The CPSIA was enacted on August 14, 2008. Section 104(b) of the CPSIA, part of the Danny Keysar Child Product Safety Notification Act, requires the Commission to promulgate consumer product safety standards for durable infant and toddler products. These standards are to be “substantially the same as” applicable voluntary standards or more stringent than the voluntary standard if the Commission concludes that more stringent requirements would further reduce the risk of injury associated with the product. The term “durable infant or toddler product” is defined in section 104(f)(1) of the CPSIA as a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years. Infant swings are one of the products specifically identified in section 104(f)(2)(K) of the CPSIA as a durable infant or toddler product.

In theFederal Registerof February 29, 2012, the Commission published a notice of proposed rulemaking (NPR) that proposed incorporating by reference ASTM F2088-11b,Standard Consumer Safety Specification for Infant Swings,with several modifications to strengthen the standard. 77 FR 7011. In this document, the Commission is issuing a safety standard for infant swings, which incorporates by reference, the new voluntary standard developed by ASTM International (formerly the American Society for Testing Materials), ASTM F2088-12a,Standard Consumer Safety Specification for Infant Swings,with the addition of a labeling modification to strengthen the standard and a revised test method to address an omission in the voluntary standard in the test method for toy mobiles that are attached to the swing.

We summarize the final rule (including differences between the proposal and the final rule) in section F of this preamble. The information discussed in this preamble comes from CPSC staff's briefing package for the infant swing rule, which is available on the CPSC's Web site athttp://www.cpsc.gov/library/foia/foia12/brief/infantswings.pdf.

ASTM F2088-12a, and its predecessors, ASTM F2088-11b and ASTM F2088-12, define an “infant swing” as “a stationary unit with a frame and powered mechanism that enables an infant to swing in a seated position. An infant swing is intended for use with infants from birth until a child is able to sit up unassisted.” ASTM F2088-12a, and its predecessors, ASTM F2088-11b and ASTM F2088-12, also address “cradle swings,” which are defined as “an infant swing which is intended for use by a child lying flat” and “travel swings,” which are defined as “a low profile, compact swing having a distance of 6 in. or less between the underside of the seat bottom and the support surface (floor) at any point in the seat's range of motion.” The standard was developed in response to incident data supplied by CPSC staff to address hazards such as: Swings tipping over or collapsing, structural failures, entanglement in the restraints, and entrapment in leg holes.

Based on a 2005 survey conducted by American Baby Group, titled, “2006 Baby Products Tracking Study,” and Centers for Disease Control and Prevention birth data, we estimate that approximately 2.7 million infant swings are sold in the United States each year. We estimate that there are at least 10 manufacturers or importers supplying infant swings to the U.S. market. Eight firms are domestic manufacturers, and two are domestic importers with a foreign parent company.

The Juvenile Products Manufacturers Association (JPMA) is the major U.S. trade association that represents juvenile product manufacturers and importers. The JPMA provides a certification program that allows manufacturers and importers to use the JPMA seal if they voluntarily submit their products for testing to an independent laboratory to determine if their products meet the most current ASTM voluntary standard. Currently, there are five manufacturers that sell JPMA-certified infant swings.

The preamble to the NPR (77 FR 7012 through 7013) summarized the data for incidents with infant swings from January 1, 2002, through May 18, 2011. In this section, we discuss CPSC staff's analysis of incidents collected between May 19, 2011 and May 23, 2012. During that period, 351 new infant swing-related incidents were reported to the CPSC. Almost all were reported to have occurred between 2009 and 2012. The majority (333 out of 351 or 95 percent) of the reports were submitted to the CPSC by retailers and manufacturers through the CPSC's “Retailer Reporting System.” The remaining 18 incident reports were submitted to the CPSC from various sources, such as the CPSC Hotline, Internet reports, newspaper clippings, medical examiners, and other state/local authorities. Two of the 351 incidents were fatal, and 349 were nonfatal; 24 of the nonfatal incidents resulted in injuries.

Of the two decedents in the fatal incidents, one was a 2-month-old who died when a blanket placed in the swing obstructed his airway, and the other was a 3-month-old who died when she rolled over to a prone position onto the soft surface of the infant swing. The report did not state whether a restraint was in use at the time of the latter incident.

There were 24 injuries reported among the 349 nonfatal incidents. Among the injured, 79 percent were 6 months old or younger; the remaining injured infants were 7 and 8 months of age. Some reports specifically mentioned the type of injury, while others only mentioned an injury with no specifics. Among the injuries specified, bumps, bruises, and lacerations were common. None required hospitalization. Most of the injuries were related to various product-related issues, such as swing seat, structural integrity, or restraint, similar to those reported and addressed in the NPR and the latest version of the voluntary standard.

Therewere an estimated total of 1,900 injuries (sample size = 73, coefficient of variation = 0.18) related to infant swings that were treated in U.S. hospital emergency departments during 2011. Although this reflects a decrease from the 2010 estimate of 2,200 injuries, the change was not statistically significant. Comparing with national injury estimates from the prior years, no statistically significant trend was observed over the 2002-2011 period.

No deaths were reported through the NEISS. About 78 percent of the injured were 6 months of age or younger, and about 91 percent were 12 months or younger. For the emergency department-treated injuries related to infant swings, the following characteristics occurred most frequently:

• Hazard—falls (78%); a majority of the reports did not specify the manner or cause of fall;

• Injured body part—head (62%);

• Injury type—internal organ injury (59%); and

• Disposition—treated and released (97%).

The hazard patterns identified among the 351 new incident reports were similar to the hazard patterns that were identified among the incidents considered for the NPR. Most of the issues were determined to be product related. They are grouped as follows (in descending order of frequency of incidents):

•Swing seat issues,either seat design or seat failure, were the most commonly reported hazard, accounting for 25 percent of the 351 incident reports and four (17 percent) injuries. Seat design issues caused the seats to lean to one side, or tilt forward or backward. Seat failures resulted in seats folding up on the infant, seat pads not staying in place, or seats falling off with no other apparent component failure. With seats that leaned to one side, the infant bumped into the swing frame; with the seat failures, the infant almost always fell out of the swing.

•Broken, detached, or loose components of the swing housing,such as the arm, leg, motor housing, or hardware, were the next most commonly reported problems. They accounted for 24 percent of the 351 incident reports and five (21 percent) injuries.

•Restraint issues,either the inadequate design of the restraint or the failure of the restraint, were reported in 23 percent of the 351 reported incidents. These issues resulted in the highest proportion of injuries (10 injuries or 42 percent). Common restraint-design scenarios included: (1) Infant falling (or nearly falling) out of the seat when leaning forward or sideways; and (2) infant putting more weight toward the back of the seat, causing the seat to tilt back and the restraint failing to prevent the infant from sliding out on his/her head. Common restraint-failure scenarios included buckles or straps breaking or detaching from the product altogether.

•Electrical or battery-related issueswere reported in 15 percent of the 351 reports. Overheating of the motor housing was the most common scenario. However, there were no injuries reported related to this issue.

•Instability of the swingwas reported in 5 percent of the incident reports. In most of these cases, the swing was described as lifting up one leg when swinging, or tipping over completely. The latter scenario resulted in one injury.

•Other product-related issues,such as inadequate clearance between seat and swing frame, broken or detached toys and mobiles, and problems with swing speed, seat fabric, and assembly instructions were reported in 6 percent of the 351 incidents. One injury was reported.

•Miscellaneous other issuesaccounted for the remaining 2 percent of the 351 incident reports. This category includes the two fatalities, which were determined to be non-product-related. Also in this category were five reports with insufficient information to characterize any specific hazard, and one report of product misuse, such as the intentional removal of the restraint; these nonfatal incidents resulted in three injuries.

Below, we describe and respond to the comments on the proposed rule. A summary of each of the commenter's topics is presented, and each topic is followed by our response. Each “Comment” is numbered to help distinguish between different topics. The number assigned to each comment is for organizational purposes only, and it does not signify the comment's value, or importance, or the order in which it was received. We received 24 comments. All of the comments can be viewed onwww.regulations.gov,by searching under the docket number of the rulemaking, CPSC-2012-0011.

(Comment 1) Sixteen comments recommend that the text of the warning specify or clarify the hazard or the consequences of not avoiding the hazard. Comments about the need to specify the consequences of not avoiding the hazard generally recommend that the warning state explicitly that there is a risk of serious injury, death, or both. Comments about the need to clarify the hazard suggest explicit references to “asphyxiation” or “choking,” or suggest references to the slump-over position or to a hunched position with the “chin touching chest.” Several of the comments recommend that the warning specify the ages of the children at risk.

(Response 1) We believe that the current warning language requirements pertaining to the slump-over hazard are insufficient and agree that the warning should be revised to clarify the hazard and the consequences of exposure to the hazard if the consumer cannot avoid it. The current warning statement does not describe the slump-over hazard, and the formatting of the warning implies that using the swing in the most reclined seat position is an additional measure intended to address the potential for the infant user to fall or strangle in the straps. In addition, one could argue that the warning statement does not describe the probable consequences of not avoiding the slump-over hazard because the warning's reference to “serious injury or death” is specific to falls and strangulations.

The final rule separates the warning statement pertaining to the slump-over hazard from the warnings about falls and strangulations and strengthens this warning statement as follows:

(Comment 2) Five comments recommend that the warning should state that infants who cannot hold up their heads unassisted should use only cradle swings. One comment states that such a change would not substantially reduce the risk.

(Response 2) The proposed revisions to the slump-over warning statement already improve the relevant warning statement in ASTM F2088-12a, by describing the hazard more explicitly, the consequences of exposure to the hazard, and the infants who are most at risk. The language, “Keep swing seat fully reclineduntil child is at least 4 months old AND can hold up head without help” (emphasis added) is the part of the revised slump-over warning intended to communicate the appropriate hazard-avoidance behavior. Several comments recommend that the highlighted portion of this statement be replaced with one that instructs consumers to use only cradle swings.2 The effectiveness of this change, therefore, depends upon whether the use of a cradle swing with these children would address more incidents than fully reclining the seat back on non-cradle swings.

As noted in the staff's briefing package for the NPR, all known swing fatalities occurred when the child was in the infant seat mode rather than the cradle mode. However, CPSC staff concluded that, for infant swings having an adjustable seat recline with a seat back angle greater than 50 degrees, fully reclining the seat back until the infant can hold up his or her head unassisted also would address the slump-over hazard. Thus, we doubt that a warning that tells consumers to use only cradle swings will be more effective than one that tells consumers to recline the seat fully.

(Comment 3) Five comments request that all infant swings, not just reclining models with a seat back angle greater than 50 degrees, bear a warning related to the slump-over hazard. One of these comments recommends that all reclining swings, regardless of the seat back angle, warn about placing the seat in the most reclined position for infants who are younger than 3 months or who cannot hold up their heads without assistance. The remaining comments recommend that certain swings bear a warning prohibiting their use with infants who are younger than 3 months or who cannot hold up their heads without assistance. Of these, one recommends that such a warning be present on all infant swings that do not lie “flat”; one recommends displaying the warning for all reclining swings, regardless of the seat back angle; two recommend that such a warning be present on all non-reclining models; and one of these two comments also recommends displaying the warning for all reclining models with seat back angles less than 50 degrees.

(Response 3) As far as the Commission knows, all infant swings currently on the market are either cradle swings or reclining swings with a maximum seat back angle greater than 50 degrees from horizontal when measured in accordance with the ASTM standard. We are unaware of any reclining swings with a maximum seat back angle less than 50 degrees from horizontal. Therefore, all reclining infant swings would bear the warning label recommending that the seat be placed in the most reclined position for infants who are younger than 4 months or who cannot hold up their heads without assistance. As noted earlier, CPSC staff has concluded that fully reclining the seat back on reclining swings with a seat back angle greater than 50 degrees addresses the slump-over hazard. Thus, although the final rule would not prevent manufacturers from including the warning on reclining swings with a maximum seat back angle less than 50 degrees from horizontal, we do not believe that mandating such a warning on these products is necessary. Cradle swings would not require the warning label because the seat back angle on these swings is not inclined enough to create the slump-over hazard.

(Comment 4) Two comments recommend the use of pictures or visual aids to clarify the warning message. One of these comments suggests that this recommendation was intended for parents whose primary language is not English, or who are not familiar with measurements described in degrees.

(Response 4) We acknowledge that well-designed graphics might be useful to illustrate the appropriate orientation of the seat back when the infant swing is used with children 3 months old and younger. However, we are not convinced that a graphic is necessary to convey this message to most consumers, and CPSC staff's prior analyses of the incident data associated with infant swings has not revealed a pattern of incidents involving people who were not literate in English. Moreover, the design of effective graphics can be difficult. Some seemingly obvious graphics are poorly understood and can give rise to interpretations that are opposite the intended meaning (so-called “critical confusions”). Thus, although the Commission may take action in the future if it believes graphic symbols are needed to reduce further the risk of injury associated with these products, the rule permits, but does not mandate, such supporting graphics.

