,135,000 $ 105,770,000 EXHIBIT 1 ANNUAL ESTIMATED RESPONDENT BURDEN AND COST TECHNICAL AND FINANCIAL REQUIREMENTS Hours and Costs Per Respondent Per Activity Total Hours and Costs Number Capital/ of Respon. Labor Startup O& M Respon. Total Total Legal Managerial Technical Clerical Hours/ Cost/ Costs per Costs/ or Hours/ Cost/

INFORMATION COLLECTION ACTIVITY Hours Hours Hours Hours Activity Activity Activity Activity Activ. Year Year Draft Page 65 Closure Records ( 280.74)

Maintain records after permanent closure or change

inservice for at least three years 0.00 0.00 0.00 0.10 0.10 $ 2.70 $ 0.00 $ 0.10 35,000 3,500 $ 98,000 Mail records to implementing agency if they cannot be maintained on site 0.00 0.00 0.00 0.50 0.50 $ 13.50 $ 0.00 $ 3.00 3,500 1,750 $ 57,750 Subtotal varies varies varies varies varies varies varies varies varies 2,249,948 $ 195,680,785 FINANCIAL RESPONSIBILITY Reading the Regulations Read the regulations 0.50 0.50 1.00 0.00 2.00 $ 140.50 $ 0.00 $ 0.00 4,698 9,396 $ 660,069 Cancellation or Nonrenewal by a Provider of Financial Assurance ( 280.109)

Prepare and submit a notice of termination of financial assurance 0.25 0.00 0.50 0.25 1.00 $ 58.75 $ 0.00 $ 3.00 5,237 5,237 $ 323,385 If necessary, prepare and submit notice of failure to obtain alternative coverage within 60 days 0.00 0.50 1.00 0.25 1.75 $ 96.25 $ 0.00 $ 3.00 524 917 $ 52,007 Reporting ( 280.110)

Gather and submit forms listed in Section 280.111( b) to the implementing agency documenting current evidence of financial responsibility 0.00 0.00 0.00 0.25 0.25 $ 6.75 $ 0.00 $ 3.00 7,833 1,958 $ 76,372 Recordkeeping ( 280.111)

Obtain and keep on file proof of financial responsibility 0.00 0.00 0.25 0.10 0.35 $ 15.95 $ 0.00 $ 0.10 261,865 91,653 $ 4,202,933 Update certification if financial assurance mechanism is modified 0.00 0.00 0.50 0.25 0.75 $ 33.25 $ 0.00 $ 0.00 13,093 9,820 $ 435,342 Bankruptcy or Other Incapacity ( 280.114)

Prepare and submit notification of commencement of bankruptcy procedures 0.50 0.25 0.50 0.25 1.50 $ 102.50 $ 0.00 $ 3.00 5,237 7,856 $ 552,504 If necessary, prepare and submit notice of inability to obtain alternative coverage within 30 days 0.00 0.50 1.00 0.25 1.75 $ 96.25 $ 0.00 $ 3.00 524 917 $ 52,007 Subtotal varies varies varies varies varies varies varies varies varies 127,753 $ 6,354,619 TOTAL varies varies varies varies varies varies varies varies varies 6,023,665 $ 666,098,497 Draft Page 66 EXHIBIT 2 ANNUAL ESTIMATED RESPONDENT BURDEN AND COST STATE PROGRAM APPROVAL Hours and Costs Per Respondent Per Activity Total Hours and Costs Number Capital/ of Respon. Labor Startup O & M Respon. Total Total Legal Managerial Technical Clerical Hours/ Cost/ Cost per Cost/ or Hours/ Cost/

INFORMATION COLLECTION ACTIVITY Hours Hours Hours Hours Activity Activity Activity Activity Activ. Year Year COMPONENTS OF A PROGRAM APPLICATION Reading the Regulations Read the regulations 4.00 4.00 8.00 0.00 16.00 $ 1,124.00 $ 0.00 $ 0.00 3 48 $ 3,372 Transmittal Letter ( 281.20( a))

Obtain a transmittal letter from the Governor's office 1.00 1.00 2.00 1.00 5.00 $ 308.00 $ 0.00 $ 0.00 3 15 $ 924 Submit letter to implementing agency 0.00 0.00 0.00 0.10 0.10 $ 2.70 $ 0.00 $ 3.00 3 0.30 $ 17 Description of State Program ( 281.20( b) and 2801.21)

