We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model BD-700-1A10 airplanes. The NPRM published in the Federal Register on September 11, 2013 (78 FR 55660). The NPRM was prompted by a report that the manufacturer has determined that some completion centers used the heater/brake monitoring unit (HBMU) logic circuit to control the line voltage of the drain mast heaters. Since the drain mast heaters are connected in parallel with the number 2 pitot static (PS) probe heater circuit, a number 2 PS probe heater failure may not be detected by the fault monitoring capabilities of the HBMU. The NPRM proposed to require modification of the air data probes and sensors. We are issuing this AD to detect and correct an unannunciated failure of two PS probe heaters, which could affect controllability of the airplane in icing conditions.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2012-32, dated December 13, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0705-0002 .

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 55660, September 11, 2013) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (78 FR 55660, September 11, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 55660, September 11, 2013).

We estimate that this AD affects 32 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0705; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section.

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

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD No. 2013-0152-E, dated July 17, 2013, to correct an unsafe condition for the Agusta Model AB412 helicopter. EASA advises that two cases of cracks were reported in the outer ring, part number (P/N) 412-010-407-105. A subsequent investigation revealed that “fatigue failure” caused the cracks. EASA states that “this condition, if not detected and corrected, could lead to the loss of main rotor blade pitch control, possibly resulting in loss of control of the helicopter.” EASA calls for repetitive inspections of the affected outer rings for a crack and replacing the outer ring with an improved outer ring, P/N 412-010-107-117, if a crack is found. If the outer ring has not been replaced, the AD requires replacing each outer ring, P/N 412-010-407-105, with an improved outer ring, P/N 412-010-107-117, within 300 flight hours or 8 months, whichever occurs first. Replacement with an improved outer ring is terminating action for the repetitive inspections, EASA states.

These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs.

AgustaWestland S.p.A. issued Alert Bollettino Tecnico No. 412-134 on July 15, 2013 (BT), to warn that two cases of cracking in the outer ring, P/N 412-010-407-105, have been reported, both attributed to fatigue failure. The BT calls for visually inspecting the outer ring for a crack with a 5X magnifying glass and a bright light. The BT added that the inspection must occur within 5 flight hours from when the BT was issued and within intervals of 25 flight hours thereafter until the outer ring is replaced. The deadline to replace the outer ring with outer ring, P/N 412-010-407-117, is 300 flight hours or no later than April 15, 2014, whichever comes first. Outer ring, P/N 412-010-407-105, was not to be used after April 15, 2014, the BT stated.

This AD requires:

• Within 5 hours time-in-service (TIS), and thereafter at intervals not to exceed 25 hours TIS, visually inspecting the swashplate outer ring, P/N 412-010-407-105, for cracks, using a 5X magnifying glass and a bright light. If a crack exists, before further flight, removing the swashplate outer ring from service.

• Within 300 hours TIS or 8 months, whichever occurs first, removing the swashplate outer ring, P/N 412-010-407-105, from service.

• Not installing a swashplate outer ring, P/N 412-010-407-105, on any helicopter.

This AD prohibits installation of a swashplate outer ring, P/N 412-010-407-105, while the EASA AD allows installation of this part under certain conditions.

There are no costs of compliance with this AD because there are no helicopters with this type certificate on the U.S. Registry.

There are no helicopters with this type certificate on the U.S. Registry. Therefore, we believe it is unlikely that we will receive any adverse comments or useful information about this AD from U.S. Operators.

Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are unnecessary because there are none of these products on the U.S. Registry and that good cause exists for making this amendment effective in less than 30 days.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. The NPRM published in the Federal Register on August 23, 2013 (78 FR 52465). The NPRM was prompted by three reports of cracking in the rear pressure bulkhead (RPBH) web. The NPRM proposed to require inspecting the RPBH web for cracking, and repairing if necessary. We are issuing this AD to detect and correct cracking of the RPBH web, which could result in in-flight decompression of the airplane and possible injury to the occupants.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2012-0219, dated October 19, 2012 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 52465, August 23, 2013) or on the determination of the cost to the public.

We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (78 FR 52465, August 23, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 52465, August 23, 2013).

We estimate that this AD affects 4 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

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

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2013-0699 ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the MCAI, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain the Boeing Company Model 737-600, -700, -800, -900, and -900ER series airplanes modified by particular supplemental type certificates (STCs). The NPRM published in the Federal Register on August 5, 2013 (78 FR 47233). The NPRM was prompted by reports of cracks found during inspections of the in-flight entertainment system radome assembly. The NPRM proposed to require repetitive detailed inspections for cracks in the radome assembly, and replacement of the radome if necessary. We are issuing this AD to detect and correct cracks in the in-flight entertainment system radome assembly, which could result in the radome (or pieces) separating from the airplane and striking the tail, and consequently reducing the controllability of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (78 FR 47233, August 5, 2013) and the FAA's response to each comment.

Boeing stated that it does not have sufficient information regarding the supplemental type certificates (STCs) referenced in the NPRM (78 FR 47233, August 5, 2013); therefore, it has no comment.

Aviation Partners Boeing stated that the installation of winglets per STC ST00830SE ( http://rgl.faa.gov/Regulatory;_and_Guidance_Library/rgstc.nsf/0/DA95C49000906C7086257BE80044D3D9?OpenDocument&Highlight=st00830se ) does not affect the accomplishment of the manufacturer's service instructions.

United Air Lines (UAL) requested that the FAA and Live TV re-evaluate the need for the reporting requirement proposed in paragraph (h) of the NPRM (78 FR 47233, August 5, 2013), and remove this proposed requirement. UAL questioned why operators would be required to fill out the service bulletin reporting form provided in Live TV Service Bulletin B737-53-0011, dated March 29, 2013, mentioned in paragraph (h) of the NPRM, and send it to Live TV every time cracking is found on a radome. UAL stated that any radome with cracking would be sent back to the manufacturer with an unserviceable tag attached and that the information on the tag would be the same information requested on the service bulletin reporting form. UAL also noted that the information requested on the reporting form is redundant because the reporting form states that when cracking is found on a radome, the technician has to record his or her name, service work order, and location of accomplishment.

We do not agree to remove the reporting requirement from this final rule. For this AD, Live TV is the STC design approval holder (DAH) and is gathering information reported by operators and reporting this information to the FAA. There is no regulatory requirement for an operator to return a part to a manufacturer. Regarding this final rule, we agree that an operator may voluntarily provide a cracked radome to Live TV, the STC DAH; however, if a reporting requirement was not mandated by this AD, an operator might elect to repair a cracked radome itself, or send it to another facility for repair, instead of sending it to Live TV, so the information requested in the reporting requirement might not be shared with Live TV. We have not changed this final rule in this regard.

UAL noted that the NPRM (78 FR 47233, August 5, 2013) proposed to require operators to record and report the serial number of any cracked radome. UAL stated that numerous times it has discovered that the radome data plate, which has the serial number specified on it, is missing. UAL commented that it can be difficult to use an operator's record keeping system to determine the serial number of a radome because the radome could have been rotated among airplanes. UAL requested guidance regarding what to do if the data plate is missing from a radome.

We agree that the serial number is an important piece of information for the reporting requirement of this final rule. However, this final rule does not require an operator to identify the radome's serial number prior to inspection. The reporting requirement is only required if cracking is found in the radome during the inspection. If cracking is found during the inspection an operator has 30 days to provide the report. This timeframe should be sufficient for operators to identify the radome's serial number by looking at the data plate or the searching the operator's tracking system. The reporting requirement is meant to help Live TV and the FAA trace back to the fabrication records for potential causes of cracking in the radome.

Based on review and consideration during Weibull Analysis, we believe that rotating radomes among airplanes is not a common occurrence. It is ultimately the operator's responsibility to maintain its airplane configurations and subsequently provide the required serial number information. We have not changed this final rule in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Αre consistent with the intent that was proposed in the NPRM (78 FR 47233, August 5, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 47233, August 5, 2013).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We estimate that this AD affects 165 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the inspections. We have no way of determining the number of aircraft that might need this replacement:

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes. That NPRM was published in the Federal Register on October 30, 2013 (78 FR 64894). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

The MCAI can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2013-0924-0002 .

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 64894, October 30, 2013) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (78 FR 64894, October 30, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 64894, October 30, 2013).

We estimate that this AD will affect 101 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $8,585, or $85 per product.

In addition, we estimate that any necessary follow-on actions will take about 10 work-hours and require parts costing $4,800 (4 per airplane), for a cost of $5,650 per product. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2013-0924; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to all Slingsby Aviation Ltd. Model T67M260 airplanes. That NPRM was published in the Federal Register on November 21, 2013 (78 FR 69785). That NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

The MCAI can be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2013-0997-0002 .

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 69785, November 21, 2013) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (78 FR 69785, November 21, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 69785, November 21, 2013).

We estimate that this AD will affect 11 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic inspection of the aluminum horizontal stabilizer attachment brackets requirement of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,870, or $170 per product.

In addition, we estimate that any necessary follow-on actions will take about 8 work-hours and require parts costing $7,250 (for all four titanium horizontal stabilizer attachment brackets), for a cost of $7,930 per product, or parts costing $9,557 (for all four aluminum horizontal stabilizer attachment brackets), for a cost of $10,237. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2013-0997; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

The Civil Aviation Authority (CAA), which is the airworthiness authority for New Zealand, has issued AD DCA/750XL/15, dated January 29, 2014 (referred to after this as “the MCAI”), to correct an unsafe condition for all Pacific Aerospace Limited Model 750XL airplanes. The MCAI states:

Pacific Aerospace Limited has issued Mandatory Service Bulletin PACSB/XL/070, Issue 1, dated January 24, 2014. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because failure of the control column attachment bolt could result in control column detachment, which could cause loss of control. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2014-0090; Directorate Identifier 2014-CE-003-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

We estimate that this AD will affect 17 products of U.S. registry. We also estimate that it will take about 1.5 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $100 per product.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $3,867.50, or $227.50 per product.

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

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Piaggio Aero Industries S.P.A Model P-180 airplanes. That NPRM was published in the Federal Register on November 20, 2013 (78 FR 69600). That NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 69600, November 20, 2013) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (78 FR 69600, November 20, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 69600, November 20, 2013).

We estimate that this AD will affect 112 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $9,520, or $85 per product.

In addition, we estimate that any necessary follow-on actions will take about 5 work-hours and require parts costing $50, for a cost of $475 per product. We have no way of determining the number of products that may need these actions.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-200.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2013-0964; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to add an AD that would apply to DORNIER LUFTFAHRT GmbH Model 228-212 airplanes. That NPRM was published in the Federal Register on November 19, 2013 (78 FR 69320). That NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (78 FR 69320, November 19, 2013) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (78 FR 69320, November 19, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 69320, November 19, 2013).

We estimate that this AD would affect 2 products of U.S. registry. We also estimate that it would take about 160 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $27,200, or $13,600 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-2013-0962; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (78 FR 69320, November 19, 2013), the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. The NPRM published in the Federal Register on September 26, 2013 (78 FR 59304). The NPRM was prompted by reports of chaffing, arcing, and burning damage to the control cabin overhead wiring and ducting with smoke and fire caused by metal clamps installed on certain hoses. The NPRM proposed to require inspecting for the presence of metal clamps, replacing metal clamps installed on the hoses to the air conditioning temperature sensor, gasper air outlet, and diffuser on the left side of the control cabin with plastic tie straps, and inspecting for and repairing damaged wire bundles. We are issuing this AD to correct incorrectly installed metal clamps, which could cause wire bundle damage and electrical arcing that could result in a fire or smoke in the control cabin of the airplane.

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the proposal (78 FR 59304, September 26, 2013) and the FAA's response to that comment.

Aviation Partners Boeing stated that the installation of winglets per STC ST01219SE ( http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/BE866B732F6CF31086257B9700692796?OpenDocument&Highlight=st01219se ) does not affect the accomplishment of the proposed requirements.

We have re-designated paragraph (c) of the NPRM (78 FR 59304, September 26, 2013) as paragraph (c)(1) in this final rule and added new paragraph (c)(2) to this final rule to state that installation of STC ST01219SE ( http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/BE866B732F6CF31086257B9700692796?OpenDocument&Highlight=st01219se ) does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD with the change described previously and minor editorial changes. We have determined that these minor changes:

• Αre consistent with the intent that was proposed in the NPRM (78 FR 59304, September 26, 2013) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (78 FR 59304, September 26, 2013).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We estimate that this AD affects 426 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

In a notice published in the Federal Register of January 5, 2000 (65 FR 493), which was subsequently amended May 10, 2001 (66 FR 23943), we announced that a food additive petition (FAP 9M4697), had been filed by the National Food Processors Association (now merged into the Grocery Manufacturers Association) on behalf of The Food Irradiation Coalition, 1350 I St. NW., Suite 300, Washington, DC 20005 (petitioner). The petition proposed to amend the food additive regulations in part 179, Irradiation in the Production, Processing and Handling of Food (21 CFR part 179), to provide for the safe use of ionizing radiation for control of food-borne pathogens and extension of shelf life in a variety of human foods up to a maximum irradiation dose of 4.5 kiloGray (kGy) for non-frozen and non-dry products, and 10.0 kGy for frozen or dry products, including: (1) Pre-processed meat and poultry; (2) both raw and pre-processed vegetables, fruits, and other agricultural products of plant origin; (3) and certain multi-ingredient food products containing cooked or uncooked meat or poultry. Subsequently, in a letter dated December 4, 2007, the petitioner amended the petition to request a response to part of the original request while the remainder of the request would remain under review. Specifically, the petitioner requested a response regarding amending the food additive regulations to provide for the safe use of ionizing radiation for control of food-borne pathogens and extension of shelf life in fresh iceberg lettuce and fresh spinach up to a maximum dose of 4.0 kGy. In response to this request, we issued a final rule in the Federal Register of August 22, 2008 (73 FR 49593), permitting the irradiation of fresh iceberg lettuce and fresh spinach (hereafter referred to as “fresh lettuce and fresh spinach”) for control of food-borne pathogens and extension of shelf life up to a maximum dose of 4.0 kGy. We based our decision on data in the petition and in our files. In the preamble to the final rule, we outlined the basis for our decision and stated that objections to the final rule and requests for a hearing were due within 30 days of the publication date (i.e., by September 22, 2008).

Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, “specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections.”

Under 21 CFR 171.110 of the food additive regulations, objections and requests for a hearing are governed by part 12 (21 CFR part 12) of FDA's regulations. Under § 12.22(a), each objection must meet the following conditions: (1) Must be submitted on or before the 30th day after the date of publication of the final rule; (2) must be separately numbered; (3) must specify with particularity the provision of the regulation or proposed order objected to; (4) must specifically state each objection on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and (5) must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection.

Following publication of the final rule permitting the irradiation of fresh lettuce and fresh spinach for control of food-borne pathogens and extension of shelf life, we received numerous submissions with objections to the rule within the 30-day objection period. The majority of these submissions were form letters expressing concern regarding one or more of the following issues: (1) Labeling of produce being irradiated and (2) potential vitamin depletion resulting from irradiation. Many of the form letters also expressed general opposition to the final rule, or objected to the rule based on issues that are outside the rule's scope such as the regulation and management of the meat industry, the number of inspectors currently available to perform inspections, and the proximity of cattle farms to produce farms. Although most of these letters requested a hearing, no evidence was identified in support of any of these objections that could be considered in an evidentiary hearing (§ 12.22(a)(5)). Therefore, these objections do not justify a hearing. 1 We will not discuss these submissions further.

There were two submissions raising specific objections. One was a letter from the Center for Food Safety (CFS) (letter to Docket No. FDA-1999-F-2405; September 17, 2008) and the second was a letter from Food & Water Watch (FWW) (letter to Docket No. FDA-1999-F-2405; September 22, 2008). The letter from CFS sought revocation of the final rule pertaining to two areas, which were enumerated as five specific objections. CFS requested a hearing on the issues raised by each objection. The letter from FWW agreed with all objections raised in the letter from CFS, and requested a hearing and stay of effective date for one additional topic not described in the CFS letter. A more detailed response to both CFS' and FWW's objections is found in section IV. We also received two letters in support of the fresh lettuce and fresh spinach rule.

Specific criteria for deciding whether to grant or deny a request for a hearing are set out in § 12.24(b). Under that regulation, a hearing will be granted if the material submitted by the requester shows, among other things, the following: (1) There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law; (2) the factual issue can be resolved by available and specifically identified reliable evidence; a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions; (3) the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requester; a hearing will be denied if the data and information submitted are insufficient to justify the factual determination urged, even if accurate; and (4) resolution of the factual issue in the way sought by the person is adequate to justify the action requested; a hearing will not be granted on factual issues that are not determinative with respect to the action requested (e.g., if the action would be the same even if the factual issue were resolved in the way sought).

A party seeking a hearing is required to meet a “threshold burden of tendering evidence suggesting the need for a hearing” ( Costle v. Pac. Legal Found., 445 U.S. 198, 214 (1980), reh. denied, 446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-21 (1973)). An allegation that a hearing is necessary to “sharpen the issues” or to “fully develop the facts” does not meet this test ( Georgia-Pacific Corp. v. U.S. EPA, 671 F.2d 1235, 1241 (9th Cir. 1982)). In judicial proceedings, a court is authorized to issue summary judgment without an evidentiary hearing whenever it finds that there are no genuine issues of material fact in dispute and a party is entitled to judgment as a matter of law (see Fed. R. Civ. P. 56). The same principle applies in administrative proceedings (see § 12.24).

A hearing request must not only contain evidence, but that evidence should raise a material issue of fact “concerning which a meaningful hearing might be held” ( Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, we need not grant a hearing (see Dyestuffs and Chemicals, Inc. v. Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911 (1960)). A hearing is justified only if the objections are made in good faith and if they “draw in question in a material way the underpinnings of the regulation at issue” ( Pactra Industries v. CPSC, 555 F.2d 677, 684 (9th Cir. 1977)). A hearing need not be held to resolve questions of law or policy (see Citizens for Allegan County, Inc. v. FPC, 414 F.2d 1125, 1128 (D.C. Cir. 1969); Sun Oil Co. v. FPC, 256 F.2d 233, 240-41 (5th Cir. 1958), cert. denied, 358 U.S. 872 (1958)).

Even if the objections raise material issues of fact, we need not grant a hearing if those same issues were adequately raised and considered in an earlier proceeding. Once an issue has been so raised and considered, a party is estopped from raising that same issue in a later proceeding without new evidence. The various judicial doctrines dealing with finality, such as collateral estoppel, can be validly applied to the administrative process (see Pac. Seafarers, Inc. v. Pac. Far East Line, Inc., 404 F.2d 804, 809 (D.C. Cir. 1968), cert. denied, 393 U.S. 1093 (1969)). In explaining why these principles ought to apply to an Agency proceeding, the U.S. Court of Appeals for the District of Columbia Circuit wrote: “The underlying concept is as simple as this: Justice requires that a party have a fair chance to present his position. But overall interests of administration do not require or generally contemplate that he will be given more than one fair opportunity.” ( Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 322 (D.C. Cir. 1972).) (See Costle v. Pac. Legal Found., 445 U.S. at 215-20. See also Pac. Seafarers, Inc. v. Pac. Far East Line, Inc., 404 F.2d 804 (D.C. Cir. 1968), cert. denied, 393 U.S. 1093 (1969).)

In summary, a hearing request must present sufficient credible evidence to raise a material issue of fact, and the evidence must be adequate to resolve the issue as requested and to justify the action requested.

The letter from CFS contains five numbered objections with requests for a hearing on each of them, and also appears to have two broad objections. FWW's letter agrees with all objections presented by CFS and presents one additional objection; they request a hearing and stay of effective date on each objection. We address CFS' two broad objections first, followed by the specific objections, as well as the evidence and information filed in support of each, comparing each objection and the information submitted in support of it to the standards for granting a hearing in § 12.24(b).

Although CFS' letter was formatted as five numbered objections with requests for a hearing on each, CFS appears to have two broad objections to the final rule providing for the safe use of ionizing radiation for control of food-borne pathogens and extension of shelf life in fresh lettuce and fresh spinach. In brief, CFS claims that: (1) We have improperly relied on studies in other fruits and vegetables and (2) we have improperly relied on studies at doses below 4.0 kGy. CFS appears to raise these objections to attempt to call into question our assessment of the nutritional impact of the final rule and ultimately our determination that the irradiation of fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe.

We disagree that we have improperly relied on studies in other fruits and vegetables. We have consistently taken the position that various scientifically validated types of data may properly support a safety determination for a proposed use of a food additive (see 21 CFR 170.20(a)). Further, we have consistently taken the position that data obtained from specific foods irradiated under specific conditions may be extrapolated and generalized to draw conclusions regarding the safety of foods of a similar type irradiated under related conditions (see 62 FR 64107 at 64110; December 3, 1997, and 70 FR 48057 at 48059; August 16, 2005). Other scientific bodies have used this approach as well. As explained in our final rule permitting the irradiation of molluscan shellfish (70 FR 48057 at 48058), the World Health Organization, in its review of the safety data on irradiated food, found that safety data on one food type can be extrapolated to other foods of similar composition and that individual studies of irradiated foods can be integrated into one database (Ref. 1). In the fresh lettuce and fresh spinach final rule, we concluded that the body of data and information we considered in our review demonstrated the safety of fresh lettuce and fresh spinach irradiated up to a maximum dose of 4.0 kGy. CFS' suggestion that such information is not sufficient to support a safety determination is unsupported by specific data or other factual information.

We also disagree that we improperly relied on studies at doses below 4.0 kGy. In analyzing the nutritional adequacy of irradiated fresh lettuce and fresh spinach, we evaluated the totality of evidence, which included studies of plant-based foods irradiated at a wide range of doses (i.e., doses above and below 4.0 kGy), information about the susceptibility of vitamins in lettuce and spinach to irradiation, information about the susceptibility of vitamins in plant matrices in general to irradiation, and estimates of the significance of fresh lettuce and fresh spinach as sources of these vitamins. For the assessment of the significance of fresh lettuce and fresh spinach as sources of vitamins, we considered the levels of the vitamins present in food, published information about the relative contribution of fresh lettuce and fresh spinach to the total dietary intake of these vitamins, and published studies and reviews summarizing the limited bioavailability of certain vitamins from green leafy vegetables. Importantly, we noted that folate, provitamin A carotenoids, and vitamin K all have limited bioavailability from green leafy vegetables; hence the contribution of these foods to overall intake of these vitamins is diminished, despite the presence of the vitamins in high amounts in foods such as spinach (Ref. 2). 2 For example, in 2001 the Institute of Medicine (IOM) concluded that provitamin A bioavailability from dietary sources (i.e., not supplemental forms) is half that previously thought (Ref. 3), and that very low bioavailability (<10 percent) is associated with raw green leafy vegetables (Ref. 4). Similar findings of limited bioavailability have been reported for folate and vitamin K from green leafy vegetables, particularly relative to supplements and other food sources, as discussed in our nutrition memorandum (Ref. 2).

We considered studies performed at doses ranging from 0.5 kGy to 56 kGy to ascertain the relative amount of vitamin loss at those doses. Specifically, we assessed studies performed at doses above 4.0 kGy for folate, provitamin A carotenoids, vitamin K, and vitamin C. As such, we did not rely solely on studies conducted below 4.0 kGy to perform the nutritional assessment; rather we considered all available data pertaining to potential nutrient loss for those vitamins. The available data included information on the levels of vitamins following treatment with doses below 4.0 kGy, information on the levels of vitamins following treatment with doses above 4.0 kGy, information on the limited bioavailability of certain vitamins and provitamins from green leafy vegetables, and information pertaining to the relative contribution of these sources to the total dietary intake of individual vitamins. Our assessment of the available data does not provide reason for a safety concern regarding potential vitamin loss from irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy. CFS provided no information to support its assertions that our reliance on studies in other fruits and vegetables and studies performed at doses below 4.0 kGy would call into question our assessment of the nutritional impact of the final rule and ultimately our determination that irradiated fresh lettuce and fresh spinach at 4.0 kGy is safe. A hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)). Therefore, we are denying CFS' objection and request for a hearing based on this objection.

The first objection raised by CFS contends that FDA “fails to determine the magnitude of nutrient losses to be expected from irradiation of fresh spinach or iceberg lettuce at or near the upper limit approved in the rule: 4 kGy.” They expound upon this objection by asserting that the majority of the studies cited in our nutrition memorandum (Ref. 2) were performed at doses below 2 kGy and on fruits and vegetables other than fresh spinach and fresh lettuce. The objection includes CFS' assertions regarding the following “nutrients”: Carotenoids/vitamin A, 3 folate, vitamin K, and vitamin C. CFS' discussion for each nutrient contains additional objections.

CFS further contends that we failed to determine the magnitude of nutrient losses to be expected from irradiating fresh spinach and fresh lettuce at or near the petitioned maximum dose because we did not address the synergistic effects of irradiation and heating. According to CFS, we should have considered that “irradiation-induced nutrient losses will be superadded to those from other industrial or home food processing methods.” CFS' assertion that we failed to determine the magnitude of nutrient losses at or near the petitioned maximum dose ultimately attempts to call into question our determination that the irradiation of fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe.

Contrary to CFS' contention and, as demonstrated in our nutrition memorandum (Ref. 2), we evaluated both the extent of nutrient loss and the nutritional importance of any such losses resulting from irradiation of fresh lettuce and fresh spinach at doses up to 4.0 kGy. Our review of a large body of data relevant to the nutritional adequacy and wholesomeness of irradiated foods has demonstrated that irradiation does not significantly alter the macronutrients (i.e., proteins, fats, and carbohydrates) of the food at the petitioned doses. However, it has been shown that some vitamins are susceptible to irradiation. The susceptibility of a vitamin to irradiation depends on factors such as the chemical structure of the vitamin, the conditions of processing, the conditions and duration of storage, and the composition of food. To determine whether or not partial vitamin loss is significant, it is essential to consider the relative contribution of the vitamin from the irradiated food to the total dietary intake of the vitamin and the sensitivity of that vitamin to irradiation.

Therefore, our analysis focused primarily on vitamins that are present in relatively high amounts in fresh lettuce and/or fresh spinach, which were identified using the criteria for nutrient content claims (§ 101.54 (21 CFR 101.54)), 4 and that contribute more than a trivial amount to the total dietary intake of that vitamin (i.e., more than 1 to 2 percent). The nutrients which meet both criteria are: Vitamin A, vitamin K, and folate. Therefore, our discussion of the nutritional impact of the proposed conditions of irradiation on fresh lettuce and fresh spinach focused on these three nutrients. 5 For each of these nutrients, we evaluated the dietary requirements, dietary sources, and susceptibility of vitamins to irradiation, and we found that there would be no significant impact on the dietary intake of those nutrients.

In the analysis specific to irradiation-induced loss of provitamin A, CFS objects to the use of six studies, five of which did not involve the irradiation of fresh lettuce or fresh spinach. We have reviewed a large body of data relevant to the safety of irradiated foods. 6 When evaluating the safety of a source of radiation to treat food intended for human consumption, we address three general areas: (1) Potential toxicity, (2) nutritional adequacy, and (3) effects on the microbiological profile of the treated food. We have consistently taken the position that various scientifically validated types of data may properly support a safety determination for a proposed use of a food additive. For example, in the case of food irradiation, we have taken advantage of the extensive research and large body of knowledge concerning the principles of radiation chemistry and the chemical composition of foods. CFS' suggestion that data and information derived from studies of analogous irradiated foods are not sufficient to support a determination that irradiated fresh lettuce and fresh spinach is safe is unsupported by specific data or other factual information.