Lastly, although the slump-over warning statement would be required on infant swings that have an adjustable seat recline with a seat back angle greater than 50 degrees, the warningstatement itself is not required to reference this 50-degree measurement. The final rule does not include any revisions to the slump-over warning statement that would introduce reference to “degrees.”

(Comment 5) One comment recommends that the infant swing recline settings include age recommendations. However, this commenter also acknowledges that developmentally delayed infants may be endangered when the parent or caregiver follows the age-recommended settings.

(Response 5) The new warning label wording in the final rule explicitly directs consumers to use the swing in the most reclined position until the infant is 4 months of age and can hold their head up without help. Once the infant is able to do this, the swing can be used in any of the other settings. Therefore, adding age recommendations to the swing settings is not necessary.

(Comment 6) One comment recommends that the slump-over warning be required to be printed in languages in addition to English. The comment suggests that the warning should be in English and Spanish at least.

(Response 6) The Commission does not dismiss the potential usefulness of providing the slump-over warning and other warning information in Spanish and other non-English languages, and it recognizes that adding Spanish versions of the warnings most likely would improve warning readability among the U.S. population more than adding any other language. Nevertheless, as noted in the response to comment 4 above, CPSC staff's prior analyses of the incident data associated with infant swings has not revealed a pattern of incidents involving people who were not literate in English. Thus, although the final rule does not prohibit manufacturers from providing the required warnings in languages other than English, the available information provides no basis for mandating that manufacturers do so.

(Comment 7) Two comments state that the product should include warnings about the importance of using the restraint system. One of these comments recommends the use of the phrase: “DO NOT PLACE INFANT IN SWING WITHOUT SECURING RESTRAINTS.” The other comment states that the warnings should “address the risks associated with a caregiver's failure to properly employ the use of restraints while the swing is in use.” One additional comment uses “failing to use the restraint system” as an example of product misuse, which should be warned against.

(Response 7) Section 8.3.1 of ASTM F2088-12a already warns about the potential for “serious injury or death from infants falling or being strangled in straps” and instructs consumers: “[a]lways secure infant in the restraint system provided.” In addition, the latter statement is nearly identical to the specific phrase recommended in the first comment cited in the comment summary. Thus, we believe that the current warning statements about this hazard are sufficient.

We do not believe that the product should include warnings about general product misuse. Consumers are less likely to read numerous warnings, especially about hazards that are highly unlikely. Therefore, warning about general product misuse or about numerous instances of product misuse that, individually, are very rare, would increase the likelihood that consumers will not receive the most important hazard information for the product.

(Comment 8) Three comments state that the product should warn against allowing infants to sleep in the swing. One of the comments suggests that the following language be added to the warning: “Do not use the swing for routine sleep.”

(Response 8) We do not believe that warning statements about not allowing infants to sleep in the swing should be added. CPSC staff's prior review of the available incident data suggests that the angle of the seat back is more relevant to the potential for slump-over deaths and that adjusting the seat back to the most reclined position would have addressed these incidents. The warnings already include a statement about adjusting the seat back to the most reclined position for those children most at risk of slumping over, and the final rule revises the warning statement to clarify this message. Thus, we believe that warnings about not sleeping in infant swings are unlikely to reduce further the incidence of slump-over deaths; additionally, the data do not support mandating such a warning.

(Comment 9) One comment recommends that there be warnings about limiting the amount of time that infants spend in the swing for “health and developmental concerns,” namely, positional/deformational plagiocephaly and developmental delays from a lack of “tummy time.”

(Response 9) Warnings are safety communications intended to inform consumers about hazards, with the ultimate goal of reducing injuries and deaths. Thus, while there may be exceptions, one generally should not provide a warning, unless a significant hazard exists. We are not aware of any reported incidents of positional/deformational plagiocephaly involving infant swings. Even if one presumes that such an association exists, CPSC staff has confirmed that this condition does not pose a hazard to infants. Similarly, developmental delays from a lack of “tummy time” are not hazardsper se,and they do not directly lead to injuries or deaths. Consequently, we do not believe that this issue rises to the level that such a mandatory warning on the product is necessary.

(Comment 10) One comment recommends that swings supported by a single arm include a warning about the increased likelihood of seat deflection.

(Response 10) We do not believe that a warning about an increased likelihood of seat deflection is necessary for single-arm infant swings. Since publication of the NPR, CPSC staff has worked with the ASTM Subcommittee on Infant Swings to develop new, improved performance requirements intended to address seat deflection. We believe that these requirements, which are part of the final rule, will effectively address the risk associated with seat deflection, and therefore, eliminate the need for a warning.

(Comment 11) One comment recommends that all swings with AC or electrical power cords include a warning label on the cords similar to that in the baby monitor standard, which warns about the strangulation hazard that such cords pose.

(Response 11) We do not believe that mandating a strangulation warning on the AC or electrical power cords that might accompany certain infant swings is appropriate at this time. The recently published voluntary standard for baby monitors, ASTM F2951-12,Standard Consumer Safety Specification for Baby Monitors,does require strangulation warnings on the cords of baby monitors, but specifies different warnings, depending on whether the product is intended to be attached to a crib or not.For transmitters that are not intended to be attached to a crib, the warning instructs consumers to keep the cord more than 3 feet away from the child. For transmitters that are intended to be attached to a crib—a situation more analogous to an infant swing that holds the infant and has an electrical power cord attached—the warning instructs consumers to use the manufacturer-supplied protective cord covering at all times. However, infant swings are not required to provide protective coverings for electrical power cords, so it is unclear how consumers would comply with such a warning.

A general warning about the risk of strangulation from these cords when the child is in the product might be more reasonable. However, we are not aware of any incidents associated with this hazard scenario involving infant swings, which suggests that this hazard does not rise to the level that a mandatory warning is necessary. Manufacturers of infant swings with cords are free to include strangulation warnings on their cords, and we can revisit the possibility of mandating such warnings if future incident data show that doing so would be appropriate.

(Comment 12) One comment states that the CPSC-proposed rule would require the tester to use a 75-lb weight and to drop it 500 times on the swing seat. The comment questions the new test method's predictive ability to replicate real-world conditions and injuries, because, the commenter states, the ASTM standard required a 25-lb weight dropped 50 times onto the seat. Next, the comment suggests that the total number of drops could be increased beyond the current 500 drops. The total number of drops could be based on a consumer survey, asking parents how many times a day they put their baby in the swing and whether they used it for one or more babies. Lastly, the comment states that it is unclear why the test involves dropping. The force of an impact, especially with a drop mass of 75 lbs repeated 500 times, could weaken the infant swing at an unreasonable and unrepresentative rate. The comment recommends instead that the test should measure the effect of a static mass placed in the seat over a period of time. Another comment questions the 75-lb requirement in the static load test and requests the justification for this requirement.

(Response 12) The current ASTM standard, F2088-12a, has adopted the CPSC staff recommendation to increase the number of drops from 50 to 500 in the dynamic load test. The additional cycles were based on CPSC staff testing, which included life cycle testing. We believe a cyclic test of 500 drops is an appropriate test to evaluate the potential for structural failure in an infant swing. Continued testing beyond 500 cycles did not reveal any new issues, and it may place an unnecessary burden on the manufacturers and test labs. Additionally, the dynamic test specifies a 25-lb load not a 75-lb load, as suggested by the comment. The 25-lb load is the approximate weight of a 95th percentile 10- to 12-month-old child, and we agree with the rationale listed in the appendix of ASTM F2088-12a. The static load test included in the standard is the only test that calls for the application of a 75-lb load in the seat. The 75-lb static load has been part of the voluntary standard since its inception in 2001; this is not something newly added by the CPSC.

Finally, the dynamic test drop height is 1 inch. We consider the forces applied from this drop to be consistent with actual forces associated with swing use. Performing the dynamic test as specified in the standard ensures consistent, repeatable testing results. Together, these tests are intended to evaluate the structural integrity of the infant swing, and we believe they are sufficient to address structural issues that would occur over the life of the product.

(Comment 13) One comment states: “Because of the constant use/storage/lending use pattern of swings, we recommend that CPSC consider including additional requirements in the standard for infant swings, such as the provisions in the crib standard that seek to reduce hardware loss or misassembly. This could include requiring hardware that doesn't back out or become loose, captive hardware, performance requirements to avoid misassembly, and a method to make sure instructions stay with the product.”

(Response 13) The CPSC has considered or addressed misassembly issues in the standards for bassinets, play yards, and cribs, based on reported incidents and known usage patterns. We are aware of these hazard patterns in other juvenile product incidents, but we have concluded that ASTM has sufficiently addressed these issues by requiring that all threaded fasteners connecting structural components have a locking mechanism, such as lock washers, self-locking nuts, or other features designed to prevent detachment due to vibration. A product evaluation by CPSC staff revealed that many current swing designs use other means, such as Valco-type (push) button fasteners, which are permanently attached to the respective component. In most swing designs, misassembly of a swing would make the frame overtly unstable or result in an unnatural appearance that would be obvious to the consumer. The addition of a misassembly requirement would add a testing requirement for an incident pattern that is not evident among the incidents reported and that is addressed by the existing standard.

(Comment 14) Multiple comments question the seat deflection test and how it relates to injury reduction. Individual comments suggest including a second test to account for the potential of increased deflection over the life of the product. Another comment states that the CPSC did not explain why the agency chose 4 inches as its performance requirement.

(Response 14) Seat deflection is a design issue that should be addressed during the product's development and verified with standard testing. The seat deflection test proposed by the Commission was a preliminary test procedure under development at the time of the NPR. CPSC staff has continued to work with ASTM to refine the seat deflection test for infant swings. ASTM's latest standard includes a new test methodology and performance requirements that measure various seat angles, as was suggested by one commenter, and it addresses satisfactorily the seat deflection issues raised by CPSC staff.

(Comment 15) One comment states that infant swings are not designed to be operated by children. Instead, the comment states that infant swings are designed to beusedby children, but they are designed to beoperatedby adults. Therefore, the comment asserts that infant swings are not subject to 16 CFR part 1505,Requirements for electronically operated toys or other electrically operated articles intended for use by children.According to the comment, third party laboratories have been interpreting 16 CFR part 1505 in this manner for many years. Adding a new interpretation to 16 CFR part 1505, the comment suggests, would create confusion and would be inconsistent with test protocols currently employed.

(Response 15) While the NPR proposed that swings operating from an a/c power source be required to conform to 16 CFR 1505, ASTM reworded the provision in ASTM F2088-12a to address the issue of assuring that ACadapters meet all national safety standards. We agree with the new language contained in ASTM F2088-12a, which is being incorporated into the final rule. Therefore, it is unnecessary to include any reference to part 1505 in the final rule.

(Comment 16) One comment recommends that the CPSC consider adding a marking on products that are manufactured after the effective date so that consumers can clearly identify new products that meet the new mandatory standard.

(Response 16) A date code is already required to be on the product under section 8.1.3 of ASTM F2088-12a and under the requirements for consumer registration of durable infant or toddler products in 16 CFR 1130.3. In addition, future changes to the standard may come into effect. Because it is not practicable to delineate every change to the standard through a new mark on the product, we decline to take such action.

(Comment 17) One comment states: “* * * the pre-existing voluntary standards unaddressed by the new regulation is [sic] the sweeping definition that places all infant swings in the same category for children up to the age of five.”

(Response 17) The proposed rule and the voluntary standard both indicate that the infant swings are “intended for use with infants from birth until a child is able to sit up unassisted.”The comment may have misunderstood the reference in theFederal Registernotice, where the“definition of a ‘durable infant or toddler product' is defined in section 104(f)(1) of the CPSIA as a durable product intended for use, or that may be reasonably expected to be used, by children under the age of 5 years.”

(Comment 18) One comment states that CPSC staff should try “to obtain a more accurate number of manufacturers who do not meet the ASTM standard” and suggests that we “count those manufacturers that sell at major retailers that require ASTM compliance” as well. The comment states that because “just ten firms are making or importing swings, CPSC could easily get direct information that would more clearly identify costs.”

(Response 18) We have attempted to obtain accurate estimates of small firms that do not conform to the ASTM voluntary standard for infant swings and information on the likely costs of conformance. Further effort would not change the results of the analysis. Nor is it necessarily easy for firms to estimate prospectively the economic impact that a regulation will have on their costs.

(Comment 19) One commenter states that the regulatory flexibility analysis should consider the effect that a product recall would have on firms “ * * * that are not known to be in compliance with the voluntary standard.”