Prepare and submit description of state program 6.00 10.00 30.00 0.00 46.00 $ 2,932.00 $ 0.00 $ 3.00 3 138 $ 8,805 Procedures for Adequate Enforcement ( 281.22 and 281.20( c))

Gather and submit information on compliance monitoring and enforcement procedures 3.00 4.00 30.00 5.00 42.00 $ 2,323.00 $ 0.00 $ 3.00 3 126 $ 6,978 Memorandum of Agreement ( 281.24 and 381.20( e))

Negotiate an MOA with EPA 10.00 6.00 15.00 5.00 36.00 $ 2,388.00 $ 0.00 $ 0.00 3 108 $ 7,164 Prepare and submit written MOA with application 4.00 6.00 8.00 2.00 20.00 $ 1,324.00 $ 0.00 $ 3.00 3 60 $ 3,981 Attorney General's Statement ( 281.25 and 2801.20( f))

Draft and submit statement from Attorney General 47.00 9.00 18.00 8.00 82.00 $ 6,621.00 $ 0.00 $ 3.00 3 246 $ 19,872 Copies of Statutes and Regulations ( 281.20( g))

Research and gather statutes and regulations 4.00 0.00 4.00 16.00 24.00 $ 1,052.00 $ 0.00 $ 0.00 3 72 $ 3,156 Submit copies as a part of the application to EPA 0.00 0.00 0.00 0.10 0.10 $ 2.70 $ 0.00 $ 3.00 3 0.30 $ 17 Subtotal varies varies varies varies varies varies varies varies varies 814 $ 54,286 ADEQUATE ENFORCEMENT AND COMPLIANCE Reading the Regulations Read the regulations 1.00 1.00 2.00 0.00 4.00 $ 281.00 $ 0.00 $ 0.00 3 12 $ 843 Sharing of Information ( 281.43( a))

Maintain files and current information on program administration 0.00 0.00 3.00 24.00 27.00 $ 807.00 $ 0.00 $ 0.00 39 1,053 $ 31,473 Submit information to EPA, if requested 0.00 0.00 0.00 0.10 0.10 $ 2.70 $ 0.00 $ 3.00 1 0.10 $ 6 Subtotal varies varies varies varies varies varies varies varies varies 1,065 $ 32,322 EXHIBIT 2 ANNUAL ESTIMATED RESPONDENT BURDEN AND COST STATE PROGRAM APPROVAL Hours and Costs Per Respondent Per Activity Total Hours and Costs Number Capital/ of Respon. Labor Startup O & M Respon. Total Total Legal Managerial Technical Clerical Hours/ Cost/ Cost per Cost/ or Hours/ Cost/

INFORMATION COLLECTION ACTIVITY Hours Hours Hours Hours Activity Activity Activity Activity Activ. Year Year Draft Page 67 APPROVAL PROCEDURES Reading the Regulations Read the regulations 1.00 1.00 2.00 0.00 4.00 $ 281.00 $ 0.00 $ 0.00 0 0 $ 0 Revision of Approved State Programs ( 281.52( a)( b))

Collect and submit information on changes in regulations or shifts in responsibilities 2.00 5.00 10.00 5.00 22.00 $ 1,234.00 $ 0.00 $ 3.00 0 0 $ 0 Prepare and submit revised application,

if requested by EPA 25.00 10.00 35.00 12.00 82.00 $ 5,459.00 $ 0.00 $ 3.00 0 0 $ 0 Subtotal varies varies varies varies varies varies varies varies varies 0 $ 0 WITHDRAWAL OF APPROVAL OF STATE PROGRAMS Reading the Regulations Read the regulations 1.00 1.00 2.00 0.00 4.00 $ 281.00 $ 0.00 $ 0.00 0 0 $ 0 Procedures for Withdrawal of Approval of State Programs ( 281.61( a)( 1))