Furthermore, vitamin A exists in food sources in two different forms: (1) Preformed vitamin A (retinol) and (2) provitamin A (carotenoids). 7 Preformed vitamin A is found in some animal-derived foods (e.g., organ meats, dairy products, eggs) and in fortified foods such as ready-to-eat cereals, whereas provitamin A carotenoids are found in foods such as dark-green vegetables, orange vegetables, orange fruits, and red palm oil (Ref. 3). There is a diverse set of foods that contributes to the total dietary intake of vitamin A in a balanced diet, including vitamin A-rich foods and provitamin A carotenoid-rich foods. Among the wide range of plant-based foods containing provitamin A carotenoids, fresh lettuce and fresh spinach are among the poorer dietary sources, due to limited bioavailability of carotenoids from these foods, as discussed earlier and reviewed by the IOM (Ref. 4). Hence, even for fresh spinach, which has a relatively high concentration of provitamin A, the actual contribution of this food to total vitamin A intake is minor due to limited bioavailability (Ref. 2). Therefore, considering the insensitivity of vitamin A and provitamin A carotenoids found in spinach to irradiation and the limited contribution of these particular foods to the total dietary intake of vitamin A, the small losses of vitamin A that might result from the irradiation of fresh lettuce or fresh spinach are not nutritionally significant (Ref. 2).

Additionally, CFS asserts that there is “no discussion of the apparent discrepancy between no carotenoid loss in carrots at 2 kGy and `low to moderate losses in beta and alpha-carotene' * * * in carrots irradiated at less than half that dose, 0.8 kGy.”  8 We were aware of the discrepancies between the two studies during our review. However, we concluded that differences in observed losses between the studies did not call into question our assessment of the nutritional impact of the final rule and determination that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe. The two studies differed in treatment dose but also other factors, including storage time, temperature during irradiation and storage, and analysis of total carotenoids (Ref. 8) versus individual carotenoids (Ref. 9), which could impact the reported levels of carotenoids. Despite differences in study design, losses of total carotenoids (alpha-carotene plus beta-carotene) were less than 20 percent in both studies. Losses of alpha-carotene (28 percent) were reported to be slightly higher than losses of beta-carotene (8 percent) in the Baraldi et al. paper (Ref. 9); however, it is important to note that alpha-carotene is present in lower amounts than beta-carotene in carrots and has half the retinol activity equivalence of beta-carotene (discussed further in this document). Further, alpha-carotene is not present in meaningful amounts in either spinach or iceberg lettuce; hence; this provitamin was not highlighted in the nutrition memorandum.

The nutritional significance of provitamin A carotenoids is that provitamin A carotenoids, including alpha and beta-carotenes, are precursors of vitamin A. Even at the highest observed losses in the cited studies (28 percent for alpha-carotene), one would not expect substantive losses of vitamin A in the total diet, in part due to inefficient conversion of alpha-carotene to retinol and the limited bioavailability of alpha-carotene from plant sources. In recognition of these limitations, the IOM has established a retinol activity equivalence of 24 micrograms of alpha-carotene (from food) to 1 microgram of retinol (meaning 24 micrograms of alpha-carotene in carrots yield only 1 microgram of retinol in the body). In contrast, the IOM estimates that 12 micrograms of food-borne beta-carotene yield one microgram of retinol in the body. Despite the relatively high concentration of beta-carotene in spinach, the bioavailability of beta-carotene from green leafy vegetables is generally considered to be low relative to other food sources of beta-carotene (even lower than raw carrot) due to inhibitory effects of the food matrix (i.e., the components of the food) on carotenoid release from food. Release of the carotenoids from the food matrix is a step that precedes the incorporation of carotenoids into mixed lipid micelles and their subsequent absorption (Refs. 4 and 10). This topic has been addressed in section IV.A and in an extensive review by the IOM (Ref. 3). Considering the limited bioavailability of provitamin A carotenoids from fresh lettuce and fresh spinach, the limited contribution of these foods to the total dietary intake of vitamin A, and the relative radiation resistance of plant-based carotenoids, we determined that the loss of carotenoids would not be a safety concern. We also note that although provitamin A carotenoids are susceptible to partial losses due to irradiation, these losses are somewhat variable and can be minimized by control of various irradiation conditions (e.g., temperature, packaging, headspace gas). Therefore, while there were variable (but not extensive) losses observed in the two carrot studies, this apparent discrepancy does not call into question the outcome of this final rule. CFS' objection attempts to call into question our assessment of the nutritional impact of the final rule and implies that there is a safety issue due to a discrepancy in losses between the two cited studies; however, they do not provide any information or data to support their objection. We are therefore denying CFS' objection and request for a hearing because a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)).

Further, CFS asserts that we failed to determine the magnitude of nutrient losses from irradiating fresh lettuce and fresh spinach because the discussion of carotenoids was limited to total carotenoid levels as opposed to analyzing specific carotenoids with “particular nutritional relevance,” such as lutein and zeaxanthin. To support this objection, CFS cites a study performed by Semba and Dagnelie (Ref. 11), that, according to CFS, demonstrates the nutritional relevance of lutein and zeaxanthin because “[l]ow dietary intake and plasma levels of lutein and zeaxanthin have been associated with low macular pigment density and increased risk of age-related macular degeneration, and on this basis these carotenoids have been considered good candidates for designation as a [sic] `conditionally essential' nutrients.” CFS fails to note that the same journal article states that these carotenoids “ may play a role in the pathogenesis of age-related macular degeneration,” that “studies are beginning to suggest that they fit the criteria for conditionally essential nutrients” and that “[s]hould controlled clinical trials show lutein and/or zeaxanthin supplementation protects against the developments or progression of ARMD [age-related macular degeneration] and other eye diseases, then lutein and zeaxanthin could be considered as conditionally essential nutrients for humans” (emphasis added) (Ref. 11). Thus, none of these statements supports CFS' claim that there currently is a scientific basis which would provide a substantial rationale for us to perform analysis on individual carotenoids. Furthermore, it should be noted that both lutein and zeaxanthin are nonprovitamin A carotenoids, meaning that neither contributes to vitamin A activity.

Additionally, in the most recently published report from the IOM on Dietary Reference Intakes (DRIs), which updated recommendations for the intake of vitamin C, vitamin E, selenium, and discussed carotenoids, the IOM stated: “[a] large body of observational epidemiological evidence suggests that higher blood concentrations of β-carotene and other carotenoids obtained from foods are associated with lower risk of several chronic diseases. This evidence, although consistent, cannot be used to establish a requirement for β-carotene or carotenoid intake because the observed effects may be due to other substances found in carotenoid-rich food, or to other behavioral correlates of increased fruit and vegetable consumption * * * [a]lthough no DRIs are proposed for β-carotene or other carotenoids at the present time, existing recommendations for increased consumption of carotenoid-rich fruits and vegetables are supported . . .” (Ref. 4).

After reviewing the relevant scientific studies, the IOM did not establish a requirement for carotenoid intake; therefore, unless the carotenoids contributed to vitamin A levels in the diet, we did not analyze specific carotenoids. For these reasons, there was no evidence that individual carotenoids needed to be analyzed when we made our safety decision on irradiation of fresh lettuce and fresh spinach at the petitioned doses. Accordingly, we are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

CFS offers three arguments to support their view that we erroneously concluded that irradiation-induced folate loss in fresh lettuce and fresh spinach is not nutritionally significant. First, CFS asserts that we did not consider any studies of irradiation-induced folate losses in iceberg lettuce. Second, CFS asserts that only one of the cited studies pertained specifically to fresh spinach. Third, CFS contends that we failed to discuss certain results from the study performed by Müller and Diehl (Ref. 12).

First, CFS asserts that “though iceberg lettuce contains considerably less folate than spinach * * *, lettuces as a group supply a larger percentage of folate than the spinach/greens groups to the average American diet,” and therefore we should have considered studies of irradiation-induced folate losses in iceberg lettuce. However, we note that iceberg lettuce is just one leafy vegetable within the category of “lettuces” (which includes Romaine, butterhead, green leaf, etc.); among the lettuces, iceberg lettuce contains the lowest concentration of folate. In our nutrition memorandum (Ref. 2), we explain that iceberg lettuce is not considered to be a “good source” of folate in accordance with § 101.54(c) and that enriched and fortified foods (e.g., cereal grains and grain-based products) make the greatest contribution to folate in the diet. Furthermore, the form of folate used for fortification is more bioavailable than naturally occurring food folates. While we did not provide an analysis for iceberg lettuce, we did analyze the potential folate loss in spinach, which is considered to contain relatively large amounts of folate. We concluded that irradiation of spinach at doses up to 4.0 kGy would not have a significant impact on the dietary intake of folate in the U.S. diet. It follows that iceberg lettuce, which does not meet the criteria for a “good source” of this nutrient, would not have a significant impact on the dietary intake of folate either. Therefore, the information provided by CFS that lettuces “as a group” supply a larger percentage of folate than the spinach/greens group is not sufficient to demonstrate that we should have considered irradiation-induced losses in iceberg lettuce. Accordingly, we are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

Second, CFS asserts that only one study was presented that considered irradiation-induced folate loss in fresh spinach. While we cited two studies considering folate loss, CFS asserts that only one study is relevant because it was performed in fresh spinach. In the final rule, we explained our position that many scientifically valid types of data may properly support a finding that a proposed use of a food additive is safe. CFS has not provided any evidence that our consideration of studies considering folate loss is inadequate to determine the magnitude of nutrient losses from irradiating fresh lettuce and fresh spinach at the petitioned doses. CFS has also not provided any additional studies that we should have considered in assessing folate loss. We are therefore denying CFS' objection and request for a hearing because a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)).

Third, CFS contends that our discussion of the study performed by Müller and Diehl (Ref. 12) did not include certain results. CFS asserts that the study reported a 12 percent loss of folate in fresh spinach when irradiated at 2.5 kGy, but we did not discuss the 21 percent loss of folate in fresh spinach when irradiated at 5.0 kGy or the 13 percent loss of folate when dehydrated spinach was irradiated at 10 kGy. The Müller and Diehl study was included in the petition and was analyzed by FDA when we made our safety assessment. We acknowledge that a greater loss of folate was shown when fresh spinach was irradiated at a higher dose (i.e., 5.0 kGy) when compared to the lower dose of 2.5 kGy. The nutrition memorandum cited the 2.5 kGy result, since it was within the range of doses under consideration in the petition and highlighted the general stability of food folate. The 5.0 kGy dose, although greater than the dose under consideration in the petition, still shows that nearly 80 percent of folate is maintained, thus supporting the general stability of this vitamin to moderate doses of irradiation. In our review of the petition, we considered the health implications from folate loss in spinach at the maximum petitioned dose (4.0 kGy), and concluded that such folate loss is not nutritionally significant because: (1) Fresh lettuce and fresh spinach contribute minimally to the dietary intake of folate; and (2) folate is found to be consistently stable to irradiation under various conditions that have been detailed in published studies.

Therefore, the information provided by CFS that a greater loss of folate was shown when fresh spinach was irradiated at a higher dose does not call into question our assessment of the nutritional impact of the final rule and determination that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe. Accordingly, we are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

CFS objects to the final rule based on our nutrition memorandum for vitamin K because CFS asserts that: (1) The Knapp and Tappel study (Ref. 13) cited in the nutrition memorandum involved the irradiation of pure vitamin K in an isooctane solution and not in a food matrix; (2) the Richardson et al. study (Ref. 14) cited in the nutrition memorandum involved indirect measurement of vitamin K activity in spinach and other vegetables after freezing, irradiation at 28 or 56 kGy, or heat-processing; (3) we “failed to consider” conflicting results in two studies (Richardson et al. (Ref. 15) and Metta et al. (Ref. 16)) from the same period as the Richardson et al. study (Ref. 14) cited in the nutrition memorandum; and (4) we failed to consider the 2007 study by Hirayama et al. (Ref. 17) that raises “similar questions” regarding the nutritional impact of irradiating fresh lettuce and fresh spinach.

First, CFS contends that the Knapp and Tappel study that involved the irradiation of pure vitamin K in an isooctane solution rather than a food matrix is of “limited value for assessing irradiation-induced loss of Vitamin K in irradiated spinach or iceberg lettuce.” We disagree with CFS' assessment. To the contrary, we maintain that this study establishes vitamin K as one of the least sensitive fat-soluble vitamins to irradiation, and therefore is relevant for assessing irradiation-induced losses. Even though the study was performed in an isooctane solution, the relative sensitivities of the vitamins to irradiation do not change; rather, the food matrix can offer protection to the vitamin, lessening the effects of irradiation because the radiation effects will be distributed to all components of the food, i.e., the principle of mutual protection (Ref. 18). We reviewed this study and found it to be adequate to determine comparative radiosensitivities under uniform conditions for vitamins A, D, E, K, as well as carotene. Therefore, the information provided by CFS that the Knapp and Tappel study involved the irradiation of vitamin K in an isooctane solution rather than a food matrix does not call into question the value of the Knapp and Tappel study in helping us assess the nutritional impact of the final rule. We are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

Second, CFS contends that the Richardson et al. study (Ref. 14) is of limited value because the study “estimated” the vitamin K content through indirect measurement of the prothrombin times of chick plasma, and the study reported “anomalous results.” According to CFS, the authors of the study reported an increase in vitamin K activity in irradiated spinach over time in addition to variability in the values obtained from different assays. CFS cites these findings to support its contention that we erroneously determined the magnitude of vitamin K loss from irradiation of fresh lettuce and fresh spinach under the petitioned conditions.

We disagree that the indirect measurement of vitamin K activity in spinach precludes this study from being useful in the assessment of potential nutrient losses. In our review of this study, we considered the prothrombin time measurement in the chick bioassay, even though indirect, to be relevant for assessing vitamin K activity in foods since the chick is sensitive to dietary vitamin K deprivation. Moreover, the prothrombin time measurement is a common parameter for measuring vitamin K status for clinical purposes (Refs. 3 and 19). Furthermore, we acknowledge the variability in the data cited by CFS; however, CFS' objection fails to note that the authors of the study in question concluded that “regardless of the variability in results * * * there was no appreciable loss of vitamin K activity in the foods preserved by any process or when stored for 15 months” (Ref. 14). Variability in results is not grounds for a study to be ignored; important information about general trends may still be gleaned from this study, which consistently found vitamin K activity was not reduced by irradiation relative to frozen or heat-processed controls. As part of their objection, CFS specifically notes that vitamin K activity after 15 months of storage was higher than directly after irradiation at both irradiation doses; however, it should be noted that irradiation may either accelerate or decelerate metabolic changes within the food, a factor which may account for differences observed following storage (Ref. 9). For example, it is known that vitamin K resides in the chloroplasts and has tight association with the thylakoid membranes. This tight association may account for the limited bioavailability of vitamin K from green leafy vegetables (Ref. 20). Processing techniques such as irradiation (particularly at high doses) may result in disruption of thylakoid membranes, an effect which may become more evident after long term storage and may account at least in part for variability in observed vitamin K activity after storage. As such, the information provided by CFS that the Richardson et al. study involved indirect measurement of vitamin K activity does not call into question the value of the Richardson et al. study in helping us assess the nutritional impact of the final rule. We are therefore denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

Third, CFS contends that we failed to consider conflicting results from two studies cited by CFS: A study performed by Richardson et al. (Ref. 15); and a study performed by Metta et al. (Ref. 16). Although neither of these studies was cited in our nutrition memorandum, we were aware of both studies when evaluating the nutritional impact of irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy. We disagree with CFS' conclusions that the Richardson et al. study demonstrated that the “Vitamin K activity of diets containing small quantities of Vitamin K was markedly decreased by irradiation with sterilizing doses of gamma rays.” CFS' objection fails to note that, in the experimental report, the authors concluded that “practically none of the vitamin K activity was lost by the irradiation process when vitamin K 1 was the source of the vitamin in the diet.” The article also concluded that “[s]ince the incidence of hemorrhage was higher in the chicks receiving the untreated spinach than it was in those receiving the irradiated spinach, it was concluded that no destruction of vitamin K occurred by the irradiation process.”

In addition, the Metta et al. study (Ref. 16) reported vitamin K deficiency in rats induced by the feeding of irradiated beef. However, we deemed the study irrelevant to the assessment of vitamin K loss in fresh lettuce and fresh spinach because the Metta et al. study assessed the vitamin K destruction of the more labile form of vitamin K found in meat (menaquinone). There are a number of different forms of vitamin K, including, but not limited to: Phylloquinone (vitamin K 1 )—the only important molecular form found in plants, menaquinones (vitamin K 2 )—which refers to a series of compounds produced by gut bacteria but also to a form of vitamin K 2, termed “menaquinone-4” that is produced in animal tissues from conversion of dietary vitamin K (K 1 , K 3 ), and menadione (vitamin K 3 ), a synthetic form (Refs. 3, 21, and 22).

Phylloquinone is the form of vitamin K that is found in spinach and other leafy greens, whereas menaquinone, although present in minor amounts, is the dominant form found in beef along with lesser amounts of dietary phylloquinone. The radiosensitivities differ among various forms of vitamin K. For example, Richardson et al. reported menadione (vitamin K 3 ) is more readily destroyed by ionizing radiation than either phylloquinone (vitamin K 1 ) or vitamin K 5 (a vitamin K analog) (Ref. 15). The Metta et al. study assessed the destruction of vitamin K found in meat and the effect on rats fed a limited diet; the lability of vitamin K in beef  9 has been noted in numerous published reviews, including those of WHO (Ref. 23), Thayer et al. (Ref. 24); and Diehl et al. (Ref. 9). We determined that the Metta et al. study was not relevant to the assessment of potential irradiated-induced phylloquinone losses in fresh lettuce and fresh spinach, and did not highlight this reference in our nutrition memorandum.

We do not agree with CFS' contention that our nutritional assessment of irradiated fresh lettuce and fresh spinach is called into question by these studies. Neither of these studies includes any information or data that would call into question our findings regarding the nutritional impact of irradiation under the petitioned conditions. We are therefore denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

Lastly, CFS asserts that a study conducted by Hirayama et al. (Ref. 17) was not reviewed by FDA in the approval process to permit ionizing radiation to treat fresh lettuce and fresh spinach, and therefore calls into question our nutritional assessment and ultimately our safety conclusion. In the Hirayama et al. study, germ-free mice were fed pelleted, sterilized animal feed. According to CFS, vitamin K 3 , a synthetic form of vitamin K, was eliminated when the pure compound was added to the feed and irradiated at 50 kGy. CFS notes that the study also showed that vitamin K 1 , the form found in spinach, was reduced by approximately 68 percent after the pelleted feed was exposed to irradiation doses of 50 kGy. CFS objects to the final rule, asserting that this study demonstrates the need for more research to determine the “differential sensitivities” of the two forms of vitamin K. We do not agree that our nutritional assessment and the safety of irradiated fresh lettuce or fresh spinach up to a maximum dose of 4.0 kGy are called into question by this study.

As previously mentioned in this document, research has demonstrated that different forms of vitamin K have variable sensitivities to irradiation. For example, the Richardson et al. study (Ref. 15) cited by CFS investigated the effects of ionizing radiation on vitamin K when different sources were used (i.e., probing the “differential sensitivities”). The sources of this vitamin were K 1 , K 3 , K 5 , dehydrated alfalfa leaf meal, and fresh spinach. The authors concluded that menadione (K 3 ) was more readily destroyed by irradiation than either vitamin K 1 or K 5, and practically no destruction of vitamin K (phylloquinone) occurred when the dietary source was natural (i.e., from alfalfa leaf meal and spinach). Clearly, it is understood that different forms of vitamin K can have variable sensitivity to irradiation, and we were aware of this fact when evaluating the nutritional adequacy of irradiated lettuce and spinach (Ref. 25). In addition, the petition proposes to irradiate spinach in its natural form, and the Richardson et al. study, which provides the most pertinent results (Ref. 15), demonstrated that there was practically no destruction of vitamin K from this natural source. Furthermore, the WHO report we evaluated during review of the petition contained information regarding the varied properties of these different forms of vitamin K (Ref. 20). Therefore, the Hirayama et al. study raised by CFS does not call into question our assessment of the nutritional impact of the final rule; we continue to conclude from all of the available evidence that the irradiation of fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy will have no significant impact on the total dietary intake of vitamin K and is safe. We are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

CFS asserts that the final rule does not provide an assessment of vitamin C loss from irradiation and further alleges that our assessment of irradiation-induced vitamin C loss in our nutrition memorandum is erroneous. CFS argues that the studies we reviewed regarding irradiation-induced loss of vitamin C showed varied results and that one source of variation in that loss is whether ascorbic acid (AA) was measured or whether AA plus dehydroascorbic acid (DHAA) was measured. Measuring AA plus DHAA yields the total ascorbic acid (TAA). Specifically, CFS states that, in light of the divergent data, experiments for irradiation of fresh lettuce and fresh spinach should be conducted measuring TAA. CFS also contends that a source of variation in vitamin C can arise from “differential Vitamin C loss in different fruits and vegetables.”

We evaluated the vitamin C loss in irradiated fresh lettuce and fresh spinach and the evaluation was provided in our nutrition memorandum (Ref. 2). However, because fresh lettuce and fresh spinach are not major contributors to vitamin C in the U.S. diet, the question of vitamin C loss from these foods was not discussed in the final rule. While spinach has a relatively high concentration of vitamin C, the combined food group of “spinach/greens” contributes less than 2 percent to the total intake of vitamin C in the diet. Other major food sources (e.g., citrus fruit, fortified juice drinks, tomatoes, peppers, potatoes, broccoli) provide the majority of vitamin C in the U.S. diet. We therefore determined that little if any reduction in intake of vitamin C in the U.S. diet is expected to result from irradiation of fresh lettuce and fresh spinach under the petitioned conditions of use.

We agree that the studies cited in our nutrition memorandum appear to report divergent results; however, for all these studies, we provided an explanation for each set of differences. For example, our nutrition memorandum states that, “[m]any of the early studies of the effects of irradiation on vitamin C levels measured AA levels only and consequently reported artificially high decreases in vitamin C,” and “AA losses of irradiated foods relative to controls may be quite different depending on whether AA levels are recorded immediately after irradiation or after typical storage conditions.” The memorandum also states that, “[i]n the most recent studies conducted on spinach and iceberg lettuce, when irradiation has been conducted at doses reflective of those that would be practical for maintaining acceptable sensory properties, reported losses were minimal.” Thus, the information provided by CFS, that the studies we reviewed regarding irradiation-induced loss of vitamin C showed varied results, does not call into question our assessment of the nutritional impact of the final rule or our conclusion that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe. We evaluated the totality of evidence and determined that the irradiation of fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy was safe. We are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

CFS contends that we do not address the synergistic effects of irradiation and heating, stating that nutrient losses would be even greater for dual processing compared to irradiation alone. In support of this objection, CFS cites a table in “Safety of Irradiated Foods” by Diehl (Ref. 9) specifically showing synergistic losses of vitamin E. We are aware that synergistic losses have been noted for vitamin E and thiamin, two vitamins that are particularly sensitive to irradiation; however, synergistic effects have not been observed for all vitamins or in all food types (Ref. 24). To determine the potential impact of irradiation at levels up to 4.0 kGy on the nutritional value of fresh lettuce and fresh spinach, we considered all vitamins known to be present in these foods, and primarily focused on vitamins that are present in relatively high amounts in one or both of these foods and vitamins for which lettuce and spinach contribute more than a trivial amount to the total dietary intake of those vitamins (i.e., more than 1 to 2 percent). There are a number of commonly consumed foods that are substantial sources of vitamin E (e.g., certain nuts and oils, margarines) (Ref. 5); these foods are discussed in the reference cited by CFS. Substantial sources of thiamin include yeast breads, ready-to-eat cereals, pastas and grains, certain meats, and milk (Ref. 5). Neither of the two vitamins particularly sensitive to irradiation, vitamin E and thiamin, has been identified as being present in relatively high amounts in fresh lettuce and/or fresh spinach and as contributing more than a trivial amount to the total dietary intake of these vitamins. Therefore, the information provided by CFS, that synergistic losses have been found for vitamin E, does not call into question our assessment of the nutritional impact of the final rule and determination that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe. Accordingly, we are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

CFS also objects that we underestimated the nutritional contribution of fresh lettuce and fresh spinach to the diet. Specifically, CFS states that we failed to consider spinach's “dramatically rising nutritional contribution” to the average American diet over time and failed to consider subpopulations which rely more heavily on spinach for nutrition than the statistically average American. Thus, CFS attempts to call into question our assessment of the nutritional impact of the final rule and ultimately our determination that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe.

According to CFS, we employed two criteria to consider which nutrients were assessed: (1) Nutrients for which spinach/iceberg lettuce are an “excellent source;” and (2) nutrients for which spinach/iceberg lettuce contribute greater than 1 to 2 percent of the statistically average American's diet. CFS asserts that we should have provided a rationale for considering only nutrients for which spinach is an “excellent source” and should have considered vitamins for which spinach is also a “good source.” CFS has mischaracterized the criteria we used for our nutritional assessment, which was explained in our nutrition memorandum (Ref. 2). We explained in the nutrition memorandum that we considered all vitamins known to be present in lettuce and spinach in relatively high amounts (greater than or equal to 10 percent of the daily value for vitamins), including vitamins for which lettuce and/or spinach were “good” or “excellent” sources, and that contribute greater than 1 to 2 percent to the total dietary intake of those vitamins. Vitamins that did not meet these two criteria were not explicitly discussed in the nutrition memorandum. While fresh spinach is a “good source” of vitamin E, vitamin B 6 , and riboflavin, fresh spinach did not contribute more than 1 to 2 percent to the total dietary intake of these vitamins. Therefore, we did not explicitly discuss these nutrients in the nutrition memorandum. CFS has not presented any evidence to call into question the criteria we used for our nutritional assessment. Therefore, we are denying CFS' objection and request for a hearing because a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)).

In addition, CFS objects to our second criteria, asserting that we rely on a “13-year old `snapshot' that misses the growing importance of [spinach] to the nutritional adequacy of American diets.” In support of this objection, CFS submitted a study performed by the Economic Research Service (ERS) of the United States Department of Agriculture (USDA) (Ref. 26). This study provides basic economic information about the market distribution of spinach in the United States. CFS points out that this study indicated an increase in the consumption of spinach from the 1970s through 2002. Table 1 of the ERS study presents “per capita use”  10 of spinach in the United States. The per capita use values for fresh market (i.e., fresh spinach) for 1994, 1995, and 1996 are 0.75, 0.67, and 0.63 pounds, respectively, and the corresponding per capita use values for total spinach are 1.71, 1.66, and 1.77 pounds, respectively. While CFS focused on the value for per capita use of total spinach, the fresh market value is more pertinent to this discussion, as fresh spinach is the subject of this regulation. The ERS study indicates that the total fresh market per capita value for spinach increased from 0.75 pounds in 1994 to 1.49 pounds in 2002. CFS asserts that we did not consider this increase in fresh spinach consumption in the nutritional assessment.

CFS further asserts that this rise in consumption of spinach could be used to provide a rough approximation of the dietary and nutritional contribution of spinach during these years (i.e., 1997 to 2002). CFS provides estimations for percent contribution of spinach to vitamin A and vitamin C intake and suggests that contributions of spinach to vitamin E, riboflavin, and vitamin B 6 intake may have increased to provide more than 1 to 2 percent of the percent daily value as well.

However, we note that our nutritional assessment included a key conservative assumption that compensates for the increase in fresh spinach consumption cited by the ERS study. Specifically, we assumed that all spinach and iceberg lettuce in the food supply would be irradiated (i.e., 100 percent commercial application). For the years of 1994, 1995, and 1996, we conservatively estimated 100 percent commercial application; values for total per capita use of spinach were 1.71, 1.66, and 1.77 pounds, respectively, during those years, and we assumed all spinach could be irradiated when evaluating the nutritional impact of irradiating fresh lettuce and fresh spinach. These values for total per capita use of spinach each exceed the value for fresh market consumption in 2002 and therefore, our assessment encompassed the increased per capita use of fresh spinach through use of this conservative approach. Since our approach did not underestimate fresh spinach consumption in our nutritional assessment, the data and information provided by CFS do not call into question our assessment of the nutritional impact of the final rule and determination that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe. Moreover, CFS' assertion that the rise in spinach consumption indicates increased contributions of spinach to the dietary intake of vitamins is not based on actual data. The estimates provided by CFS are purely speculative; the estimates do not account for recent changes in calculation of vitamin A equivalency and presume no other changes in the U.S. diet (during the same time period) related to intakes of other foods containing vitamin A and provitamin A and certain water-soluble vitamins listed by CFS. Because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)), and a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)), we are denying CFS' objection and request for a hearing.