(Response 19) The Regulatory Flexibility Act requires an evaluation of the likely economic impacts of conforming to the standard that is being proposed, not the economic impact of violating the standard. If firms comply with the standard, recalls related to nonconformance would be avoided.

ASTM F2088, “Standard Consumer Safety Specification for Infant Swings,”is the voluntary standard that was developed to address the identified hazard patterns associated with the use of infant swings. Section 104(b) of the CPSIA requires the Commission to assess the effectiveness of the voluntary standard in consultation with representatives of consumer groups, juvenile product manufacturers, and other experts. We have consulted with these groups regarding the ASTM voluntary standard, ASTM F2088, throughout its development. The standard was first approved in 2001, and revised in 2003, 2008, 2009, twice in 2011, and twice in 2012. ASTM F2088-11b was the version of the standard referenced in the NPR. In response to the proposed rule, the ASTM Subcommittee on Infant Swings, in collaboration with CPSC staff, approved and published two versions of the standard since publication of the NPR, including, ASTM F2088-12a (approved on September 1, 2012, and published in September 2012), which mainly incorporates the proposed modifications in the proposed rule, with a few clarifications and modifications that strengthen the standard. ASTM F2088-12a contains more stringent requirements than its predecessor, ASTM F2088-11b, and would reduce further the risk of injury associated with infant swings.

In the NPR, the Commission proposed safety standards for infant swings based on the voluntary standard for infant swings, ASTM F2088-11b. We proposed additional requirements that were intended to strengthen the voluntary standard.See77 FR 12182. Since the publication of this notice, ASTM has published two newer versions of the standard, ASTM F2088-12 and ASTM F2088 12a. The newest version, ASTM F 2088-12a, includes additional changes that were not addressed previously, modifies the CPSC proposed language, or adopts the proposal, with some differences.

The final rule incorporates by reference ASTM F2088-12a as a mandatory standard, with two modifications. Some of the more significant requirements of ASTM F2088-12a are listed below. The requirements that have been added to the ASTM voluntary standard since the NPR are in italics:

• Stability test—intended to prevent tip over. Swing models that rotate about the horizontal axis are positioned on an inclined surface with the swing facing forward and then facing backward. Swings that do not rotate about the horizontal axis are tested in the position most likely to fail.This was modified in ASTM F2088-12 to clarify the test procedure, as proposed by the Commission in the NPR.

• Test to prevent unintentional folding—intended to ensure that any locking/latching mechanisms remain functional after testing.

• Tests on restraint system—intended to prevent slippage and breakage during regular use.

• Requirements for cradle swing orientation—intended to ensure that the surface remains relatively flat both while in motion and while at rest.

• Requirements forelectrically poweredswings—intended to prevent leakage and otherwise protect consumers.These requirements originally applied only to battery-operated swings but were expanded in ASTM F2088-12 to encompass all electrically powered swings, as proposed by the Commission in the NPR. ASTM F2088-12a extends the compliance requirements of all AC adaptors and includes a list of accepted national safety standards. There are also some editorial differences between the NPR and ASTM F2088-12a.

• Requirement for toy mobiles—intended to ensure that toys within a child's reach do not detach when pulled. This requirement was new to the 2011a standardand was modified for the 2012 standard to prevent detachment when pulled horizontally as well (as proposed in the February 2012 NPR).

• Shoulder strap requirement—In the NPR, we proposed that shoulder straps be required for swing seats with angles greater than 50 degrees.The seat back angle measurement procedure has been updated since the NPR. Now it addresses the issues that the CPSC proposed to address with the seat deflection test included in the NPR. Now it now addresses seats that fold up or tilt, by limiting the severity of angles created by the seat and seat back, or by requiring shoulder straps as part of the restraint system.

• Dynamic and static load requirements—intended to ensure that the infant swing can support these loads without breaking.The dynamic load test procedure was modified in F2088-12 to mirror proposed changes in the February 2012 NPR, including increasing the number of times the weight is dropped.

The voluntary standard also includes: (1) Torque and tension tests to ensure that components cannot be removed; (2) requirements for several infant swing features to prevent entrapment and cuts (minimum and maximum opening size, small parts, exposed coil springs, protective components, hazardous sharp edges or points, and edges that can scissor, shear, or pinch); (3) requirements for the permanency and adhesion of labels; (4) a leg opening test to ensure that occupants cannot slide out; (5) requirements for instructional literature; and (6) restraint system requirements. Additionally, all testing must be performed without adjusting or repositioning the swing, and swings with multiple seat configurations must be placed in the most disadvantageous position for testing. The following is a discussion of how the new standard addresses the issues raised in the NPR.

The Commission proposed a preliminary test procedure to address the seat deflection issue and specifically asked for comments on the proposed test method in the NPR. In addition, the CPSC continued to work with ASTM to refine the seat deflection test for infant swings. ASTM F2088-12a includes new language that contains a more comprehensive requirement based on maximum seat angle specifications, which includes additional seat back angle measurements or shoulder strap requirements. We believe this requirement addresses more adequately the incidents where a child falls out of the seat due to seat deflection.

We raised two issues in the NPR regarding stability testing and both are addressed in ASTM F2088-12a. ASTM F2088-12a has added the requirement for testing of alternative swing designs in the worst-case orientation, as recommended by the Commission. So now not only are traditional horizontal access swings tested for stability, but also nontraditional, alternative designs with other than a horizontal axis of swing motion must also be tested to the new requirements.

The second stability issue the CPSC raised was intended to refine the testing on swings with “L-” shaped cantilevered legs. The CPSC raised the issue out of concern that a test lab could interpret this test to require that the force be applied at the end of the “L-” shaped leg that is not in the vertical plane of the latch. In this case, the maximum force normally associated with folding is at the end of the leg vertically under the latch. However, after further discussions with ASTM, we have concluded that the current wording allows testing to be performed as stated in the NPR, and the proper testing location for this design is readily apparent to all involved. Therefore, the infant swing unintentional folding test statement proposed in the NPR, as a clarification to the existing test procedure, is not included in the final rule.

The NPR proposed electrical testing requirements to reduce the likelihood of overloading electrical components, battery leakage, or electrical failures that could lead to fire. As part of these requirements, ASTM F2088-12a does not include the following statement: “The test shall be conducted using a new swing.” However, the testing on swing samples is done largely independent of the electrical components. Therefore, the electrical components on a swing sample normally can be considered “new,” even after other components have been tested. By accepting deletion of that statement, the number of samples required to complete a test is reduced. We accept the electrical overload requirement—as stated in ASTM F2088-12a—as sufficient.

The NPR proposed increasing the dynamic drop test cycles from 50 to 500 cycles to improve structural integrity and reveal potential structural issues of the swing components. Increasing the number of dynamic impact cycles to which the swing will be tested will reduce the possibility of structural failures, and it is expected to lead to a decrease in the number and severity of injuries. ASTM included this change in ASTM F2088-12a.

The NPR proposed modifying mobile and toy retention requirements to allow the force to be applied in any direction at or below the horizontal plane, in the orientation most likely to fail. This change is contained in ASTM F2088-12a.

In addition to the changes discussed above, in response to the NPR, ASTM made two other changes to ASTM F2088-12 and 12a, which we find acceptable. One change deals with the seat back recline fixture. ASTM accepted CPSC staff's recommendation to use steel plates—as opposed to wood boards—for the seat back recline fixture and then added more design changes to adjust the center of gravity of the fixture to approximate more accurately the weight distribution of an actual child. The device is now identified as the “Hinged Weight Gage-Infant,” and a drawing of the figure is included in the ASTM standard. This change will improve the accuracy of testing, and therefore, improve the safety of the standard. This change was not proposed in the NPR, but it was developed with the participation of CPSC staff.

The other issue ASTM addressed was a clarification to the AC adapters supplied with the product. ASTM F2088-12 states: “6.1.5 AC adapters supplied with the product must be compliant with the appropriate current national standard for AC adapters.”ASTM received a number of comments after ASTM F2088-12 was published, asking for clarification of what “appropriate current national standard” meant in the requirement. ASTM added new wording and a note to make this clearer, and ASTM F2088-12a includes those changes. We find these changes to be acceptable.

Section 1223.1 of the final rule states that part 1223 establishes a consumer product safety standard for infant swings. We received no comments on this provision and are finalizing it without change.

Section 1223.2(a) of the final rule provides language to incorporate by reference ASTM F2088-12a,Standard Consumer Safety Specification forInfant Swings.Section 1223.2(a) also provides information on how to obtain a copy of the ASTM standard or to inspect a copy of the standard at the CPSC or National Archives and Records Administration. We received no comments on this provision, but we are changing the language in the incorporation in the final rule to refer to ASTM F2088-12a, the current version of the standard.

In the NPR, § 1223.2(b) proposed to add two new requirements to ASTM F2088-11b to make the standard more stringent than the current voluntary standard and to reduce the risk of injury associated with infant swings: (1) A performance requirement and test method to address electrical overload in infant swing motors and batteries, as well as an accessible component temperature requirement and a requirement to ensure that swings that run on a/c power are safe; and (2) a performance requirement and test method to address seat deflection. We also proposed two major modifications to ASTM F2088-11b that would make the standard more stringent than the voluntary standard at that time and would reduce the risk of injury associated with infant swings: (1) An increase in the number of test cycles used in the dynamic load test, from 50 cycles to 500 cycles, and (2) a modification to the mobile test to account for mobiles that can be pulled in downward directions other than straight down vertically. Finally, in proposed § 1223.2(b) of the NPR, we proposed to clarify the test methods for the dynamic load test, the stability test, the unintentional folding test, and the seat back angle measurement method.

As discussed in the previous section of this preamble, the additional requirements in proposed § 1223.2(b) either have been incorporated into ASTM F2088-12a, or we are satisfied with ASTM's changes from the proposal or explanations regarding why some proposals were not necessary. Therefore, the language in proposed § 1223.2(b) of the NPR is no longer necessary.

Finally, as discussed previously in the response to comment 1 in section D of this preamble, we received many comments regarding the inadequacy of the slump-over warnings in section 8.3 of ASTM F2088-11b. Section 8.3 of ASTM F2088-12a contains the identical slump-over warning contained in section 8.3 of ASTM F2088-11b that we proposed in the NPR. We agree that the current warning language requirements pertaining to the slump-over hazard in ASTM F2088-12a are insufficient and that the warning should be revised to clarify the hazard and the consequences of exposure to the hazard if the consumer cannot avoid it. The warning statement required in ASTM F2088-12a does not describe the slump-over hazard, and the formatting of the warning implies that using the swing in the most reclined seat position is an additional measure intended to address the potential for the infant user to fall or strangle in the straps. In addition, one could argue that the warning statement does not describe the probable consequences of not avoiding the slump-over hazard because the warning's reference to “serious injury or death” is specific to falls and strangulations.

Therefore, in place of the language proposed in § 1223.2(b) of the NPR, § 1223(b)(1) of the final rule requires that infant swings must comply with the ASTM F2088-12a standard with two exceptions. In the case of the first exception to the ASTM standard, instead of complying with section 8.3.1 of ASTM F 2088-12a, infants swings are required to have warning statements for products that have an adjustable seat recline with a maximum seat back angle greater than 50 degrees from horizontal, measured in accordance with 7.13 of ASTM F 2088-12a, that address the following:

• Always secure infant in the restraint system provided.

• Never leave infant unattended in swing.

• Discontinue use of swing when infant attempts to climb out.

• Travel swings are required to have a warning indicating: “Always place swing on floor. Never use on any elevated surface.”

A second exception to the requirements in ASTM F2088-12a specifies the test method for testing toy mobiles that are attached to the swing. The final rule provides new language for the test method described in section 7.12.2 of ASTM F2088-12a. We are adding this language in response to information from ASTM that ASTM had inadvertently omitted updating the test method described in section 7.12.2 of ASTM F2088-12a to reflect the latest revision that ASTM had made to the test fixture used in section 7.12.2. We have added ASTM's revised version of the test method language in the final rule text in § 1223(b)(2). This is the language that ASTM is balloting to revise section 7.12.2 in its standard.

The Administrative Procedure Act (APA) generally requires that the effective date of the rule to be at least 30 days after publication of the final rule. 5 U.S.C. 553(d). The preamble to the proposed rule indicated that the standard would become effective 6 months after publication of the rule in theFederal Register. We sought comment on how long it would take infant swing manufacturers to come into compliance. We received one comment stating that the Commission should “* * * consider extending the effective date to one year to help minimize a possibility of a substantial loss of revenue from the potential product recalls on the small manufacturers and importers.” Almost all of the requirements proposed in the NPR were incorporated into ASTM F2088-12a, and the final rule differs from the proposed rule only in the requirement that an additional warning label regarding use has been added. Therefore, we believe that an effective date of 6 months after publication of the final rule is sufficient to allow for review of the new requirements thoroughly and to ensure that new infant swings manufactured or imported after that date are in compliance with the new requirements. The 6-month effective date is consistent with the effective date established in most other rules issued under section 104 of the CPSIA. Accordingly, the final rule will be effective 6 months after publication in theFederal Register, unchanged from the proposed rule.