Gather information for program transfer 2.00 2.00 16.00 8.00 28.00 $ 1,414.00 $ 0.00 $ 0.00 0 0 $ 0 Prepare and submit transfer notification 0.00 0.50 1.00 1.00 2.50 $ 116.50 $ 0.00 $ 3.00 0 0 $ 0 Develop and submit plan for information transfer at least 90 days before the transfer 2.00 4.00 8.00 2.00 16.00 $ 974.00 $ 0.00 $ 3.00 0 0 $ 0 Subtotal varies varies varies varies varies varies varies varies varies 0 $ 0 TOTAL varies varies varies varies varies varies varies varies varies 1,879 $ 86,608 Draft Page 68 EXHIBIT 3 ANNUAL ESTIMATED AGENCY BURDEN AND COST UST TECHNICAL AND FINANCIAL REQUIREMENTS Hours and Costs Per Respondent Per Activity Total Hours and Costs Number Capital/ of Respon. Labor Startup O & M Respon. Total Total INFORMATION COLLECTION Legal Managerial Technical Clerical Hours/ Cost/ Cost Cost or Hours/ Cost/

ACTIVITY Hours Hours Hours Hours Activity Activity Activity Activity Activ. Year Year UST SYSTEMS: DESIGN, CONSTRUCTION, INSTALLATION AND NOTIFICATION Review and file notification forms 0.00 0.00 0.50 0.25 0.75 $ 19.58 $ 0.00 $ 0.00 30,000 22,500 $ 587,400 Enter information into a database 0.00 0.00 0.00 0.10 0.10 $ 1.83 $ 0.00 $ 0.00 30,000 3,000 $ 54,900 Subtotal varies varies varies varies varies varies varies varies varies 25,500 $ 642,300 RELEASE DETECTION Review demonstration of the effectiveness of an alternative method of release detection for piping 0.00 2.00 8.00 0.00 10.00 $ 325.84 $ 0.00 $ 0.00 0 0 $ 0 Review demonstration of the effectiveness of an alternative method of release detection for tanks 0.00 2.00 8.00 0.00 10.00 $ 325.84 $ 0.00 $ 0.00 0 0 $ 0 Subtotal varies varies varies varies varies varies varies varies varies 0 $ 0 RELEASE REPORTING, INVESTIGATION, AND CONFIRMATION Review and file information on suspected releases 0.00 0.50 2.00 0.50 3.00 $ 90.59 $ 0.00 $ 0.00 9,792 29,376 $ 887,057 Enter information into a database 0.00 0.00 0.00 0.10 0.10 $ 1.83 $ 0.00 $ 0.00 9,792 979 $ 17,919 Review and file information on major spills and overfills over 25 gallons or the reportable quantity 0.00 0.50 2.00 0.50 3.00 $ 90.59 $ 0.00 $ 0.00 7,833 23,499 $ 709,591 Enter information into a database 0.00 0.00 0.00 0.10 0.10 $ 1.83 $ 0.00 $ 0.00 7,833 783 $ 14,334 Review and file information on minor spills and overfills under 25 gallons or the reportable quantity that could not be cleaned up within 24 hours of the occurrence 0.00 0.25 1.00 0.25 1.5 $ 45.30 $ 0.00 $ 0.00 1,000 1,500 $ 45,300 Enter information into a database 0.00 0.00 0.00 0.10 0.10 $ 1.83 $ 0.00 $ 0.00 1,000 100 $ 1,830 Subtotal varies varies varies varies varies varies varies varies varies 56,238 $ 1,676,031 EXHIBIT 3 ANNUAL ESTIMATED AGENCY BURDEN AND COST UST TECHNICAL AND FINANCIAL REQUIREMENTS Hours and Costs Per Respondent Per Activity Total Hours and Costs Number Capital/ of Respon. Labor Startup O & M Respon. Total Total INFORMATION COLLECTION Legal Managerial Technical Clerical Hours/ Cost/ Cost Cost or Hours/ Cost/