CFS also objects to the final rule by alleging that we did not consider atypical consumers of spinach such as Asian women, women 60 years of age or older, and vegetarians. We are aware that there is variation in the amount of fresh spinach consumed by different U.S. subpopulations; however, CFS provided no evidence that spinach is a more significant source of certain vitamins for any particular subpopulation. Indeed, to establish the contribution and significance of spinach as a source of specific vitamins in the diet, the complete diet must be considered. For example, when assessing the relative contribution of spinach and other leafy greens to the vitamin A content of the diet, the dietary intake of other major contributors of vitamin A (including vitamin A rich foods such as organ meats and dairy products) and provitamin A rich foods (such as carrots, tomatoes, and fortified ready-to-eat cereals) should be included. In addition, according to the IOM, bioavailability of provitamin A carotenoids should be taken into account. In the absence of data on the complete diet, it is not possible to determine the percent contribution of spinach and lettuce to the dietary intake of vitamins for these population subgroups and whether the relative contribution of spinach and lettuce to the dietary intake of these vitamins varies for the subpopulations cited by CFS. While the ERS study indicates that Asian women and women 60 years of age or older consume a relatively greater amount of fresh spinach compared to statistically average Americans, CFS did not establish that the small losses of some vitamins that could result from the petitioned use of irradiation of fresh spinach would be nutritionally significant (i.e., exceed a trivial amount for the total diet) for any of these population subgroups. Thus, the information provided by CFS regarding certain subpopulations that consume more spinach is not sufficient to support CFS' assertion that we failed to protect “atypical” consumers and therefore underestimated the nutritional contribution of fresh lettuce and fresh spinach to the diet. We are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

CFS also objects that we “failed to conduct a cumulative assessment of irradiation-induced nutrient losses in fresh spinach and iceberg lettuce in combination with irradiation-induced nutrient losses in other foods already approved for irradiation * * *.” CFS contends that by “breaking out” fresh lettuce and fresh spinach from the original petition, the nutritional impact will appear lessened, even if the impact of irradiating all the foods covered in the original petition is significant. Accordingly, CFS believes that we should conservatively assume that the entire supply of any given food will be irradiated at the maximum permitted dose when approving a petition. CFS' contention therefore attempts to call into question our assessment of the nutritional impact of the final rule and our determination that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe.

We explained in the final rule our criteria for evaluating whether irradiation of fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy would have an adverse effect on the nutritional quality of the diet. Our analysis focused on the effects of irradiation on those nutrients for which at least one of these foods may be identified as an “excellent source” or a “good source” and for which they contribute more than a trivial amount to the total dietary intake (i.e., the nutrients that had the potential to impact the diet). We based our decision on both the data and information submitted in the petition, as well as other data and information in our files. We determined that, based on the available data and information, the effects of irradiation on nutrient levels in fresh lettuce and fresh spinach treated under the proposed conditions will be insignificant and will not adversely affect the nutritional quality of the overall U.S. diet.

CFS alleges that “breaking out” fresh lettuce and fresh spinach from the foods covered in the original petition lessens the apparent overall nutritional impact of irradiated foods. However, the vitamin loss resulting from this regulation is negligible and therefore will not affect any cumulative assessment. CFS also asserts that we should conservatively assume that the entire supply of any given food will be irradiated at the maximum permitted dose during the approval of a petition. We agree with CFS and have chosen to employ this approach when assessing nutritional losses induced by irradiation. The nutrition memorandum notes that we, in our reviews and analysis of nutritional data, operate under the assumption that the entire supply of a given food may be irradiated at the maximum permitted dose. Contrary to what CFS appears to assert, the discussion of data at lower doses in the nutrition memorandum does not negate this assumption; rather, it reflects a review of published data on irradiation of various plant foods at both lower and higher doses. CFS has not submitted sufficient information to support the conclusion that nutrient loss in fresh lettuce or fresh spinach irradiated under the petitioned conditions, in combination with nutrient losses in other foods already approved for irradiation, would call into question our assessment of the nutritional impact of the final rule and would be a safety concern. Accordingly, we are denying CFS' objection and request for a hearing because a hearing will not be held on the basis of mere allegations or denials or general descriptions of positions or contentions (§ 12.24(b)(2)).

In another overall objection to the final rule, CFS objects to our safety evaluation of irradiated fresh lettuce and fresh spinach, stating that “FDA has failed to determine whether irradiation of fresh spinach and iceberg lettuce . . . will increase the risk of food-borne disease from radiation-insensitive pathogens such as Clostridium botulinum . . . .” Specifically, CFS asserts that our analysis did not adequately address the possibility that the suppression of radiation-sensitive bacteria by irradiation might offer enhanced growth conditions for pathogens that are more resistant to irradiation, such as C. botulinum (the bacterium that produces the toxin which causes the disease botulism). CFS presents three arguments to support this objection: (1) We did not provide a discussion of radiation-insensitive pathogens other than C. botulinum; (2) the study by Petran et al. (Ref. 27), which we cited to support our conclusion that irradiation will not increase the risk of botulism, did not involve irradiation of fresh lettuce or fresh spinach; and (3) the microbiology memorandum (Ref. 28) contained contradictory statements. We will address each argument in this document.

First, CFS asserts that we erred by not evaluating irradiation's potential effect on radiation-insensitive pathogens other than C. botulinum. Historically, it has been our practice to evaluate microbiological pathogens that have been identified as a potential hazard for a specific type of food and which are also of public health significance (see, for example, 70 FR 48057, August 16, 2005 (amending the food additive regulations to provide for the safe use of ionizing radiation for control of Vibrio species and other food-borne pathogens in fresh or frozen molluscan shellfish); 65 FR 64605, October 30, 2000 (amending the food additive regulations to provide for the safe use of ionizing radiation to control microbial pathogens in seeds for sprouting); 65 FR 45280, July 21, 2000 (amending the food additive regulations to provide for the safe use of ionizing radiation for the reduction of Salmonella in fresh shell eggs); 62 FR 64107, December 3, 1997 (amending the food additive regulations to provide for the safe use of a source of radiation to treat refrigerated or frozen uncooked meat, meat byproducts, and certain meat food products to control food-borne pathogens and extend product shelf life); 55 FR 18538, May 2, 1990 (amending the food additive regulations to provide for the safe use of sources of ionizing radiation for the control of food-borne pathogens in poultry); and 50 FR 29658, July 22, 1985 (amending the food additive regulations to permit gamma radiation treatment of pork to control Trichinella spiralis )). In the microbiology memorandum, we provide a discussion of the food-borne disease outbreaks and pertinent pathogens most commonly associated with the consumption of fresh lettuce and fresh spinach. The microbiology memorandum identifies Escherichia coli O157:H7, Listeria monocytogenes, and Salmonella enterica serovars as pathogens of public health significance, and discussed these pathogens in detail. We also discuss C. botulinum in the microbiology memorandum and in the final rule, not because C. botulinum has been identified as a reasonable hazard for either fresh lettuce or fresh spinach, but because this pathogen has been identified as being both radiation-insensitive and of public health significance, and to demonstrate the impact that elimination of native microflora may have on the ability of this type of pathogen to proliferate and elaborate toxin. However, it is not our burden to discuss possibly irrelevant pathogens. CFS does not provide information related to additional radiation-insensitive pathogens of public health significance that may be present in fresh lettuce or fresh spinach that we have not considered, and the objection contains no information that would cause us to change our safety determination. We are therefore denying CFS' objection and request for a hearing because a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)).

Second, CFS asserts that the Petran et al. study (Ref. 27), which we cited in support of our conclusion that irradiation will not increase the risk of botulism, did not involve irradiation of fresh lettuce or fresh spinach, and therefore, did not address the safety concern that irradiation may provide enhanced growing conditions for radiation-insensitive pathogens due to the “elimination” of spoilage and other bacteria. CFS also objects to the final rule based on this study because C. botulinum multiplies more rapidly on shredded cabbage than romaine lettuce, asserting that this observation demonstrates that pathogens can have markedly different growth patterns on different vegetables, underscoring the illegitimacy of extrapolating from data on one vegetable to another.

The Petran et al. study (Ref. 27) assesses the potential for growth and toxin production of heat-shocked C. botulinum spores in fresh-cut romaine lettuce and shredded cabbage. While the produce was not irradiated, the study was chosen because it offers a non-competitive environment for C. botulinum elaboration, reflecting conditions that would be generated if produce were irradiated in the presence of C. botulinum spores. C. botulinum is a Gram-positive anaerobic sporeformer, and this study examined the potential for outgrowth and toxin production under conditions of temperature abuse in both aerobic and anaerobic conditions. As stated in our microbiology memorandum, there was no toxin production detected in either the vented or non-vented packaging at 12.7 °C (~55 °F) or lower after 28 days. Toxin was produced only under conditions of extreme temperature abuse after all samples became unmistakably inedible, i.e., after 14 days at 21 °C (~70 °F). The study demonstrated that even under ideal growth conditions for C. botulinum where the levels of native microflora were greatly reduced, toxin production was not elaborated until after the produce was clearly inedible. Moreover, CFS has not presented evidence or a rationale that changes our conclusion that the “growth and toxin expression by Gram-positive anaerobic sporeformers would not present a likely additional hazard in this application of irradiation.”

CFS also objects to the use of the Petran et al. study because it did not involve fresh lettuce or fresh spinach; rather, the study explored the potential for growth and toxin production by C. botulinum in samples of romaine lettuce and cabbage packaged in aerobic and anaerobic conditions exposed to temperature abuse, which represent ideal conditions for growth and toxin production by C. botulinum . CFS uses the example of C. botulinum multiplying more rapidly on shredded cabbage than on romaine lettuce as evidence that one cannot extrapolate from data on one type of leafy green vegetable to draw conclusions about other leafy green vegetables (i.e., fresh lettuce and fresh spinach). We recognize that in the study, toxin was produced in the non-vented cabbage sample after 7 days of storage at 21 °C (nearly 70 °F), a timeframe that was shorter than the timeframe for toxin production in romaine lettuce. However, we do not agree that these results indicate the illegitimacy of extrapolating data from one type of leafy green vegetable to another leafy green vegetable. CFS fails to note that all of the samples for which toxin production was observed were clearly inedible prior to toxin production, and that toxin was not produced for at least 28 days in any of the samples that were vented. Indeed, the study demonstrated that it is extremely unlikely for an anaerobic sporeformer to grow and produce toxin in lettuce products that are handled properly (i.e., not stored at 70 °F for 7 days) and are of acceptable quality for consumption. Furthermore, all leafy green vegetables (e.g., iceberg lettuce, spinach, romaine lettuce, and cabbage) are grown and harvested under similar conditions and therefore the probability of contamination with C. botulinum is similar. As stated in the microbiology memorandum, this type of contamination is unlikely. CFS did not provide any data to demonstrate that C. botulinum has been identified as a hazard in green leafy vegetables or that the likelihood of toxin production would be greater for either fresh lettuce or fresh spinach than it is in romaine lettuce or cabbage. CFS' objection did not include any new information or data that would call into question our findings about this study. Accordingly, the information provided by CFS, that the Petran et al. study did not involve the irradiation of fresh lettuce or fresh spinach, is not sufficient to call into question our determination that irradiating fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is safe. We are therefore denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

Further, it is important to note that the standards of microbiological safety of fresh lettuce and fresh spinach are independent of the final rule permitting the irradiation of fresh lettuce and fresh spinach. Irradiation is just one potential control contributing to the mitigation of food-borne pathogens, and its intended technical effect is to reduce, not eliminate, spoilage and pathogenic bacteria. Therefore, the final rule is not predicated on irradiation, by itself, resulting in fresh lettuce and fresh spinach that are pathogen-free.

The final portion of the CFS objection contends that the our microbiology memorandum contains contradictory statements, and therefore, the question of whether the growth of C. botulinum or other radiation-insensitive pathogens present on irradiated fresh lettuce or fresh spinach would be enhanced by the suppression of competing bacteria remains unanswered. CFS asserts that when discussing the Petran et al. study, the microbiology memorandum states that the spoilage microorganisms “attain previous levels within days of treatment,” but when discussing the Zhang et al. study (2006) (Ref. 29), the memorandum states that “relative reductions [in numbers of viable bacteria during 9 days of storage] persisted . . .” CFS contends that these statements are contradictory and that our conclusion that spoilage microorganisms “attain previous levels within days of treatment” is erroneous.

CFS' objection implies that both statements cannot be true and that we misinterpreted the Zhang et al. study. However, we disagree that either statement is false. The Zhang et al. study (Ref. 29) reported substantially lower total bacterial counts for the irradiated samples as compared to the unirradiated control on the same day. Our microbiology memorandum's statement that “relative reductions [in numbers of viable bacteria during 9 days of storage] persisted . . .” is, therefore, correct. However, while these lower levels of bacteria persisted, the native microflora was also recovering as evidenced through the increase in total bacterial counts over the storage period. In the case of the 0.5 kGy and 1.0 kGy irradiation trials, bacterial counts attained initial levels (i.e., the control level on day zero) within days of treatment. For the 1.5 kGy sample, the total bacterial counts did not reach the control level by the end of the 9-day storage period, but the total bacterial counts increased as storage time increased. The results of the 1.5 kGy sample therefore demonstrate the veracity of both of the memorandum's statements: The native microflora was able to recover and the substantially lower bacterial counts persisted throughout the 9-day storage period. At the end of the 9-day storage period, the unirradiated control was reported to have 7.60 Log CFU/g  11 or approximately 4 million colony forming units per gram, which resulted in the spoilage of tissue. On the same day, the sample irradiated at 1.5 kGy contained approximately 50 thousand colony forming units per gram, which was lower than the unirradiated control, but significantly larger than the nearly 200 colony forming units that were present immediately following irradiation. Thus, the statements in the microbiology memorandum are both correct, and we maintain that the memorandum accurately and reliably reflects the information in the cited publication. Accordingly, we are denying CFS' objection and request for a hearing because the data and information submitted by CFS are insufficient to justify the factual determination urged, even if accurate (§ 12.24(b)(3)).

CFS' final objection contends that we have failed to consider alternatives to irradiation of fresh lettuce and fresh spinach. However, we evaluate a particular food additive only for its safety. Section 409(c)(1) of the FD&C Act requires FDA to establish a regulation prescribing, with respect to one or more proposed uses of the food additive involved, the conditions under which such additive may be safely used. The FD&C Act does not require us to consider alternatives as a factor in deciding whether to grant a food additive petition. We evaluated the safety of irradiating fresh lettuce and fresh spinach at a maximum dose not to exceed 4.0 kGy based on three appropriate areas relevant to safety: (1) Potential toxicity; (2) nutritional adequacy; and (3) effects on the microbiological profile of the treated food. Based on the data and studies submitted in the petition and other information in our files, we properly concluded that the proposed use of irradiation to treat fresh lettuce and fresh spinach with absorbed doses that will not exceed 4.0 kGy is safe. Therefore, we are denying CFS' objection and request for a hearing because CFS raises a factual issue that is not determinative with respect to the action requested (e.g., the action would be the same even if the factual issue were resolved in the way sought) (§ 12.24(b)(4)).

FWW submitted objections to the final rule in a letter dated September 22, 2008, which concurred with objections put forth by CFS, and included an additional objection. FWW asserts that there is a basis to stay the approval of the final rule and to convene a public evidentiary hearing on the issue of the quality of the irradiated produce at the dose levels approved and whether there is technology currently available to achieve the pathogen reduction desired while still preserving the organoleptic properties of the produce. FWW asserts that approval of this petition raises issues of safety and deception to the consumer under section 409 of the FD&C Act because irradiating fresh lettuce and fresh spinach at the petitioned doses may result in organoleptic degradation and may not achieve pathogen reduction.

In support of its objection, FWW cites a 2008 study by Gomes et al. (Ref. 30), which according to FWW, demonstrated that doses higher than 1 kGy were necessary to ensure elimination of food-borne pathogens from bagged spinach leaves. Additionally, FWW quotes Dr. Mike Doyle, Director of the Center for Produce Safety at the University of Georgia, who stated that, “in a commercial processing plant, products are stacked in cartons for treatment, so the dose must be strong enough to irradiate every part of the package and that could lead to some products being `overly treated,' which could render the product unappetizing.” Thus, FWW asserts that pathogen reduction may require strong irradiation doses that will result in organoleptic degradation.

It appears from the objection that FWW has misinterpreted the intended technical effect from irradiation of fresh lettuce and fresh spinach to be the elimination of microbial contamination instead of the control of microbial contamination, as stated in the final rule. FWW provides no information to call into question our conclusions that the irradiation of fresh lettuce and fresh spinach is safe and will achieve the intended technical effect of controlling microbial contamination at doses not to exceed 4.0 kGy. In addition, we acknowledge that radiation-induced chemical changes, if sufficiently large, may cause changes in the organoleptic properties of the food. However, such organoleptic changes do not necessarily render the food unsafe, and FWW has not provided any evidence that would establish a link between organoleptic changes and the safety of irradiated foods. Moreover, food processors have an incentive to minimize the extent of the chemical changes in the food to avoid undesirable effects on taste, odor, color, or texture. Therefore, we are denying FWW's objection and request for a hearing because a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)).

FWW also asserted that irradiation is not effective against all food-borne pathogens (e.g., viruses) and could lead consumers to an incorrect conclusion that a product is safe even though it may still be contaminated. While we recognize that irradiation is not effective against viruses, the final rule permitting the irradiation of fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy is not predicated on the irradiation treatment eliminating all potential pathogens. In the final rule, we concluded that the use of irradiation up to a maximum dose of 4.0 kGy on fresh lettuce and fresh spinach was safe. During the review, we considered chemical, toxicological, nutritional, and microbiological effects resulting from the application of ionizing radiation to fresh lettuce and fresh spinach. It was demonstrated that the petitioned use of irradiation would not raise safety concerns and that the treatment achieved its intended technical effects (i.e., reduction of microorganisms and extension of shelf life). Therefore, we are denying FWW's objection and request for a hearing. FWW has not provided any evidence to demonstrate that the final rule would lead consumers to an incorrect conclusion that a product is safe even though it may still be contaminated; a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(2)). In addition, FWW's assertion that irradiation is not effective against all food-borne pathogens is not determinative with respect to the action requested; a hearing will not be granted unless resolution of the factual issue in the way sought is adequate to justify the action requested (§ 12.24(b)(4)).

Section 409 of the FD&C Act requires that a food additive be shown to be safe before marketing. Under 21 CFR 170.3(i), a food additive is “safe” if “there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” In our August 22, 2008, final rule approving the use of irradiation of fresh lettuce and fresh spinach up to a maximum dose of 4.0 kGy, we concluded, based on our evaluation of the data submitted in the petition and other relevant material, that the petitioned use of irradiation is safe for its intended use for the control of food-borne pathogens and extension of shelf life in fresh lettuce and fresh spinach.

The petitioner has the burden to demonstrate the safety of the additive to gain FDA approval. However, once we make a finding of safety in an approval document, the burden shifts to an objector, who must come forward with evidence that calls into question our conclusion (see section 409(f)(1) of the FD&C Act).

CFS and FWW have not established that we overlooked or misinterpreted significant information in the record to reach our conclusion that the use of irradiation up to a maximum dose of 4.0 kGy for control of food-borne pathogens and extension of shelf life in fresh lettuce and fresh spinach is safe. Therefore, we have determined that the final rule should not be modified or revoked based on the objections. We are also denying the requests for a hearing because the objections do not meet the standard for granting a hearing as discussed in this document. In addition, FWW's request for a stay of the effectiveness of the August 22, 2008, regulation until a hearing is held is moot because we are denying all hearing requests. Thus, we are confirming August 22, 2008, as the effective date of the regulation.

The following sources are referred to in this document. References marked with an asterisk (*) have been placed on display at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, under Docket No. FDA-1999-F-2405 (formerly 1999F-5522) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov . References without asterisks are not on display; they are available as published articles and books.

FinCEN exercises regulatory functions primarily under the Currency and Foreign Transactions Reporting Act of 1970, as amended by the USA PATRIOT Act of 2001 and other legislation, which legislative framework is commonly referred to as the “Bank Secrecy Act” (“BSA”). 1 The BSA authorizes the Secretary of the Treasury (“Secretary”) to require financial institutions to keep records and file reports that “have a high degree of usefulness in criminal, tax, or regulatory investigations or proceedings, or in the conduct of intelligence or counterintelligence activities, including analysis, to protect against international terrorism.”  2 The Secretary has delegated to the Director of FinCEN the authority to implement, administer, and enforce compliance with the BSA and associated regulations. 3 FinCEN is authorized to promulgate anti-money laundering (“AML”) and suspicious activity report (“SAR”) filing requirements for financial institutions subject to the BSA. 4

The AML program provisions of the BSA require financial institutions to establish programs that include, at a minimum: (1) The development of internal policies, procedures, and controls; (2) the designation of a compliance officer; (3) an ongoing employee training program; and (4) an independent audit function to test programs. When prescribing minimum standards for AML programs, FinCEN must “consider the extent to which the requirements imposed under [the AML program requirement] are commensurate with the size, location, and activities of the financial institutions to which such regulations apply.”  5 The SAR filing provisions of the BSA authorize FinCEN to require any financial institution, and any director, officer, employee, or agent of any financial institution to report any suspicious transaction relevant to a possible violation of law or regulation, and under other specified circumstances described below.

FinCEN has promulgated AML program and SAR regulations for a number of financial institutions. These financial institutions include banks, casinos, money services businesses, brokers or dealers in securities, mutual funds, insurance companies, futures commission merchants, and introducing brokers in commodities and loan and finance companies. 6 The BSA's definition of “financial institution” includes specified categories of businesses and professions, as well as “any business or agency which engages in any activity which the Secretary of the Treasury determines, by regulation, to be an activity which is similar to, related to, or a substitute for any activity in which any business described in [31 U.S.C. 5312(a)(2)(A)-(X)] is authorized to engage.”  7 Thus, FinCEN may promulgate regulations for businesses and professions that are not listed in the statutory definition of financial institution. 8

With this Final Rule, FinCEN establishes AML program and SAR requirements for the Federal National Mortgage Association (“Fannie Mae”), the Federal Home Loan Mortgage Corporation (“Freddie Mac”), and the Federal Home Loan Banks (“Banks” or “FHL Banks,” collectively, the “Housing GSEs”). FinCEN believes that the Final Rule will augment FinCEN's regulatory and strategic initiatives. The Housing GSEs are involved in providing financing to the residential mortgage market and thus are exposed to the risk of fraud. Although the business of the Banks differs in a number of respects from that of Fannie Mae and Freddie Mac, all of the Housing GSEs are involved in providing financing to the residential mortgage market and thus are vulnerable to fraud and other financial crimes. Also, both the primary and secondary residential mortgage markets are vulnerable to fraud and money laundering in terms of the proceeds of crime being invested in real property or securitized mortgages and related financial instruments. By purchasing mortgage loans, extending loans secured by mortgages and other real estate related collateral, and engaging in a variety of related financial activities, the Housing GSEs have access to, and are in a unique position to provide, information on suspected mortgage fraud and money laundering that has proven valuable to law enforcement and regulators in the investigation and prosecution of mortgage fraud and other financial crimes. While current fraud reporting by the Housing GSEs, discussed below, has value in combating fraud, the establishment of AML and SAR programs by the Housing GSEs will enable them to support broader regulatory and law enforcement efforts to combat mortgage fraud and related financial crimes consistent with the purposes of the BSA.

The Federal Housing Finance Regulatory Reform Act of 2008 (the “Reform Act”)  9 created the Federal Housing Finance Agency (“FHFA”) as an independent agency of the Federal government. FHFA was established on the date of enactment of the Reform Act, July 30, 2008, to be the Federal regulator of the Housing GSEs. 10 FHFA has regulatory authority over Fannie Mae, Freddie Mac, and the Banks (collectively referred to in FHFA regulations as the “regulated entities”), and over the Office of Finance of the Federal Home Loan Bank System. 11 FHFA is responsible for ensuring that the Housing GSEs: (1) Operate in a safe and sound manner, including being capitalized adequately and maintaining internal controls; (2) carry out their public policy missions; and (3) engage in activities that foster liquid, efficient, competitive, and resilient national housing finance markets. Where FHFA has not acted with superseding regulations, the Housing GSEs continue to operate under regulations promulgated by the Office of Federal Housing Enterprise Oversight (“OFHEO”) and the Federal Housing Finance Board (“FHFB”). 12

Congress chartered Fannie Mae and Freddie Mac primarily to establish secondary market facilities for residential mortgages to promote access to mortgage credit throughout the nation. Specifically, Congress established Fannie Mae and Freddie Mac to provide stability in the secondary market for residential mortgages, respond appropriately to the private capital market, and provide ongoing assistance to the secondary market for residential mortgages, including activities relating to mortgages on housing for low-and moderate-income families involving a reasonable economic return that may provide less of a return than Fannie Mae's and Freddie Mac's other activities. 13

The Banks were organized under the Federal Home Loan Bank Act (“The Bank Act”). 14 The Banks are financial cooperatives; only members of a Bank may purchase the capital stock of a Bank, and only members, and certain eligible housing associates (such as State housing finance agencies), may obtain access to secured loans, known as advances, or other Bank products. 15 Each Bank is managed by its own board of directors and serves the public interest by enhancing the availability of residential mortgage and community lending credit though its member institutions. 16 Any eligible institution (generally a Federally-insured depository institution or State-regulated insurance company) may become a member of a Bank if it satisfies certain criteria and purchases a specified amount of the Bank's capital stock. 17 The Bank Act also requires each Bank to establish an affordable housing program and contribute a specified portion of its previous year's net income to support that program. 18

On January 27, 2010, FHFA issued fraud reporting regulations, codified at 12 CFR part 1233, “Reporting of Fraudulent Financial Instruments,” to implement the provisions of the Safety and Soundness Act with respect to the discovery and reporting of fraud, in furtherance of the supervisory responsibilities of FHFA. 19 That regulation requires each Housing GSE to submit timely information on actual or possible fraud on all Housing GSE programs and products, 20 including, but not limited to a timely report to FHFA upon discovery that it has purchased or sold a fraudulent loan or financial instrument, or if the Housing GSE suspects a possible fraud relating to the purchase or sale of any loan or financial instrument. As discussed infra, certain parts of FHFA reporting format are based upon FinCEN's SAR format. The regulation, and associated guidance subsequently published by FHFA, 21 requires each Housing GSE to establish and maintain internal controls, policies, procedures, and operational training programs, and designate a fraud officer to oversee implementation and periodic monitoring (at least annually) of the fraud reporting program.

On November 8, 2011, FinCEN issued a Notice of Proposed Rulemaking (“NPRM”) to solicit comments on proposed AML and SAR regulations for the Housing GSEs. 22 The proposed rules contained standards and requirements that are substantially identical to those in FinCEN's AML and SAR regulations for banks, mortgage companies, and other financial institutions that offer retail consumer banking services and mortgage loans.

This Final Rule is based on the NPRM and adopts, without significant change, all of the regulatory provisions proposed in the NPRM. The AML regulation promulgates the four minimum requirements noted earlier. The SAR regulation requires reporting of suspicious activity in accordance with the standards and procedures specified in the NPRM and contained in all of FinCEN's SAR regulations. 23 The Final Rule does not require the Housing GSEs to comply with any other BSA reporting or recordkeeping regulations, such as currency transaction reporting. 24

FinCEN believes that much of the effort necessary to meet these regulatory obligations, including information gathering, may be accomplished through business operations already undertaken as part of normal transaction negotiation, including due diligence and review of mortgage loans and related assets for purchase and securitization, and as collateral for advances and other investments, products, and services. As described in more detail below, the Housing GSEs have been filing SAR-like reports with FHFA for a number of years, and in other respects have supported the anti-fraud and anti-money laundering efforts of various law enforcement and regulatory agencies. FinCEN believes the Final Rule will enhance and strengthen the Housing GSEs' critical role in government and industry efforts to protect consumers, mortgage finance businesses, and the U.S. financial system from mortgage fraud, money laundering, and other financial crimes.