Once there is a safety standard in effect for infant swings, it will be unlawful for anyone to manufacture, distribute, or import an infant swing into the United States that is not in conformity with this standard. 15 U.S.C. 2068(1).

In addition, section 14(a)(2) of the CPSA, 15 U.S.C. 2063(a)(2), imposes the requirement that products subject to a children's product safety rule must be tested by a third party conformity assessment body accredited by the Commission to test the product. As discussed in section A of this preamble, section 104(b)(1)(B) of the CPSIA refers to standards issued under this section as “consumer product safety standards.” Under section 14(f)(1) of the CPSA, 15 U.S.C. 2063(f)(1), the term “children'sproduct safety rule” includes all standards enforced by the Commission. Thus, the infant swing standard will be a children's product safety rule, subject to third party testing and certification.

The Commission is required to issue a notice of requirements (NOR) to explain how laboratories can become CPSC-accepted third party conformity assessment bodies to test infant swings to the new safety standard. On May 24, 2012, the Commission published in theFederal Registerthe proposed rule,Requirements Pertaining to Third Party Conformity Assessment Bodies,77 FR 31086, which, when finalized, would establish the general requirements and criteria concerning testing laboratories, including a list of the children's product safety rules for which the CPSC has published NORs for laboratories. The Commission proposed a new NOR for the safety standard for infant swings in that proposed rule.See77 FR at 31113. The final NOR for the safety standard for infant swings will be issued once the final rule forRequirements Pertaining to Third Party Conformity Assessment Bodiesis published in theFederal Register. That final rule will address the issuance of the NOR for infant swings.

The Regulatory Flexibility Act (RFA) requires that final rules be reviewed for their potential economic impact on small entities, including small businesses. Section 604 of the RFA requires that the Commission prepare a final regulatory flexibility analysis when it promulgates a final rule. The final regulatory flexibility analysis must describe the impact of the rule on small entities and identify any alternatives that may reduce the impact. Specifically, the final regulatory flexibility analysis must contain:

• A succinct statement of the objectives of, and legal basis for, the rule;

• A summary of the significant issues raised by public comments in response to the initial regulatory flexibility analysis, a summary of the assessment of the agency of such issues, and a statement of any changes made in the proposed rule as a result of such comments;

• A description of, and, where feasible, an estimate of, the number of small entities to which the rule will apply;

• A description of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities subject to the requirements and the type of professional skills necessary for the preparation of reports or records; and

• A description of the steps the agency has taken to reduce the significant economic impact on small entities, consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the rule, and why each one of the other significant alternatives to the rule considered by the agency, which affect the impact on small entities, was rejected.

The NPR for infant swings was based on the voluntary ASTM standard for infant swings ASTM F2088-11b. The Commission proposed several modifications, additions, and clarifications at that time. Most of the proposed changes have been incorporated into ASTM F2088-12a, which the final rule incorporates by reference, along with one additional change, modifying the slump-over warning.

Infant swings are typically produced and/or marketed by juvenile product manufacturers and distributors. We estimate that currently, there are at least 9 domestic manufacturers and one domestic importer supplying infant swings to the U.S. market. Infant swings from five of the 10 firms have been certified as compliant with the ASTM voluntary standard ASTM F2088-11b by JPMA, the major U.S. trade association that represents juvenile product manufacturers and importers. Two additional firms claim compliance with F2088-11b.

Information on annual sales of infant swings can be approximated using information from the 2005 survey conducted by the American Baby Group (2006 Baby Products Tracking Study). About 79 percent of new mothers own at least one infant swing—61 percent own full-sized infant swings, and 33 percent own smaller travel infant swings. Approximately 31 percent of full-sized infant swings and 26 percent of travel infant swings were handed down or purchased secondhand. Thus, about 69 percent of full-sized infant swings, and 74 percent of travel infant swings were acquired new. This suggests annual sales of about 2.7 million infant swings to households (.69 × .61 × 4.1 million births per year + .74 × .33 × 4.1 million births per year).

Typically, infant swings are used for only a few months early in a child's life. Therefore, we have estimated the risk of injury based on the number of infant swings in the households of new mothers. Based on data from the2006 Baby Products Tracking Study,approximately 3.9 million infant swings are owned by new mothers (0.61 percent own full-size × 4.1 million births + 0.33 percent own travel size × 4.1 million births). This suggests that at least 3.9 million infant swings may be available to children during the first year of their lives. During 2011, there were an estimated 1,900 emergency department-treated injuries to children under age 5 related to infant swings. Consequently, there would have been about 4.9 emergency department-treated injuries annually for every 10,000 infant swings available for use in the households of new mothers.

As noted earlier, there are approximately 10 domestic firms currently known to be producing or selling infant swings in the United States. Under U.S. Small Business Administration (SBA) guidelines, a manufacturer of infant swings is small if it has 500 or fewer employees, and an importer is considered small if it has 100 or fewer employees. Based on these guidelines, five domestic manufacturers are small firms. The remaining firms are four large domestic manufacturers and one large domestic importer. There may be additional unknown small manufacturers and importers operating in the U.S. market.

The expected impact of the final rule on small manufacturers will differ based on whether their infant swings are compliant with ASTM F2088-11b. Firms whose infant swings meet the requirements of ASTM F2088-11b are generally expected to continue to do so as new versions of the standard are published, typically within 6 months, which is the amount of time JPMA allows for products in their certification program to shift to a new standard. Many of these firms are active in the ASTM standards development process, and compliance with the voluntary standard is part of an established business practice. Therefore, it is likely that firms supplying infant swings that comply with ASTM F2088-11b (which went into effect for JPMA certification purposes in May 2012) would also comply with ASTM F2088-12a by March 2013, even in the absence of a mandatory standard.

The direct impact on the three known small domestic manufacturers whose infant swings are compliant with ASTM F2088-11b is not expected to be significant. Each firm will need tomodify the slump-over warning label for their infant swings. This is not generally expected to be costly; although some firms may experience larger costs than others, depending upon their label development process, and where the warning labels are affixed on their products. One firm estimates that the one-time cost of changing their labels, including development time and materials, would be approximately $1,000 per model.

Complying with ASTM F2088-12a's requirements could necessitate product redesign for some infant swings believed not to be compliant with ASTM F2088-11b. The redesign would be minor if most of the changes involve adding straps and fasteners or using different mesh or fabric; but the redesign could be more significant if changes to the frame are required. Consequently, the final rule potentially could have a significant direct impact on the two small manufacturers of infant swings that are believed not to have conformed to ASTM F2088-11b, regardless of how they choose to meet the staff-recommended warning label requirement. One manufacturer estimated that a complete infant swing redesign would cost approximately $400,000, not including significant overhead costs, such as engineering time, which at $100 per hour, easily could increase overall redesign costs by $100,000 or more. However, a complete product redesign is unlikely to be necessary in most cases, and any direct impact may be mitigated if costs are treated as new product expenses that can be amortized.

It is possible that the two firms whose infant swings are neither certified as compliant, nor claim to be compliant with ASTM F2088-11b, in fact, are compliant with the standard. We have identified many such cases with other products. To the extent that these firms may supply compliant infant swings and have developed a pattern of compliance with the voluntary standard, the direct impact of the final rule will be less significant than described above.

Although the direct impact of the final rule should not be significant for most small manufacturers, there are indirect impacts as well. These impacts are considered indirect because they do not arise directly as a consequence of the requirements of the final rule. Nonetheless, these indirect costs could be significant. Once the final rule becomes effective, and the notice of requirements is in effect, all manufacturers will be subject to the additional costs associated with the third party testing and certification requirements. This will include the physical and mechanical test requirements specified in the final rule; lead and phthalates testing is already required, and hence, it is not included here.3

Based on information provided by manufacturers, additional industry input, and information obtained when staff was developing the third party testing rule, third party testing costs for ASTM F2088-12a (including toy testing, which is part of the infant swings voluntary standard) are estimated to be around $900 per model sample. Testing overseas potentially could reduce third party testing costs, but that may not always be practical.

On average, each small domestic infant swing manufacturer supplies six models of infant swings to the U.S. market annually. Therefore, if third party testing was conducted every year, third party testing costs for each manufacturer might add about $5,400 annually to the manufacturer's costs, assuming only one sample of each model had to be tested. Based on a review of firm revenues, the impact of third party testing to ASTM F2088-12a is unlikely to be significant for small manufacturers unless a large number of samples had to be tested for each model.

CPSC staff was unable to identify any small importers currently operating in the U.S. market. However, if any exist, they would need to find an alternate source of infant swings if their existing supplier does not come into compliance with the requirements of the staff-recommended final rule. They could also discontinue importing any noncomplying infant swings, possibly replacing them with another juvenile product. As is the case with manufacturers, importers will be subject to third party testing and certification requirements; consequently, they would experience costs similar to those for manufacturers, if their supplying foreign firm(s) does not perform third party testing.

Under section 104 of the CPSIA, one alternative that would reduce the impact on small entities would be to make the voluntary standard mandatory with no modifications. However, while this alternative would eliminate any additional costs associated with the slump-over label change in the final rule, firms supplying noncompliant infant swings could still require substantial product redesign in order to meet the voluntary standard. Because of the frequency and severity of the incidents associated with slump-over incidents, we do not recommend this alternative.

A second alternative would be to set an effective date later than 6 months. This would allow suppliers additional time to modify and/or develop compliant infant swings and spread the associated costs over a longer period of time. We generally consider 6 months sufficient time for suppliers to come into compliance with a mandatory standard; it is common in the industry, representing the amount of time that the JPMA allows for products in their ASTM certification program to shift to a new standard.

This rule contains information collection requirements that are subject to public comment and review by the U.S. Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The preamble to the proposed rule (77 FR 7021 through 7022) discussed the information collection burden of the proposed rule and specifically requested comments on the accuracy of our estimates. We did not receive any comments from the public concerning the information collection burden of the proposal. However, in response to a comment made by OMB, the final rule makes a modification regarding the information collection burden. OMB noted that all 10 firms identified should be considered when accounting for the labeling burden.

As indicated in the NPR (77 FR 7021 through 7022), there are 10 known firms supplying infant swings to the U.S. market. In the NPR, we estimated that five of the 10 firms already made product labels that comply with ASTM F2088. We revise our burden estimate to assume that all 10 firms already use labels on both their products and packaging, but they might need to make some modifications to their existing labels. Based on this revision, our revised burden estimate is as follows: The estimated time required to make these modifications is about 1 hour per model. Each of these firms supplies an average of five different models of infant swings; therefore, the estimated burden hours associated with labels is 1 hour × 10 firms × 5 models per firm = 50 annual hours.

We estimate that hourly compensation for the time required to create and update labels is $28.36 (U.S.Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” September 2011, Table 9, total compensation for all sales and office workers in goods-producing private industries:http://www.bls.gov/ncs/). Therefore, the estimated annual cost associated with the proposed requirements is $1,418 ($28.36 per hour × 50 hours = $1,418).

We have applied to OMB for a control number for this information collection, and we will publish a notice in theFederal Registerproviding the number when we receive approval from OMB.

Section 26(a) of the Consumer Product Safety Act (CPSA), 15 U.S.C. 2075(a), provides that where a consumer product safety standard is in effect and applies to a product, no state or political subdivision of a state may either establish or continue in effect a requirement dealing with the same risk of injury unless the state requirement is identical to the federal standard. Section 26(c) of the CPSA also provides that states or political subdivisions of states may apply to the Commission for an exemption from this preemption under certain circumstances. Section 104(b) of the CPSIA refers to the rules to be issued under that section as “consumer product safety rules,” thus implying that the preemptive effect of section 26(a) of the CPSA would apply. Therefore, a rule issued under section 104 of the CPSIA will invoke the preemptive effect of section 26(a) of the CPSA when the rule becomes effective.

The Commission's regulations provide a categorical exclusion for the Commission's rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This final rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required.

The Coast Guard will enforce the special local regulations in 33 CFR 100.1101 on November 11, 2012 from 7 a.m. to 11:30 a.m. in support of the annual San Diego Fall Classic (Item 1 on Table 1 of 33 CFR 100.1101). The Coast Guard will enforce the special local regulations on the navigable waters of Mission Bay from Fiesta Island and along the southern and western shore of Vacation Isle. The event will consist of approximately 100 participants in rowing shells ranging from 26 to 55 feet in length. Each race will consist of heats of approximately six to eight rowing shells. The sponsor will provide seven to nine safety perimeter vessels to patrol the racecourse.