ACTIVITY Hours Hours Hours Hours Activity Activity Activity Activity Activ. Year Year Draft Page 69 RELEASE RESPONSE AND CORRECTIVE ACTION FOR UST SYSTEMS CONTAINING PETROLEUM OR HAZARDOUS SUBSTANCES Receive and review initial response report 0.00 0.00 0.50 0.00 0.50 $ 15.02 $ 0.00 $ 0.00 7,833 3,917 $ 117,652 Enter information into a data base 0.00 0.00 0.00 0.50 0.50 $ 9.13 $ 0.00 $ 0.00 7,833 3,917 $ 71,515 Review and file summary report of initial abatement measures 0.00 1.00 4.00 0.25 5.25 $ 167.49 $ 0.00 $ 0.00 7,833 41,123 $ 1,311,949 Review and file information on initial site characterization 0.00 1.00 4.00 0.25 5.25 $ 167.49 $ 0.00 $ 0.00 7,833 41,123 $ 1,311,949 Enter information into a database 0.00 0.00 0.00 0.25 0.25 $ 4.57 $ 0.00 $ 0.00 7,833 1,958 $ 35,797 Review and file free product removal report 0.00 1.00 4.00 0.25 5.25 $ 167.49 $ 0.00 $ 0.00 1,567 8,227 $ 262,457 Enter information into a database 0.00 0.00 0.00 0.10 0.10 $ 1.83 $ 0.00 $ 0.00 1,567 157 $ 2,868 Review and file soil and groundwater investigation report 0.00 1.00 4.00 0.25 5.25 $ 167.49 $ 0.00 $ 0.00 3,133 16,448 $ 524,746 Enter information into a database 0.00 0.00 0.00 0.25 0.25 $ 4.57 $ 0.00 $ 0.00 3,133 783 $ 14,318 Review and file corrective action plan 1.00 2.00 8.00 0.25 11.25 $ 397.85 $ 0.00 $ 0.00 2,350 26,438 $ 934,948 Notify public of the release and the corrective action plan through an appropriate means 0.00 0.00 1.00 0.25 1.25 $ 34.60 $ 0.00 $ 0.00 2,350 2,938 $ 81,310 Hold a public hearing and consider comments on the proposed corrective action plan 0.00 2.00 8.00 0.00 10.00 $ 325.84 $ 0.00 $ 0.00 2,350 23,500 $ 765,724 Notify the owner or operator whether plan is approved or disapproved 0.00 0.25 0.00 0.25 0.50 $ 15.27 $ 0.00 $ 3.00 2,350 1,175 $ 42,935 Review and file the report on results of implementing the plan 2.00 4.00 16.00 0.25 22.25 $ 791.13 $ 0.00 $ 0.00 2,350 52,288 $ 1,859,156 Give public notice if the approved plan fails to achieve established cleanup levels, and termination of plan is being considered ( failure rate of 5%) 0.00 0.00 1.00 0.25 1.25 $ 34.60 $ 0.00 $ 0.00 118 148 $ 4,083 Subtotal varies varies varies varies varies varies varies varies varies 224,138 $ 7,341,407 OUT OF SERVICE UST SYSTEMS AND CLOSURE Review and file notification of closure or a change in service 0.00 0.00 0.50 0.25 0.75 $ 19.58 $ 0.00 $ 0.00 35,000 26,250 $ 685,300 Subtotal varies varies varies varies varies varies varies varies varies 26,250 $ 685,300 EXHIBIT 3 ANNUAL ESTIMATED AGENCY BURDEN AND COST UST TECHNICAL AND FINANCIAL REQUIREMENTS Hours and Costs Per Respondent Per Activity Total Hours and Costs Number Capital/ of Respon. Labor Startup O & M Respon. Total Total INFORMATION COLLECTION Legal Managerial Technical Clerical Hours/ Cost/ Cost Cost or Hours/ Cost/

ACTIVITY Hours Hours Hours Hours Activity Activity Activity Activity Activ. Year Year Draft Page 70 FINANCIAL RESPONSIBILITY Review and file submitted financial assurance information 0.00 0.00 0.50 0.25 0.75 $ 19.58 $ 0.00 $ 0.00 7,833 5,875 $ 153,370 Enter financial assurance information into a database 0.00 0.00 0.00 0.10 0.10 $ 1.83 $ 0.00 $ 0.00 7,833 783 $ 14,334 Notify owners or operators if they no longer meet financial assurance responsibilities 0.00 0.25 0.00 0.25 0.50 $ 15.27 $ 0.00 $ 3.00 5,237 2,619 $ 95,680 Review and file notification of failure to obtain alternative financial assurance due to cancellation or non renewal of policy 0.00 0.25 1.00 0.25 1.50 $ 45.30 $ 0.00 $ 0.00 524 786 $ 23,737 Review and file notification of commencement of bankruptcy procedures 0.00 0.25 1.00 0.25 1.50 $ 45.30 $ 0.00 $ 0.00 5,237 7,856 $ 237,236 Review and file notification of failure to obtain alternative financial assurance due to bankruptcy 0.00 0.25 1.00 0.25 1.50 $ 45.30 $ 0.00 $ 0.00 524 786 $ 23,737 Subtotal varies varies varies varies varies varies varies varies varies 18,704 $ 548,094 TOTAL varies varies varies varies varies varies varies varies varies 350,829 $ 10,893,132 Draft Page 71 EXHIBIT 4 ANNUAL ESTIMATED AGENCY BURDEN AND COST STATE PROGRAM APPROVAL Hours and Costs Per Respondent Per Activity Total Hours and Costs Number Capital/ of Respon. Labor Startup O & M Respon. Total Total INFORMATION COLLECTION ACTIVITY Legal Managerial Technical Clerical Hours/ Cost/ Cost Cost or Hours/ Cost/

