As an initial point, UWAG's argument here   and the comments provided to EPA during the rulemaking   fail to demonstrate that any of these are actually significant problems, as opposed to theoretical possibilities. CR 068.100 at 1366 ( JA XX) ( during the rulemaking, EPA invited comments on whether it should consider nonaquatic impacts, see 65 Fed. Reg. at 49,075/ 2 ( JA XX), but in response EPA received no data from commenters supporting assertions that these side effects pose significant environmental problems.)

Moreover, UWAG's contention that EPA " ignored" these potential impacts is simply untrue. EPA considered each of these, and concluded they would not be a significant problem, particularly for new facilities, which have maximum flexibility in design and location. See, e. g., CR 068.100 at 1366 70 ( JA XX XX)  74  ( land use impacts on wetlands can be avoided by not building in wetlands or through the wetlands permit process in CWA § 404 ( at 1367); issues concerning the aesthetics of and reduced visibility from vapor plumes can be addressed using newer technology and land area buffers ( at 1367); similarly, salt deposition problems can be avoided using land area buffers ( at 1368); and increased energy use under this Rule will only be a tiny percentage of total energy use ( at 1367

68)); 66 Fed. Reg. at 65,296/ 3 ( JA XX) ( emissions of sulfer dioxide, nitrogen oxides, carbon dioxide and lead from power plants will increase less than 0.02%

annually as a result of this rule; emissions from manufacturers under this rule not projected to increase at all); TDD at 3 4 ( JA XX) ( Table 3 5 showing energy impacts as 0.027% of new generating capacity over the next 20 years), at 3 6 ( JA XX) ( Table 3 7 showing air emissions increases of 0.02%).

Having considered these impacts, EPA is entitled to great deference in deciding what weight to give these impacts in making the scientific and policy judgments that the Agency made in establishing this Rule. Weyerhaeuser Co.,

590 F. 2d at 1053 ("[ T] he judicial function is completed when we have assured ourselves that EPA has expressly considered the probable environmental impacts of its regulations."); BP Exploration & Oil, Inc., 66 F. 3d at 802 (" If any entity has the ability to weigh the relative impact of two environmental harms, it is the  75  EPA."). Moreover, EPA's Rule should be upheld because the agency examined the relevant information and articulated a reasonable explanation for its decision.

Motor Vehicle Mfr. Ass'n., 463 U. S. at 43.

4. UWAG's Other Criticisms of EPA's Track I Requirements Should Be Rejected.

a. UWAG contends ( UWAG Br. at 20 21) that the alternative requirements provision in 40 C. F. R. § 125.85 ( which allows facilities to request less stringent alternative requirements under certain conditions) is an inadequate means of addressing non impingement/ entrainment impacts because ( 1) it only allows consideration of air quality, water resources and energy markets and not other effects such as land use and aesthetics; ( 2) only allows consideration of local effects; and ( 3) only allows consideration of " significant" effects. First, EPA's alternative requirements provision only provides for exceptions based on " local"

impacts because EPA has already concluded that these impacts are not significant on a national level, as discussed above. CR 068.100 at 1366 70 ( JA XX XX).

Second, with respect to the non inclusion of land use and aesthetics as a basis for alternative requirements, EPA reasonably concluded that: ( 1) land use impacts will not be significant under this rule, because new facilities can be designed and located to avoid them, CR 068.100 at 1367 ( JA XX); and ( 2) the aesthetics of visible vapor plumes from cooling towers are a " small issue" when weighed  76  against the serious environmental impacts of once through cooling. CR 068.100 at 1367 ( JA XX). Third, UWAG's complaint that the alternative requirements provision demands a demonstration of " significant" impacts is puzzling. UWAG cannot reasonably contend that EPA should have allowed the alternative requirements provision to be used where there are " insignificant" impacts.

b. Although UWAG does not actually develop an argument on this point, in several places in its brief it makes statements to the effect that EPA failed to consider the costs of its regulation, failed to demonstrate particular benefits that would be achieved, and should have conducted a cost benefit analysis. UWAG Br. at 13, 16, 18 19. To the extent that UWAG is arguing that this rule should be remanded on any of these grounds, it is incorrect. As an initial point, as is clear from the discussion above with respect to the Environmental Petitioners' arguments, UWAG cannot reasonably contend that EPA ignored the cost of this Rule. Indeed, EPA rejected dry cooling technology in part on the basis of cost. See Argument I. A above.