The comment period on the NPRM ended on January 9, 2012. FinCEN received five comments. Comments were submitted by a Federal government agency (two letters), a trade association, representatives of some of the Housing GSEs, and a Federal government anti-fraud task force. 25 The supporting comments emphasized the value of streamlining the current process under which SAR information from the Housing GSEs reaches FinCEN, and the substantial value of SARs predicted to cover a broader range of suspected financial crimes. FHFA has expressed strong support for FinCEN issuing AML and SAR regulations for the Housing GSEs. The public comments that expressed some opposition to the NPRM were based primarily on speculation that compliance costs and burdens would outweigh any potential benefits to law enforcement, and on the view that the current FHFA fraud reporting requirements are sufficient to support broad based government anti-fraud and anti-money laundering efforts.

As noted in the NPRM, the BSA does not expressly identify any of the Housing GSEs in its definition of “financial institution.” The BSA's definition of financial institution lists numerous types of businesses, including commercial banks and other depository institutions. 26 The definition also includes a “catch-all” provision that authorizes the Secretary to include additional types of businesses if the Secretary determines, by regulation, that they engage in any activity “similar to, related to, or a substitute for” any activity of any of the listed businesses. 27

The Housing GSEs work closely with other BSA-defined financial institutions; in fact, the majority of the Housing GSEs' counterparties and members are commercial banks, thrifts, credit unions, and insurance companies. Many of the products and services offered by the Housing GSEs can be viewed as substitutes for or related to products and services offered by commercial banks and nonbank financial institutions included in the BSA's definition of financial institution.

The main role of the Housing GSEs is to support the primary mortgage market and affordable housing through the purchase, guarantee, and securitization of mortgage loans and the extension of loans secured primarily by mortgage loans and real estate related assets. The Banks also provide grants or subsidies for affordable housing and community investment. Typically, a significant portion of these mortgage loans are made by commercial banks, credit unions, and savings and loan associations, which are already financial institutions under the BSA and subject to FinCEN's regulations. 28 Some of the Banks also have acquired member asset programs whereby they acquire fixed-rate, single-family mortgage loans from participating member institutions, which also are generally commercial banks or other depository institutions already included within the BSA's definition of financial institutions. Thus, FinCEN believes that the Housing GSEs engage in activities that are “similar to, related to, or a substitute for” financial services that are provided by other BSA-defined financial institutions. For this reason, FinCEN hereby exercises its authority under 31 U.S.C. 5312(a)(2)(Y) to define the Housing GSEs as financial institutions.

One commenter noted that Congress enacted Section 1115 of the Housing and Economic Recovery Act of 2008 (“HERA”), 29 which required FHFA to promulgate the fraud reporting regulations at 12 CFR 1233, without adding the Housing GSEs to the list of financial institutions in the BSA, or otherwise requiring the Housing GSEs to comply with FinCEN or FHFA regulations that would require AML and SAR programs. The commenter urged FinCEN to “presume that Congress acted intentionally where it specifically adds language to one statute over another.” The commenter further stated that “[I]f Congress had intended for the [Housing] GSEs to be considered financial institutions under the BSA, then the statute would have been amended to specifically include the [Housing] GSEs. Rather, Congress enacted separate anti-fraud requirements in HERA that are unique to the FHLBank's wholesale business structure.”

FinCEN is not persuaded by the commenter's analysis regarding Congress's intent, or by the commenter's interpretation of the BSA. Rather, FinCEN believes that Congress enacted the “catch-all” provision at 31 U.S.C. 5312(b)(2)(Y) in order to give the Secretary and his delegate, FinCEN, the discretion, in future regulatory actions, to add businesses and professions to the statutory list of financial institutions, and thereby make them subject to certain provisions of the BSA. 30 FinCEN believes that neither Congress, nor any other legislative or regulatory body, would be able to list all of the types of businesses that may be vulnerable to money laundering for all time. As businesses evolve, so do the criminal schemes designed to exploit them for illegal financial gain. The “catch-all” provision implicitly recognizes this fact, and gives FinCEN discretion to determine the types of businesses that should become subject to regulations implementing the BSA.

The scope of the Final Rule is limited. It defines the Housing GSEs as “financial institutions” under 31 U.S.C. 5312(a)(2)(Y) for the purposes of requiring them to establish AML programs and report suspicious activities, as well as allow them to participate in special information sharing procedures to deter money laundering and terrorist activity. The term “Housing government sponsored enterprise” is added as a new defined term at 31 CFR 1010.100(mmm) for these purposes. Notably, the Final Rule does not amend the general definition of “financial institution” under FinCEN's regulations at 31 CFR 1010.100(t) because adding Housing GSEs to the general definition would trigger other recordkeeping and reporting requirements that FinCEN does not consider appropriate for the Housing GSEs at this time.

Under this Final Rule, the Housing GSEs are required to establish and maintain AML programs, and to file SARs directly with FinCEN, as of the regulatory compliance date. As emphasized in the NPRM, FinCEN does not expect the transition to compliance with the Final Rule to be unreasonably difficult or costly, primarily because the Housing GSEs already are required to have policies, management oversight, personnel training, and internal compliance review and various procedures and systems in place to comply with FHFA's current fraud reporting regulation and guidance. 31 These programmatic features are substantively very similar to those required in all AML regulations issued by FinCEN. Moreover, pursuant to the terms of a Memorandum of Understanding (“MOU”) between FinCEN and FHFA, the Housing GSEs have been filing separate reports with FHFA regarding suspicions of fraud, using technical specifications provided by FinCEN, in accordance with FHFA's guidance. FHFA, in turn, has provided this information to FinCEN in the form of SARs (albeit regarding a narrower range of suspicious activity than is covered in FinCEN's typical SAR regulations). 32 FHFA agrees that this indirect reporting structure should be restructured to better support the needs of law enforcement and extend the benefit of the BSA's “safe harbor” to the Housing GSEs. FHFA also agrees that a direct reporting structure from the Housing GSEs to FinCEN would be more streamlined than the current practice because direct reporting would, in part, eliminate the burden created by the significant effort FHFA devotes to providing information received from the Housing GSEs and filing to FinCEN as SARs.

The indirect reporting structure is inadequate to support the needs of law enforcement because reports are not available to law enforcement with the same speed they would be if they were filed directly. Additionally, law enforcement does not have the same ease of access to the records supporting any report filed by the Housing GSEs with FHFA as it would if the reports were filed directly with FinCEN under the obligations of the BSA. Direct filing by the Housing GSEs will result in a wider range of information made available to law enforcement more promptly. Finally, the indirect reporting structure does not allow the Housing GSEs to avail themselves of the BSA's “safe harbor.” The current reporting regime required by FHFA has its own “safe harbor,” but does not cover the same range of reporting as the BSA safe harbor, nor does it offer the same broad protection.

The comments on the NPRM primarily focused on the potential benefits, costs, and burdens of implementing the AML program and SAR filing requirements proposed in the NPRM. Three of the comments express the view that the Housing GSEs have limited access to useful SAR information about specific retail mortgage finance transactions. Two of these comments also stated that: (1) The current FHFA fraud reporting requirements are sufficient to support law enforcement, and any FinCEN SAR requirement would yield little, if any, additional useful information not already obtained by FHFA; (2) any new SAR requirement would result in duplicative SAR filings on the same suspicious activity, such as one report from a retail bank or non-bank mortgage company, and one report from the Housing GSE; and (3) any new AML and SAR regulations would require the Housing GSEs, particularly the Banks, to implement new detection, monitoring, and reporting practices, controls and systems, and possibly modify existing business models. In their view, the potential costs and burdens associated with any new AML or SAR regulations would not result in any corresponding substantial or justifiable benefit to law enforcement and regulators.

The three previously referenced comments cautioned that the Housing GSEs have limited interactions with parties to a primary market mortgage loan transaction (i.e., the lender, the borrower and various persons typically engaged in closing a primary purchase, refinance or home equity loan transaction) and, therefore, the Housing GSEs have limited access to information on the borrower's qualifications, the terms and circumstances regarding the loan, and other transaction-related information typically included in a SAR. Two of these comments also express the view that, due to the Banks' limited access to transactional information, extending AML and SAR requirements to the Housing GSEs, particularly the Banks, will not provide law enforcement with access to information on fraud related or non-fraud related money laundering or other financial crimes that FHFA does not already receive under the current FHFA reporting regime. These two comments further stated that the Banks, in particular, would likely need to restructure their current business practices, systems, and models to “peer through” their wholesale transactions and obtain information usually gathered at the origination stage to a greater extent than their current business practices and systems accomplish. The comments therefore urged that any new FinCEN AML or SAR requirements should not require the acquisition of transaction information that is not already obtained by the Housing GSEs in the ordinary course of business under current practices. One comment specifically requested that FinCEN confirm that any new AML and SAR rules will not require the Banks to establish new IT monitoring or data-mining systems of the kind adopted by higher risk institutions engaged in retail banking.

The comments further stated that the current FHFA fraud reporting regulations and guidance are sufficient to provide law enforcement and regulators with information necessary to investigate and prosecute mortgage fraud and fraud related money laundering and other financial crimes typically associated with residential mortgage transactions, and that FinCEN's AML and SAR program requirements therefore are unnecessary.

One comment stated that the rules proposed in the NPRM would require the Banks to duplicate the efforts of “99 percent” of the Banks' customer base (i.e., retail banks and other insured depository institutions, all of whom already have a SAR filing obligation under applicable FinCEN and Federal banking regulations), thus resulting in overlapping or duplicative SAR reports on the same suspicious activity. One of the comments that generally supported the NPRM nonetheless cautioned that the proposed rules could result in “unintended consequences.” The comment noted, as an example of an unintended consequence, the likelihood of duplicative, overlapping requirements and SAR filings. One comment concluded simply that the potential additional benefits to law enforcement “appear to be minimal.”

The comments noted that the Banks already have expended significant time and resources on establishing and maintaining policies, procedures, systems and employee training to comply with FHFA's fraud reporting requirements. The comments concluded that FHFA requirements, and the programs established to comply with them, should be given time to “mature.” The comments expressed the view that any new rules should be issued only if it becomes evident that the current FHFA fraud reporting regime is determined to be inadequate. FinCEN believes the addition of the Housing GSEs within FinCEN's framework for SAR reporting will be the most efficient overall approach.

In the NPRM, FinCEN requested comment on whether it would be appropriate to include in a Final Rule any provisions that account for the differences in the business, operation, and mission of the Banks and Fannie Mae and Freddie Mac. Three comments noted that the practices followed by Freddie Mac and Fannie Mae in connection with due diligence on loan pools, and related consideration of credit, interest rate, and operational risks, differ from those followed and considered by the Banks in connection with examination of loans and other assets as collateral for advances. Two comments stated that if FinCEN goes forward with final rules, FinCEN should take into account the differences in business models and practices of the Banks, on the one hand, and those of Fannie Mae and Freddie Mac, on the other. One comment urged that the requirements and standards in any final rules should be abbreviated and streamlined for the Banks, again arguing that the Banks generally do not obtain detailed borrower and transaction related information from their retail banking members in the ordinary course of business. Three comments, including one from FHFA, also urged that any final rules should be “phased-in” to give the Housing GSEs sufficient time to make changes to policies, procedures, systems, and business practices that would be deemed appropriate to comply with the Final Rule, and FinCEN's new uniform SAR requirements mandated on July 1, 2012. 33

The comments that supported the NPRM expressed opinions and conclusions largely contrary to those expressed in the comments summarized above. The supporting comments highlight the following benefits, among others, of the rules proposed in the NPRM: (1) The new SAR rules, by requiring the Housing GSEs to file SARs directly with FinCEN, will enhance FinCEN's database, reduce burdens on government resources, and strengthen the mortgage fraud prevention programs and initiatives of the Housing GSEs and FinCEN; (2) the rules will give law enforcement and regulators quicker access to SAR information that is critical to investigations, and keep them better informed about evolving criminal schemes; (3) the rules will enhance coordination on analysis and investigations by FinCEN, FHFA, FHFA-OIG, and other law enforcement authorities on the Federal, State, and local levels that have access to FinCEN's BSA database; and (4) the AML rules will bolster HERA's reporting requirement, which likely will result in better information for investigations and enforcement actions. FinCEN finds these views persuasive and believes the Final Rules will support Administration and government efforts to combat mortgage fraud and other financial crimes.

FinCEN believes that both the AML program and SAR filing requirements are necessary and appropriate for the Housing GSEs and other businesses involved in mortgage finance, in order to give law enforcement and regulatory agencies valuable, timely information on specific instances of suspected mortgage fraud and mortgage finance related money laundering, as well as provide insight into emerging patterns of regional and national criminal activity. The information from SARs and other BSA-related information assists law enforcement and regulators with the development of their strategic goals and policies, as well as with the deployment of valuable resources to high crime areas.

FHFA's fraud reporting program is important in that it allows FHFA to both monitor the Housing GSEs' success in identifying fraud and mitigate attendant risks, and assess the impact that involvement in such transactions may have on the Housing GSEs' operational risks and overall safety and soundness. FHFA's reporting system, however, was not designed to support the multi-jurisdictional and inter-governmental investigations, prosecutions, and trend analyses that rely on SAR data and other BSA-related information in FinCEN's databases. Only FinCEN, as the nation's financial intelligence unit and administrator of the BSA, has the authority and resources to collect, analyze, and disseminate this vast amount of information to its Federal, State, and local law enforcement and regulatory partners securely and confidentially. The BSA and FinCEN's implementing regulations also permit sharing of primary and secondary mortgage market transactional information, in a secure and confidential manner, among financial institutions that enroll in FinCEN's 314(b) program. 34 These functions cannot be accomplished by FHFA, or any other government agency, under current Federal and State laws and regulations. The faster that information from the Housing GSEs makes its way into the BSA database, the sooner FinCEN and other agencies will be able to access that information to support investigations and enforcement actions related to money laundering, fraud, and other financial crimes.

FinCEN expects there will be transactions involving the Housing GSEs with respect to which two or more SARs will be submitted to FinCEN concerning the same transaction or activity, and in this respect, the SARs arguably may be viewed as “duplicative” or “overlapping.” For example, one SAR may be submitted by the retail-level originator or lender, and one “overlapping” SAR by a Housing GSE regarding the same transaction or activity. Based on the SARs filed to date under the MOU between FinCEN and FHFA, FinCEN believes a number of these “overlapping” SARs likely will concern a specific loan or loan pool repurchased by the originating institution upon the request of the Housing GSE, pursuant to the terms of the Housing GSE's contract with the originating institution or servicer. For example, a contract may permit a Housing GSE to demand repurchase upon discovery by the Housing GSE, a loan servicer, the originating institution, or a combination of these or other financial professionals, of loan related fraud or delinquency, including payment default, borrower misrepresentation, or some irregularity or discrepancy in the appraisal or loan documentation. The SAR forms, however, also may contain non-overlapping information and—in any event—will reflect the unique perspective and analyses of the two, or more, SAR filers. The availability of different data presented from different business perspectives by organizations with different, but complementary, roles in mortgage finance may be useful for law enforcement to gain a more comprehensive understanding of the transaction and its circumstances. FinCEN views this consequence of the existence of parallel reporting requirements for banks, non-bank residential mortgage lenders and originators, and Housing GSEs as a significant potential advantage to law enforcement and regulators that justifies the relatively minor additional costs and burdens to be borne by the Housing GSEs. This view is further confirmed by FinCEN's broad experience in requiring SAR reporting from a range of financial institutions, a small percent of which may contain reporting of partially overlapping information, but which together add significant value.

FinCEN's issuance of final AML and SAR rules for non-bank residential mortgage lenders and originators emphasized the critical importance of institutions establishing an AML program and filing SARs in order to prevent and identify mortgage fraud and other financial crimes. 35 FinCEN expressed its view that the establishment of a complete AML program is essential for institutions to have an effective SAR filing program. Each of the “four pillars” of an AML program is critical to holding up the overall structure of the program. It would be difficult to expect useful SAR reporting without the pillars of an AML program firmly in place. FinCEN's regulations are structured to ensure that financial institutions are knowledgeable of risks and vigilant against fraud and other crimes. All of FinCEN's AML regulations require covered institutions to implement risk-based programs that take into account the unique risks associated with that particular institution's products and services, as well as the institution's size, market, and other issues. Thus, each Housing GSE's AML program would necessarily be different than those of other Housing GSEs with different business models and practices, as well as different product, geographic, and other risks. As a result, FinCEN believes that the AML regulations in this Final Rule inherently recognize the differences in the business models and practices of the Banks, Fannie Mae, and Freddie Mac, and that separate regulatory requirements for the Banks, on the one hand, and Fannie Mae and Freddie Mac, on the other, are unnecessary. 36 Under a risk-based approach to implementation of the Final Rule, FinCEN expects prevention of money laundering and other financial crimes, such as mortgage fraud, to be key goals underlying the various policies and procedures in an effective AML program for each Housing GSE. Therefore, the AML regulation proposed in the NPRM is adopted in this Final Rule without significant changes.

FinCEN believes it is important to highlight the value of SARs that will be filed by the Housing GSEs. As one comment noted, law enforcement agencies have advised FinCEN and FHFA that SARs from the Housing GSEs under the present MOU procedures are very useful in the investigation and prosecution of financial crimes. Filing SARs directly with FinCEN will increase the speed and ease with which law enforcement and regulators can access and utilize the information contained in those valuable SARs. Finally, FinCEN's SAR database has been a “one-stop” integrated system for law enforcement and regulator access to valuable information on suspected financial crimes. It is appropriate, efficient, and consistent with FinCEN's statutory mandate to consolidate all suspicious activity reports from financial institutions in the database where they can be of the most value. 37

As FinCEN explained in the NPRM, the new SAR regulations will require the reporting of a potentially broader range of financial crimes than under FHFA's fraud reporting regulations. This, along with the ability to share information among the Housing GSEs and with other financial institutions, may well result in the Housing GSEs filing more SARs than fraud reports filed pursuant to FHFA's regulations. FinCEN also acknowledges that limited access to transactional information of a residential mortgage loan may limit the ability of a Housing GSE to include in a SAR all of the information typically found in a SAR filed by a retail bank or mortgage company. FinCEN expects that some of the Housing GSEs may need to establish new, or modify existing, policies, procedures, systems, organizational controls, or employee training arrangements. Nonetheless, FinCEN believes that these changes, and any related investments, will not need to be as extensive as some of the comments suggest, and that a substantial part of the new suspicious activity reporting and AML program requirements of this Final Rule may be integrated into existing procedures, controls, systems, and training programs with relatively minor costs. FinCEN emphasizes that each Housing GSE already has established procedures, systems, and controls to submit reports to FHFA when a Housing GSE discovers it has purchased or sold a fraudulent loan or financial instrument (e.g., a mortgage-backed security), or suspects a possible fraud relating to the purchase or sale of any loan or financial instrument. Under FHFA's guidance and the MOU, FHFA then transmits some of these reports to FinCEN using a SAR. 38

FinCEN believes that new investment in elaborate, expensive systems will not be necessary for the Banks, Freddie Mac, or Fannie Mae to comply with the Final Rule. For those Banks that anticipate the need to submit a relatively low number of SARs, they may establish procedures to submit individual SARs via FinCEN's established Web-based electronic system, which does not require acquisition of any new systems or modifications to systems used to comply with FHFA filing requirements. FinCEN and other agencies have issued substantial guidance on the development of risk-based AML and SAR reporting programs. 39 FinCEN believes the Housing GSEs may build on their existing risk management procedures and prudential business practices to ensure compliance with this Final Rule with minimal cost. In sum, FinCEN believes that the Final Rule does not impose significant costs on the Housing GSEs.

FinCEN also wishes to emphasize that, by the designation of the Housing GSEs as “financial institutions” under the BSA, the Housing GSEs, as well as their directors, officers, employees, and agents, are covered by the BSA's liability safe harbor for financial institutions that file SARs. 40 This safe harbor is intended to encourage financial institutions to report suspicious activities, even if, as here, the SAR regulation will likely require reporting of a wider range of suspected fraud, money laundering, and financial crimes related to the products and services offered by the Housing GSEs than those entities may currently be accustomed to report.

Section 1010.100(mmm) defines the key terms used in the Final Rule. The definitions reflect FinCEN's determination that AML program and SAR requirements should be applied to the Housing GSEs. The definition of “Housing government sponsored enterprise” includes: (1) The Federal National Mortgage Association; (2) the Federal Home Loan Mortgage Corporation; and (3) each Federal Home Loan Bank. The definition does not include any entity-affiliated party  41 of Fannie Mae, Freddie Mac, or any Bank, including the Office of Finance of the Federal Home Loan Bank System.

Section 1010.810(b)(10) delegates authority to examine the Housing GSEs for compliance with the requirements of this Final Rule to FHFA. FHFA is the Federal regulator for the Housing GSEs and enforces its own statutes and regulations regarding safety and soundness. FHFA is FinCEN's delegate for examination for compliance with FinCEN's regulations. FinCEN will work with FHFA to coordinate and direct such delegated compliance examination activities. FinCEN retains enforcement authority under the BSA, including for the imposition of civil penalties for violations of these regulations.

Section 1030.210(a) requires each Housing GSE to develop and implement an AML program reasonably designed to prevent the Housing GSE from being used to facilitate money laundering or the financing of terrorist activities, and other financial crimes, including mortgage fraud. The program must be in writing and must be approved by senior management. A Housing GSE's written program also must be made available to FinCEN upon request.

Section 1030.210(b) sets forth the minimum requirements of a Housing GSE's AML program. Beyond these minimum requirements, however, the Final Rule is intended to give Housing GSEs the flexibility to design their programs to mitigate their own specific risks. Section 1030.210(b)(1) requires the AML program to incorporate policies, procedures, and internal controls based upon the Housing GSE's assessment of the risks of money laundering, terrorism finance, and other financial crimes associated with its products, counterparties, distribution channels, and geographic locations. A Housing GSE's assessment of counterparty-related information is a key component to an effective AML program. Thus, a Housing GSE's AML program must ensure that the Housing GSE obtains the information necessary to make its AML program effective. Such information may, but is not required to, include relevant information on individual borrowers and the financial institutions that are the Housing GSE's counterparties or members. The specific means of obtaining such information is left to the discretion of the Housing GSE.

In the NPRM, FinCEN stated that it anticipated that the Housing GSEs may need to amend existing agreements to ensure that they receive necessary customer information. Upon consideration of the comments on the NPRM, FinCEN highlights that amendment of agreements may not be necessary, and FinCEN emphasizes that the Final Rule does not require such amendments. However, the determination whether agreements may need amendment is a matter that the Housing GSEs' management should consider in assessing risks associated with products and services subject to the AML and SAR requirements. The AML program requirement does not obligate the Housing GSEs to obtain information that they do not already receive in the ordinary course of business under current practices, particularly with regard to information on individual borrowers the Housing GSEs do not receive in the ordinary course of business. For purposes of making the required risk assessment, a Housing GSE must consider all relevant information that is currently available to them, including whether the retail financial institutions that are its customers are subject to AML program requirements under the BSA.

Policies, procedures, and internal controls also must be reasonably designed to ensure compliance with BSA requirements. Housing GSEs may conduct some of their operations through third parties. Some elements of the compliance program may best be performed by personnel of such third parties, in which case it is permissible for a Housing GSE to delegate contractually the implementation and operation of those aspects of its AML program to such an entity, and to rely on the compliance program of such third parties if the third parties are subject to an independent AML program requirement under the BSA. Any Housing GSE that delegates responsibility for aspects of its AML program to a third party, however, remains fully responsible for the effectiveness of the program, as well as ensuring that examiners are able to obtain information and records relating to the AML program.

Section 1030.210(b)(2) requires that a Housing GSE designate a compliance officer to be responsible for administering the AML program. The person should be competent and knowledgeable regarding BSA requirements and money laundering and fraud issues and risks, and should be empowered with full responsibility and authority to develop and enforce appropriate policies and procedures. The role of the compliance officer is to ensure that (1) the program is implemented effectively; (2) the program is updated as necessary; and (3) appropriate persons are trained and educated in accordance with section 1030.210(b)(3).

Section 1030.210(b)(3) requires that a Housing GSE provide for education and training of appropriate persons. Employee training is an integral part of any AML program. To carry out their responsibilities effectively, employees of a Housing GSE (and of any third party not already receiving training as part of another AML program requirement) with responsibility under the program must be trained in the requirements of the Final Rule and money laundering and fraud risks generally so that they can identify red flags associated with existing or potential customers and transactions. Such training may be conducted by outside or in-house seminars, and may include computer-based training. The nature, scope, and frequency of the education and training program of the Housing GSE will depend upon the employee functions performed. However, those with obligations under the AML program must be sufficiently trained to carry out their responsibilities effectively. Moreover, these employees should receive periodic updates and refreshers regarding the AML program.

Section 1030.210(b)(4) requires that a Housing GSE provide for independent testing of the program on a periodic basis to ensure that it complies with the requirements of the Final Rule and that the program functions as designed. An outside consultant or accountant need not perform the testing and review. The review may be conducted by an officer, employee or group of employees, so long as the reviewer is not the designated compliance officer and does not report directly to the compliance officer. The frequency of the independent testing will depend upon the Housing GSE's assessment of risks posed by its operations. Any recommendations resulting from such testing should be reviewed by senior management. A Housing GSE may also rely on the testing performed by third parties that are subject to an independent AML program requirement. Section 1030.210(c) states that compliance with the AML program requirements will be determined by FinCEN or its delegate.

Section 1030.320(a) contains the rules setting forth the obligation of Housing GSEs to report suspicious transactions that are conducted or attempted by, at, or through a Housing GSE and involve, independently or in the aggregate, at least $5,000 in funds or other assets. It is important to recognize that transactions are reportable under this Final Rule and 31 U.S.C. 5318(g) regardless of whether they involve currency. The $5,000 minimum amount is consistent with existing SAR filing requirements for other financial institutions.

Section 1030.320(a)(1) contains the general statement of the obligation to file reports of suspicious transactions. The obligation extends to transactions conducted or attempted by, at, or through a Housing GSE. The Final Rule also contains a provision in section 1030.320(a)(1) designed to encourage the reporting of transactions that appear relevant to violations of law or regulation, even in cases in which the Final Rule does not explicitly so require, such as in the case of a transaction falling below the $5,000 threshold.

Section 1030.320(a)(2) specifically describes the four categories of transactions that require reporting. A Housing GSE is required to report a transaction if it knows, suspects, or has reason to suspect that the transaction (or a pattern of transactions of which the transaction is a part): (i) Involves funds derived from illegal activity or is intended or conducted to hide or disguise funds or assets derived from illegal activity; (ii) is designed, whether through structuring or other means, to evade the requirements of the BSA; (iii) has no business or apparent lawful purpose, and the Housing GSE knows of no reasonable explanation for the transaction after examining the available facts; or (iv) involves the use of the Housing GSE to facilitate criminal activity. 42

A determination as to whether a report is required must be based on all the facts, circumstances and information to which the Housing GSE has access, in the ordinary course of its business, relating to the transaction and customer of the Housing GSE in question. Different fact patterns and circumstances will require different judgments. Some examples of red flags associated with existing or potential customers are referenced in previous FinCEN reports and guidance on mortgage fraud and SAR filing. However, the means of commerce and the techniques of money laundering are continually evolving, and there is no way to provide an exhaustive list of suspicious transactions or red flags. FinCEN will continue to pursue a regulatory approach that involves a combination of guidance, training programs, and government-industry information exchange so that implementation of any new AML program and SAR reporting regulations can be accomplished in the most flexible and cost efficient way possible, while protecting the primary and secondary mortgage markets and the financial system as a whole from fraud, money laundering, and other financial crimes.