Hours Hours Hours Hours Activity Activity Activity Activity Activ. Year Year APPROVAL PROCEDURES Examine state program application and notify the state whether the application is complete 0.00 1.00 4.00 0.00 5.00 $ 162.92 $ 0.00 $ 0.00 3 15 $ 489 Review the complete state program application and tentatively determine approval or disapproval for a state program 8.00 16.00 40.00 0.00 64.00 $ 2,425.52 $ 0.00 $ 0.00 3 192 $ 7,277 Issue public notice of the tentative decision 0.00 0.50 0.00 0.25 0.75 $ 25.97 $ 0.00 $ 0.00 3 2.25 $ 78 Receive and review public comments 0.00 1.00 4.00 0.00 5.00 $ 162.92 $ 0.00 $ 0.00 3 15 $ 489 Conduct public hearing, if necessary 0.00 2.00 2.00 0.00 4.00 $ 145.66 $ 0.00 $ 0.00 3 12 $ 437 Make a final decision on approval or disapproval for a state program 0.00 1.00 4.00 0.00 5.00 $ 162.92 $ 0.00 $ 0.00 3 15 $ 489 Issue notice of the final decision 0.00 0.50 0.00 0.25 0.75 $ 25.97 $ 0.00 $ 0.00 3 2.25 $ 78 Review the revision of approved state program and tentatively determine approval or disapproval 2.00 4.00 10.00 0.00 16.00 $ 606.38 $ 0.00 $ 0.00 0 0 $ 0 Issue public notice of the tentative decision 0.00 0.50 0.00 0.25 0.75 $ 25.97 $ 0.00 $ 0.00 0 0 $ 0 Notify state if decision receives negative public comment and either withdraw the decision or respond to the negative public comments 0.00 1.00 4.00 0.25 5.25 $ 167.49 $ 0.00 $ 3.00 0 0 $ 0 Subtotal varies varies varies varies varies varies varies varies varies 254 $ 9,337 WITHDRAWAL OF APPROVAL OF STATE PROGRAMS Review and file transfer notification and plan 1.00 2.00 8.00 0.25 11.25 $ 397.85 $ 0.00 $ 0.00 0 0 $ 0 Publish notice of the transfer 0.00 0.50 0.00 0.25 0.75 $ 25.97 $ 0.00 $ 0.00 0 0 $ 0 Conduct withdrawal proceedings in accordance with 40 CFR 271.23( b) and ( c) 2.00 4.00 16.00 0.00 22.00 $ 786.56 $ 0.00 $ 0.00 0 0 $ 0 Subtotal varies varies varies varies varies varies varies varies varies 0 $ 0 TOTAL varies varies varies varies varies varies varies varies varies 254 $ 9,337 Draft Page 72 6( e) Bottom Line Burden and Costs Respondent Tally Exhibit 5 summarizes the total annual hour and cost burden to UST owners and operators and to States ( as respondents seeking program approval). As shown in the exhibit, EPA estimates the annual respondent burden to be approximately 6.03 million hours and $ 666.19 million. The bottom line burden to respondents over three years is estimated to be approximately 18.09 million hours and $ 1,998.57 million.