At the same time, EPA reasonably interpreted the statute to mean that a cost benefit analysis was not required. As discussed above in the Statutory Background section, EPA interpreted the statutory direction to adopt " best technology available" ( in light of the statutory language applicable to " best 46/ National Wildlife Fed'n, 286 F. 3d at 570 ( Under CWA § 306, the EPA Administrator " must take costs into consideration, but does not require that she conduct a cost benefit analysis."); Chemical Mfrs. Ass'n, 870 F. 2d at 262 ( in establishing " best available technology" standards, EPA " must inquire into the initial and annual costs of applying the technology and make an affirmative determination that those costs can be reasonably borne by the industry."); CPC Int'l, Inc., 540 F. 2d at 1341 (" There is no language in [ 33 U. S. C. § 1316] requiring a cost benefit analysis.").

 77  available technology" and " best available demonstrated technology") to permit EPA to establish national requirements to install technology that was " technically available, economically practicable, and where EPA has also considered the other environmental impacts of the requirements, such as energy impacts." CR 068.007 at 1182 ( JA XX). Moreover, the case law with respect to the " best available technology" requirement in CWA § 306, 33 U. S. C. § 1316, makes clear that no cost benefit analysis is required, 46/ and the same should be true for the very similarly phrased " best technology available" requirement here. CR 206.014 at 1888 90 ( JA XX XX). Further, the legislative history of CWA § 316( b) states that the " best technology available" phrase is " intended to be interpreted to mean the best technology available commercially at an economically practicable cost."

118 Cong. Rec. 33,762 ( 1972), reprinted in 1 Legislative History of the Water Pollution Control Act Amendments of 1972, 93rd Cong., 1st Sess., at 264 ( Comm.

Print 1973). This provides further support for EPA's focus on determining  78  whether the technology chosen was technically available and economically practicable, rather than on comparing costs with benefits.

UWAG's references to Executive Order 12,866 ( UWAG Br. at 17 n. 10) and the Unfunded Mandates Reform Act ( UWAG Br. at 19) do not help it here.

Executive Order 12,866 expressly states that it " does not create any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, it agencies or instrumentalities, its officers or employees, or any other person." Exec. Order No. 12,866, § 10, 58 Fed. Reg. 51,735, 51,744 ( Sept.

30, 1993). With respect to the Unfunded Mandates Reform Act (" UMRA"),

UMRA § 202( a) is clear that its requirements ( including a cost benefit analysis)

apply to a regulation only if the cost of the regulation will exceed $ 100 million per year. 2 U. S. C. § 1532( a). EPA concluded that the cost of this Rule will not reach the statutory threshold, and thus that the UMRA requirements did not apply. 66 Fed. Reg. at 56,329/ 1 2 ( JA XX).

Finally, UWAG's reliance on United States Steel Corp. v. Train, 556 F. 2d 822, 850 ( 7th Cir. 1977), is misplaced. UWAG Bf. at 18 19. That decision did not hold that EPA was required to do a cost benefit analysis to support CWA § 316( b)

regulations. Instead, that court held only that an argument on that point was not ripe at that time, and the court assumed that EPA would conduct a " limited costbenefit analysis" when the time came. As discussed above, EPA has interpreted 47/ On a separate note, UWAG also questions EPA's authority to require flow to be reduced to the level that is commensurate with a closed cycle recirculating cooling system, but then says it does not raise that issue in this case. UWAG Br. at 12 n. 7. To the extent that the Court is interested in this issue, EPA fully responded to this authority argument in the administrative record. See, e. g., 66 Fed. Reg. at 65,313/ 2 3 ( JA XX); CR 068.010 at 1196 97 ( JA XX XX).

 79  its obligation with respect to costs under CWA § 316( b) as ( 1) the consideration of costs in a manner similar to the consideration of costs under CWA § 306 and ( 2) the determination that the chosen technology is " economically practicable"

( meaning that it can be reasonably borne by the affected industries), with no requirement for a cost benefit analysis. 65 Fed. Reg. at 49,094/ 2 ( JA XX).

Because that interpretation is reasonable, it should be upheld by this Court.