Section 1030.320(a)(3) provides that the obligation to identify and to report a suspicious transaction rests with the Housing GSE involved in the transaction. However, where more than one Housing GSE, or another financial institution with a separate suspicious activity reporting obligation, is involved in the same transaction (or related transactions), only one report is required to be filed, provided it contains all relevant information and each institution maintains a copy of the report and any supporting documentation related to the SAR. There is, however, no obligation for the Housing GSEs to notify each other or work together in such circumstances. Each Housing GSE must evaluate customer activity and relationships for fraud, money laundering, and other financial crime risks, and design a suspicious transaction monitoring and reporting program that is appropriate for the particular Housing GSE in light of such risks.

Section 1030.320(b) sets forth the filing procedures to be followed by Housing GSEs making reports of suspicious transactions. Within 30 days after a Housing GSE becomes aware of a suspicious transaction (or within 60 days if no suspect has been identified), it must report the transaction by completing a SAR and filing it with FinCEN. Supporting documentation relating to each SAR is to be collected and maintained separately by the Housing GSE and made available upon request by FinCEN, FHFA or any appropriate Federal, State, or local law enforcement agency, or any Federal regulatory authority that examines the Housing GSE for compliance with the BSA. FinCEN's SAR regulations provide that the documentation supporting a SAR that is maintained by the filer, is deemed to be filed with the SAR. Thus, supporting documentation may be disclosed to the authorities referenced above to whom a SAR form may be disclosed, consistent with the rules of construction, described below. For situations requiring immediate attention, Housing GSEs are to telephone the appropriate law enforcement authority in addition to filing a SAR.

Section 1030.320(c) provides that the filing Housing GSE must maintain copies of SARs and the underlying related documentation for a period of five years from the date of filing. 43 As indicated above, supporting documentation is to be made available to FinCEN and appropriate law enforcement and regulatory authorities, upon request.

Section 1030.320(d)(1) reinforces the statutory prohibition against the disclosure by a financial institution of a SAR (regardless of whether the report would be required by the Final Rule or is filed voluntarily). 44 The section requires that a SAR and information that would reveal the existence of that SAR (“SAR information”) be kept confidential and not be disclosed, except as authorized within the rules of construction. The regulation includes rules of construction that identify actions an institution may take that are not precluded by the confidentiality provision. These actions include the disclosure of SAR information to FinCEN, FHFA, or appropriate Federal, State, or local law enforcement agencies, or a Federal regulatory authority that examines the Housing GSE for compliance with the BSA. This confidentiality provision also does not prohibit the disclosure of the underlying facts, transactional information, and documents upon which a SAR is based, or the sharing of SAR information within the Housing GSE's corporate organizational structure for purposes consistent with Title II of the BSA, as determined by FinCEN in regulation or in guidance. 45

Section 1030.320(d)(2) incorporates the statutory prohibition against disclosure of SAR information, other than in fulfillment of their official duties consistent with the BSA, by government users of SAR data. The section also clarifies that official duties do not include the disclosure of SAR information in response to a request for non-public information  46 or for use in a private legal proceeding, including a request under 31 CFR 1.11. 47

Section 1030.320(e) provides protection from liability for making reports of suspicious transactions, and for nondisclosures of such a report, to the full extent provided by 31 U.S.C. 5318(g)(3). This statutory safe harbor, unlike that afforded to the Housing GSEs under FHFA regulations, 48 contains no express requirement that the report has been filed in “good faith,” and legal authority strongly supports the proposition that there is no implicit “good faith” limitation to this safe harbor. 49 One commenter nevertheless suggested that the difference between FHFA safe harbor and the BSA safe harbor could result in the Housing GSEs being subject to civil liability for making reports pursuant to the BSA. FinCEN disagrees with that assessment. Because this Final Rule defines the Housing GSEs as financial institutions under the BSA, a Housing GSE should be able to avail itself of the broader BSA safe harbor for reports it files pursuant to the BSA. Congress has made two safe harbors available to institutions under two separate statutes. These safe harbor provisions do not contradict, supersede, or conflict with one another. Nothing in the law implies that Congress intended to make only the narrower safe harbor applicable when an institution was on its face entitled to both. FinCEN thinks it more persuasive to consider both safe harbors to be applicable according to their terms.

Section 1030.320(f) notes that compliance with the obligation to report suspicious transactions will be examined by FinCEN or its delegates, and provides that failure to comply with the Final Rule may constitute a violation of the BSA and FinCEN's regulations.

Section 1030.320(g) provides that the new SAR requirement is effective when an anti-money laundering program required by the regulations is required to be implemented.

Section 1030.500 states that the Housing GSEs are covered by the special information procedures to detect money laundering and terrorist activity requirements set forth and cross referenced in sections 1030.520 (cross-referencing to 31 CFR 1010.520) and 1030.540 (cross-referencing to 31 CFR 1010.540). Sections 1010.520 and 1010.540 implement sections 314(a) and 314(b)  50 of the USA PATRIOT Act, respectively, and generally apply to any financial institution listed in 31 U.S.C. 5312(a)(2). 51 For the sake of clarity, the Final Rule adds subpart E to Part 1030 to confirm that the section 314 rules will continue to apply to the Housing GSEs.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires that a regulation that has a significant economic impact on a substantial number of small entities, small businesses, or small organizations must include an initial regulatory flexibility analysis describing the regulation's impact on small entities. Such an analysis need not be undertaken if the agency has certified that the regulation will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 605(b). In this case, the Final Rule applies only to the Housing GSEs, none of which is a small entity for purposes of this requirement. Accordingly, FinCEN hereby certifies that this Final Rule will not have a significant economic impact on a substantial number of small entities for purposes of the Regulatory Flexibility Act. Therefore, no analysis under the Regulatory Flexibility Act is required. See 5 U.S.C. 601(2) and 603(a).

This Final Rule pertains to the Housing GSEs. As a result, the Final Rule does not contain any information collection requirement that requires the approval of the Office of Management and Budget under the Paperwork Reduction Act. See 44 U.S.C. 3501 et seq.

Executive Orders 13563 and 12866 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this Final Rule is designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the Final Rule has been reviewed by the Office of Management and Budget.

Section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), Public Law 104-4 (March 22, 1995), requires that an agency prepare a budgetary impact statement before promulgating a rule that may result in expenditure by the State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 202 of the Unfunded Mandates Act also requires an agency to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. Taking into account the factors noted above and using conservative estimates of average labor costs in evaluating the cost of the burden imposed by the Final Rule, FinCEN has determined that it is not required to prepare a written statement under Section 202.

For the reasons set forth in the preamble, Chapter X of Title 31 of the Code of Federal Regulations is amended as follows:

On August 1, 2012 (77 FR 45523), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Virginia. In the NPR, EPA proposed approval of amendments to Virginia's major NSR permitting regulations under the Virginia Administrative Code (VAC) to incorporate requirements for PM 2.5 . Additionally, EPA proposed to approve these revisions and portions of other related submissions for the purpose of determining that Virginia has met its statutory obligations with respect to the infrastructure requirements of CAA section 110(a) which relate to Virginia's PSD permitting program and are necessary to implement, maintain, and enforce the 1997 8-hour ozone and PM 2.5 NAAQS, the 2006 PM 2.5 NAAQS, and the 2008 lead NAAQS. The formal SIP revision request was submitted by Virginia on August 25, 2011.

Virginia's August 25, 2011 SIP submittal included revisions to the general definitions under Chapter 10 of 9VAC5 (specifically 9VAC5-10-30), as well as revisions to Articles 8 (PSD) and 9 (nonattainment NSR) under Chapter 80 of 9VAC5. The following regulations under Article 8 are revised: 9VAC5-80-1615 (Definitions); 9VAC5-80-1635 (Ambient Air Increments); 9VAC5-80-1695 (Exemptions); 9VAC5-80-1715 (Source Impact Analysis); and 9VAC5-80-1765 (Sources Affecting Federal Class I Areas—Additional Requirements). Under Article 9, the regulations at 9VAC5-80-2010 (Definitions) and 9VAC5-80-2120 (Offsets) are amended.

As discussed in the NPR, in light of litigation EPA proposed to take no action with regard to the Significant Impact Level (SIL) regulation at paragraph A(2) of 9VAC5-80-1715 ( See, 77 FR 45523). On January 22, 2013, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) in Sierra Club v. EPA (705 F.3d 458, 469), issued a judgment that, inter alia, vacated and remanded the provisions at 40 CFR 51.166(k)(2), which were promulgated as part of the October 20, 2010 “Prevention of Significant Deterioration for Particulate Matter Less than 2.5 Micrometers (PM 2.5 )—Increments, Significant Impact Levels (SILs) and Significant Monitoring Concentrations (SMC),” (2010 PSD PM 2.5 Rule). 1 These provisions were the Federal counterparts to Virginia's PM 2.5 SIL regulations at paragraph A(2) of 9VAC5-80-1715. Additionally, the court vacated the provisions at section 51.166(i)(5)(i)(c), which were the Federal counterparts to Virginia's PM 2.5 SMC regulations at paragraph E(1) of 9VAC5-80-1695 ( See, Sierra Club v. EPA, 705 F.3d at 469). EPA proposed approval of Virginia's PM 2.5 SMC provisions in our NPR. In light of the court's decision, by letter dated February 13, 2013, Virginia officially withdrew from the August 25, 2011 submittal the PM 2.5 SIL regulation at paragraph A(2) of 9VAC5-80-1715, and the portion of paragraph E(1) of 9VAC5-80-1695 pertaining to the PM 2.5 SMC. Accordingly, EPA is not finalizing approval of these provisions. Therefore, EPA's approval with respect to sections 5-80-1695 and 5-80-1715 is limited to the remaining revisions which were not impacted by the court decision.

Subsequent to publication of the NPR, on January 4, 2013, the D.C. Circuit, in Natural Resources Defense Council v. EPA , 2 issued a decision that remanded the EPA's 2007 and 2008 rules implementing the 1997 PM 2.5 NAAQS. The court's remand of EPA's 2008 implementation rule, “Implementation of New Source Review (NSR) Program for Particulate Matter Less Than 2.5 Micrometers (PM 2.5 )” (referred to herein as “the 2008 NSR PM 2.5 Rule”), 3 is relevant to this final rulemaking. This rule promulgated NSR requirements for implementation of PM 2.5 in both nonattainment areas (nonattainment NSR) and attainment/unclassifiable areas (PSD). The court found that EPA erred in implementing the PM 2.5 NAAQS pursuant to the general implementation provisions of subpart 1 of part D of title I of the CAA, rather than pursuant to the additional implementation provisions specific to particulate matter nonattainment areas in subpart 4. The court ordered the EPA to “repromulgate these rules pursuant to Subpart 4 consistent with this opinion,” ( Id. at 437). Although the court declined to establish a deadline for EPA's response to the remand, EPA intends to promulgate new generally applicable implementation regulations for the PM 2.5 NAAQS in accordance with the requirements of subpart 4. In the interim, however, states and EPA still need to proceed with implementation of the PM 2.5 NAAQS in a timely and effective fashion in order to meet statutory obligations under the CAA and to assure the protection of public health intended by those NAAQS.

As discussed in the NPR, VADEQ's August 25, 2011 SIP submittal included revisions to Virginia's nonattainment NSR program consistent with the provisions promulgated in the 2008 NSR PM 2.5 Rule. Specifically, under Article 9, the state submitted amendments to the regulations at 9VAC5-80-2010 (Definitions) and 9VAC5-80-2120 (Offsets) for approval into the SIP, including the PM 2.5 significant emission rates (SERs), regulation of certain PM 2.5 precursors (SO 2 and NO X ), the regulation of PM 10 and PM 2.5 condensable emissions, and the emissions offset requirements. In light of the D.C. Circuit's remand of the 2008 NSR PM 2.5 Rule and for the reasons explained below, EPA is not prepared at this time to grant full approval to VADEQ's August 25, 2011 submittal as to these elements.

EPA is in the process of evaluating the requirements of subpart 4 as they pertain to nonattainment NSR. In particular, subpart 4 includes section 189(e) of the CAA, which requires the control of major stationary sources of PM 10 precursors (and hence under the court decision, PM 2.5 precursors) “except where the Administrator determines that such sources do not contribute significantly to PM 10 levels which exceed the standard in the area.” The evaluation of which precursors need to be controlled to achieve the standard in a particular area is typically conducted in the context of the state's preparing and the EPA's reviewing of an area's attainment plan SIP. In this case, there is only one designated PM 2.5 nonattainment area in the State, the Virginia portion of the Washington, DC-MD-VA nonattainment area for the 1997 annual PM 2.5 NAAQS. Virginia submitted an attainment plan for this area on April 4, 2008.

On January 12, 2009, EPA finalized a clean data determination for the area, (74 FR 1146), which suspended the requirement for the state to submit, among other things, an attainment plan SIP for the area. Accordingly, on January 23, 2012, Virginia withdrew the attainment plan SIP, and it is no longer before EPA. As EPA does not have before it the state's analysis as to which precursors need to be controlled in the area as contained in the attainment plan SIP, it cannot fully approve as complying with the CAA a nonattainment NSR SIP that only addresses a subset of the scientific PM 2.5 precursors recognized by EPA.

On the other hand, while VADEQ's submittal may not yet contain all of the elements necessary to satisfy the CAA requirements when evaluated under subpart 4, the revisions represent a considerable strengthening of Virginia's currently approved nonattainment NSR SIP which does not address PM 2.5 at all. Therefore, EPA is granting limited approval to the nonattainment NSR provisions in VADEQ's August 25, 2011 submittal.

For the reasons explained above, EPA is not evaluating at this time whether Virginia's submittal will require additional revisions to satisfy the subpart 4 requirements. Once EPA re-promulgates the Federal PM 2.5 regulations with respect to nonattainment NSR permitting in response to the court's remand, EPA will consider whether a limited disapproval should also be finalized. Moreover, Virginia has submitted a request to redesignate the nonattainment area, which, if granted, would absolve the State of any further obligation to comply with the subpart 4 requirements for nonattainment NSR as to this area. Alternatively, VADEQ can obtain full approval by, if necessary, revising its regulations accordingly to address EPA's revised regulations and submitting them to EPA as a formal SIP revision.

As previously discussed, VADEQ's August 25, 2011 SIP submittal also includes revisions to Virginia's PSD program consistent with the provisions promulgated in the 2008 NSR PM 2.5 Rule. Specifically, under Article 8, the following regulations are revised (with the previously noted exceptions): 9VAC5-80-1615 (Definitions); 9VAC5-80-1635 (Ambient Air Increments); 9VAC5-80-1695 (Exemptions); 9VAC5-80-1715 (Source Impact Analysis); and, 9VAC5-80-1765 (Sources Affecting Federal Class I Areas—Additional Requirements). As the requirements of subpart 4 only pertain to nonattainment areas, it is EPA's position that the portions of the 2008 NSR PM 2.5 Rule that address requirements for PM 2.5 attainment and unclassifiable areas are not affected by the D.C. Circuit's opinion in NRDC v. EPA. Moreover, EPA does not anticipate the need to revise any PSD requirements promulgated in the 2008 NSR PM 2.5 Rule in order to comply with the court's decision. Accordingly, EPA's approval of Virginia's SIP as to the PSD requirements promulgated by the 2008 NSR PM 2.5 Rule does not conflict with the court's opinion.

Similarly, in the NPR, EPA also proposed to approve portions of related infrastructure (or CAA Section 110(a)(2)) SIP submissions, for the purpose of determining that Virginia has met its statutory obligations with respect to the PSD-related infrastructure requirements of CAA section 110(a) for the 1997 8-hour ozone and PM 2.5 NAAQS, the 2006 PM 2.5 NAAQS, and the 2008 lead NAAQS. Virginia submitted the related infrastructure SIP revisions on the following dates: November 13, 2007, December 13, 2007, July 10, 2008, September 2, 2008, April 1, 2011, and March 9, 2012. For the reasons explained above, it is also EPA's position that EPA's approval of the portions of the above identified Virginia's infrastructure SIPs which relate to compliance with the PSD requirements set forth in Sections 110(a)(2)(C), (D)(i)(II), and (J) does not conflict with the court's remand of the 2008 NSR PM 2.5 Rule. 4

In addition to the proposed approval of the PSD portions of section 110(a)(2)(D)(i)(II), EPA stated in the NPR that: “Because Virginia has met its obligations with respect to the visibility requirements of section 110(a)(2)(D)(i)(II) by virtue of its regional haze SIP, which EPA took final action to approve on March 23, 2012 (77 FR 16397), EPA is also proposing to approve the portions of Virginia's previous infrastructure submittals related to the visibility requirements of section 110(a)(2)(D)(i)(II) for the 1997 ozone, 1997 PM 2.5 , 2006 PM 2.5 , and 2008 lead NAAQS.”

As discussed in Section III, below, EPA has already taken separate and final action to approve the portions of these identified SIP submittals which relate to the section 110(a)(2)(D)(i)(II) visibility requirements for the 1997 ozone, 1997 PM 2.5 , 2006 PM 2.5 , and 2008 lead NAAQS. Therefore, EPA is taking no action on the proposed approval of the visibility requirements for these identified SIP submittals. 5 EPA is only taking final action to approve the portions of the above identified infrastructure SIPs which relate to Virginia's PSD program.

Other specific requirements of Virginia's August 25, 2011 SIP submittal and the rationale for EPA's proposed action are explained in the NPR and will not be restated here.

EPA received two sets of comments on the August 1, 2012 NPR. A full set of these comments is provided in the docket for today's final action. A summary of the comments and EPA's responses are provided herein.

Comment: The first commenter asserted simply that the Federal government should not be involved in state affairs.

EPA Response: As Congress has recognized, the regulation of air pollution in Virginia is not a “state affair” for which Virginia bears sole responsibility. The CAA establishes a partnership between state and Federal entities for the protection and improvement of the nation's air quality. Under CAA section 109, EPA is required to establish National Ambient Air Quality Standards (NAAQS) for the protection of public health and welfare. Subsequent to the promulgation (or revision) of a NAAQS, states are required by CAA section 110 to adopt and submit to EPA for approval, a SIP which provides for the implementation, maintenance, and enforcement of the NAAQS. Virginia's August 25, 2011 SIP submittal met that requirement. In addition, section 110(a)(2)(C) specifically requires that state plans include a PSD and nonattainment NSR permit program as required in parts C and D of Title I of the Clean Air Act. The action being finalized today consistent with EPA's responsibilities under CAA section 110.

A second commenter submitted two substantive comments. First, the commenter raised concerns regarding EPA's determination that Virginia has met its obligations with respect to the visibility requirements of section 110(a)(2)(D)(i)(II) by virtue of its regional haze SIP. Second, the commenter raised several concerns about the legality of SILs and SMCs, as well as Virginia's adoption of them.

Comment 1: The commenter claimed that Virginia's regional haze SIP is insufficient to ensure compliance with visibility requirements under CAA section 110(a)(2)(D)(i)(II). The commenter stated that Virginia's regional haze SIP only received limited approval due to its reliance on the Clean Air Interstate Rule (CAIR) for best available retrofit technology (BART) for electric generating units. The commenter alleged that EPA cannot rely on Virginia's regional haze SIP for satisfying section 110(a)(2)(D)(i)(ii) because it did not receive full approval, because CAIR has been remanded by the D.C. Circuit, and because EPA provided no explanation for how the regional haze SIP meets the requirements of section 110(a)(2)(D)(i)(II) as they relate to the 1997 ozone NAAQS, the 1997 and 2006 PM 2.5 NAAQS, and the 2008 lead NAAQS. The commenter stated that EPA should either revoke its approval of the Virginia regional haze SIP or, at a minimum, provide an explanation for how the regional haze SIP ensures visibility will be protected for the aforementioned NAAQS.

Response 1: In the NPR for this rulemaking, EPA proposed to approve the following infrastructure SIP submittals as meeting the infrastructure requirements of section 110(a)(2)(D)(i)(II) (visibility protection): The November 13, 2007 Virginia submittal for the 1997 8-hour ozone and PM 2.5 NAAQS; the December 13, 2007 Virginia submittal for the 1997 8-hour ozone NAAQS; the July 10, 2008 and September 2, 2008 Virginia submittals for the 1997 p.m.2.5 NAAQS; the April 1, 2011 Virginia submittal for the 2006 p.m.2.5 NAAQS; and, the March 9, 2012 Virginia SIP submittal for the 2008 lead NAAQS. The August 2012 NPR was not the first or the most recent proposed rulemaking issued by EPA relating to Virginia's compliance with the visibility requirements set forth in Section 110(a)(2)(D)(i)(II).

On June 13, 2012, EPA issued a final rule granting limited approval to the Virginia regional haze SIP ( See, 77 FR 35287). In that final rulemaking action, EPA also approved Virginia's regional haze SIP as satisfying the infrastructure requirements of CAA sections 110(a)(2)(D)(i)(II) and (J), as they relate to the 1997 8-hour ozone NAAQS and the 1997 and 2006 PM 2.5 NAAQS. Subsequently, on September 24, 2013, when acting upon Virginia's infrastructure SIP for the 2008 lead NAAQS, EPA approved that SIP as meeting the infrastructure requirements of sections 110(a)(2)(D)(i)(II) and (J). ( See, 78 FR 58462 (Sept. 24, 2013)). Most recently, EPA has proposed to approve Virginia's infrastructure SIPs for the 2008 ozone and 2010 NO 2 NAAQS as meeting the infrastructure requirements in sections 110(a)(2)(D)(i)(II) and (J) ( See, 78 FR 39651 (July 2, 2013) (2008 ozone NAAQS) and 78 FR 47264 (August 5, 2013) (2010 NO 2 NAAQS)).

Therefore, as part of the August 2012 NPR for this rulemaking, EPA inadvertently proposed to approve Virginia's previously submitted infrastructure SIPs as meeting the infrastructure requirements of section 110(a)(2)(D)(i)(II) for the 1997 8-hour ozone NAAQS, and the 1997 and 2006 PM 2.5 NAAQS. Since final action had been taken for this requirement during June 2012, further action was not required. As to EPA's approval of Virginia's compliance with the 110(a)(2) requirements for visibility (set forth in sections 110(a)(2)(D)(i)(II) and (J)) for the 2008 lead NAAQS, subsequent to the August 2012 NPR, EPA issued a final rulemaking on such requirements on September 24, 2013. Because EPA has already taken separate proposed and final rulemaking actions to approve these elements of the Virginia SIP, EPA is taking no further action on its proposed approval of the visibility requirements of section 110(a)(2)(D)(i)(II) as they relate to the aforementioned NAAQS. 6 Additionally, EPA received and responded to similar comments as part of some or all of these previous rulemakings. Therefore, EPA is not responding to the comment that Virginia's regional haze SIP is insufficient to ensure compliance with visibility requirements under CAA section 110(a)(2)(D)(i)(II), as we have already responded to similar comments in our other actions ( See, 77 FR 35287; 78 FR 34970; 78 FR 39651; and 78 FR 47263). As a result, EPA sees no need for further action or response as part of this final rulemaking.

Comment 2: The same commenter argued that “Virginia's regulations establishing SILs and SMCs are illegal under the CAA and should be disapproved by EPA” ( See, Sierra Club Comments at 4). Here the commenter took issue with both EPA's establishing SILs and SMCs generally, and with the PM 2.5 SILs proposed by Virginia specifically. First, citing to the litigation in Sierra Club v. EPA (D.C. Circuit, No. 10-1413), the commenter asserts that EPA lacks the authority to establish SILs and SMCs because they improperly allow sources to avoid otherwise applicable CAA requirements. The commenter asserted that, therefore, EPA should disapprove those portions of Virginia's SIP submittal pertaining to the PM 2.5 SILs and SMCs, rather than approving the SMCs and taking no action on the SILs, as proposed.

Secondly, the commenter asserted that the specific SILs at 9VAC5-80-1715A and B should be disapproved because they do not provide VADEQ with sufficient discretion to require a cumulative impact analysis regardless of whether a source's impact is below the SIL. In addition, the commenter asserts that the SIL values in paragraphs A(2) and B(1) of section 5-80-1715 are set at different levels and could lead to confusion. Moreover, the commenter asserted that the SIL values in paragraph 5-80-1715B(1) are not sufficiently protective of Class I areas because, unlike the SIL values in paragraph A, paragraph B does not distinguish different SIL values based on area classifications. Finally, the commenter asserts that the thresholds in paragraph 5-80-1715B(1) are improperly incorporated into Virginia's SIP because they have as their basis Appendix S of 40 CFR part 51, which applies in situations where EPA has not approved a state's preconstruction review program.

EPA Response 2: As previously discussed, in light of the D.C. Circuit's vacatur of 40 CFR 51.166(k)(2) and (i)(5)(i)(c), Virginia has officially withdrawn the corresponding state rules with which the commenter takes issue from the August 25, 2011 SIP submittal. Thus, there is no need to further consider the commenter's assertion that EPA should disapprove those provisions in this rulemaking because Virginia no longer asks that EPA consider them for approval as part of its SIP.

As to any apparent conflict between the two SIL provisions in Virginia's SIP submission, paragraph A(2) of 9VAC5-80-1715 has been withdrawn and thus the commenter's concern regarding any potential for confusion between the two provisions is addressed by withdrawal of one provision from the SIP submission.

As to the SILs in paragraph B(1), the commenter is incorrect in the claim that these SIL values were only intended to apply in states without an EPA-approved PSD program. While it is true that those SIL values are published in Appendix S of 40 CFR part 51, they are also published in section 51.165(b)(2). Section 51.165(b) implements section 110(a)(2)(D)(i) of the CAA and applies to sources or modifications locating in attainment or unclassifiable areas that would cause or contribute to a violation of any NAAQS in any area. This is the basis for their inclusion in Virginia's SIP. These SILs establish the threshold at or above which a new major stationary source or major modification will be considered to cause or contribute to a violation of an ambient air quality standard, and thus subject to the requirements in 40 CFR 51.165(b). EPA has recognized that the values in section 51.165(b)(2) may also be used in the PSD program to support the demonstration required by 40 CFR 51.165(k)(1) and section 165(a)(3) of the CAA that proposed construction will not cause or contribute to a violation of the NAAQS. However, contrary to the commenter's assertion, the Federal regulations set forth at section 51.165(b) do not impede a permitting authority's discretion to require a cumulative impact analysis to make the showing required by section 51.166(k)(1) and section 165(a)(3) of the CAA where the source's impact is below a SIL value in section 51.165(b). Similarly, the corresponding state regulation at 9VAC5-80-1715B(1) does not impede the state's permitting authority discretion. Both provisions address the threshold above which a source will be considered to cause or contribute to a NAAQS violation. However, the provisions do not preclude a determination that a source may be considered to cause and contribute to a NAAQS violation even when the impact is below a SIL value set forth in 40 CFR 51.165(b)(2) which is utilized by the permitting authority. In fact, the court in Sierra Club v. EPA (705 F.3d 458, 469), declined to vacate the PM 2.5 SIL value at section 51.165(b)(2) because the court explicitly found that, unlike section 51.166(k)(2), this provision does not improperly restrict permitting authorities' discretion ( See 705 F.3d at 465-66). There is nothing in section 9VAC5-80-1715B(1) that would preclude VADEQ from imposing additional requirements on any sources necessary to show that a source does not cause or contribute to a NAAQS violation, including those sources impacting Class I areas. Therefore, except for the exceptions noted, EPA is finalizing the proposal to grant approval to Virginia's August 25, 2011 submittal.