EXHIBIT 5 TOTAL ESTIMATED RESPONDENT BURDEN AND COST SUMMARY Total Capital/ Total INFORMATION Hours/ Labor Startup O & M Cost/ COLLECTION ACTIVITY Year Cost Cost Cost Year Technical and Financial Requirements 6,023,665 $ 302,537,879 $ 57,131,192 $ 306,428,707 $ 666,098,497 State Program Approval 1,879 $ 86,551 $ 0 $ 57 $ 86,608 TOTAL 6,025,543 $ 302,624,430 $ 57,131,912 $ 306,428,764 $ 666,185,105 Agency Tally Exhibit 6 summarizes the estimated burden to EPA. As shown in the exhibit, EPA estimates that the annual Agency burden is approximately 0.35 million hours and $ 10.90 million. The bottom line burden to the Agency over three years is estimated to be approximately 1.05 million hours and $ 32.70 million.

EXHIBIT 6 TOTAL ESTIMATED AGENCY BURDEN AND COST SUMMARY Total Capital/ Total INFORMATION Hours/ Labor Startup O & M Cost/ COLLECTION ACTIVITY Year Cost Cost Cost Year Technical and Financial Requirements 350,829 $ 10,228,071 $ 0 $ 22,761 $ 10,893,132 State Program Approval 254 $ 9,337 $ 0 $ 0 $ 9,337 TOTAL 351,083 $ 10,237,408 $ 0 $ 22,761 $ 10,902,469 Draft Page 73 6( f) Reasons for Change in Burden This ICR is a comprehensive description of the total respondent burden for all information collection activities related to the UST program. EPA has revised its respondent universe and burden estimates based on updated data from OUST and industry sources. Because of these revisions, the total annual burden to respondents has decreased from the previous ICR ( 6.25 million hours per year) by approximately 0.22 million hours annually to 6.03 million hours. TECHNICAL AND FINANCIAL REQUIREMENTS In modifying hourly respondent labor costs and technical and financial burden estimates under this ICR, EPA ensured that all respondent activities were covered by this ICR, including the development and gathering of information, not only information reporting and recordkeeping. EPA also conducted consultations with trade associations and contractors ( see section 3( b) of this ICR). Based on these consultations, EPA increased the labor burden associated with many activities associated with the use and management of USTs, adjusted the labor rates for facilities and contractors, and added capital and O& M costs to various activities covered in the ICR. EPA believes that the revised burden reflects a more comprehensive and, therefore, more accurate portrait of the existing burden on the regulated community.

STATE PROGRAM APPROVAL PROCEDURES For State program approval procedures, this ICR estimates that the annual respondent burden will decrease slightly over the previous ICR. This increase has resulted, in part, from the smaller number of States that are expected to apply for State program approval. ( The previous ICR estimated that four States would apply for program approval each year, while this ICR estimates that three States will submit State program materials each year). In addition, EPA revised its burden estimates based on several years of program experience and on input from State program officials. EPA believes that these changes resulted in a more accurate reflection of the burden placed on the State programs by the SPA process.

6( g) Burden Statement Exhibit 7 presents the average annual respondent hourly burden for each UST facility and for each State applying for program approval. As shown in the exhibit, for UST facilities, the total hourly burden for conducting the activities covered in this ICR is estimated to average approximately 23 hours per respondent annually. The reporting burden is estimated to average 11 hours per respondent per year. This estimate includes time for preparing and submitting notices, preparing and submitting demonstrations and applications, reporting releases, gathering information, and preparing and submitting reports. The recordkeeping burden for UST facilities is estimated to average 12 hours per respondent per year. This estimate includes time for gathering information and for developing and maintaining records. Draft Page 74 EXHIBIT 7 TOTAL AVERAGE RESPONDENT BURDEN INFORMATION COLLECTION ACTIVITY Average Reporting Burden ( Hours) Average Recordkeeping Burden ( Hours) Total Average Burden ( Hours)

Technical and Financial Requirements 10.91 11.69 22.60 State Program Approval 19.63 28.54 48.17 For States applying for program approval, the total hourly burden is estimated to average approximately 48 hours per State annually. The reporting burden is estimated to average 20 hours per respondent per year. This estimate includes time for preparing and submitting an application and associated information. The recordkeeping burden is estimated to be 28 hours per respondent per year. This estimate includes time for maintaining application files.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence.