Under the provisions of 33 CFR 100.1101, persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

This notice is issued under authority of 33 CFR 100.1101 and 5 U.S.C. 552(a). In addition to this notice in theFederal Register, the Coast Guard will provide the maritime community with extensive advance notification of this enforcement period via the Local Notice to Mariners, state, or local agencies.

The City of Tacoma has requested to place the Murray Morgan Bridge (South 11th Street Bridge) in the closed or down position and to not open the bridge for vessel traffic to facilitate a major rehabilitation project on the bridge. The Murray Morgan Bridge crosses Thea Foss Waterway (previously known as City Waterway) at mile 0.6, at Tacoma, WA. The Murray Morgan Bridge is a vertical lift bridge. During this deviation the bridge will be placed in the closed or down position. There will be a debris containment system attached to the underside of the bridge for the duration of construction activities. A minimum vertical clearance of 57 feet above mean high water will be provided beneath the bridge and the attached debris containment system, at all times during the deviation period. Vessels which do not require a bridge opening may continue to transit beneath the bridge during this closure period. Under normal operations the bridge operates under 33 CFR 117.1063 which requires a two hour notice for an opening and allows the bridge to remain closed during morning and afternoon rush hours. This current deviation states the lift span of the Murray Morgan Bridge across Thea Foss Waterway, mile 0.6, need not open from 8 a.m. on November 10, 2012 through 8 p.m. December 21, 2012; except as otherwise outlined in this article and through ongoing coordination with waterway users. During this deviation period the bridge will be placed in the open position from 8 a.m. November 22 through 8 p.m. November 25, 2012 and from 8 a.m. December 8 through 8 p.m. December 9, 2012.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The City of San Francisco requested a temporary change to the operation of the Third Street Drawbridge, mile 0.0, over China Basin, at San Francisco, CA. The Third Street Drawbridge navigation span provides a vertical clearance of 7 feet above Mean High Water in the closed-to-navigation position. The draw opens on signal if at least one hour notice is given as required by 33 CFR 117.149. Navigation on the waterway is recreational.

The drawspan will be secured in the closed-to-navigation position 9 a.m. to 6 p.m. on November 10, 2012, to allow spectators to the RedBull Flugtag to cross the bridge during the event. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised. The drawspan can be operated upon 30 minutes advance notice for emergencies requiring the passage of waterway traffic.

Vessels that can transit the bridge, while in the closed-to-navigation position, may continue to do so at any time.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

EPA is withdrawing the September 14, 2012 (77 FR 56775), direct final rule that makes several determinations relating to 1997 8-hour ozone nonattainment areas in California and thereby suspending certain attainment-related requirements for as long as these areas continue to meet the 1997 8-hour ozone national ambient air quality standard. The subject areas include Amador and Calaveras Counties, Chico, Kern County, Mariposa and Tuolumne Counties, Nevada County, Sutter County, and Ventura County. In the direct final rule, EPA stated that if adverse comments were received by October 15, 2012, the rule would be withdrawn and not take effect. On September 10, 2012, EPA received a comment, which it interprets as adverse and, therefore, EPA is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed rulemaking action, also published on September 14, 2012 (77 FR 56797). EPA will not institute a second comment period on this action.

Accordingly, the amendment to 40 CFR 52.282 published in theFederal Registeron September 14, 2012 (77 FR 56775) on page 56782 is withdrawn as of November 7, 2012.

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at:http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0756 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 7, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0756, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

•Mail:OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Hand Delivery:To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions athttp://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for residues of fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, its metabolites and degradates, in or on cotton, undelinted seed at 0.1 parts per million (ppm). These time-limited tolerances expire on December 31, 2014.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative,i.e.,without having received any petition from an outside party.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

This is the first section 18 request received for the use of fluridone on cotton. Since the introduction of glyphosate resistant cotton in 1997, twenty-one weed species have developed resistance to glyphosate. Glyphosate-resistant palmer amaranth is the most serious of these species across all the major agronomic crops in the southern U.S. Glyphosate-resistant palmer amaranth was confirmed in Arkansas in 2006. Since 2006, it has become the most severe weed problem that Arkansas cotton producers face. Greater than 95% of Arkansas cotton and 80% of soybean contain the glyphosate tolerant gene and thus glyphosate is the base herbicide for weed control. A significant economic loss is expected to occur on nearly 25% of acres grown or about 160,000 acres.

After having reviewed the Arkansas emergency exemption application, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of fluridone on cotton for control of glyphosate-resistant palmer amaranth in Arkansas.

As part of its evaluation of the emergency exemption application, EPAassessed the potential risks presented by residues of fluridone in or on cotton. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2014, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on cotton, undelinted seed after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether fluridone meets FIFRA's registration requirements for use on cotton or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of fluridone by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Arkansas to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for fluridone, contact the Agency's Registration Division at the address provided underFOR FURTHER INFORMATION CONTACT.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of, and to make a determination on, aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for residues of fluridone on cotton, undelinted seed at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates non-threshold risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fluridone used for human risk assessment is shown in Table 1. of this unit.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to fluridone, EPA considered exposure under the time-limited tolerances established by this action as well as all existing fluridone tolerances in 40 CFR 180.420. EPA assessed dietary exposures from fluridone in food as follows:

i.Acute exposure.Such effects were identified for fluridone. In estimating acute dietary exposure for the subpopulation, females 13-49 years, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance level residues, DEEM (Ver. 7.81) default processing factors (as necessary) and 100 percent crop treated (PCT) for all commodities.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA used tolerance level residues, DEEM (Ver. 7.81) default processing factors (as necessary) and 100 PCT for all commodities.

iii.Cancer.Based on the data summarized in Unit IV.A., EPA has concluded that fluridone does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv.Anticipated residue and PCT information.EPA did not use anticipated residue or PCT information in the dietary assessment for fluridone. Tolerance level residues and 100 PCT were assumed for all food commodities.

2.Dietary exposure from drinking water.The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluridone in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluridone. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

Based on the FQPA Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluridone for acute exposures are estimated to be 9.6 parts per billion (ppb) for surface water and 0.67 ppb for ground water. EDWCs of fluridone for chronic exposures for non-cancer assessments are estimated to be 2.5 ppb for surface water and 0.67 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 9.6 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.5 ppb was used to assess the contribution to drinking water.

3.From non-dietary exposure.The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g.,for lawn and garden pest control, indoor pest control, termiticides, swimming in treated water, and flea and tick control on pets).

Fluridone is currently registered for one use that could result in residential handler and residential post-application exposures: Consumer use to control aquatic weeds in ponds. EPA assessed residential exposure using the following assumptions: Residents or consumers may experience short-term (1-30 days) skin contact or inhalation exposures. These exposures are assessed through residential handler scenarios. Post-application exposures of children and adults through contact with treated swimming ponds are also anticipated. These exposures are expected to be short- and intermediate-term (1-6 months) in duration through dermal, ingestion, aural, buccal/sublingual, and nasal/orbital exposure. All residential handler and post-application scenarios from the uses of fluridone have been assessed and no risks of concern have been identified (MOE ≤100). The scenarios for residential handler and post-application exposure (combined dermal and inhalation) resulted in MOEs of 1,800 and 23,000, respectively.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at:http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4.Cumulative effects from substances with a common mechanism of toxicity.Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found fluridone to share a common mechanism of toxicity with any other substances, and fluridone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluridone does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1.In general.Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity.Based on the results in the developmental toxicity studies in rats and rabbits and in a three-generation reproduction study, no increased sensitivity of fetuses or pups (as compared to adults) was demonstrated for fluridone. There are no concerns or residual uncertainties for prenatal/postnatal toxicity following exposure to fluridone.

3.Conclusion.EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for fluridone is complete except for the lack of an immunotoxicity study and a neurotoxicity battery (i.e.,acute and subchronic neurotoxicity) that meets the new data requirements in 40 CFR part 158 for conventional pesticide registration. However, the existing toxicology database for fluridone does not show any evidence of treatment-related effects on either the nervous or the immune system. In addition, fluridone does not belong to any class of compounds (e.g.,the organotins, heavy metals, or halogenated aromatic hydrocarbons) that would be expected to be immunotoxic. Based on the currently available data for fluridone, the Agency expects that findings from the additional studies will not result in a lower point of departure POD than that currently in use for overall risk assessment, and therefore, a database uncertainty factor is not needed to account for the lack of these studies.

ii. There is no indication that fluridone is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that fluridone results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment utilized 100 PCT and tolerance-level residues (established or recommended). EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fluridone in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluridone.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1.Acute risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. An adverse effect resulting from a single oral exposure was identified for only the subpopulation females 13-49 years. Using the exposure assumptions described in this unit for acute exposure, EPA has concluded that acute exposure to fluridone from food and water will utilize less than 1% of the aPAD for females 13-49 years. Therefore, fluridone is not expected to pose an acute risk.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluridone from food and water will utilize 4% of the cPAD for children 1-2 years, the population group receiving the greatest exposure. Based on the explanation in the unit regarding residential use patterns, chronic residential exposure to residues of fluridone is not expected.

3.Short-and Intermediate-term risk.Short- and intermediate-term aggregate exposure takes into account short-term residential exposure or intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Fluridone is currently registered for uses that could result in short- and intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures to fluridone.

Using the exposure assumptions described in this unit for short-term and intermediate-term exposures, EPA has concluded the combined short-term food, water, and residential exposures and the intermediate-term food, water, and residential exposures each result in aggregate MOEs of 290 (liquids for pouring applications + swimming exposure) to 340 (liquids for garden hose end sprayer + swimming exposure). Because EPA's level of concern for fluridone is a MOE of 100 or below, these MOEs are not of concern.

5.Aggregate cancer risk for U.S. population.Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, fluridone is not expected to pose a cancer risk to humans.

6.Determination of safety.Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluridone residues.

Adequate enforcement methodologies (enzyme-linked immunosorbant assay (ELISA), high performance liquid chromatography with ultraviolet detection (HLPC/UV), and liquid chromatography with tandem mass spectroscopy (LC-MSMS)) are available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established an MRL for fluridone.

Therefore, time-limited tolerances are established for residues of fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, including its metabolites and degradates, in or on cotton, undelinted seed at 0.1 ppm. This tolerance expires on December 31, 2014.

This final rule establishes tolerances under FFDCA sections 408(e) and 408(l)(6). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801et seq.), EPA will submit a report containing this rule 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 theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR part 180 is amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0455 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 7, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0455, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

•Mail:OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

•Hand Delivery:To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions athttp://www.epa.gov/dockets/contacts.htm.

In theFederal Registerof August 22, 2012 (77 FR 50661) (FRL-9358-9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1F7937) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that the tolerance in the 40 CFR 180.617 be amended by increasing the established tolerance for residues of the fungicide metconazole, 5-[(4-chlorophenyl)-methyl]-2, 2-dimethyl-1-(1H-1, 2, 4-triazol-1-ylmethyl) cyclopentanol, measured as the sum of cis- and trans- isomers, in or on corn, sweet, stover from 4.5 parts per million (ppm) to 25.0 ppm. That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket,http://www.regulations.gov.There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has modified the proposed tolerance level by increasing the tolerance for residues of corn, sweet, stover to 30 ppm. The reason for this change is explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticidechemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for metconazole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with metconazole follows.

EPA's analysis of the impact of the proposed increase of the corn stover tolerance will have a minimal impact on exposure of livestock to metconazole and will not change the safety determination EPA made for metconazole in tolerance rulemaking published in theFederal Registerof August 17, 2011 (76 FR 50898) (FRL-8882-7) and the initial establishment of the corn stover tolerance published in theFederal Registerof May 7, 2009, 74 FR 21260, FRL-8408-6. In the aggregate risk assessment supporting those actions, EPA included exposure from previously established tolerances for corn and corn by-products, including corn stover (See Metconazole: Human Health Assessment for Proposed Uses on Tuberous and Corm Vegetables Subgroup 1C and Bushberry Subgroup 13-07B, EPA Docket Number EPA-HQ-OPP-2010-0621). In that risk assessment, metconazole exposure to humans due to the presence of metconazole in animal livestock feed items was calculated based on the tolerance levels in livestock commodities consumed by humans (e.g.,meat and milk). Tolerance levels in livestock commodities are driven by the tolerance levels in livestock feed items, taking into account the makeup of the livestock diet. EPA's analysis of the impact of raising the corn stover tolerance shows that there will be no increase in the maximum reasonably balanced dietary burden for beef cattle, swine, or poultry but a small increase for diary cattle. There is no increase for beef cattle, swine, or poultry because sweet corn stover is only a significant feed item in dairy cattle. Although there is an increase in the estimated dietary burden of metaconazole for dairy cattle associated with the proposed increase in the corn stover tolerance, the increase is relatively small (less than 15 percent) and, based on data from a cattle feeding study with metaconazole, EPA has determined that the small increase in dietary burden to dairy cattle will not result in metaconazole residues in food commodities from dairy cattle that exceed existing tolerances. Thus, despite the increase in the corn stover tolerance, the aggregate risk assessment underlying the 2009 and 2011 metconazole rulemakings, which assumed residue levels in food commodities from dairy cattle at existing tolerances levels, remains an accurate estimate of metconazole risk.