Chevron, 467 U. S. at 843 & n. 11; Sutherland, 228 F. 3d at 173 (" When reviewing an agency determination, federal courts must accord substantial deference to an agency's interpretation of the statutes it is charged with administering.") 47/

B. EPA Reasonably Included Additional Design And Construction Requirements in 40 C. F. R. § 125.84( b)( 4) and ( 5) To Further Minimize Impingement and Entrainment in Certain Circumstances.

Even where a facility operates a closed cycle cooling system, it still may be withdrawing millions of gallons of water a day, creating a risk of significant impingement and entrainment of fish and other aquatic organisms. To address this risk, EPA's rule requires that facilities have additional design and construction  80  technologies or operational measures for minimizing impingement and entrainment of fish and other aquatic organisms that are either ( 1) threatened or endangered or otherwise protected species, or ( 2) migratory and/ or sport or commercial species of concern to the relevant fisheries managers. 66 Fed. Reg. at 65,340/ 2 3, 40 C. F. R. § § 125.84( b)( 4) and ( b)( 5). The establishment of specific requirements for a specific facility is left to the individual permitting process. 66 Fed. Reg. at 65,275 76 ( JA XX XX).

UWAG challenges these requirements on the grounds that they are " completely undefined," inconsistent with the goals of clarity, consistency and reduced regulatory burden and unsupported by the record. UWAG Br. at 22 30.

For the reasons discussed below, UWAG's contentions are incorrect.

These requirements are not " completely undefined," as UWAG contends.

UWAG Br. at 23 26. In promulgating this rule, EPA discussed the types of measures that it contemplated could be used to meet these design and construction requirements. 66 Fed. Reg. at 65,275/ 3 ( JA XX). EPA identified ( 1) intake screens, such as fine mesh screens and aquatic filter barrier systems, that exclude smaller organisms from entering the cooling water intake structure; ( 2) passive intake systems such as wedgewire screens, perforated pipes, porous dikes, and artificial filter beds, which also exclude organisms from entering the intake  81  structure; ( 3) diversion and/ or avoidance systems that guide fish away from the intake before they are impinged or entrained; and ( 4) fish handling systems such as bypass systems, fish buckets, fish baskets, fish troughs, fish elevators, fish pumps, low preassure spray wash systems, and fish sills, that either divert organisms away from impingement at the intake structure, or collect impinged organisms and protect them from further injury as they are transferred back to the water. 66 Fed. Reg. at 65,275/ 3 ( JA XX).

Further, EPA explained that it was not prescribing particular measures because the various design and construction options have different feasabilities depending on site specific factors such as type of location, intake flow rate, speed and variability of currents, extent to which water contains debris that may cause clogging and the like. 66 Fed. Reg. at 65, 275/ 3 ( JA XX); CR 068.109 at 1388 ( JA XX) ("[ A] s the site specific application of these requirements reflects, it is not feasible to assess optimization of such technologies for all new facilities on a national basis due to the numerous technologies that exist and the site specific factors that affect their selection, combination, and optimization.")

Similarly, UWAG's claim that there is no standard for determining " when"

these additional design and construction requirements apply, and no " procedure"

for learning in advance whether the permitting authority will impose any such  82  requirements ( UWAG Br. at 24 25) misses the point. These requirements are applied on a site specific basis as a result of communications between the facility and the permitting authority during the permit proceeding. 66 Fed. Reg. at 65,276/ 1 ( JA XX).

Overall, UWAG's arguments on this point   as well as its arguments that these requirements may lead to inconsistent decisions by permitting authorities ( UWAG Br. at 26 28) and that the rule contains no " analysis" or " guidance" for deciding how to fulfill these requirements ( UWAG Br. at 29)   amount to a complaint that EPA has decided to take a site specific approach on these design and construction requirements. UWAG's opposition to this approach here is inconsistent with its repeated insistence that a site specific approach was preferable. UWAG Br. at 11 (" UWAG and other commentors urged EPA to retain and refine the long established site specific approach described above [ in UWAG's brief]."); Comments of the Utility Water Act Group on EPA's Proposed § 316( b) Rule for New Facilities and ICR No. 1973.01, DCN W 00 32,

Comment 1.68 ( Nov. 9, 2000), at 40 ( JA XX) ("[ S] ince state authorities and fishery experts have a variety of different values to protect, some of which may be in conflict with others, it would, again, be wildly unrealistic to expect  83  ` consistency.' ` Inconsistency' may merely mean that different states have balanced competing values differently, which is as it should be.").