[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66747-66748]
[FR Doc No: 2013-26548]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-N-2013-1328]

Sickle Cell Disease Public Meeting on Patient-Focused Drug
Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on Patient-Focused Drug
Development for sickle cell disease. Patient-Focused Drug Development
is part of FDA's performance commitments in the fifth authorization of
the Prescription Drug User Fee Act (PDUFA V). The public meeting is
intended to allow FDA to obtain patients' perspectives on the impact of
sickle cell disease on daily life and on available therapies for sickle
cell disease.

DATES: The public meeting will be held on February 7, 2014; from 10
a.m. to 4 p.m. Registration to attend the meeting must be received by
January 27, 2014. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the meeting. Submit electronic or
written comments by April 8, 2014.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, in Sections B and C of
the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the
public meeting participants is through Building 1, where routine
security check procedures will be performed. For more information on
parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm370867.htm.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-
5003, Fax:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected sickle cell disease to be the focus of a meeting
under Patient-Focused Drug Development, an initiative that involves
obtaining a better understanding of patients' perspectives on the
severity of the disease and the available therapies for the condition.
Patient-Focused Drug Development is being conducted to fulfill FDA's
performance commitments made as part of the authorization of PDUFA V
under Title I of the Food and Drug Safety and Innovation Act (Pub. L.
112-144). The full set of performance commitments is available on the
FDA Web site at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA has committed to obtain the patient perspective in 20 disease
areas during the course of PDUFA V. For each disease area, the Agency
will conduct a public meeting to discuss the disease and its impact on
patients' daily lives, the types of treatment benefit that matter most
to patients, and patients' perspectives on available therapies for
sickle cell disease. These meetings will include participation of FDA
review divisions, the relevant patient community, and other interested
stakeholders.
    On April 11, 2013, FDA published a notice (78 FR 21613) in the
Federal Register announcing the disease areas for meetings in fiscal
years (FYs) 2013 through 2015, the first 3 years of the 5-year PDUFA V
timeframe. To develop the list of disease areas, the Agency used
several criteria that were outlined in the April 2013 notice. The
Agency obtained public comment on these criteria and potential disease
areas through a notice for public comment published in the Federal
Register on September 24, 2012 (77 FR 58849), and through a public
meeting held on October 25, 2012. In selecting the disease areas, FDA
carefully considered the public comments received and the perspectives
of its review divisions. By the end of FY 2015, FDA will initiate
another public process for determining the disease areas for FYs 2016
and 2017. More information, including the list of disease areas and a
general schedule of meetings, is posted on FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on sickle cell disease and on
current approaches to treatment. Approximately 100,000 people in the
United States, and millions of people worldwide, have sickle cell
disease. Sickle cell disease is an inherited red blood cell disorder
resulting from a mutation in the beta globin gene. Red blood cells are
more prone to an abnormal shape and rigidity, causing multi-organ
damage over time. Some of the effects of sickle cell disease are
painful crises, increased risk of infections, stroke, pulmonary
hypertension, acute chest syndrome, recurrent priapism, gallstones, and
kidney dysfunction.
    Therapies to prevent the complications of sickle cell disease are
limited and can include prescription medications and blood
transfusions. Bone marrow transplantation is an option for some
patients. Other therapies, such as pain medications, antibiotics,
supplemental oxygen, and vitamin supplements, are used to manage
specific health effects of the disease. New approaches to treating
sickle cell disease or preventing its complications are being explored,
including new medications, advances in transplantation, and gene
therapies. FDA is interested in obtaining a better understanding of
patients' perspectives on sickle cell disease, including the symptoms
that matter most to patients, limitations to current treatment
approaches, opportunities for new treatment approaches, and specific
considerations regarding sickle cell disease in pediatric patients.
    The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, organized by
topic. For each topic, a brief patient panel discussion will begin the
dialogue, followed by a facilitated discussion inviting comments from
other patient and patient stakeholder participants. In addition to
input generated through this public meeting, FDA is interested in
receiving patient input addressing these questions