In the August 17, 2011 and May 7, 2009Federal Registeractions, EPA concluded that there is reasonably certainty that no harm will result to the general population and to infants and children from aggregate exposure to metconazole residues. That conclusion was based on the findings that metconazole did not pose either an acute or cancer risk and that chronic exposure to metconazole from food and water falls well below the safe exposure level for all population groups, including children 1 to 2 years old, the population group receiving the greatest exposure. Refer to the August 17, 2011 (76 FR 50898) (FRL-8882-7),Federal Registerdocument, available athttp://www.regulations.gov,for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in theFederal Registerdocuments in support of this action.

An adequate high performance liquid chromatography with tandem mass spectrometry (Method D0604, entitled “The Determination of Residues of BAS 555 F and its Metabolites in Corn and Cotton Matrices Using LC/MS/MS”), with the German multi-residue method DFG S19 as a confirmatory method, is adequate as an enforcement method. Method D0604 determines metconazole (cis—and transisomers), 1,2,4-triazole (T), triazolyalanine (TA), and triazolylacetic acid (TAA). DFG S19 uses gas chromatography/nitrogen phosphorus detection (GC/NPD) or gas chromatography/mass spectrometric detection (GC/MS). The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for metconazole on corn, sweet, stover.

Based on the analysis of the residue field trial data on field corn stover and using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures, the tolerance for sweet corn stover was increased.

Therefore, tolerances are established for residues of metconazole, 5-[(4-chlorophenyl)-methyl]-2, 2-dimethyl-1-(1H-1, 2, 4-triazol-1-ylmethyl) cyclopentanol, measured as the sum of cis- andtransisomers, in or on corn, sweet, stover at 30.0 ppm.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501et seq.), nor does it requireany special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801et seq.), EPA will submit a report containing this rule 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 theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objectionor request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2012-0009 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 7, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0009, by one of the following methods:

•Federal eRulemaking Portal: http://www.regulations.gov.Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

•Mail:OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•Hand Delivery:To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions athttp://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.

In theFederal Registerof March 14, 2012 (77 FR 15012) (FRL-9335-9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E7959) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.574 be amended by establishing tolerances for residues of the fungicide fluazinam, (3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-pyridinamine), in or on fruiting vegetables group, pepper/eggplant subgroup 8-10B at 0.10 parts per million (ppm); and cucurbit vegetables, melon subgroup 9A at 0.08 ppm. That document referenced a summary of the petition prepared on behalf of IR-4 by ISK Biosciences Corporation, the registrant, which is available in the docket,http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Additionally, in theFederal Registerof July 25, 2012 (77 FR 43562) (FRL-9353-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a PP 2F7977 by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077. The petition requested that 40 CFR 180.574 be amended by establishing tolerances for residues of the fungicide fluazinam in or on soybean, seed at 0.01 ppm; and soybean, hulls at 0.02 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket,http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petitions, EPA has revised the tolerances for several commodities. The reason for these changes is explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fluazinam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluazinam follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Following subchronic and chronic exposure to fluazinam, the liver appeared to be a primary target organ in rats, dogs, and mice. Signs of liver toxicity included changes in clinical chemistry (increased serum alkaline phosphatase and aspartate aminotransferase), increased absolute and/or relative liver weights, increased incidences of gross lesions (pale, enlarged, pitted, mottled, accentuated markings), and a variety of histopathological lesions. Treatment-related effects were also observed in other organs following subchronic and chronic exposure to fluazinam, but these effects were not consistently noted in all three species or in all studies in a given species. In a subchronic inhalation toxicity study in rats, pulmonary effects were observed at the mid and high doses. These effects included dose-related increases in lung/bronchial weights and increased incidences of alveolar macrophages and peribronchiolar proliferation in both sexes.

In the developmental toxicity study in rabbits, treatment-related maternal effects (decreased food consumption and increased liver histopathology) were noted in the absence of fetal effects. In the 2-generation rat reproduction study, decreased pup weight gain was seen at the highest dose tested, in the presence of decreased food consumption and liver histopathology in parental animals. In a developmental toxicity study in rats, fetal effects included decreases in body and placental weights, increased incidences of facial/palate clefts, diaphragmatic hernias, delayed ossification in several bone types, increases in late resorptions, as well as evidence of a greenish amniotic fluid and post-implantation loss. Maternal effects, including decreases in body weight gain/food consumption and increases in waterconsumption and urogenital staining, were observed at the same dose level. In the rat developmental neurotoxicity (DNT) study, effects in pups (including decreases in body weight/body weight gain and delayed preputial separation) were noted in the absence of maternal toxicity.

In an acute neurotoxicity study in rats, effects included decreases in motor activity and soft stools; these effects were considered to be due to systemic toxicity and not a result of frank neurotoxicity. No signs of neurotoxicity were observed in two subchronic neurotoxicity studies in rat up to the highest dose tested. A neurotoxic lesion described as vacuolation of the white matter of the central nervous system was observed in subchronic and chronic studies in mice and dogs; however, this lesion was found to be reversible and is attributed to an impurity. Based on the level of this impurity in technical grade fluazinam, the risk assessment for the parent compound is considered protective of the effects noted. In an immunotoxicity study in mice, significant suppressions of anti-sheep red blood cell antibody-forming cell assay response were demonstrated at the highest dose tested.

In a rat carcinogenicity study, there was some evidence that fluazinam induced an increase in thyroid gland follicular cell tumors in male rats. There were statistically significant positive trends for thyroid gland follicular cell adenocarcinomas and combined follicular cell adenomas/adenocarcinomas. The incidences of thyroid gland adenomas seen at 100 ppm (3.8 mg/kg/day) and adenocarcinomas at 1,000 ppm were slightly outside their respective ranges for the historical controls. However, this increased incidence of thyroid tumors at 100 ppm was not observed in male rats in another chronic study. Further in the rat carcinogenicity study where these effects were seen, the animals in the lower dose groups were only microscopically examined for thyroid lesions if abnormalities were observed in that organ at gross necropsy and therefore, the incidences of thyroid tumors in the lower dose groups may have been somewhat misleading (too high). In one mouse carcinogenicity study, clear evidence of a treatment-related increase of hepatocellular tumors was observed in male mice; in another mouse carcinogenicity study, there was equivocal evidence that fluazinam may have induced an increase in hepatocellular tumors in male mice. There was no evidence of statistically significant tumor increases in female mice or rats in any study and no evidence of mutagenic activity in the submitted mutagenicity studies for fluazinam. EPA has classified fluazinam as having suggestive evidence of carcinogenicity. Due to the equivocal and inconsistent nature of the cancer response in the rat and mouse studies, the Agency determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluazinam.

Specific information on the studies received and the nature of the adverse effects caused by fluazinam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin document, “Fluazinam. Human Health Risk Assessment to Support New Uses on Soybeans, the Melon Subgroup (9-A), and the Pepper/Eggplant Subgroup (8-10B), and to Support Registration Review” at pages 43-49 in docket ID number EPA-HQ-OPP-2012-0009.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for fluazinam used for human risk assessment is shown in Table 1 of this unit. To assess short-term dermal exposure, the dermal toxicity and dermal absorption studies were used to determine a refined dermal equivalent dose (RDD). To calculate a RDD,in vitroresults using rat skin are corrected for any differences betweenin vitroandin vivoabsorption rates and species differences between rats and humans. This refinement in dermal absorption is important because absorption by human skin is usually lower than that by rat skin. Accordingly, the combined use of the data from three dermal absorption studies and two testing systems offers greater precision in estimating human dermal absorption, which strengthens the reliability of the dermal risk assessment.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to fluazinam, EPA considered exposure under the petitioned-for-tolerances as well as all existing fluazinam tolerances in 40 CFR 180.574. EPA assessed dietary exposures from fluazinam in food as follows:

i.Acute exposure.Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for fluazinam. In estimating acute dietary exposure, EPA used food consumption information from the 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA utilized tolerance-level residues, 100 percent crop treated (PCT) for all commodities, and used DEEM default processing factors, when appropriate.

ii.Chronic exposure.In conducting the chronic dietary exposure assessment, EPA used the food consumption data from the USDA 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA utilized tolerance-level residues for all commodities except apple (for which the average field trial residue value was used), assumed 100 PCT for all commodities, and used DEEM default processing factors, when appropriate.

iii.Cancer.EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or non-linear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to fluazinam. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii.

iv.Anticipated residue information.Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

2.Dietary exposure from drinking water.The residues of concern indrinking water for risk assessment are parent fluazinam and its degradates, including DCPA, CAPA, DAPA, HYPA, and AMPA. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluazinam and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluazinam and its degradates. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluazinam and its degradates for surface water are estimated to be 226 parts per billion (ppb) for acute exposures and 37.8 ppb for chronic exposures. For ground water, the EDWCs are estimated to be 0.404 ppb for both acute and chronic exposures.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The water concentration values of 226 ppb and 37.8 ppb were used to assess the contribution to drinking water in the acute and chronic dietary risk assessments, respectively.

3.From non-dietary exposure.The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluazinam is currently registered for following use that could result in residential exposures: On turf at golf courses only. EPA assessed potential residential short-term post-application dermal exposure from individuals, including adults, youth (11 to <16 years old), and children (6 to <11 years old), playing golf on treated turf. The short- and intermediate-term toxicological endpoints for fluazinam are the same for the dermal route of exposure. As a result, only the short-term dermal exposure was assessed. The resulting short-term risk estimates are considered to be protective of intermediate-term exposure and risk.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found athttp://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4.Cumulative effects from substances with a common mechanism of toxicity.Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found fluazinam to share a common mechanism of toxicity with any other substances, and fluazinam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluazinam does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www.epa.gov/pesticides/cumulative.

1.In general.Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity.The prenatal and postnatal toxicology database for fluazinam includes rat and rabbit developmental toxicity studies, a 2-generation reproductive toxicity study in rats, and a DNT study in the rat. There was no evidence of increased quantitative or qualitative susceptibility in the rabbit developmental toxicity study or the rat 2-generation reproductive toxicity study; however, evidence of increased qualitative susceptibility of fetuses was observed in the rat developmental toxicity study and evidence of increased quantitative susceptibility of fetuses was observed in the rat DNT study.

In the developmental toxicity study in rats, fetal effects (increased incidences of facial/palate clefts and other rare deformities in the fetuses) were observed in the presence of minimal maternal toxicity (decreased body weight gain and food consumption, and increased water consumption and urogenital staining). In the rat DNT study, decreases in body weight/body weight gain and a delay in completion of balano-preputial separation were observed in pups in the absence of maternal effects, suggesting increased quantitative susceptibility of the offspring.

3.Conclusion.EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for fluazinam is complete.

ii. There is no evidence that fluazinam results in increased susceptibility inin uterorabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study; however, increased qualitative susceptibility was noted in the rat developmental toxicity study. The degree of concern for the observed effects is low because fetal effects were observed only at the highest dose tested in the presence of maternal toxicity, and there is a clear NOAEL for the fetal effects seen. Additionally, the NOAEL (50 mg/kg/day) identified in the developmental toxicity study in rats is significantly higher than the NOAEL used (7 mg/kg/day) to establish the aRfD for females 13-49. Therefore, the aRfD is protective of any potential developmental effects and there are no residual uncertainties for prenatal and/or postnatal toxicity.