A few of UWAG's arguments require a short additional response.

First, UWAG incorrectly claims that EPA's regulation of " operational measures"

is beyond the Agency's authority because CWA § 316( b) is only concerned with " technology." UWAG Br. at 24. Operational measures include such matters as maintenance ( such as cleaning or rotating screens to ensure proper operation), and temporary shutdowns or flow reductions ( during, for example, spawning or migration events). These measures are reasonably understood to be part of EPA's authority to regulate " technology" because the common meaning of " technology"

includes not only the configuration of physical structures but also the methods by which they are operated. Webster's II New Riverside University Dictionary ( 1984), at 1188 ( defining technology as " the application of science esp. to industrial or commercial objectives" and "[ t] he whole body of methods and materials used to achieve such objectives").

Second, with respect to UWAG's argument that EPA did not adequately consider the cost of the design and construction requirements ( UWAG Br. at 29),

neither UWAG or any other commentor raised this issue to EPA during the 48/ United States v. L. A. Tucker Truck Lines, 344 U. S. 33, 37 ( 1952) (" courts should not topple over administrative decisions unless the administrative body . . . has erred against objection made at the time appropriate under its practice").

49/ For example, EPA estimated that the capital costs of traveling screens with fish handling features could be as high as $ 1,037,000. EA at 6 5 ( Table 6 2) ( JA XX).

 84  adminstrative process, and thus UWAG cannot raise it now. 48/ Moreover, contrary to UWAG's claim ( UWAG Br. at 29), EPA did consider the cost of the design and construction requirements. TDD at 2 3, 2 26 to 2 56 ( JA XX, XX XX). EPA's focus on wedgewire screens and fish return systems with traveling screens ( which UWAG criticizes at 29) was appropriate because the costs of those technologies are at least representative and in some cases among the more expensive on the list of potential design and construction technologies. CR 068.108 at 1386 ( JA XX). 49/ Overall, EPA concluded that the costs of this Rule would be " economically practicable," 66 Fed. Reg. at 65,282/ 1 ( JA XX), and UWAG has not shown otherwise.

In summary, because UWAG has not demonstrated how the additional design and construction requirements are unreasonable or beyond EPA's authority, they should be upheld.

C. EPA Reasonably Chose To Set An Intake Velocity Limit Based on " Through Screen Velocity" And To Set The Limit at 0.5 Feet Per Second. 50/ See, e. g., Technical Evaluation of the Utility of Intake Velocity as an Indicator of Potential Adverse Environmental Impact under Clean Water Act Section 316( b) (" Intake Velocity Technical Evaluation") Graph of Swim Speed Data, DCN 2 028A ( JA XX) ( showing that majority of fish species can swim out of intake flows moving at 0.5 feet per second, but that more species would be unable to escape as the intake velocity speed is increased).

 85  A key factor in minimizing the impingement and entrainment of aquatic organisms is reducing the velocity at which water is drawn into the cooling water intake structure. Both the data in the record and common sense supports the conclusion that higher intake velocities lead to higher impingement and entrainment. CR 014.018 at 131 132 ( JA XX XX). 50/

Notably, UWAG does not challenge the concept of intake velocity regulation. Instead, UWAG argues that EPA ( 1) should have chosen a different method of measuring intake velocity, ( 2) set the 0.5 ft/ s limit without adequate information and at a standard that will preclude some beneficial technologies, and ( 3) based the limit on " approach velocity" figures but set the standard as a " through screen velocity," thus adding a significant measure of stringency that is not considered in EPA's analysis. UWAG Br. at 30 34. As discussed below, both EPA's selection of the measurement method and the setting of the numerical limit were reasonable judgments within EPA's scientific and technical expertise, and should be upheld by this Court. 51/ As the names suggest, " through screen velocity" is the speed of the water flow as it goes through the screen on an intake structure, which is where impingement occurs. The " approach velocity" is the speed of the water flow a short distance in front of the screen, as it " approaches" the screen.