through written comments that can be submitted to the public docket
(see ADDRESSES). When submitting comments to the docket, please provide
some context to your comment by indicating whether you are an
adolescent or young adult, or older adult. If you are commenting on
behalf of a child or other loved one who has sickle cell disease,
please indicate that and answer the following questions as much as
possible from the patient's perspective.
Topic 1: The Effects of Sickle Cell Disease That Matter Most to You
    1. Of all of the ways that sickle cell disease affects your health,
which one to three effects have the greatest impact on your life?
(Examples may include pain crises, breathing problems, difficulty
concentrating, tiredness, infections, and others.)
    2. How does sickle cell disease affect your life on an ``average''
day?
    a. Are there activities that you cannot do at all or as well as you
would like on these ``average'' days? Please describe, using specific
examples. (Examples may include sleeping through the night,
concentrating at work or at school, participating in physical
activities, and others.)
    3. How does sickle cell disease affect your life on the ``worst''
days, such as days when you have a pain crisis or have to be
hospitalized for some reason?
    a. Are there activities that you cannot do at all or as well as you
would like on these ``worst'' days? Please describe, using specific
examples.
    4. What worries you most about how sickle cell disease could affect
your health in the future?
    5. What specific concerns do you have about sickle cell disease:
    a. In infants and young children?
    b. In adolescents and young adults?
    c. In older adults?
Topic 2: Perspectives on Treatments for Sickle Cell Disease
    1. Are you currently using any prescription medicines or medical
treatments to prevent or treat any negative effects of your sickle cell
disease? Please describe these treatments, which may include blood
transfusions, supplemental oxygen and prescription medications such as
hydroxyurea, antibiotics, pain medications, and others.
    a. How well do these treatments work for you? For example, how well
do they reduce your number of pain crises, hospitalizations, or
strokes? How well do they help you manage your pain, breathing
difficulties, or other health effects?
    b. What are the biggest problems with these treatments? (Examples
may include side effects of medicine, going to the hospital for
treatment, frequent blood tests, etc.) How do these problems affect
your daily life?
    2. Besides prescription medications, what else do you do to prevent
or treat any negative effects of your sickle cell disease? Please
describe any medications purchased at a store without a prescription,
home remedies, diet changes, massages, or other therapies.
    a. What specific parts of your sickle cell disease do these
treatments address?
    b. How well do these treatments work for you?
    c. What are the biggest problems with these treatments?
    3. What parts of your sickle cell disease do your current
treatments not treat at all or not as well as you would like?
    4. Assuming that there is no cure for sickle cell disease, what
specific things would you look for in an ideal treatment?
    5. If you had the opportunity to consider participating in a
clinical trial studying experimental treatments for sickle cell
disease, what things would you consider when deciding whether or not to
participate? Examples may include how severe your sickle cell disease
is, how well current treatments are working for you, your concern about
serious risks, and other things.

B. Meeting Attendance and/or Participation

    If you wish to attend this meeting, visit https://patientfocusedsicklecell.eventbrite.com. Please register by January 27,
2014. Those who are unable to attend the meeting in person can register
to participate in a live Webcast of the meeting. You will be asked to
indicate in your registration whether you plan to attend in person or
via the Webcast. Your registration should also contain your complete
contact information, including name, title, affiliation, address, email
address, and phone number.
    Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of disability, please contact Graham
Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
    Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. They will also be
asked to send a brief summary of responses to the topic questions to
<EMAIL_ADDRESS>Panelists will be notified of their
selection soon after the close of registration on January 27, 2014. FDA
will try to accommodate all patients and patient stakeholders who wish
to speak, either through the panel discussion or audience
participation; however, the duration of comments may be limited by time
constraints.
    Interested members of the public, including those who attend the
meeting in person or through the Webcast, are invited to provide
electronic or written responses to the questions pertaining to Topics 1
and 2 to the public docket (see ADDRESSES). Comments may be submitted
until April 8, 2014.

    Dated: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26548 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Page 50861]
[FR Doc No: 2023-16471]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP23-913-000.
    Applicants: Granite State Gas Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: A Limited Section 4 Rate
Change to be effective 9/1/2023.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5023.
    Comment Date: 5 p.m. ET 8/8/23.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) 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.

Filings in Existing Proceedings

    Docket Numbers: RP21-993-000.
    Applicants: Cove Point LNG, LP.
    Description: Report Filing: Cove Point--2023 Report of Operational
Sales and Purchases of Gas to be effective N/A.
    Filed Date: 7/27/23.
    Accession Number: 20230727-5015.
    Comment Date: 5 p.m. ET 8/8/23.
    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings 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<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 27, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-16471 Filed 8-1-23; 8:45 am]
BILLING CODE 6717-01-P