Additionally, while a DNT study in rat did not show evidence of neurotoxicity, the study showed evidence of increased quantitative susceptibility of offspring. Although the NOAEL for this study (2 mg/kg/day) is lower than that used for the aRfD for females 13-49 (7 mg/kg/day), the effects noted in the DNT study are considered to be postnatal effects attributable to multiple doses; therefore, the study endpoint is not appropriate for acute dietary exposures. The cRfD (0.011 mg/kg/day) is based on a lower NOAEL (1.1 mg/kg/day), and is considered to be protective of potential developmental effects. Therefore, the degree of concern is low for the observed effects and there are no residual uncertainties with regard to prenatal and/or postnatal neurotoxicity.

iii. There are no residual uncertainties identified in the exposure databases. The acute and chronic dietary food exposure assessments were performed based on 100 PCT for all commodities. Additionally, the acute assessment is based on tolerance-level residues for all commodities, and the chronic assessment is based on tolerance-levelresidues for all commodities except apple (for which the average field trial value was used). These assumptions result in high-end estimates of dietary exposure. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to fluazinam in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children. Incidental oral exposure of toddlers is not expected from any use pattern for fluazinam. These assessments will not underestimate the exposure and risks posed by fluazinam.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluazinam will occupy 28% of the aPAD for females 13-49 years old; and 21% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure for the general population, including infants and children.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to fluazinam from food and water will utilize 51% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of fluazinam is not expected.

3.Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluazinam is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to fluazinam.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 730 for children 6-<11 years old, 880 for youth 11-<16 years old, and 970 for adults. Because EPA's level of concern for fluazinam is a MOE of 100 or below, these MOEs are not of concern.

4.Intermediate-term risk.Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Based on the discussion in Unit III.C.3., short-term risk estimates are considered to be protective of intermediate-term exposure and risk.

5.Aggregate cancer risk for U.S. population.Based on the discussion in Unit III.A., EPA has concluded that the cPAD is protective of possible cancer effects.

6.Determination of safety.Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fluazinam residues.

An adequate gas chromatography with electron capture detection (GC/ECD) method (6148-94-0170-MD-001) is available to enforce fluazinam tolerances on plant commodities. An adequate enforcement method for the determination of AMGT is also available. The method is a high performance liquid chromatography with ultraviolet detection (HPLC/UV) enforcement method entitled “Method Evaluation for the Analysis of AMGT in Grapes.”

The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for fluazinam on the commodities associated with this action.

EPA received several comments to the docket, EPA-HQ-OPP-2012-0009; however, only one of these public submissions was in response to the Notice of Filing for PP 1E7959, while the remaining comments pertained to unrelated petitions in theFederal Registernotice. For PP 1E7959, the commenter stated that no residue should be allowed for fluazinam and that they do not support manufacture or use of this product. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework. In addition, the commenter included several adverse effects they believed were seen in animal toxicology studies for fluazinam. EPA has found that there is a reasonable certainty of no harm to humans after considering the toxicological studies and the exposure levels of humans to fluazinam.

Based on the data supporting the petitions, EPA revised the proposed tolerances on melon subgroup 9A from 0.08 ppm to 0.07 ppm; pepper/eggplant subgroup 8-10B from 0.10 ppm to 0.09 ppm; and soybean, hulls from 0.02 ppm to 0.05 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures.

Therefore, tolerances are established for residues of fluazinam, (3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)-2-pyridinamine), in or on melon subgroup 9A at 0.07 ppm; pepper/eggplant subgroup 8-10B at 0.09 ppm; soybean, seed at 0.01 ppm; and soybean, hulls at 0.05 ppm.

This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801et seq.), EPA will submit a report containing this rule 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 theFederal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. Why is EPA using a direct final rule?

EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment as this action merely adds language to 40 CFR 300.805(c) of the NCP to broaden the technology, to include computer telecommunications or other electronic means, that the lead agency is permitted to use to make the administrative record file available to the public. By updating language used to describe permitted technology, the lead agency will be able to serve the information needs of a broader population, while maintaining the ability to provide traditional means of public access, such as paper copies and microform, to the administrative record file. However, in the “Proposed Rules” section of today'sFederal Register,we are also publishing a separate proposed rule to add language to broaden the technology that the lead agency is permitted to use to make the administrative record file available to the public under 40 CFR 300.805(c), if adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see theADDRESSESsection of this document.

If EPA receives adverse comment, we will publish a timely withdrawal in theFederal Registerinforming the public that this direct final rule will not take effect. We would address all public comments in any subsequent final rule based on the proposed rule.

A.Submitting Confidential Business Information (CBI).Do not submit this information to EPA throughwww.regulations.govor email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with the procedures set forth in 40 CFR part 2.

B.Tips for Preparing Your Comments.When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading,Federal Registerdate and page number).

• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible.

• Make sure to submit your comments by the comment period deadline identified.

In 1980, Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601-9675 (“CERCLA” or “the Act”), in response to releases or substantial threats of releases of hazardous substances into the environment or releases or substantial threats of releases into the environment of any pollutant or contaminant which may present an imminent and substantial danger to the public health or welfare.

To implement CERCLA, EPA promulgated the revised National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets guidelines and procedures for responding to releases or substantial threats of releases of hazardous substances into the environment and releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. EPA has revised the NCP on several occasions. The most recent comprehensive revision was on March 8, 1990 (55 FR 8666).

Under CERCLA section 113(k)(1) and 40 CFR 300.800(a), the lead agency is required to establish an administrative record that “* * * contains the documents that form the basis for the selection of a response action.” These documents are further described in 40 CFR 300.810. In addition, CERCLA section 113(k)(2)(A) requires that EPA establish “* * * procedures for the appropriate participation of interested persons in the development of the administrative record * * * ” for a removal action. For remedial actions, EPA “* * * shall provide for the participation of interested persons, including potentially responsible parties, in the development of the administrative record * * *” CERCLA section 113(k)(2)(B). That is, EPA should provide the public with an opportunity to participate in the selection of a response action. In addition, CERCLA section 117 requires EPA to allow for public comment on certain aspects of a proposed remedial action. Participation by interested persons (including affected communities) ensures that EPA (or the lead agency, if not EPA) has considered the concerns of the public, including potentially responsible parties (PRPs), in the selection of a response action.

CERCLA section 113(k)(1) requires that a copy of the administrative record be available to the public “* * * at or near the facility at issue.” 40 CFR 300.805(a). In addition, a docket containing the administrative record file should be located at the Regional office or other central location. 40 CFR 300.805(a). In the case of an emergency removal, the administrative record need only be available for public inspection at the central location, unless otherwise requested (e.g.,by a member of the public). 40 CFR 300.805(a)(5), 300.805(b). Reflective of the technology available at the time of the last revision to the NCP (March 8, 1990 (55 FR 8666)), the “lead agency may make the administrative record file available to the public in microform.” 40 CFR 300.805(c).

The administrative record file located at or near the site should be placed in one of the information repositories that may already exist for community involvement purposes. An information repository contains documents that relate to a Superfund site and the Superfund program in general. An information repository is required at all remedial action sites and any site where a removal action is likely to extend beyond 120 days.See40 CFR 300.430(c)(2)(iii), 300.415(n)(3)(iii), 300.415(n)(4)(i). The information repository may contain information beyond the scope of the administrative record, since the documents in the administrative record file relate to a particular response action selection decision at a site. For example, an information repository might contain copies of site-specific press releases or public fact sheets.

This direct final rule amends 40 CFR 300.805(c)—Location of the Administrative Record File in Subpart I—Administrative Record for Selection of Response Action of the National Oil and Hazardous Substances Pollution Contingency Plan, to acknowledge advancements in technologies used to manage and convey information to the public. Specifically, this revision will add language to broaden the technology, to include computer telecommunications or other electronic means, that the lead agency is permitted to use to make the administrative record file available to the public regarding documents that form the basis for the selection of a response action. This amendment does not limit the lead agency's ability to make the administrative record file available to the public in traditional forms such as paper and microform. The lead agency should assess the capacity and resources of the public to utilize and maintain an electronic- or computer telecommunications-based repository to make a decision on which approach suits a specific site. Based on the preferences of the community and the lead agency's assessment of the site-specific situation, the lead agency will determine whether to provide: (1) Traditional forms (e.g. paper copies; microform) (2) electronic resources, or (3) both traditional forms and electronic resources.

Since the passage of the CERCLA2 , as amended, the Federal government has made strides in encouraging electronically-available data. For example, theElectronic Freedom of Information Act Amendments of 1996, 3 amending section 552(a) of title 5, United States Code, popularly known as theFreedom of Information Act,provides for public access to information in an electronic format. Specifically, “For records created on or after November 1, 1996, within one year after such date, each agency shall make such records available, including by computer telecommunications or, ifcomputer telecommunications means have not been established by the agency, by other electronic means.”4 In addition, “* * * an agency shall provide the record in any form or format requested by the person if the record is readily reproducible by the agency in that form or format. Each agency shall make reasonable efforts to maintain its records in forms or formats that are reproducible for purposes of this section.”5

As of 2010, 99% of the over 16,800 public libraries in the U.S. had public computers connected to the internet, with an average of 16 computer stations per library. Over 85% of these libraries had public wireless internet access, with approximately 6% planning to add access over the next year.6 However, the presence of an electronic- or computer telecommunications-based repository does not preclude establishing a traditional paper-based repository. The lead agency should always assess the capacity and resources of the specific community to utilize and maintain an electronic- or computer telecommunications-based repository. Based on the preferences of the community and the lead agency's assessment of the site-specific situation, the lead agency will determine whether to provide: (1) Traditional forms (e.g. paper copies; microform) (2) electronic resources, or (3) both traditional forms and electronic resources. Community preferences and access to technological resources may be gleaned through community interviews conducted as part of the planning for the Community Involvement Plan at a site.7 In addition, in accordance with Section 508 of the Rehabilitation Act of 1973, as amended, the lead agency is responsible for ensuring that all electronic and information technology is accessible to persons with disabilities. This involves procuring, creating, maintaining and using electronic and information technology, including, Web sites, software, hardware, video and multimedia, and telecommunications, that is Section 508 compliant,8 as well as incorporating other techniques to ensure accessibility.

EPA conducted an assessment of Superfund information repositories (IR) as part of the Office of Solid Waste and Emergency Response Community Engagement Initiative, Action 13, Part B.9 While site information repositories were traditionally paper copies of documents maintained at locations near Superfund sites, today there are varying degrees of usage of electronic resources to store information, including CDs, DVDs and Web sites. For this assessment, EPA was interested in how the repositories are organized and maintained, as well as investigating how current technological resources could be utilized to improve public accessibility to Superfund site information and the general cost and time associated with maintaining a repository. The approach adopted for this assessment consisted of two distinct studies: (1) A survey of EPA regional practices for establishing and maintaining information repositories, and (2) an on-site assessment of the content, completeness, and organization of information repositories. The on-site assessment consisted of visits to 28 information repositories in five EPA regions to assess the content, completeness, and organization of the repositories. A complete account of the information repository assessment and findings can be found in theSuperfund Information Repository Assessment Report(Assessment Report).10

This assessment found that despite the careful attention and time dedicated to appropriately locating and maintaining an information repository, it appears to be an under-utilized and outdated source of information for most communities. In general, community members inquire about information repositories relatively infrequently (between 1-6 times per year). The frequency of repository use seems to be highest for newly listed National Priorities List (NPL) sites and during the pre-Record of Decision phase in the Superfund remedial process. New materials and instructions are sent by the lead agency to the repository, and the repository staff is responsible for adding and removing documents. Due to the variation in organization and maintenance of repositories, there can be inconsistency between repositories. Most repositories contain useful information and are organized in such a way that specific documents can be found. However, some repositories lack important documents or are poorly organized due to public usage over the years.

In almost all repositories visited for this assessment, computers are available. Some of these computers did not have CD drives to avoid the introduction of viruses into the library computer system, or the CD drives were not functional. All of the libraries that were visited had internet access.

Permitting the lead agency to provide the administrative record file to the public via computer telecommunications or other electronic means could help to alleviate situations with document access that have been known to sometimes occur with disorganized or misplaced paper files. Electronic access to site documents will also make this information more widely available and accessible to a broader public audience. The presence of an electronic- or computer telecommunications-based repository does not preclude establishing a traditional paper-based repository. The lead agency should always assess the capacity and resources of the specific community to utilize and maintain an electronic- or computer telecommunications-based repository to make a decision on which approach suits a specific site. Based on the preferences of the community and the lead agency's assessment of the site-specific situation, the lead agency will determine whether to provide: (1) Traditional forms (e.g. paper copies; microform) (2) electronic resources, or (3) both traditional forms and electronic resources. Community preferences and access to technological resources may be gleaned through community interviews or community technical needs assessments conducted as part of the planning for the Community Involvement Plan at a site.11

Under Executive Order 12866 (58 FR 51735, October 4, 1993) and Executive Order 13563 (76 FR 3821, January 21, 2011), this action is not a “significant regulatory action” and is therefore notsubject to OMB review. This action merely adds language to 40 CFR 300.805(c) of the NCP to broaden the technology, to include computer telecommunications or other electronic means, that the lead agency is permitted to use to make the administrative record file available to the public. This action will enable the lead agency to serve the information needs of a broader population while maintaining the ability to provide traditional means of public access, such as paper copies and microform, to the administrative record file. This action does not impose any requirements on any entity, including small entities. Therefore, pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), after considering the economic impacts of this action on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This action does not contain any unfunded mandates or significantly or uniquely affect small governments as described in Sections 202 and 205 of the Unfunded Mandates Reform Act of 1999 (UMRA) (Pub. L. 104-4). This action does not create new binding legal requirements that substantially and directly affect Tribes under Executive Order 13175 (63 FR 67249, November 9, 2000). This action does not have significant Federalism implications under Executive Order 13132 (64 FR 43255, August 10, 1999). Because this action has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq.,nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994). This action does not involve technical standards; thus, the requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272) do not apply. The Congressional Review Act, 5 U.S.C. 801et seq.,generally provides that before certain actions may take effect, the agency promulgating the action must submit a report, which includes a copy of the action, to each House of the Congress and to the Comptroller General of the United States. Because this action does not contain legally binding requirements, it is not subject to the Congressional Review Act.