 86  1. EPA Reasonably Chose to Set a " Through Screen Velocity" Standard Rather Than an " Approach Velocity" Standard.

UWAG argues that EPA should have set the intake velocity standard as an " approach velocity" rather than a " through screen velocity" based on UWAG's contentions that approach velocity is more important than through screen velocity ( UWAG Br. at 31) and that most studies have examined approach velocity.

UWAG Br. at 31 32.51/ As an initial point, UWAG provides no citations in support of these contentions. That alone is a sufficient basis for this Court to reject UWAG's argument on this point.

Moreover, even taking UWAG's arguments at face value, UWAG fails to demonstrate that EPA's decision was arbitrary. EPA considered the options of approach velocity and through screen velocity, and chose through screen velocity because ( 1) many recently constructed facilities are designed to meet throughscreen velocity limits based on readily available technologies, and ( 2)

throughscreen velocity is easier to measure accurately and therefore will be easier to implement for facilities and regulators. CR 056.041 at 958 ( JA XX). While 52/ The June 2000 version of this document in the record ( and thus the Joint Appendix) bears the date of a preliminary draft ( April 10, 2000) on pages 2 9, because the person making the revisions neglected to change the header when the document was revised.

 87  UWAG may prefer a different decision, it has not demonstrated that EPA's decision was irrational.

2. EPA's Decision to Set the Intake Velocity Limit at 0.5 ft/ s Was Supported by the Record and Will Not Preclude Appropriate Technologies.

Contrary to UWAG's argument ( UWAG Br. at 30, 33 34), the 0.5 ft/ s standard was supported in the record and will not preclude appropriate technologies. First, EPA's selection of the 0.5 ft/ s standard was based on EPA's analysis of the available data and studies, which supported the conclusion that a 0.5 ft/ s standard would be protective with a reasonable margin of safety.

CR 014.018 at 131 ( JA XX); Background and Justification for Using a Through

Screen Velocity of 0.5 Foot per Second as a Threshold Criterion Value for the Section 316( b) Rulemaking ( June 2000), 52/ DCN # 1 1054 TC ( JA XX XX);

Intake Velocity Technical Evaluation, Graph of Swim Speed Data, DCN 2 028A ( JA XX) ( showing that majority of fish species can swim faster than 0.5 ft/ s).

Further, EPA concluded that this standard was achievable because a survey of facilities built in the past 15 years demonstrated that the standard was already being met by the majority of recently built facilities. 66 Fed. Reg. at 28,864 ( JA 53/ UWAG cites to similar figures ( see UWAG Br. at 33, noting that 79% of recently built electric generating facilities meet the 0.5 ft/ s standard) and argues that this shows that the remaining facilites " cannot" meet the standard. UWAG's point is incorrect, because these figures show facilities that meet the 0.5 ft/ s standard even in the absence of any requirement to do so. Thus, these figures do not demonstrate that the other facilities could not meet the standards, but only that they currently do not in the absence of any regulation requiring compliance. Morever, the question for this rule is not whether some existing facilities can meet the standard, but whether not yet built facilities could be designed to meet the standard. That a large majority of recently built facilities meet the 0.5 ft/ s standard even in the absence of a requirement to do so demonstrates that the 0.5 ft/ s standard is reasonable for new facilities.

54/ A " velocity cap" covers an intake structure that otherwise has a vertical inflow and converts the flow to a horizontal flow. See diagram in Design of Water Intake Structures for Fish Protection, DCN # 2 032, at 67, Figure IV 20 ( JA XX).

 88  XX) ( 73% of the manufacturing facilities and 62% of the electricity generating facilities built in the last 15 years meet the 0.5 ft/ s limitation.) 53/ Thus, this standard is reasonable on the record that was before the Agency.

Second, in response to UWAG's claim that the 0.5 ft/ s standard will preclude certain beneficial technologies such as a velocity cap ( UWAG Br. at 33

34), 54/ EPA notes that the velocity cap can be designed to meet the performance standard by increasing the area of the intake opening. Further, velocity caps work not by increasing velocity as a cue to fish ( as stated in UWAG Br. at 33) but by converting a vertical inflow ( which fish do not avoid) to a horizontal inflow ( which fish will avoid). See Design of Water Intake Structures for Fish Protection, DCN # 2 032, at 66 67 ( JA XX); TDD, Appendix A at A 31 ( JA XX). 55/ UWAG anticipates this point and argues that, if an alternative " Track II" technology with a higher than 0.5 ft/ s intake velocity leads to results comparable to what could be achieved under Track I, then Track I is not the " best technology available." UWAG Br. at 33 34. UWAG's argument here should be rejected. If the " Track II" alternative is comparable ( which is all that Track II requires), then it is not better.