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.” Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its PSD and nonattainment NSR programs consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving Virginia's August 25, 2011 submittal as a revision to the Virginia SIP, with the exception of paragraph A(2) of 9VAC5-80-1715, and the portion of paragraph E(1) of 9VAC5-80-1695 pertaining to PM 2.5 which were withdrawn by Virginia on February 13, 2013. EPA is finalizing a limited approval of the amendments to the nonattainment NSR regulations set forth at 9VAC5-80-2010 (Definitions) and 9VAC5-80-2120 (Offsets). EPA is also approving the August 25, 2011 SIP submittal and the relevant portions of the above identified infrastructure SIP submittals which relate to the PSD requirements set forth in CAA sections 110(a)(2)(C), (D)(i)(II), and (J) for the 1997 PM 2.5 , 2006 PM 2.5 , and 2008 lead NAAQS. EPA is also approving the relevant portion of Virginia's infrastructure submittal relating to the PSD permit program pursuant to CAA section 110(a)(2)(D)(i)(II) for the 1997 ozone NAAQS. As previously discussed, EPA is not taking final action on its proposal to approve the portions of the Virginia infrastructure SIP submittals (which were identified in the NPR and are identified above) related to the visibility requirements of section 110(a)(2)(D)(i)(II) for the 1997 ozone, 1997 PM 2.5 , 2006 PM 2.5 , and 2008 lead NAAQS, because a final rulemaking action has previously been taken.

Additionally, on December 20, 2012 (77 FR 75380), EPA approved revisions to Articles 8 and 9 of 9VAC5, chapter 80. Neither that action nor the current action removes the pre-existing limited approval status of Virginia's PSD and nonattainment programs ( See, Section III: General Information Pertaining to SIP Submittals from the Commonwealth of Virginia, 77 FR 75380-81, and Section IV, herein). However, the December 20, 2012 revisions to the table in paragraph 52.2420(c) inadvertently omitted reference to the limited approval status. In the interest of clarity, EPA is correcting that omission in this action. EPA is also adding a citation for the revised 9VAC5-80-1935 to the table in paragraph 52.2420(c). This revision was discussed in both the proposed and final rulemaking actions, but was inadvertently omitted from the table itself.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 28, 2014. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to Virginia's PSD and nonattainment NSR programs may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

40 CFR Part 52 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

EPA is approving new MOVES2010a-based onroad emissions inventories and budgets for the Allen, Greene, Vanderburgh, Warrick, and Vigo Counties 1997 8-hour ozone maintenance areas that will replace MOBILE-based inventories and budgets in the SIP. These areas were redesignated to attainment of the 1997 8-hour ozone standard, effective on the following dates: Allen County on February 12, 2007 (72 FR 1292), Greene County on December 29, 2005 (70 FR 69085), Vanderburgh and Warrick Counties on January 30, 2006 (70 FR 77026), and Vigo County on February 6, 2006 (71 FR 541). MOBILE6.2-based onroad emissions inventories and budgets were approved in those actions. Upon the effective date of this action, the MOVES-based budgets must be used in future transportation conformity analyses for these areas, as required by section 176(c) of the CAA. See the official release of the MOVES2010 emissions model (75 FR 9411-9414) for background, and section II.(c) below for details.

Under the CAA, states are required to submit, at various times, control strategy SIP revisions and maintenance plans for nonattainment and maintenance areas for a given national ambient air quality standard (NAAQS). These SIP revisions and maintenance plans include budgets of onroad mobile source emissions for criteria pollutants and/or their precursors. Transportation plans and projects “conform” to (i.e., are consistent with) the SIP when they will not cause or contribute to air quality violations, or delay timely attainment of the NAAQS or an interim milestone.

EPA previously approved MOBILE6.2-based budgets for the Allen, Greene, Vanderburgh, Warrick, and Vigo Counties 8-hour ozone maintenance areas for volatile organic compounds (VOCs) and nitrogen oxides (NO X ). The Allen County area's ozone maintenance plan established 2020 budgets. The Greene, Vanderburgh, Warrick, and Vigo Counties areas' ozone maintenance plans established 2015 budgets. These budgets demonstrated a reduction in emissions from the monitored attainment year.

The MOVES model is EPA's state of the art tool for estimating highway emissions. EPA announced the release of MOVES2010 in March 2010 (75 FR 9411). Use of the MOVES model is required for regional emissions analyses for transportation conformity determinations outside of California that begin after March 2, 2013.

The MOVES model was used to estimate emissions in the areas for the same milestone years as the original onroad emissions inventories and budgets in the SIP. The Indiana Department of Environmental Management (IDEM) is revising the onroad emissions inventories and budgets using the latest planning assumptions, including population and employment updates. In addition, newer vehicle registration data have been used to update the age distribution of the vehicle fleets. Since future demonstrations of conformity will use emissions estimates derived with MOVES, it is appropriate to establish benchmarks based on MOVES. The interagency consultation groups for these areas have had extensive consultation on the requirements and need for new budgets.

During the state public comment periods for these submittals, Indiana did not receive any comments for the Allen County, Vigo County, or Vanderburgh and Warrick Counties submittals. Indiana received comments requesting clarification on the Greene County submittal from concerned citizens and the Hoosier Environmental Council, and provided responses to the clarifications requested.

Indiana submitted final budgets to EPA, based on MOVES2010a, that cover the Allen County (submitted July 2, 2013), Greene County (submitted July 8, 2013), Vanderburgh and Warrick Counties (submitted July 2, 2013), and Vigo County (submitted July 2, 2013), Indiana areas.

For Allen County, the new MOVES2010a-based budgets are for the year 2020 for both VOCs and NO X . For Greene, Vanderburgh, Warrick, and Vigo Counties, the new MOVES2010a based budgets are for the year 2015 for both VOCs and NO X . The budgets for these areas are detailed later in this notice. Indiana also provided the areas' total emissions, including onroad mobile emissions inventories based on MOVES2010a, for the attainment year, the interim budget year, and the maintenance year. The combined emissions reduction from all sectors between the attainment year and the maintenance year for each area is shown as well. Total emissions include point, area, nonroad mobile and onroad mobile sources. The total emissions and combined emissions reduction from all sectors from the attainment year to the maintenance year for VOC and NO X are shown for each area in tables 1 through 8.

I. General Information A. Notice-and-Comment Under the APA

Section 553 of the APA, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this rule final without prior proposal and opportunity for comment because no significant EPA judgment is involved in making a finding of failure to submit SIPs, or elements of SIPs, required by the CAA, where states have made no submissions to meet the requirement. Thus, notice and public procedure are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B). As the EPA has explained in prior rulemakings, see e.g., 58 FR 51270, 51272, n.7 (October 1, 1993), under section 110(k)(1), the CAA provides the EPA with a 60-day period after receiving a submittal from a state in which to determine whether a submittal is complete. If no plan is submitted, the CAA requires the EPA to make a determination to that effect within 6 months of the deadline for submittal. Since Congress provided the EPA only 60 days to determine whether a state that has made some submittal failed to submit a complete SIP, and it is generally impossible to assess a submittal for completeness and then provide notice-and-comment before making a final determination within 60 days, the EPA believes that Congress clearly intended that the EPA should not go through notice-and-comment rulemaking prior to making findings of failure to submit a complete SIP when the state has made some submittal. In this case, the EPA is making findings that the state has made no submittal, and therefore no complete submittal, more than 6 months after the deadline for submittal, but the EPA similarly believes that Congress did not intend that the EPA go through notice-and-comment rulemaking in this case.

The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2014-0032. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the EPA Docket Center, EPA/DC, William Jefferson Clinton Building, Room 3334, 1301 Constitution Avenue NW., Washington, DC The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744 and the telephone number for the Office of Air and Radiation Docket and Information Center is (202) 566-1742.

Subpart 5, part D of title I of the CAA requires states with areas that are designated nonattainment for the 2008 Lead NAAQS to develop a SIP providing how the state will attain the air standards. Section 172 of the CAA specifies the required elements of a SIP for an area designated nonattainment for the 2008 Lead NAAQS. These requirements include, but are not limited to, an attainment demonstration, reasonably available control measures (RACM) and reasonably available control technology (RACT), annual emissions reductions as necessary to ensure reasonable further progress (RFP) and contingency measures. Most states with lead nonattainment areas designated in 2010 have submitted SIPs addressing these requirements as required under the CAA. However, one state, Pennsylvania, has not yet submitted SIPs for three nonattainment areas—the Lyons and North Reading nonattainment areas in Berks County and the Lower Beaver Valley nonattainment area in Beaver County. These SIPs were due on June 30, 2012. By this action, the EPA is making a finding that Pennsylvania has failed to submit the required complete SIPs for these three nonattainment areas.

On October 15, 2008, the EPA promulgated revised NAAQS for lead. 1 The agency revised the level of the primary lead standard from 1.5 micrograms per cubic meter (μg/m 3 ) to 0.15 μg/m 3 , and also revised the averaging time and form of the lead standards. The calculation method for the averaging time is a “rolling” 3-month period with a maximum (not-to-be-exceeded) form, evaluated over a 3-year period. The EPA also revised the secondary NAAQS to make it identical to the revised primary standard. In conjunction with strengthening the lead standards, the EPA improved the existing lead monitoring network by requiring monitors to be placed in areas with sources, such as certain industrial facilities, and at other sites.

On November 16, 2010, the EPA identified or “designated” 16 areas, consisting of 17 partial counties, as “nonattainment areas” not meeting the 2008 NAAQS for lead. In this first round, the EPA designated areas nonattainment based on 2007-2009 air quality monitoring data. These designation actions were effective on December 31, 2010. On November 8, 2011, the EPA completed a second round of designations, based on monitoring data from 2008-2010, including monitors newly established under the 2008 Lead NAAQS Rule. In this second round, the EPA designated five areas, including five partial counties, as nonattainment and designated the remaining areas in the country as attainment/unclassifiable or unclassifiable for the 2008 Lead NAAQS. These designation actions were effective on December 31, 2011. For the full listing of areas designated nonattainment for the 2008 Lead NAAQS (15 states, 21 nonattainment areas and 22 partial counties) see ­http://www.epa.gov/leaddesignations/2008standards/documents/2011-11-08/LeadNAAreaList.pdf.

The three areas in Pennsylvania were designated nonattainment in the first round, effective December 31, 2010. In accordance with the CAA, attainment SIPs for these areas were required to be submitted no later than June 30, 2012. As explained in further detail in the 2008 Lead NAAQS Rule, the key required elements of the attainment SIP include the attainment demonstration, RACM/RACT, RFP and contingency measures. The attainment demonstration provides details on how a nonattainment area will reduce pollution and provides a plan for the area to meet the lead NAAQS. Under subpart 5 part D of title I of the CAA, an attainment demonstration for these areas is required to show how the nonattainment area will attain the 2008 Lead NAAQS as expeditiously as practicable, but no later than 5 years after the effective date of designation, or December 31, 2015, for the areas designated in the first round for which Pennsylvania failed to submit an attainment SIP. The attainment demonstration takes into account projected emission reductions from existing federal and state measures, plus any additional RACM/RACT that are adopted by the state to attain “as expeditiously as practicable.” Air quality modeling of these projected emissions reductions in future years is an important element of the attainment demonstration.

Each nonattainment SIP must include RACM/RACT as necessary for the area to attain the 2008 Lead NAAQS. The CAA requires the state to demonstrate that it has adopted all RACM, considering economic and technical feasibility and other factors, that are needed to show that the area will attain the lead standards as expeditiously as practicable. The 2008 Lead NAAQS Rule sets forth more specific guidance for making RACM and RACT determinations.

Each plan must also ensure that the area is making RFP in terms of emission reductions and air quality improvements toward attainment. The 2008 Lead NAAQS Rule provides that the RFP element of a SIP include a detailed schedule for the implementation of RACM (including RACT) that accurately indicates the corresponding annual emission reductions to be achieved.

SIPs must also include contingency measures, which are emission reduction measures to be undertaken if the area fails to satisfy the RFP requirement or fails to attain the 2008 Lead NAAQS by the attainment date. These measures are to take effect without significant further action by the state or the EPA. As discussed in the 2008 Lead NAAQS Rule, the EPA generally expects that contingency measures will be implemented as expeditiously as practicable, and will be fully implemented within 60 days of the EPA notifying the state that contingency measures are necessary.

The Clean Data Policy represents the EPA's interpretation that certain requirements of subpart 1 of part D of title I of the Act are by their terms not applicable to areas that are attaining the NAAQS. 2 The specific requirements that are inapplicable to an area attaining the standard are the requirements to submit a SIP that provides for: attainment of the NAAQS, implementation of all RACM, RFP and implementation of contingency measures for failure to meet deadlines for RFP and attainment. The EPA has previously applied the Clean Data Policy to the 2008 Lead NAAQS. See e.g., 77 FR 35653 (June 14, 2012) (proposed determination of attainment of the 2008 lead standards for Bristol, TN); 77 FR 52232 (August 29, 2012) (final rule). For more information about the history, rationale and application of the Clean Data Policy, see 77 FR 35653-35654.

We note that several lead nonattainment areas currently have air quality that attains the 2008 Lead NAAQS, but have not yet completed the process for redesignating the area to attainment. Where the EPA has published in the Federal Register a clean data determination for an area, a state's obligation to submit RACM/RACT, contingency measures, RFP and attainment demonstrations for that area are suspended as of the effective date of the clean air determination. This suspension will remain in effect unless the EPA subsequently determines, after notice-and-comment rulemaking, that the area has again violated the 2008 Lead NAAQS, in which case the requirements are again due or the area is redesignated to attainment, in which case the requirements are permanently no longer applicable. Thus, states with areas that have received final clean data determinations and have not submitted SIPs for these areas are not subject to the final action in this rule.

Section 179(a)(1) of the CAA establishes specific consequences if the EPA finds that a state has failed to submit a SIP or, with regard to a submitted SIP, if the EPA determines it is incomplete or if the EPA disapproves it. Additionally, any of these findings also triggers an obligation for the EPA to promulgate a FIP if the state has not submitted, and the EPA has not approved, the required SIP within 2 years of the finding.

The EPA is finding that Pennsylvania has failed to make the required nonattainment SIP submissions for the Lyons and North Reading nonattainment areas in Berks County and the Lower Beaver Valley nonattainment area in Beaver County. If the EPA has not affirmatively determined that Pennsylvania has made the required complete nonattainment SIP submissions within 18 months of the effective date of this action then, pursuant to CAA section 179(a) and (b) and 40 CFR 52.31, the offset sanction identified in CAA section 179(b)(2) will apply in any area subject to the findings for which a complete submission has not been made. If the EPA has not affirmatively determined that Pennsylvania has made a complete submission for each area subject to the findings within 6 months after the emission offset sanction is imposed, then the highway funding sanction will also apply in any area subject to the finding for which a complete submission has not been made, in accordance with CAA section 179(b)(1) and 40 CFR 52.31. The 18-month clock will stop and the sanctions will not take effect, within 18 months after the date of this finding, if the EPA finds that Pennsylvania has made a complete nonattainment SIP submission for each area for which the finding is being made or if the EPA makes a determination the area is attaining the standard consistent with the EPA's Clean Data Policy. In addition, the EPA is not required to promulgate a FIP if Pennsylvania makes the required SIP submittal, and the EPA takes final action to approve the submittal, or if EPA makes a final determination the area is attaining the standard consistent with the Clean Data Policy, within 2 years of the EPA's finding. Contemporaneous with the signing of this rule, the EPA Region 3 Regional Administrator is sending a letter to the governor of Pennsylvania informing the governor that the EPA is determining that Pennsylvania has failed to make the required SIP submissions for the specified areas. This letter and any accompanying enclosures have been included in the docket for this action.

In this action, the EPA is making a finding of failure to submit for Pennsylvania with regard to areas designated nonattainment for lead in 2010. Pennsylvania has not yet submitted attainment SIPs for three nonattainment areas—the Lyons and North Reading nonattainment areas in Berks County and the Lower Beaver Valley nonattainment area in Beaver County.

In accordance with CAA section 179, this finding starts the 18-month emission offset sanctions clock, the 24-month highway funding sanctions clock and a 24-month clock for the promulgation by the EPA of a FIP. This action will be effective on February 25, 2014.

This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under EO 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. This final action does not establish any new information collection requirement apart from that already required by law. This action makes a finding that Pennsylvania failed to submit attainment SIPs for the 2008 Lead NAAQS as required by the CAA. Burden means the total time, effort or financial resources expended by persons to generate, maintain, retain, 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 Office of Management and Budget (OMB) control number. The OMB control numbers for the EPA's regulations in the CFR are listed in 40 CFR Part 9.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice-and-comment rulemaking requirements under the APA or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations and small governmental jurisdictions. For the purpose of assessing the impacts of this final action on small entities, small entity is defined as: (1) A small business that is a small industry entity as defined in the U.S. Small Business Administration (SBA) size standards ( See 13 CFR 121); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this final action on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final action will not impose any requirements on small entities. This action makes a finding that Pennsylvania failed to submit attainment SIPs for the 2008 Lead NAAQS as required by the CAA.

This action contains no federal mandate under the provisions of Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538 for state, local and tribal governments and the private sector. The action imposes no enforceable duty on any state, local or tribal governments or the private sector, because the requirement to submit an attainment SIP is established in the Clean Air Act. Therefore, this action is not subject to the requirements of section 202 and 205 of the UMRA.

This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action makes a finding that Pennsylvania failed to submit attainment SIPs for the 2008 Lead NAAQS as required by the CAA.

EO 13132, titled “Federalism” (64 FR 43255, August 10, 1999), requires the EPA to develop an accountable process to ensure “meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the EO to include regulations that have “substantial direct effects on the states or the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.” This final action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The CAA establishes the scheme whereby states take the lead in developing plans to meet the NAAQS. This action will not modify the relationship of the states and the EPA for purposes of developing programs to implement the NAAQS. Thus, Executive Order 13132 does not apply to this action.

EO 13175, titled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires the EPA to develop an accountable process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.” This final action does not have tribal implications, as specified in EO 13175. This action responds to the requirement in the CAA for states to submit nonattainment SIPs for the 2008 Lead NAAQS.

The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is subject to Executive Order 13045 because it is making findings that Pennsylvania failed to submit nonattainment SIPs for the 2008 Lead NAAQS as required by the CAA. The enforceable measures in the attainment SIPs will ensure that the areas will attain the NAAQS for lead, which was established to protect public health, including the health of children, with an adequate margin of safety.

This action is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.

Section 12(d) of the NTTAA of 1995 Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impracticable. VCS are technical standards (e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by VCS bodies. The NTTAA directs the EPA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable VCS. This action does not involve technical standards. Therefore, the EPA did not consider the use of any VCS.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations and low-income populations in the United States. The EPA has determined that this final action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not directly affect the level of protection provided to human health or the environment. This rule is making a finding that Pennsylvania failed to submit nonattainment SIPs for the 2008 Lead NAAQS as required by the CAA. The enforceable measures in the attainment SIPs will ensure that the areas will attain the NAAQS for lead, which was established to protect public health, including the health of minority and low income populations, with an adequate margin of safety.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives and the Comptroller General of the United States prior to publication of the action in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective February 25, 2014.

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the Third Circuit within 60 days from the date this action is published in the Federal Register . Filing a petition for reconsideration by the Administrator of this final action does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review must be filed, and shall not postpone the effectiveness of this action.

I. Background

In FR Doc. 2012-11548 (77FR 29034) of May 16, 2012, the final rule entitled “Reform of Hospital and Critical Access Hospital Conditions of Participation,” there were technical errors that are identified and corrected in the regulations text of this correcting amendment.

On page 29075 of the May 16, 2012 Federal Register final rule, in the amendatory instructions for 42 CFR 482.42, we revised the introductory text of paragraph (a) to include the provisions of paragraph (a)(1). However, we inadvertently neglected to omit paragraph (a)(1) from the regulations text. In addition, we proposed to remove the burdensome requirement for an infection log at paragraph (a)(2), but inadvertently omitted the removal of paragraph (a)(2) from the regulations text.

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive this notice and comment procedure if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice.

Section 553(d) of the APA ordinarily requires a 30-day delay in effective date of final rules after the date of their publication in the Federal Register . This 30-day delay in effective date can be waived, however, if an agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the findings and its reasons in the rule issued. The provision finalized in the final rule noted above has previously been subjected to notice and comment procedures. These corrections do not make substantive changes to the requirement that was finalized in the final rule. In addition, we believe it is important for the public to have the correct information as soon as possible and find no reason to delay the dissemination of it.

For the reasons stated above, we find that both notice and comment and the 30-day delay in effective date for the correction notice are unnecessary. Therefore, we find there is good cause to waive notice and comment procedures and the 30-day delay in effective date for this correction notice.

Accordingly, 42 CFR chapter IV is corrected by making the following correcting amendments to part 482:

This final rule denies most aspects of a petition for reconsideration of a February 27, 2012, final rule (77 FR 11626) that expanded the applicability of Federal Motor Vehicle Safety Standard (FMVSS) No. 213, “Child restraint systems,” from child restraint systems (CRSs) for children weighing up to 65 lb to CRSs for children weighing up to 80 lb. The final rule also adopted use of a 10-year-old child (10YO) test dummy (HIII-10C) to test CRSs manufactured for children weighing 65 to 80 lb. The test dummy weighs about 78 lb.

Generally speaking, in NHTSA's compliance test for FMVSS No. 213, NHTSA has the choice of assessing the performance of a CRS when installed on a bench seat by way of the simulated lower anchorages of the “child restraint anchorage system”  1 of the standard seat assembly or by a seat belt. That is, child restraint manufacturers must ensure that their products meet the requirements of FMVSS No. 213 when NHTSA tests the CRS attached by the child restraint anchorage system connectors and when the agency tests the CRS attached by the seat belt. During the course of this particular rulemaking, the Alliance of Automobile Manufacturers (Alliance) submitted a comment  2 on an aspect of the rulemaking proposal relating to how NHTSA would use the 10YO dummy in compliance tests, particularly with respect to an issue concerning attaching CRSs by the child restraint anchorage system. 3 The Alliance pointed out that the child restraint anchorage system was developed by NHTSA to withstand crash forces in a crash generated by a mass on the system of 65 lb (mass of child plus that of CRS). 4 Given such a design parameter, the group stated that vehicle manufacturers would never recommend that a CRS be installed using the vehicle child restraint anchorage system when used to restrain children represented by the 10YO dummy (the dummy alone weighs about 78 lb). Subsequently, the Alliance and the Association of Global Automakers (Global Automakers) submitted a joint comment stating that “review of the actual supporting test data and load calculations reveals that the LATCH load requirements were developed using a combined maximum child+CRS weight of 65 pounds.”  5 6 The vehicle manufacturer groups also expressed concern about “a trend toward increased weight of child restraints . . . [that] could call into question the validity of the 48 pound estimate for appropriate maximum child weight capacity.”  7

The information from the vehicle manufacturers was important to NHTSA in determining how we should use the new 10YO test dummy in compliance testing. After assessing all available information, NHTSA decided that it would not subject child restraints with internal harnesses to compliance testing using the 10YO test dummy while the CRS is attached by the child restraint anchorage system anchorages, since that scenario would be contrary to vehicle manufacturers' instructions for using child restraint anchorage systems and inconsistent with the design parameters of the anchorage system.

Furthermore, the agency determined that, given that NHTSA will not test a child restraint with the child restraint anchorage system on the standard seat assembly using the 10YO dummy for the above reasons, there is a need to inform consumers on the use of child restraint anchorage systems to reduce the likelihood that a CRS would be used in a manner that is inconsistent with the assessed performance of the harness-equipped CRS and the design limits of child restraint anchorage systems. Some new harness-equipped CRSs have been produced that are heavier than all CRSs made in the past, and some are recommended for children weighing more than 48 lb.

In the 2012 final rule, we adopted a labeling instruction informing consumers not to use the child restraint anchorage system when restraining a total weight of more than 65 lb. 8 NHTSA determined that a label is needed to reduce the likelihood that consumers will use the child restraint anchorage system lower anchorages with a child+CRS weight that is too heavy for the anchorages, which would pose an unreasonable risk of overloading the vehicle anchorage system in a crash. Overloading the vehicle lower anchorages could be catastrophic for the child occupant, as the CRS could dislodge from the vehicle seat. The instruction provided a clear and consistent message regarding the use of the child restraint anchorage system and improved the current situation where consumers are provided inconsistent or no information about the child weight limit for the lower bars. The information helps to ensure that the child restraint anchorage systems (particularly the lower anchorages) are used in a manner that comports with the design parameters of the vehicle system.

NHTSA received a petition for reconsideration on the label from several consumer advocates. 9 The petitioners did not oppose informing consumers of the weight limits of the lower anchorages per se, but instead did not support a 65 lb limit. They requested that the 65 lb combined weight should be increased to 80 to 85 lb, believing this is needed to “preserve the extended use of lower anchors.”

Petitioners believe that when NHTSA developed FMVSS No. 225, the agency referred several times in the preamble to a child weight of 65 lb. Petitioners “surmise that FMVSS 213 [sic] rule was for anchors to be strong enough to accommodate [CRSs] that would in themselves weigh at least 15, possibly 20 pounds, which implies a combined weight of at least 80 to 85 lbs.” The petitioners state that “the decision to adopt 65 pounds as the combined maximum weight . . . will unnecessarily restrict the use of the LATCH system and force caregivers back to using seat belts for anchoring forward-facing [CRSs].” The petitioners also state that their intent in petitioning for reconsideration of the rule was to “minimize the likelihood that vehicle manufacturers will apply the same formula” to tether anchorages. 10

A number of persons sent letters or met with NHTSA in support of the petition for reconsideration or to ask questions about the labeling requirement. 11 Several suggest that NHTSA suspend the requirement for the label, increase the 65 lb combined weight limit on the label, or require vehicle manufacturers to increase the strength of child restraint anchorage systems to accommodate a higher combined weight. Several letter writers express the view that the final rule should have addressed tether weight limits.

Several of the letters and other submissions are summarized below.

Representatives from the Dorel Juvenile Group (Dorel) and others met with NHTSA to express their view that the new labeling requirement reduces use of child restraint anchorage systems. They believe that the current status quo (current recommendations and practice) is to use child restraint anchorage systems for installing child restraints with internal harnesses for a child weight up to 48 lb. They also add that child safety seats now weigh between 15 to 33 lb, so the new label would exclude the use of child restraint anchorage systems for a “large” number of children who are still in harnessed-CRSs. They state that because child restraint anchorage systems are easier to use and have a higher rate of correct installation than seat belts, a child restraint anchorage system installation is safer than a belt installation. They suggest that in the short term, NHTSA should suspend the new label requirement, and that in the long term, NHTSA should increase the strength of the child restraint anchorage system.

Safe Ride News (SRN) wrote in a letter that the agency should suspend the labeling requirement because the label will “cause a lot of confusion” and affect public perception of the safety of child restraint anchorage systems “without improving actual safety in any significant way.” The letter writer believes that public education messages will become “extremely muddied due to the variability from CR [child restraint] to CR.” SRN also states its concern that “lower-anchor weight limits will spill over to tether-anchor weight limits.” Further, in another letter, SRN suggests that NHTSA require a child-weight limit of 50 lb as a “compromise” that “eliminates the formula of child-weight plus CR-weight.” Under SRN's suggestion, child restraint manufacturers may set their own weight limits for the use of child restraint anchorage systems up to that ceiling with a possible lower weight limit for extremely heavy child restraint models.

The Juvenile Products Manufacturers Association (JPMA) submitted a letter in support of Dorel's submission and Safe Ride News' letter, repeating many points of earlier correspondence. 12 Those points include that the extended use of lower anchorages should be preserved; that use of tethers should be increased; that efforts should be made to minimize the likelihood that vehicle manufacturers will similarly restrict tether anchor use; that parents might not remember or even initially know to switch to the seat belt during the several-year course of a CRS's use; and, that innovation by CRS manufacturers to reduce loads on anchors through energy management features should be supported. JPMA also expressed the view that NHTSA should suspend the label and “consider strengthening the anchorage strength requirements of FMVSS 225 immediately.” In a later submission, JPMA states that the label will result in “lack of trust in LATCH” because it results in varying weight limits, and in some cases weight limits lower than the 40 or 48 lb currently used in the field. JPMA also believes that the label will lead to early graduation to boosters due to the wording on the label and because CRSs might not achieve a tight fit with a seat belt or may be too difficult to install with a seat belt.