For the reasons set out above, title 40, chapter I of the Code of Federal Regulations is amended as follows:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing thesuspension of such communities will be published in theFederal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act.This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act.The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification.This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism.This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform.This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act.This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501et seq.

Accordingly, 44 CFR part 64 is amended as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act.This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act.As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification.This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism.This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform.This final rule meets the applicable standards of Executive Order 12988.

Accordingly, 44 CFR part 67 is amended as follows:

This is a synopsis of the Commission'sReport and Order,adopted January 27, 2010, and released January 29, 2010. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 Twelfth Street SW., Washington, DC 20554. This document may also be purchased from the Commission's duplicating contractors, Best Copy and Printing, Inc., 445 12th Street SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or via emailwww.BCPIWEB.com.This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. The Commission will send a copy of thisReport and Orderin a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act,see5 U.S.C. 801(a)(1)(A).

The allotment changes that were adopted herein was subject to the final outcome of proceedings in MM Docket No. 00-148, and none of the vacant channels allocated in this proceeding will be available for auction until final resolution in MM Docket No. 00-148. In this instance, the proceedings in MM Docket No. 00-148 are considered final.See Quanah, Texas, et al,76 FR 42573, published July 19, 2011. Thus, the FM broadcast construction permits for Channel 288C2 at Rule, Texas (MM-FM957-C2) and Channel 255C3 at Crowell, Texas (MM-FM1034-C3) will be auctioned in the upcoming FM Auction 94, scheduled for March 26, 2013. Channel 293A at Knox City, Texas and Channel 251C3 at Quanah, Texas will be auctioned in a future FM auction that will be announced in a subsequent Commission Order.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

NMFS and the Council manage the snapper-grouper fishery off the southern Atlantic states under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The Council prepared the FMP and NMFS implements the FMP through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Section 305(c) of the Magnuson-Stevens Act (16 U.S.C. 1855(c)) provides the legal authority for the promulgation of emergency regulations.

The final rule for the Comprehensive Annual Catch Limit Amendment (Comprehensive ACL Amendment) to the Fishery Management Plan (FMP) for the Snapper-Grouper Fishery of the South Atlantic Region, and several other plans (77 FR 15916, March 16, 2012), effective April 16, 2012, implemented, in part, ACLs and accountability measures (AMs) for yellowtail snapper, as required by National Standard 1 of the Magnuson-Stevens Act. The commercial ACL for yellowtail snapper implemented through the final rule for the Comprehensive ACL Amendment is 1,142,589 lb (518,270 kg), round weight. The AM implemented through that rule states that the commercial sector will close if commercial landings reach or are projected to reach the commercial ACL.

On September 4, 2012 (77 FR 53776), NMFS published a temporary rule to close the commercial sector for yellowtail snapper in the South Atlantic on September 11, 2012, because NMFS determined that the commercial ACL for yellowtail snapper would be reached by that date. However, updated information revealed that yellowtail snapper could remain open for additional time until the ACL was reached. NMFS announced through a Fishery Bulletin on September 10, 2012, the cancellation of the previously announced closure. NMFS published a temporary rule on September 13, 2012 (77 FR 56563) with similar information. This would have been the first time yellowtail snapper would have closed in season since the ACL was first implemented in April 2012.

A new stock assessment for yellowtail snapper was completed by the Florida Fish and Wildlife Conservation Commission (FWCC), Fish and Wildlife Research Institute (FWRI), in May 2012,and reviewed by the Center for Independent Experts. The assessment indicates that the stock is not overfished nor undergoing overfishing. Results of the stock assessment suggest that the ABC could increase, which could allow an increase in the commercial ACL and positive social and economic benefits to commercial fishermen and dealers. The assessment was reviewed by the SSC on October 10, 2012. The SSC recommended the ABC for yellowtail snapper could increase to 4,050,000 lb (1,837,049 kg) based on the assessment. The South Atlantic Comprehensive ACL Amendment and the Generic ACL Amendment to the Red Drum, Reef Fish Resources, Shrimp, and Coral and Coral Reefs FMPs for the Gulf of Mexico (Generic ACL Amendment) (76 FR 82044, December 29, 2011) allocated 25 percent of the yellowtail snapper ABC to the Gulf of Mexico and 75 percent of the yellowtail snapper ABC to the South Atlantic. The Comp ACL Amendment and Generic ACL Amendment set the ABC equal to the ACL. Therefore, the ABC/ACL for the Gulf of Mexico would be 1,012,500 lb (459,262 kg), round weight, and the ABC/ACL for the South Atlantic would be 3,037,500 lb (1,377,787 kg), round weight. In the South Atlantic, the commercial allocation is 52.56 percent and the recreational allocation is 47.44 percent, which results in a commercial ACL of 1,596,510 lb (724,165 kg), round weight, and a recreational ACL of 1,596,510 lb (724,165 kg), round weight. Therefore, NMFS has determined that the commercial ACL for yellowtail snapper may increase to 1,596,510 lb (724,165 kg), round weight.

The Council and NMFS are developing Regulatory Amendment 15 to the FMP to implement the increased commercial ACL for yellowtail snapper on a permanent basis. This regulatory amendment is expected to become effective sometime in 2013. Pursuant to section 305(c) of the Magnuson-Stevens Act, this temporary rule may be effective for not more than 180 days after publication. However, it can be extended for an additional 186 days provided that the public has an opportunity to comment on the rule. Therefore, NMFS is soliciting public comment on this temporary rule, and may extend these measures for up to an additional 186 days if Regulatory Amendment 15 is not effective before then.

At its September 2012 meeting, the Council requested that NMFS promulgate emergency regulations to adjust the commercial ACL for yellowtail snapper based on the results of the May 2012 stock assessment conducted by FWRI, the SSC's anticipated October 2012 ABC recommendation, and the current commercial and recreational sector allocations. This temporary rule for emergency action is necessary to preserve a significant economic opportunity that otherwise might be foregone.

NMFS' Policy Guidelines for the Use of Emergency Rules (62 FR 44421, August 21, 1997) list three criteria for determining whether an emergency exists. This emergency rule is promulgated under those criteria. Specifically, in order to promulgate an emergency rule, NMFS' policy guidelines require that an emergency:

(1) Result from recent, unforeseen events or recently discovered circumstances; and

(2) Present serious conservation or management problems in the fishery; and

(3) Can be addressed through emergency regulations for which the immediate benefits outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as would be expected under the normal rulemaking process.

The unforeseen circumstance in this case is that a new stock assessment has recently been completed by the FWRI providing new information on the status of yellowtail snapper. The assessment indicates that the stock is neither overfished nor undergoing overfishing, and that additional yellowtail snapper may be harvested without negatively impacting the stock.

Harvest of yellowtail snapper is very close to reaching the current commercial sector ACL. Not increasing the commercial ACL for yellowtail snapper, based on the latest stock assessment, could result in negative economic impacts for those who depend on the commercial harvest of yellowtail snapper, especially in the Florida Keys.

Finally, the immediate benefit of implementing this emergency action outweighs the value of advance notice and public comment. The Southeast Fisheries Science Center has projected that if this rule is not implemented the commercial yellowtail snapper ACL would be reached in October 2012. NMFS must implement this temporary rule immediately to allow for the continued commercial harvest of this increased portion of the commercial ACL to give fishermen the opportunity to achieve OY for the fishery.

This action is issued pursuant to section 305(c) of the Magnuson-Stevens Act, 16 U.S.C. 1855(c). The Assistant Administrator for Fisheries, NOAA (AA), has determined that this temporary rule is necessary to preserve a significant economic opportunity that otherwise might be foregone for the yellowtail snapper component of the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.

This temporary rule has been determined to be not significant for purposes of Executive Order 12866.

The AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because they would be contrary to the public interest. The Southeast Fisheries Science Center has projected that the commercial yellowtail snapper ACL would be reached in October 2012. Failure to increase the commercial ACL for yellowtail snapper would result in unnecessary adverse economic impacts for those dependent upon the commercial harvest of yellowtail snapper, especially in the Florida Keys. NMFS must implement this temporary rule immediately to allow for continued commercial harvest of this increased portion of the commercial ACL to give fishermen the opportunity to achieve OY for the fishery. Comments submitted on this temporary rule through the Federal e-Rulemaking Portal:http://www.regulations.govand received by NMFS no later than December 7, 2012, will be considered during an extension of this temporary rule.

For the reasons listed above, the AA also finds good cause to waive the 30-day delay in effectiveness of the action under 5 U.S.C. 553(d)(3).

Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601et seq.are inapplicable. Accordingly, no Regulatory Flexibility Analysis is required and none has been prepared.

For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:

Regulations governing the Atlantic herring (herring) fishery are found at 50 CFR part 648. The regulations require annual specification of the overfishing limit, acceptable biological catch, annual catch limit (ACL), optimum yield, domestic harvest and processing, U.S. at-sea processing, border transfer, and the sub-ACL for each management area. The 2012 Domestic Annual Harvest was set as 91,200 metric tons (mt); the sub-ACL allocated to Area 1A for the 2012 fishing year (FY) was 26,546 mt and 0 mt of the sub-ACL was set aside for research in the 2010-2012 specifications (75 FR 48874, August 12, 2010). However, due to an over-harvest in Area 1A in 2010, the FY 2012 sub-ACL in Area 1A was revised to 24,668 mt on February 24, 2012 (77 FR 10978, February 24, 2012).

Section 648.201 requires the Administrator, Northeast Region, NMFS (Regional Administrator), to monitor the herring fishery in each of the four management areas designated in the Fishery Management Plan for the herring fishery and, based on dealer reports, state data, and other available information, to determine when the harvest of herring is projected to reach 95 percent of the management area sub-ACL. When such a determination is made, NMFS must publish notification in theFederal Registerand prohibit herring vessel permit holders from fishing for, catching, possessing, transferring, or landing more than 2,000 lb (907.2 kg) of herring per trip or landing more than once per calendar day in or from the specified management area for the remainder of the closure period. Transiting Area 1A with more than 2,000 lb (907.2 kg) of herring on board is allowed under the conditions described below.

The Regional Administrator has determined, based on dealer reports and other available information that 95 percent of the total herring sub-ACL allocated to Area 1A for 2012 is projected to be harvested on November 5, 2012. Therefore, effective 1200 hr local time, November 5, 2012, federally permitted vessels may not fish for, catch, possess, transfer, or land more than 2,000 lb (907.2 kg) of herring per trip (and landing herring no more than once per calendar day) in or from Area 1A through December 31, 2012. Vessels may transit through Area 1A with more than 2,000 lb (907.2 kg) of herring on board, provided such herring was not caught in Area 1A and provided all fishing gear aboard is stowed and not available for immediate use as stated in § 648.23(b). Effective 1200 hr, November 5, 2012, federally permitted dealers are also advised that they may not purchase herring from federally permitted herring vessels that harvest more than 2,000 lb (907.2 kg) of herring from Area 1A through 2400 hr local time, December 31, 2012.

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

The Assistant Administrator for Fisheries, NOAA (AA), finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be impracticable and contrary to the public interest. This action closes the herring fishery for Management Area 1A until January 1, 2013, under current regulations. The regulations at § 648.201(a) require such action to ensure that herring vessels do not exceed the revised 2012 sub-ACL allocated to Area 1A. The herring fishery opened for the 2012 fishing year on January 1, 2012. Data indicating the herring fleet will have landed at least 95 percent of the revised 2012 sub-ACLallocated to Area 1A have only recently become available. If implementation of this closure is delayed to solicit prior public comment, the sub-ACL for Area 1A for this fishing year can be exceeded, thereby undermining the conservation objectives of the FMP and requiring any excess to be subtracted from the Area 3 sub-ACL for the fishing year following the total catch determination. The AA further finds, pursuant to 5 U.S.C. 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reasons stated above.