UWAG also claims that some technologies listed by EPA as possible ways of meeting the design and construction requirement ( under 40 C. F. R. § 125.84( b)( 4) and ( 5)) cannot meet the 0.5 ft/ s limit. UWAG Br. at 34. UWAG does not identify which technologies it is referring to, so it is not possible to specifically respond. As a general matter, however, EPA examined the feasibility of meeting the 0.5 ft/ s limit and determined it was achievable through a number of intake technologies that are currently in use. 66 Fed. Reg. at 65,278 79 ( JA XXXX

 89  Thus, velocity caps do not need to exceed the 0.5 ft/ s standard to work. Finally, if a particular velocity cap with an intake velocity greater than 0.5 ft/ s can minimize impacts comparable to those that meet the 0.5 ft/ s standard, then facilities can use the former under Track II. 40 C. F. R. § 125.84( d) ( facilities can avoid the 0.5 ft/ s limit and certain other Track I requirements if they demonstrate that their proposed technologies under Track II will achieve comparable reductions to what they would achieve under Track I); CR 014.018 at 132 ( JA XX). 55/

Third, in response to UWAG's claim that basing the limit on approach velocities but applying it to the through screen velocities adds a significant measure of stringency that was not considered in EPA's analysis ( UWAG Br. at 32), EPA recognized that through screen velocity is faster than approach velocity.  90  See, e. g., CR 206.119 at 1963 ( JA XX) (" a 0.5 ft/ s through screen velocity will effectively reduce approach velocities to values lower than 0.5 ft/ s"). EPA,

however, determined that the 0.5 ft/ s limit was reasonable in light of the readily available technologies that can meet the limit, the practicality of implementing the design through screen velocity limit, and the fact that the swim speed data was laboratory data that did not include all fish species and did not account for real world conditions ( such as debris covering a portion of the intake, which causes intake velocity through the unobstructed portions to increase). CR 014.018 at 131 ( JA XX) and CR 206.119 at 1963 ( JA XX).)

For these reasons, EPA's selection of the 0.5 ft/ s velocity limit should be upheld.

D. EPA's Proportional Flow Limits Are Supported by The Record And Were Within The Scope Of EPA's Reasonable Scientific And Technical Judgment.

Under 40 C. F. R. § 125.84( b)( 3), new facilities with cooling water intake structures must limit the volume of their intake based on the size of the water body from which they are removing the water. This limitation is based on EPA's judgment that, at a certain point, the volume of water withdrawn by a facility is disproportionately large in relation to the size of the water body, which results in unwarranted environmental impacts. 66 Fed. Reg. at 65,277/ 2 3 ( JA XX). 56/ " Natural thermal stratification" is the naturally occurring division of a waterbody into horizontal layers of differing densities as a result of variations in temperature at different depths. 66 Fed. Reg. at 65,339/ 2 ( JA XX). " Turnover" occurs when the horizontal layers within the waterbody are destabilized and become more fully mixed. Maintaining the natural patterns of stratification and turnover is important because it is integral to the seasonal cycling of nutrients and oxygen which in turn is important for spawning and survival of organisms.

 91  For intake structures on freshwater rivers and streams, the intake flow must be no more than 5% of the annual average flow of the river or stream. 40 C. F. R.

§ 125.84( b)( 3)( i). For intake structures on a lake or reservoir, the intake flow must be at a level that will not disrupt the natural thermal stratification or turnover pattern56/ of the water body, unless the relevant fisheries agency determines that such disruption will be beneficial. 40 C. F. R. § 125.84( b)( 3)( ii). Finally, for estuaries and tidal rivers, the intake flow must be no more than 1% of the volume of water in the area under the influence of the intake structure. 40 C. F. R. § 125.84( b)( 3)( iii).