An individual, Alisa Baer, wrote that introducing “strict lower anchor weight limits of CR + child = 65 pounds will further complicate” child restraint anchorage systems. The letter writer states that parents typically do not understand how fast a child grows and that a parent may opt not to use a CRS when their child is on the cusp of the weight limit out of fear that the child will soon outgrow the CRS, when in reality the child could have much more time before exceeding the weight limit. The writer states that “ugly numbers—like 37 or 41 [lb]—are scary to parents & technicians,” and “will likely erode confidence in the LATCH system” because people may “[think] `is the LATCH system so fragile that if the child was 38 pounds instead of 37 it might not hold in a crash?' ”

Consumers Union sent a letter stating that it was “worried that the new rules may encourage parents to secure heavier child seats using standard safety belts instead of the LATCH system.” Consumers Union states that “each CRS will still feature a different maximum recommended child weight limit, based on the differences between the seat's weight and the 65 lb limit of the lower LATCH anchors,” which, the letter writer believes, will confuse caregivers.

Diono  13 sent a letter expressing its belief that the 65-lb combined weight threshold was “far too conservative a limitation given the dynamic capacity of the lower anchors in vehicles” and asks that NHTSA “allow a maximum weight of CRS plus occupant to be limited to 80 lbs with the use of lower anchors.” These are the same arguments that Diono made in response to the NPRM when the company was named Sunshine Kids. Diono believes that there is “much data from testing analysis that has shown lower anchors support total masses larger than the proposed limit of 30.5 kg,” and states that it has data from its sled testing which “show that with a combined mass of 78 lbs to ~110 lbs the lower anchors see dynamic loads well within the dynamic capacity of the lower anchors.” Diono also states that “ECE-R44 has recommended the combined weight limit be 33 kgs (Combined mass of CRS plus occupant) or 72.6 lbs.”

The Alliance submitted correspondence focused on the need for the label to address rear-facing child restraints equipped with an internal harness that are sold for heavier children, which are used without a tether. The Alliance highlights that it reviewed “some of the heavier 3-in-1 child restraints currently on the market, especially those which have been certified for use up to 40/45 lbs rearward-facing,” and notes that “a potential weight combination of up [sic] 73.8 lbs becomes apparent—without use of a tether.” The Alliance seeks “to ensure that the label is also applied to rear-facing child restraints.”

NHTSA also received correspondence from Graco asking that harness-equipped CRSs recommended for children up to 70 lb in weight should be excluded from the head excursion requirements if the CRS height restrictions do not accommodate the HIII-10C dummy.

Graco also raises a question about S5(f) of the final rule, which applies to harness-equipped CRSs. S5(f) refers to the weight of the test dummy used to test the CRS. Graco suggests that NHTSA publish a list of the weights for each test dummy to make it “easy for manufacturers to determine which [anthropomorphic test device] and CRS combinations need to be tested with each type of belt and provide more standardized results for consumers.”

NHTSA has evaluated all relevant issues presented above and has made the following decisions in responding to those issues.

NHTSA has determined that the information presented by the label in question is necessary to address a safety need. The information reduces the likelihood that consumers will use the child restraint anchorage system with a combined weight of child plus CRS weight too high for the anchorages in a crash. FMVSS No. 225 requires the anchorage system to withstand crash forces resulting from a combined (child+CRS) mass of 65 lb. 14 Not having information about the weight limits poses an unreasonable risk of overloading the child restraint anchorage system given that CRS weights are increasing (currently there is no limit on the size and mass of CRSs), harness-equipped CRSs are being produced that are marketed for children of heavier masses than 40 lb, and peak vehicle accelerations are much higher now (some exceed 60 g) than the 48 g the agency had assumed in 1999 when designing the strength requirements of FMVSS No. 225. We believe that information about child weight limits needs to be provided on the CRS, given the design limits of child restraint anchorage systems and the changing physical demands on the system from modern child restraint and vehicle designs.

In an April 11, 2011 letter to NHTSA, the Alliance and Global Automakers expressed support for a label such as that adopted by the 2012 rule. These vehicle manufacturer groups expressed concern “that there appears to be a trend toward increased weight of child restraints. This trend, if it continues, could call into question the validity of the 48 pound estimate for appropriate maximum child weight capacity.” NHTSA agrees that this development is a cause for concern, and believes that the labeling requirement addresses this potential safety problem.

The market has not provided the information consumers need. Vehicle and CRS users' manuals have conflicting or a lack of information on the maximum child weight limit for lower anchor use. Most vehicle manufacturers do not include a child weight limit for lower anchor use in their vehicle owner's manual. A 2011 manual developed by SRN, “LATCH Manual,” 15 indicates that only about 54 percent of vehicle “makes” provides information on the weight limits of child restraint anchorage systems. 16

Child restraint manufacturers' recommendations for using the child restraint anchorage system are also varied and generally unhelpful. NHTSA reviewed approximately 40 CRS manuals from different CRS manufacturers to see the current recommendations of CRS manufacturers. In our sample, Dorel and Evenflo did not specify a maximum child weight for use with the child restraint anchorage system. Graco and Recaro specified using the vehicle manufacturer's weight limits for use of the child restraint anchorage system and also specified a maximum child weight of 48 lb for use of the anchorages. Britax recommended that consumers follow vehicle manufacturers' instructions and that, if a vehicle manufacturer does not provide a limit, consumers should assume a 40 lb maximum child weight limit for lower anchors. Diono recommended use of the child restraint anchorage system for children weighing up to 65 lb (corresponding to the weight of a 50th percentile 9.5 year-old) and even, for some models, 80 lb (corresponding to the weight of a 50th percentile 11 year-old).

Since most vehicles do not specify a child weight limit for lower anchor use, and since CRS instruction manuals generally have no information (e.g., Dorel and Evenflo), refer to the vehicle owner's manual (Graco, Britax, Recaro), or have conflicting information on the child weight limit for using the lower anchorages (Graco, Recaro), many consumers are unaware or unsure as to the weight limits of child restraint anchorage systems. A consumer looking in the CRS manual might be referred to a non-existent vehicle owner's manual instruction on child weight limits for lower anchor use, or might be informed that the anchorage system may be used to a weight beyond the intended design limit of many if not most vehicles' anchorage systems.

This problematic situation can be fixed if the CRS has the required information about the weight limits. With the information, consumers will have convenient access to facts about the child weight limit for lower anchor use. A label with the information will provide clear and consistent information for determining the child weight limit for lower anchor use, which will be easily accessible to the caregiver at all times. 17 Consumers following this information will virtually eliminate the risk of anchorage failure in a crash. 18

We do not believe that specifying a combined (child+CRS) weight limit in the vehicle owners' manual rather than on a CRS label would be as effective at communicating the information as placing a label on the CRS. First, the consumer will need to determine the weight of the CRS and then calculate the maximum child weight limit. We believe that these additional actions required by the consumer are unreasonable; the consumer is unlikely to take the step of assessing the CRS weight or may not bother to make the calculation. Second, a recent survey  19 conducted by the agency showed that only 14 percent of caregivers use the vehicle owners' manuals for information about installing CRSs. This indicates that most consumers will not learn of the instruction by way of the vehicle owner's manual.

We disagree with JPMA's and Diono's assertion that the label will result in lack of confidence in child restraint anchorage systems. We believe that the label will provide clear and consistent information on the use of child restraint anchorage systems and will thereby promote more trust in child restraint anchorage systems. More importantly, the information will virtually eliminate the risk of a failure of an anchorage system in attaching a CRS to the vehicle. 20 Such failures, not the label, would reduce consumer confidence in child restraint anchorage systems. We are taking action now to instruct consumers of the intended use of the anchorage system to avoid failures in the field.

The petitioners state that they wish to “preserve the extended use of lower anchors.” They state that the preamble for the final rule establishing FMVSS No. 225 refers to a child weight of 65 lb, and that the intent of the agency in establishing the standard was “for anchors to be strong enough to accommodate CRs [sic] that would in themselves weigh at least 15, possibly 20 pounds, which implies a combined weight of at least 80 to 85 lbs.”

Agency Response: The petitioners' view is incorrect. The preambles  21 analyzing, explaining, and developing the rationale for FMVSS No. 225's strength requirement overwhelmingly refer to a combined weight (child+CRS) of 65 lb. The entire engineering analysis upon which the strength requirement was based uses a combined weight of 65 lb.

To illustrate, NHTSA explained the basis for FMVSS No. 225's 15 kN strength requirement in a 2003 document responding to petitions for reconsideration of various aspects of the 1999 final rule. NHTSA stated that the agency based the strength requirement—

References to a “child” weight of 65 lb rather than to a “combined” weight in the 2010 SNPRM were in error, as the Alliance, JPMA and others have pointed out. Such references were imprecise and limited in describing the assumptions underlying the strength requirement of child restraint anchorage systems. The Alliance explained that the load calculations for the 15 kN strength requirement were based on a combined maximum (child+CRS) weight of 65 lb. 22 The Alliance and others were concerned that the proposed wording that referred to a 65-lb child weight did not adequately account for the weight of the CRS and thus would be providing misinformation. NHTSA agreed with the commenters and made the correction in the final rule.

The present petitioners state that “What is proposed [sic] in the final rule, is, in effect, a major change of interpretation of anchor weight limits without any opportunity for assessment and comment that is usual in regulatory changes.”

This assertion is without merit. As explained above, the agency did not make a “change of interpretation of anchor weight limits” by basing the final rule on a combined child+CRS weight of 65 lb. A 65 lb combined weight limit was the established engineering basis for the strength requirement of FMVSS No. 225 from the beginning of the standard. The 2010 SNPRM was in error in referring to a child weight alone of 65 lb. The 2012 final rule remedied the error by referencing combined weight (child+CRS).

Moreover, the weight to which the label refers was an issue well within the scope of the present rulemaking. The question of the weight limits of child restraint anchorage systems and the safe use of the anchorage system with heavier children were crucial aspects of the 2010 SNPRM (see section VII.a. of the SNPRM, 75 FR at 71659). Upon proposing a label to inform consumers of the limits of the child restraint anchorage system, the SNPRM specifically asked for comment on the child weight variable: “Comments are requested on the label's reference to the 65 lb (29.5 kg) threshold.” 75 FR at 71659.

In addition, vehicle manufacturer groups (Alliance and Global Automakers) and JPMA commented on the SNPRM, informing NHTSA that the proposed wording that referred to a 65-lb child weight alone did not adequately account for the weight of the CRS and was thus providing incorrect information. NHTSA benefited from the comments and corrected the weight limit to reflect the weight of the child+CRS, as designed by FMVSS No. 225, in the final rule. The agency was not required to reissue another proposal for notice and comment to make this correction.

Diono believes that there is “much data from testing analysis that has shown lower anchors support total masses larger than the proposed limit of 30.5 kg” and states that it has data from its sled testing which “show that with a combined mass of 78 lbs to ~ 110 lbs the lower anchors see dynamic loads well within the dynamic capacity of the lower anchors.” Diono believes that its tests show that, with a combined child and child restraint weight of 80 lb, the dynamic loads on the anchors are in the range of 9 kN at each lower anchor. Diono also states that NHTSA has tested CRSs (some weighing 30 lb) for many years using the Hybrid III 6-year-old (HIII-6C) dummy weighing 48 lb (for a combined weight of 78 lb) as part of its compliance program with no anchorage failures. Based on this information, Diono concludes that there is a very safe margin with the use of lower anchorages for a combined child and CRS weight of 80 lb.

The agency disagrees that Diono's test data indicate that NHTSA should amend the labeling requirement in such a way that condones the use of the lower anchorages with a combined child and CRS weight of 80 lb. Diono's testing consisted of sled tests using the FMVSS No. 213 test bench and a sled pulse (47 G pulse and a 35 mph velocity) representing the crash pulse of a 2001 Toyota Echo in an NCAP frontal crash test. The docket submissions from Diono show that for sled tests performed with the 47 G pulse and combined child and CRS weight of 82 lb (65 lb dummy + estimated 17 lb CRS) and 97 lb (80 lb dummy + estimated 17 lb CRS), the peak total load on the child restraint anchorages were 25.7-27.3 kN. Those loads clearly exceed the 15 kN quasi-static load minimum strength requirement of the anchorage system per FMVSS No. 225.

Furthermore, while the Toyota Echo pulse at 48 G in an NCAP test was considered a severe pulse in early 2000s, current NCAP data shows that many recent vehicle models have stiffer front ends than the Echo, with peak accelerations in excess of 50 G.

Additionally, Diono's data are inadequate because the data were obtained from sled tests conducted with an FMVSS No. 213 test bench seat. The child restraint anchorage system bars on the bench seat are designed and constructed to withstand repeated loading in 30-35 mph sled tests, i.e., they are reinforced over and above the anchorages of actual vehicles. Diono did not provide any actual vehicle test data (static or dynamic). The strength of child restraint anchorage systems in vehicles is evaluated according to specifications in FMVSS No. 225, which include a quasi-static load test of 15 kN applied to the lower anchors and tethers and a quasi-static load test of 11 kN applied only to the lower anchors. The lack of anchorage failures on NHTSA's test bench does not indicate that real-world vehicles' anchorages are strong enough to hold the force generated by higher weight children.

Diono referred to Economic Commission for Europe Regulation No. 44 (ECE R.44), “Restraining Devices for Child Occupants of Power-Driven Vehicles,” and ECE R.14, “Safety Belt Anchorages, ISOFIX Anchorages, and Top Tether Anchorages,” stating that these regulations limit to 72.6 lb the combined weight of child and child restraint for ISOFIX use, even though ECE R.14 has slightly less stringent requirements on the ISOFIX anchors than FMVSS No. 225.

NHTSA does not find this view persuasive. For one thing, ECE R.44 limits the maximum child weight for CRSs with harnesses and CRSs equipped with ISOFIX to 40 lb, and specifies that the CRS weight be less than or equal to 33 lb. FMVSS No. 213 does not have such limitations on CRS design at this time. Thus, the overall risk of overloading the anchors in Europe is inherently lower than in the U.S. In this country, a label is needed to limit the weight on the anchorages to within design parameters.

Second, no showing has been made by Diono that the ECE requirements are sufficient to meet the safety need in the U.S. that is met by FMVSS No. 225. In a 2010 Transportation Research Laboratory (TRL) contract report, Hynd et al. 23 noted that there is evidence that the current ECE R.14 anchorage strength test requirements may be inadequate for some dummy and CRS combinations allowed in ECE R.44. We are not convinced that FMVSS No. 225's requirements should be made similar to those of ECE R.14.

Diono also states that the 2012 final rule's labeling requirement on lower anchor use contradicts Transport Canada's recent update of Canadian Motor Vehicle Safety Standard (CMVSS) No. 213, “Child restraint systems,” which permits the use of lower anchors to install child restraints with harnesses for children weighing up to 65 lb.

We do not agree. Transport Canada has yet to consider the recent updates to FMVSS No. 213 incorporating the 10-year-old dummy for testing child restraints. We expect Canada to have similar issues as the U.S. regarding child restraint misuse, incorrect installations, and consumer confusion as to the child restraint anchorage systems. Transport Canada may be considering the merits of the label in the future.

The petitioners request that NHTSA “provide any test or field data suggesting the need for a reinterpretation of the original statement that FMVSS 225 was devised for a child weighing 65 to 80 . . . lbs.” As explained above, FMVSS No. 225 was developed to ensure that crash forces generated by a 65 lb combined weight will be withstood; it did not presume a child weight alone of 65 to 80 lb. The label is intended to inform consumers about the design limits of child restraint anchorage systems and to keep use of the lower anchorages to within the anchorage system's design limits. The engineering analyses underlying the FMVSS No. 225 strength requirement have been fully discussed. The agency is not obligated to provide “test or field data” to justify why we disagree with the petitioners' view that the weight limit should be based on a child weight alone of 65 to 80 lb.

Nonetheless, there are empirical data on this issue. There has been failure of a child restraint anchorage system in testing conducted by Transport Canada (30-35 mph) involving full frontal rigid barrier crash tests of model year (MY) 2009 and 2010 vehicles. Transport Canada placed child restraints in the outboard rear seating positions using the child restraint anchorage system (including the top tether). 24 The program involved 28 crash tests with the HIII-6C dummy and 4 crash tests with the HIII-10C dummy. The weight of the CRSs used in the tests ranged from 11.4 lb to 25.11 lb. The peak vehicle acceleration in these crash tests ranged from 30 g to 68 g. The total anchorage loads (sum of forces on the lower anchors and the tether anchor) ranged from 7.5 kN to 20.8 kN with the HIII-6C dummy, and from 13.3 kN to 20.4 kN with the HIII-10C dummy (see Tables A1(a) and A1(b) in the Appendix to this preamble).

The failure occurred in a 35 mph frontal crash test of a 2010 Kia Forte with the HIII-10C dummy restrained in Safety 1st Apex 65 child restraint. The CRS was installed in the right outboard rear seat with lower and top tether anchorages. The CRS weighed about 13 lb. The combined weight (child+CRS) in this test was 90 lb, the peak vehicle acceleration was 46 G. The total maximum anchorage loads measured in this test was 20,395 N. During the test, the inboard anchor, which was held in place by two bolts, pulled through the sheet metal resulting in a failure at the attachment point. The anchorage failure demonstrates a finite limit to the strength of the child restraint anchorages.

We are concerned that there are factors in play that have developed in recent years that raise the possibility that the limits of the child restraint anchorage system will be surpassed in more and more vehicles by the ordinary use of modern day CRSs in modern vehicles if measures are not in place to prevent this from happening. CRSs with internal harnesses are being produced that are recommended for children weighing 65 lb or more. The average weight of CRSs was 15 lb when FMVSS No. 225 was first issued; now CRSs are marketed that weigh more than 30 lb. Further, the strength requirements of the child restraint anchorage system were based on a 48 g vehicle acceleration, which is a level being surpassed among current vehicle models in a 35 mph frontal crash. In contrast, there are vehicle models in the current fleet that have peak vehicle acceleration in excess of 50 g in a 35 mph frontal crash.

Also presented in the Appendix in Tables A1(a) and A1(b) are the results of NHTSA's computed maximum total inertial loads on the child restraint anchorage system (F) using the combined weight of the child dummy and the CRS (m) and the peak vehicle acceleration (a), 25 using Newton's second law of motion (F=ma). 26 A comparison of the measured and computed total anchorage loads indicates that in 13 of 32 tests (41 percent), the computed anchorage loads were within 10 percent of the measured anchorage loads. In an additional 13 tests (40 percent), computed anchorage loads were within 20 percent of the measured loads. The general similarity between the measured and computed values provides a source of confidence in the anchorage strength requirements in FMVSS No. 225, which was based on a similar inertial load computation using a combined CRS+child weight of 65 lb and a peak acceleration of 48 G.

Almost all of the tests showed the integrity of present day child restraint anchorage systems in vehicles. The relatively low rate of anchorage failures in the Transport Canada vehicle crash tests may be because many vehicle manufacturers are designing the child restraint anchorage systems to be stronger than that required by FMVSS No. 225; the anchorage loads from the combined CRS+dummy weight and the peak vehicle acceleration were within the strength capabilities of vehicle anchorages.

Diono suggests a combined child+CRS weight limit of 80 lb. We believe that this suggestion raises an unreasonable risk that the lower anchorages would be overloaded, resulting in anchorage failure. The computed total child restraint anchorage load for a peak vehicle acceleration of 65 g and a combined child+CRS weight of 80 lb is 23,187 N, which is significantly higher than the measured total anchorage loads in the Transport Canada test series. Since there are vehicle models with peak vehicle accelerations of approximately 60-70 g, 27 having total anchorage loads exceeding 23,000 N is a distinct possibility if the combined weight limit is increased to 80 lb as suggested. Thus, we decline the request.

Another matter of concern to us is the low usage rate of the tether anchor and how nonuse of the tether, among other things, results in higher loads being imposed on the lower anchorages. Our survey data  28 indicates that approximately 30 percent of forward-facing child restraints that are installed using the lower anchorages do not have the tether attached. To study this and other issues, NHTSA performed sled tests at the agency's Vehicle Research and Test Center (VRTC) to measure the loads experienced by child restraint anchorages in a simulated crash. VRTC conducted 24 sled tests using the weighted 6-year-old Hybrid III dummy and three child seat models (Safety 1st Apex 65, Sunshine Kids Radian 65 and Britax Frontier 85) in two vehicle bucks (2010 Kia Forte and 2010 Ford Focus). 29 The child restraint models were selected because these models are marketed for heavier/older children, and because these CRSs were tested in the vehicle crash tests at Transport Canada. The two vehicle bucks were selected because both the Kia Forte and the Ford Focus had high measured anchorage loads in the Transport Canada frontal vehicle crash test program.

The agency selected two 35 mph, 35 g and 100 millisecond (ms) pulses to simulate a frontal crash. One of the pulses was front loaded while the second one was rear loaded (see Figure 1). 30 These two acceleration pulses were selected to cover the different vehicle acceleration pulse shapes observed in 35 mph full frontal rigid barrier crash tests.

The agency specifically selected the Kia Forte because of the lower anchorage failure observed in the vehicle crash test conducted by Transport Canada (discussed in the previous section). Transport Canada's tests used the Safety 1st Apex 65 CRS (approximately 13 lb) and the HIII-10C dummy (77 lb), for a combined weight of about 90 lb. VRTC's test used the same Safety 1st CRS model and a weighted HIII-6C dummy (66 lb), for a combined weight of approximately 79 lb.

VRTC conducted a sled test with the Kia Forte buck and a front loaded sled pulse (shown in Figure 1), with the CRS installed in the right rear outboard seating position using the lower anchors and the top tether. Post-test evaluation showed some deformation of the sheet metal with some forward pull of the lower anchorages but not a complete failure of the anchorages. The total anchorage loads (lower anchors+tether) was measured to be 17,330 N and the total load on the lower anchors (inboard+outboard) was 11,666 N (See Table A2 in the Appendix). However, VRTC later conducted another test, identical to the first except the tether was not attached. In that test, there was complete failure of the lower anchor hardware. The entire bolt and nut assembly pulled through the sheet metal. The total measured force on the lower anchors in this test was 14,922 N, which is 30 percent higher than the total lower anchor load in the earlier test with the tether attached.

NHTSA has reviewed all the sled tests conducted at VRTC (three child restraints in two vehicle bucks) and has determined that the ratio of lower anchor loads (when the tether is not attached) to lower anchor loads (when the tether is attached) ranges from 1.3 to 1.6. That is, these sled test results indicate that the loads on the lower anchorages are 30-60 percent higher when the tether is not used to install the CRS than when the full child restraint anchorage system (lower anchors+tether anchor) are used to install the CRS.

Thus, in further answer to Diono and others as to why we disagree with the suggested approach to increase weights to 80 lb, there is evidence of lower anchor failure when the tether was not attached at a combined weight of only 78 lb. Since we have evidence that 30 percent of forward-facing child restraints installed using the lower anchorages do not have the tether attached in the real world, 31 the labeling requirement reduces the possibility of field failure of lower anchorages, such as that observed in the sled test with the Kia Forte buck, when the combined (child and child restraint) weight approaches 80 lb.

The petitioners would like to “preserve the extended use of lower anchors.” Ms. Baer said in correspondence to NHTSA that “ugly numbers—like 37 or 41 [lb]—are scary to parents & technicians,” and “will likely erode confidence in the LATCH system.” Consumers Union stated its belief that it will confuse caregivers when “each CRS will still feature a different maximum recommended child weight limit, based on the differences between the seat's weight and the 65 lb limit of the lower LATCH anchors.”

Agency Response: NHTSA has evaluated the petition and the related correspondence and has decided to partially grant the petition. NHTSA is making two primary changes to the labeling requirement.

First, we agree with the view that the wording of the label specified in the 2012 final rule could lead consumers to misunderstand the instruction, remove the harness from the CRS before they should, or otherwise not follow the instruction. NHTSA is thus amending S5.5.2(g)(1)(ii) of the 2012 final rule to remove the instruction from that section. Instead, the instruction will be placed on a diagram that FMVSS No. 213 presently requires to be on CRSs under S5.5.2(l) of the standard. S5.5.2(l)(3) requires CRSs to be labeled with an installation diagram showing the CRS installed in a seating position equipped with a child restraint anchorage system (S5.5.2(l)(3)). We are adding a provision to S5.5.2(l)(3) to specify that a statement about child weight be included with the diagram.

The statement consists of a phrase, “Do not install by this method for a child weighing more than * lb.” The “*” value is the difference between 65 lb and the CRS weight, as discussed in the 2012 final rule. Alternatively, as discussed in the next section, the “*” value may be rounded up, subject to certain conditions.

An example of the installation diagram with the information for the child weight limit for lower anchor use and for promoting tether use is shown below in Figure 2.

The advantage of using the diagram is that it separates the child weight limit for lower anchor use from all the other information on the label in S5.5.2(g)(1)(ii) and puts it in a location where relevant installation information is provided. It is also advantageous to use diagrams over words to communicate information. The instruction on weight limits is concise and clear. This change will add more clarity regarding the child weight limits and will also be easily available to the caregiver installing the CRS.

Second, NHTSA concurs that the uniquely specific weight values provided on each CRS, based on the difference between 65 lb and the actual weight of the CRS, could be confusing to some consumers. For this reason, the agency is amending the final rule to add some flexibility in the maximum child weight calculation so that the label could be rounded up to display a child weight that is a multiple of five lb, which will be easier for consumers to remember, possibly less confusing to them, and appropriate from a safety point of view. This “rounding up” of the value is at the option of the manufacturer.

To provide this flexibility, the agency balanced the merits of allowing the child weight limit to be rounded up with the need to avoid an unreasonable risk of potentially overloading the anchorages. We also recognized the need to give different accommodation for CRSs in the forward-facing and rearward-facing modes.

NHTSA is amending the February 27, 2012 final rule to permit CRS manufacturers some flexibility in the calculated child weight limit for use with child restraint anchorage systems. We are retaining the requirement that the CRS must specify a maximum child weight for lower anchor use unique to each CRS model. Under the 2012 final rule, the maximum child weight that must be specified on the label is less than or equal to the difference between 65 lb and the weight of the CRS in pounds. Under today's final rule, that requirement is retained, but we are also providing manufacturers an option of rounding the value up to the next multiple of 5 lb. We are adding a provision in FMVSS No. 213 that specifies a lookup table for the maximum child weight limit in multiples of 5 lb for different weight ranges (65 − CRS weight (lb)) and are providing manufacturers the option of employing the table to round up the child weights. See Table 1, below.

We recognize that there is a possibility that this amendment will permit a manufacturer to indicate a child weight limit on the label that, when combined with the CRS weight, the combined (child+CRS weight limit) could marginally exceed 65 lb. For instance, if the CRS weighed 19 lb, then x = 65 lb minus 19 lb = 46 lb; rounding up results in a child weight limit on the label) = 50 lb. This would lead to a combined (CRS + child) weight = 50 lb + 19 lb = 69 lb. Although this combined weight is greater to a slight degree than 65 lb, we believe this situation is acceptable for the following reasons.

First, data indicate that vehicles are equipped with child restraint anchorage systems (lower anchorages plus tether anchorage) that sufficiently surpass the minimum strength requirement of FMVSS No. 225 such that the anchorages will withstand crash forces generated by a combined (child+CRS) weight of 70 lb. NHTSA performed quasi-static tests on the child restraint anchorages in eleven MY 2006-2011  34 vehicle models and 18 MY 2013 vehicle models  35 to explore the strength of the anchorages in the current fleet. (These vehicles were previously crash-tested, but NHTSA examined the vehicles to assess the condition of the child restraint anchorage systems to determine the suitability of the vehicles for inclusion in the quasi-static test program.) The tests consisted of pulling the lower anchorages alone at the two outboard rear seating positions using the Static Force Application Device 2 (SFAD 2)  36 as specified in FMVSS No. 225, using the same loading rate but to higher loads or to anchorage failure. A static pull test was also conducted on the tether anchors alone in three rear seating positions using a cable at loading rates similar to that specified in FMVSS No. 225, but again to higher loads or to anchorage failure. 37

Among the 11 MY 2006-2011 vehicle models tested, 19 lower anchor sets (comprising two lower anchor bars) and 27 tether anchors were subjected to quasi-static loads. Of these, 14 lower anchor sets had strengths greater or equal to 20 kN, and all the tether anchors had strengths greater than 10 kN. Among the 18 MY 2013 vehicle models tested, 37 lower anchor sets and 46 tether anchors were subjected to quasi-static loads, among which 24 lower anchor sets had strengths greater than 20 kN and 25 tether anchors had strengths greater than 10 kN. 38

The test results are set forth in a technical document placed in the docket. All in all, the results indicate that the quasi-static lower anchorage strength in current vehicles is significantly higher that required by FMVSS No. 225. The lowest force that produced lower anchor failure was 19.7 kN (2010 Kia Forte). 39 Our testing suggests that child restraint anchorage systems as currently manufactured are capable of withstanding the forces from a combined weight of 70 lb in a crash.

Second, although there is no consistent and direct correlation between dynamic to static strength of anchorage systems and the dynamic to static strength ratio is vehicle specific, data show that child restraint anchorage systems are able to withstand higher loads dynamically than statically. Our test data demonstrate that the dynamic strength of the child restraint anchorage systems (lower anchors+tether anchor) in our tests was greater than the 15 kN load required by FMVSS No. 225. In the Alliance's petition for reconsideration of the strength requirements of the 1999 final rule, the Alliance indicated that the quasi-static test load of FMVSS No. 225 simulating a high-speed impact should be approximately 50 percent of the expected dynamic load. 40 As discussed in the 2003 final rule responding to petitions for reconsiderations (68 FR 38218), Toyota determined that the tether anchorage was able to withstand about 30 percent greater loads dynamically than statically. NHTSA has considered these findings and believes that data indicate that the child restraint anchorage system will be able to withstand the crash forces generated by the combined child weight (rounded up) + CRS weight.

Rear-facing CRSs typically do not have a top tether attachment. When FMVSS No. 225 became effective in 1999, rear-facing child restraints were generally recommended for children weighing up to 20 lb. Currently in the market, there are “3-in-1” child restraints that alone weigh more than 20 lb that are recommended to use rear-facing with children weighing up to 45 lb. Thus, for these CRSs, the combined weight of CRS and the maximum weight of child recommended for the CRS exceeds 65 lb. Since these rear-facing child restraints are only attached using the lower anchorages without a tether, the lower anchorages are subjected to greater loads in a crash than if a similar weight child and CRS were in the forward-facing mode with the tether attached.

In its correspondence sent to the agency, the Alliance requested that NHTSA make clear that the label limiting the combined (child+CRS) weight to 65 lb for lower anchor use also must be placed on rear-facing child restraints.

In response, we agree to reiterate that the labeling requirement of the February 2012 final rule applies to those CRSs using lower anchorages in the rear-facing mode. There is good reason for the applicability to these CRSs, as the safety need addressed by the label is relevant to rear-facing CRSs as it is to forward-facing CRSs. However, we believe that the combined child+CRS weight should not exceed 65 lb for CRSs in the rear-facing mode under any circumstances, unlike the potential 70 lb limit for forward-facing restraints using the 3-point anchorage attachment (lower anchors plus tether anchor). This is because FMVSS No. 225 requires the minimum strength of lower anchorages alone to be only 11 kN (compared to the 15 kN strength of the full 3-point anchorage system).

Accordingly, manufacturers of covered rear-facing CRSs must specify a maximum child weight limit for lower anchor use. (Again, the covered CRSs are those that are recommended for use in the rear-facing mode, for which the combined weight of the CRS and the maximum recommended child weight for the rear-facing mode exceeds 65 lb.) We are retaining the provision that each covered CRS must be labeled with the maximum child weight for use with the lower anchors, which is less than or equal to the difference between 65 lb and the weight of the CRS in pounds. The CRS manufacturer is to provide the child weight on the installation diagram specified by S5.5.2(l).

However, under today's final rule, we are also providing manufacturers an alternative of using a maximum child weight value that is a multiple of 5 lb by way of a lookup table. This alternative is adopted to enable manufacturers to avoid displaying an “ugly number” for the child weight. We are adding a provision in FMVSS No. 213 that specifies the lookup table for the maximum child weight limit in multiples of 5 lb for different weight ranges (60 − CRS weight (lb)) and are providing manufacturers the option of employing the table to obtain the maximum child weight limit. The maximum child weight limit is based on a calculation of 60 lb minus the weight of the CRS. We are using 60 lb rather than 65 lb as a starting point to ensure that the rounded value does not exceed 65 lb. This is important because for rear-facing restraints, the top tether will not be employed so the lower anchorages will be experiencing more crash forces than the full child restraint anchorage system. See Table 2, below.

Based on our testing experience, we believe that a set of minimally compliant lower anchorages (with a quasi-static strength of 11 kN) has sufficient dynamic strength to withstand inertial loads from a combined weight of 65 lb in a 35 mph frontal crash. 42

For CRSs that have a rear-facing and forward-facing mode with internal harnesses, we prefer that the CRS provide installation diagrams in both modes along with a corresponding maximum child weight limit for lower anchor use, if such a limit is required. However, we are not requiring installation diagrams in both modes at this time. If a CRS manufacturer only provides one installation diagram and if a child weight limit is required in only one of the modes (rear-facing or forward-facing), then the diagram shall depict the installation in that particular mode along with the corresponding child weight limit. Alternatively, if a child weight limit is required in both modes and only one installation diagram is provided, then the child weight limit is either less than or equal to the difference between 65 and the CRS weight (lb) or the lesser of the child weight limits determined by way of Table 1 for the forward-facing mode and Table 2 for the rear-facing mode.

The petitioners express concern that the 65 lb combined maximum weight limit “will unnecessarily restrict the use of the LATCH system and force caregivers back to using seat belts for anchoring forward-facing” child restraints.

We do not agree that the new label will significantly reduce the number of CRSs that are installed with the lower anchorages of child restraint anchorage systems. Currently, technicians at child seat inspection stations recommend use of the child restraint anchorage system for children weighing between 40-48 lb, which corresponds to about a 6-year-old (see Table 3, below). 43 We reviewed the weights of harness-equipped CRSs in the market since 2008  44 to assess what the child weight limit for lower anchor use would be per the new labeling requirement. The detailed data are provided in Table A3 in the appendix to this preamble. Our review of 69 forward-facing harness-equipped CRSs showed that only 3 percent (2/69) of CRS models would have a child weight limit less than 40 lb. A child weight of 40 lb corresponds to a 50th percentile 5-year-old child by weight (see Table 3, below). Twenty-nine (29) percent (20/69) would have a child weight limit of 40 or 45 lb. Thirty-six (36) percent (25/69) would have a child weight limit greater or equal to 50 lb for lower anchor use per the new labeling requirement, which corresponds to approximately a 40th percentile 7-year-old child, by weight. Finally, 32 percent (22/69) would not require a label specifying maximum child weight for lower anchor use since the combined CRS and maximum recommended child weight in harness-equipped CRSs is less than 65 lb (17 of these CRSs have a recommended child weight of 40 lb and for the remaining 5 CRSs it is 50 lb). Thus, the label will expand lower anchor use past the 48 lb child weight limit for forty-four (44) percent of child restraints, and only restricts approximately 3 percent of CRS models to a child weight limit less than 40 lb for lower anchor use. Overall, the label will not reduce current lower anchor use but will provide clarity and assurance that the anchors can be used as the child grows, which may in fact increase use of the anchors.

The agency found no infant carriers for which the combined CRS+child weight (CRS weight + maximum child weight recommended for infant seat) exceeded 65 lb; therefore, no infant carrier will currently need the label.

Among 46 CRS convertible and 3-in-1 models which can be used in rear-facing mode, only 4 CRS models (8.7 percent) had a combined child+CRS weight (maximum child weight + CRS weight recommended for rear-facing mode) in excess of 65 lb, which requires a label specifying the maximum child weight for lower anchor use (See Table A3 in the Appendix to this preamble). Among these 4 CRSs, one CRS weighs 33.8 lb with a recommended child weight in rear-facing mode of 40 lb, and the remaining 3 CRSs weighed between 22.3-25.8 lb with a recommended child weight in rear-facing mode of 45 lb. 45 It is unlikely that these CRSs will be used in rear-facing mode to the maximum recommended child weight of 40-45 lb since, as discussed in the next section, the child may get too tall to sit comfortably rear-facing or may exceed the height requirement before the weight limit is reached.

Permitting the calculated child weight limit to be a multiple of 5 lb will result in values that will be easier for the consumer to understand. The agency will incorporate this label in education material so that consumers are aware that there is a maximum child weight limit for lower anchor use and to look for this information on the CRS.

Field data show that harness-equipped CRSs are not now being widely used by consumers for children weighing more than 50 lb. The agency analyzed data from the National Child Restraint Use Special Study (NCRUSS)  46 to examine this issue. The survey data show that among children restrained in forward-facing harness-equipped CRSs (for both seat belt and lower anchor installation), 92.3 percent of the children weighed 40 lb or less, 5.9 percent weighed 41 to 50 lb, and only 1.5 percent weighed more than 50 lb (see Figure 3). Data suggest that children are outgrowing CRSs by height rather than by weight.

Since rear-facing harness-equipped CRSs are now designed for older/heavier children, the agency also used the NCRUSS survey to explore how these CRSs are used in the field. The NCRUSS survey show that 83.4 percent of children in rear-facing convertible or all-in-one seats (both of which are equipped with harnesses) weighed 25 lb or less, 13.2 percent weighed 26 to 30 lb, 3.2 percent weighed 30 to 35 lb (corresponding to a 50th percentile 4-year-old or 75th percentile 3-year-old), and 0.2 percent weighed more than 35 lb. The NCRUSS survey also show that 85.1 percent of children in rear-facing infant seats weighed 25 lb (corresponding to a 50th percentile 18 month old) or less, 13.9 percent weighed 26 to 30 lb, 47 and 1 percent weighed more than 30 lb (see Figure 4). The NCRUSS survey show that children weighing more than 35 lb are almost never restrained in rear-facing child restraints.

The petitioners state that “the decision to adopt 65 pounds as the combined maximum weight . . . will unnecessarily restrict the use of the LATCH system and force caregivers back to using seat belts for anchoring forward-facing [CRSs].” JPMA states that CRSs might not achieve a tight fit with a seat belt or may be too difficult to install with a seat belt and that parents might not know to switch to the seat belt during the several-year course of a CRS's use. Dorel states that child restraint anchorage systems are easier to use and have a higher rate of correct installation than seat belts, so an installation by the former is safer than a belt installation.

Agency Response: These arguments are speculative and unsupported. Field data show a high percentage of children weighing over 40 lb restrained in forward-facing CRSs installed with seat belts, i.e., consumers are now attaching CRSs with seat belts at a high rate. The consumers will not be “forced back” to doing something different. 48 Moreover, recent field data  49 shows that most children graduate to booster seats when they reach approximately 40 lb, which corresponds to a 95th percentile 3-year-old or a 50th percentile 5-year-old. Thus, it appears unlikely that the label will “force caregivers back to using seat belts for anchoring forward-facing” CRSs since many children do not now use harness-equipped CRSs when they reach 40 lb in weight.

The arguments that new seat belt designs are incompatible with CRS installation are speculative. Views are evolving regarding the compatibility of new belt designs, such as inflatable seat belts, with CRS installation. For instance, Britax initially recommended against CRS installation using inflatable belts, but has changed its mind and now permits CRS installations with the belts. We do not have reason to believe that seat belts with advanced technologies cannot be designed to install CRSs. We also note that SAE J1819 is undergoing revisions to improve compatibility of seat belts and child restraint anchorages with CRSs. 50 It would be premature for NHTSA to conclude that changes in seat belt design render installation of CRSs by seat belts unfeasible.

Regarding Dorel's statement, NHTSA believes that the statement is not germane to the issue of the design limits of child restraint anchorage systems. If the anchorages are used in a manner that results in material failure because the design limits of the anchorage system were exceeded, the child passenger is at risk regardless of the relative ease of using child restraint anchorage systems or the tightness of the installation of CRSs on the anchorages.

The petitioners also state that their intent in petitioning for reconsideration of the rule was to “minimize the likelihood that vehicle manufacturers will apply the same formula” to tether anchorages. Issues relating to weight limits for the top tether anchorage are out of scope of this rulemaking.

The petitioners believe that NHTSA should require vehicle manufacturers to increase the strength of child restraint anchorage systems to accommodate a higher combined weight. This issue is out of scope of this rulemaking.

Graco requests that the 10YO test dummy only be used to test CRSs when the dummy fits in the seat as per the manufacturer's recommended usage. Graco states that it produces a harness-equipped CRS recommended for a 70 lb child, but limits the recommended seated height of the child occupant and limits the head height relative to the seat. Graco asks that the 10YO dummy not be used to evaluate performance of the CRS if the dummy exceeds the recommended limits on seating height. Graco believes that in the real world, the seat would not be used with a child of this stature, and as a result, the 10YO dummy may give inaccurate readings. Alternatively, Graco suggests that the dummy be used to evaluate CRSs to assess structural integrity, chest resultant, and knee excursion limits but not the head excursion requirement. Graco states that the head excursion measurement resulting from the use of the 10YO dummy would not represent the real world due to the dummy being significantly taller than the recommended child occupant.

The agency is denying Graco's request. It is not in the public interest to exclude testing those CRSs recommended for children of a weight range represented by the 10YO dummy but whose height may be lower than that of the dummy.

The agency indirectly addressed this issue in the rulemaking. In the 2008 SNPRM (73 FR 3908), we had considered whether FMVSS No. 213 should expressly require that each CRS be capable of fitting the test dummy that is specified in S7 of the standard to evaluate the CRS. The agency only received comments from JPMA, which stated that child restraints are designed to accommodate the dummies with which they will be tested and that an explicit “fit” requirement is not required. After reviewing the comment, the agency decided not to pursue a fit requirement, assuming it was not needed because manufacturers already ensure that CRSs accommodate/fit the appropriate child dummies.

Graco is now indicating that a CRS it has produced is recommended for children represented by the 10YO dummy weight-wise, but does not fit the dummy height-wise. We do not believe it would be in the interest of safety to exclude the CRS from testing with the 10YO dummy, or exclude the CRS from a performance requirement, because the CRS does not actually fit the dummy. We believe that a better approach would be to subject the CRS to testing with the dummy if the manufacturer recommends the CRS for use with children represented by the dummy, as designated by S7 of FMVSS No. 213.

We have not been provided with any compelling information to exclude Graco's CRS from testing with the dummy. Graco has the option to lower the child weight recommendation of the CRS in question from 70 lb to 65 lb to avoid testing with the dummy, or it could continue to market the CRS for children over 65 lb and ensure that the CRS meets the FMVSS No. 213 requirements when tested with the 10YO (such as by redesigning the CRS to have a harness slot that can properly accommodate the 10YO dummy and/or making any structural changes needed to ensure integrity and performance using this dummy).

The February 2012 final rule adopted a provision (S5(f)) that basically excludes CRSs equipped with an internal harness from FMVSS No. 213 while attached to the lower anchors of the child restraint anchorage system under certain circumstances. The circumstances are: The test dummy used to test the CRS is of a weight such that the dummy's weight plus the CRS weight exceeds 65 lb. In a March 29, 2012 letter on this provision, Graco states that:

In response, NHTSA agrees that the provision in the 2012 final rule implies a need for information on the test dummy weights. However, as Graco notes, the test dummy weights vary, and the addition of clothing, shoes, and instrumentation (the weights for which are not specified in NHTSA's regulations) can affect the “weight” of the test dummy and add undue uncertainty to the test provisions of the standard. Uncertainty results from variability in the weight of the dummy due to variances in the clothing, shoes, and instrumentation used with a particular dummy. We conclude that, to avoid this uncertainty, S5(f) should be slightly revised to move from a reference of “a test dummy of a weight” to “the average weight of the child represented by the test dummy.” The average weight of the child represented by the dummy can be specified in FMVSS No. 213—which NHTSA is specifying in this final rule  51 —and is not subject to the same degree of variation as the “test dummy of a weight” provision. Thus, we will reword S5(f) to exclude from lower anchor testing CRSs tested with a dummy that results in the combined weight of the CRS and the average weight of child represented by the test dummy (shown in a table in the standard) to exceed 65 pounds in the forward-facing mode and 65 pounds in the rear-facing mode. 52

Using the average child weight represented by the test dummy eliminates the variability of dummy weights due to differences in instrumentation and clothing. The average child weights are within the weight range for dummy selection specified in S7.1.2 and so would not change the method of testing CRSs. In addition, using the average child weight in the referenced table ensures that the child restraint system is tested using lower anchors with the test dummy closest to the maximum child weight limit on the label for lower anchor use.

An example illustrating this is as follows. If a CRS weighing 19 lb has a label specifying 50 lb as the maximum child weight for lower anchor use, this CRS will be tested using the lower anchors with the Hybrid III 6-year-old dummy. The average weight of the child represented by this test dummy is 45 lb.

The agency has considered the impact of this regulatory action under E.O. 12866 and E.O. 13563 and the Department of Transportation's (DOT's) regulatory policies and procedures. This rulemaking action was not reviewed by the Office of Management and Budget under E.O. 12866. This rulemaking is also not significant under DOT's regulatory policies and procedures (44 FR 11034, February 26, 1979).

This response to a petition for reconsideration mostly denies the petition. The few changes that are being made are minor, mostly to clarify a labeling requirement and to provide flexibility to CRS manufacturers regarding the wording of the label. We estimate that today's final rule has no effect on the estimated costs and benefits and other economic impacts of the February 27, 2012 final rule.

The Regulatory Flexibility Act of 1980, as amended, requires agencies to evaluate the potential effects of their proposed and final rules on small businesses, small organizations and small governmental jurisdictions. I hereby certify that this final rule will not have a significant economic impact on a substantial number of small entities. Small organizations and small governmental units will not be significantly affected since the potential cost impacts associated with this final rule will not significantly affect the price of child restraints.

This final rule denies most of the petition for reconsideration of the February 2012 final rule. To the extent we are amending the original final rule, the amendments are minor, mostly to clarify a labeling requirement, and adequate lead time is provided. The cost of revising the label is minimal.

NHTSA has analyzed this rulemaking action for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action would not have any significant impact on the quality of the human environment.

NHTSA has examined this final rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999) and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that the rulemaking would not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The final rule would not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

NHTSA rules can preempt in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemption provision: When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter. 49 U.S.C. 30103(b)(1). It is this statutory command by Congress that preempts any non-identical State legislative and administrative law addressing the same aspect of performance.

The express preemption provision described above is subject to a savings clause under which “[c]ompliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person from liability at common law.” 49 U.S.C. 30103(e) Pursuant to this provision, State common law tort causes of action against motor vehicle or equipment manufacturers that might otherwise be preempted by the express preemption provision are generally preserved. However, the Supreme Court has recognized the possibility, in some instances, of implied preemption of such State common law tort causes of action by virtue of NHTSA's rules, even if not expressly preempted. This second way that NHTSA rules can preempt is dependent upon there being an actual conflict between an FMVSS and the higher standard that would effectively be imposed on motor vehicle or equipment manufacturers if someone obtained a State common law tort judgment against the manufacturer, notwithstanding the manufacturer's compliance with the NHTSA standard. Because most NHTSA standards established by an FMVSS are minimum standards, a State common law tort cause of action that seeks to impose a higher standard on motor vehicle or equipment manufacturers will generally not be preempted. However, if and when such a conflict does exist—for example, when the standard at issue is both a minimum and a maximum standard—the State common law tort cause of action is impliedly preempted. See Geier v. American Honda Motor Co., 529 U.S. 861 (2000).

Pursuant to Executive Order 13132 and 12988, NHTSA has considered whether this rule could or should preempt State common law causes of action. The agency's ability to announce its conclusion regarding the preemptive effect of one of its rules reduces the likelihood that preemption will be an issue in any subsequent tort litigation.

To this end, the agency has examined the nature (e.g., the language and structure of the regulatory text) and objectives of this rule and finds that this rule, like many NHTSA rules, prescribes only a minimum safety standard. As such, NHTSA does not intend that this rule preempt state tort law that would effectively impose a higher standard on motor vehicle or equipment manufacturers than that established by this rule. Establishment of a higher standard by means of State tort law would not conflict with the minimum standard announced here. Without any conflict, there could not be any implied preemption of a State common law tort cause of action.

With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729, February 7, 1996) requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement.

Pursuant to this Order, NHTSA notes as follows. The preemptive effect of this rule is discussed above. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceeding before they may file suit in court.

NHTSA has provided a 60-day comment period (77 FR at 11645) and a 30-day comment period (78 FR at 77554) on the collection of information requirement in the previous final rule. 53 The agency asked for public comments on a collection of information titled, “Consolidated Child Restraint System Registration, Labeling and Defect Notifications.” OMB Control Number: 2127-0576. The requested expiration date of approval is 3 years from the approval date. We requested approval of a revision to a currently approved collection, and for revising an existing label and adding a sentence to the printed instructions of certain child restraint systems (CRSs with internal harnesses for which the combined weight of the CRS and the maximum recommended child weight for use with internal harness exceeds 65 lb). The added sentences will inform the consumer that the lower anchors of a child restraint anchorage system may be used up to a combined weight of child and harnessed-child restraint of 65 lb. The purpose of this label is to reduce consumer confusion about using the lower anchors and to reduce the risk that the lower anchors will be used in a way that is beyond the design limitations of the anchorage system.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272) directs NHTSA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies, such as the Society of Automotive Engineers (SAE). The NTTAA directs the agency to provide Congress, through the OMB, explanations when we decide not to use available and applicable voluntary consensus standards.

NHTSA has reviewed available information and has determined that there are no voluntary consensus standards relevant to this rulemaking.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million in any one year (adjusted for inflation with base year of 1995). This final rule would not result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector of more than $100 million annually.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental, health, or safety risk that NHTSA has reason to believe may have a disproportionate effect on children. This rulemaking is not subject to the Executive Order because it is not economically significant as defined in E.O. 12866.

Executive Order 13211 (66 FR 28355, May 18, 2001) applies to any rulemaking that: (1) Is determined to be economically significant as defined under E.O. 12866, and is likely to have a significantly adverse effect on the supply of, distribution of, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. This rulemaking is not subject to E.O. 13211.

The Plain Language Writing Act of 2010 (P. L. 111-274) and Executive Order 12866 require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

—Have we organized the material to suit the public's needs?

—Are the requirements in the rule clearly stated?

—Does the rule contain technical language or jargon that is not clear?

—Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

—Would more (but shorter) sections be better?

—Could we improve clarity by adding tables, lists, or diagrams?

—What else could we do to make this rulemaking easier to understand?

If you have any responses to these questions, please send them to NHTSA at the ADDRESSES section in the heading of this final rule.

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In consideration of the foregoing, NHTSA amends 49 CFR part 571 as follows:

NMFS regulations at 50 CFR 648.90(a)(4)(iii)(C) authorize the Regional Administrator (RA) to reduce the scallop fishery sub-ACL to the amount projected to be caught, and increase the groundfish fishery sub-ACL up to the amount reduced from the scallop fishery if, by January 15 of each year, the scallop fishery is expected to catch less than 90 percent of its GB or SNE/MA yellowtail flounder sub-annual catch limit (sub-ACL). This adjustment is intended to help achieve optimum yield, while not threatening an overage of the ACLs for the stocks.

Based on the most current available data, NMFS projects that the scallop fishery will have unused quota in the 2013 fishing year (FY). Although for the first time starting in FY 2013, three Scallop Access Areas will remain open during the month of February, NMFS' analysis assumed similar scallop fleet effort and behavior to past years. It is possible that the additional open areas will increase effort and potentially result in higher yellowtail flounder bycatch. However, NMFS accounted for this uncertainty by using the high-end estimates of the catch projections. As of January 15, the projections indicate that the scallop fishery is expected to catch 41.5 mt of GB yellowtail, or 49.8 percent of its FY 2013 sub-ACL, and 43.6 mt of SNE/MA yellowtail, or 71.4 percent of its FY 2013 sub-ACL. Because the scallop fishery is not expected to catch its entire allocation of GB and SNE/MA yellowtail flounder, this rule transfers the unused quota for the remainder of the 2013 FY of GB and SNE/MA yellowtail flounder from the Atlantic scallop fishery to the NE multispecies fishery. The intent is to provide additional harvest opportunity to the NE multispecies fishery while ensuring sufficient amounts of GB and SNE/MA yellowtail flounder are available for the scallop fishery.

Based on the new projections of GB and SNE/MA yellowtail flounder catch by the scallop fishery, effective February 20, 2014, through April 30, 2014, NMFS reduces the scallop sub-ACL for both stocks to the amount projected to be caught, and increases the groundfish sub-ACLs. To account for uncertainty in inseason catch projections, NMFS increases the groundfish sub-ACLs by 90 percent of the amount reduced from the scallop sub-ACLs. This results in an additional 37.7 mt of GB yellowtail flounder, and 15.7 mt of SNE/MA yellowtail flounder, for the groundfish fishery. Table 1 summarizes the revisions to the FY 2013 sub-ACLs, and Table 2 shows the revised allocations for the NE multispecies fishery as allocated between the sectors and common pool based on final sector membership for FY 2013.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that the management measures implemented in this final rule are necessary for the conservation and management of the NE multispecies fishery and consistent with the Magnuson-Stevens Act, and other applicable law.

This action is authorized by 50 CFR part 648 and is exempt from review under Executive Order 12866.

The NMFS Assistant Administrator finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment for this in season sub-ACL adjustment because notice and comment would be impracticable and contrary to the public interest. The regulations at § 648.90(a)(4)(iii)(C) grant the RA authority to reduce the scallop fishery sub-ACL to the amount projected to be caught, and increase the groundfish sub-ACL by 90 percent of the amount reduced from the scallop sub-ACLs in order to maximize the GB and SNE/MA yellowtail flounder yield. The updated projections of GB and SNE/MA yellowtail flounder catch in the scallop fishery only became available on January 15, 2014, therefore NMFS could not have taken this action earlier. In addition, the current fishing year ends on April 30, 2014. If NMFS allowed for the time necessary to provide for prior notice and comment, the resulting delay in the sub-ACL adjustments could prevent in the short-term NE multispecies vessels from fully harvesting GB and SNE/MA yellowtail flounder catch at higher rates and potentially prevent the full harvest of the sub-ACLs of other groundfish stocks that are caught coincidentally with GB and SNE/MA yellowtail flounder before the end of the fishing year on April 30, 2014. Given the significant decreases in catch limits for many groundfish stocks in FY 2013, any delay in increasing such limits through this transfer could prevent fishermen from attempting to offset their current negative economic circumstances. Giving effect to this rule as soon as possible will provide immediate relief to fishermen.

The NMFS Assistant Administrator also finds good cause pursuant to 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness for this action for these same reasons. This rule provides additional harvest opportunity to the NE multispecies fishery while ensuring sufficient amounts of GB and SNE/MA yellowtail flounder are available for the scallop fishery. A delay in the sub-ACL adjustments could prevent in the short-term, given the end of the fishing year on April 30, 2014, NE multispecies vessels from fully harvesting GB and SNE/MA yellowtail flounder catch at higher rates and potentially prevent the full harvest of the sub-ACLs of other groundfish stocks that are caught coincidentally with GB and SNE/MA yellowtail flounder. Further, there is no need to allow the industry additional time to adjust to this rule because it does not require any compliance or other action on the part of individual scallop or groundfish fishermen.

Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and one has not been prepared.