As discussed below, these requirements are supported by the record and are within the scope of EPA's reasonable scientific and technical judgment.

UWAG's arguments to the contrary ( UWAG Br. at 35 39) are incorrect.

1. The Proportional Flow Limits For Rivers And Estuaries Are Supported By The Record And Are Reasonable. 57/ As a initial point, EPA disagrees with UWAG's suggestion that Track I's requirements of both closed cycle cooling and the proportional flow requirement is " a belt and suspenders approach." UWAG Br. at 36 n. 19. The volume capacity requirement based on closed cycle cooling is the fundamental method of minimizing environmental impact, while the proportional flow limits minimize impacts from the remaining withdrawals   that is, the water that is still withdrawn by a facility that employs a recirculating cooling system. Thus, these two requirements are not duplicative, but represent two separate steps toward minimizing the environmental impacts of cooling water intake structures.

 92  In challenging EPA's 5% limit for rivers and 1% limit for estuaries, UWAG contends that ( 1) EPA assumed that taking 5% or 1% of the water from these water bodies would equate to taking 5% or 1% of the eggs and larvae, which UWAG claims is incorrect because eggs and larvae are not necessarily evenly distributed in the water, UWAG Br. at 35 36; and ( 2) the limits of 5% and 1% are arbitrary and not supported by the record. UWAG Br. at 36 37.57/

First, with respect to UWAG's argument concerning the distribution of eggs and larvae, UWAG is incorrect in stating that EPA failed to recognize that eggs and larvae are not always evenly distributed in the water. EPA did not claim that there was always a one to one correspondence between water volume and quantity of eggs and larvae, but concluded that the volume of water withdrawn is " closely linked" to the amount of eggs and larvae entrained. 66 Fed. Reg. at 65,277/ 2 ( JA XX) (" Entrainment impacts of cooling water intake structures are closely linked to the amount of water passing through the intake structure, because  93  the eggs and larvae of some aquatic species are free floating and may be drawn with the flow of cooling water into an intake structure.") Though EPA does not contend that the withdrawal of any given percentage of the water in a river or estuary will always equate to the entrainment of that exact same percentage of eggs and larvae, EPA's decision to use percentage of water volume as a surrogate for percentage of eggs and larvae was a reasonable regulatory approach.

Second, EPA's selection of the 5% and 1% figures was technology based:

EPA determined that the 5% and 1% limits were already being achieved by the majority of existing facilities, 66 Fed. Reg. at 65,277/ 1 ( JA XX) ( 90% of existing facilities on rivers and 92% of existing facilities on estuaries meet these requirements), and thus concluded that methods for meeting these limits were " technically available and economically practicable for the industry as a whole."

66 Fed. Reg. at 65,277/ 1 2 and 65,301/ 1 ( JA XX, XX); CR 068.076 at 1305 ( JA 58/ To determine whether this requirement would prevent new facilities from finding locations to build, EPA analyzed the impact that the proportional flow requirement would have on the availability of riverside locations for facilities with intake structures. The Agency concluded that the 5% limit would permit the location of intake structures on tens of thousands of miles of rivers. 66 Fed. Reg. at 65,281/ 1 2 ( JA XX) ( over 131,000 miles of rivers would be available for facilities withdrawing up to 18 millions of gallons per day (" MGD"), over 53,000 river miles would be available for 85 MGD facilities and over 14,000 river miles would be available for 700 MGD facilities). Thus, UWAG cannot reasonably argue that this regulation leaves new facilities without location options.

59/ CR 068.103 at 1376 (" Recent trends in the electric generating industry have incorporated more advanced technologies, including combined cycle turbines and recirculating cooling systems, which are more energy efficient and require less cooling water").

 94  XX). 58/ EPA further concluded that the 5% and 1% figures would be protective.

66 Fed. Reg. at 65,277/ 1 2 and 65,301/ 1 ( JA XX, XX). In particular, EPA chose to set these figures conservatively to account for the cumulative impact where multiple intakes withdraw water from the same water body. 66 Fed. Reg. at 65,277/ 1 and 65,301/ 2 ( JA XX, XX). Given that 90% or more of existing facilities were meeting this requirement even in the absence of any requirement to do so, EPA's decision to set these standards for new facilities ( which have more flexibility as to location and design, and can adopt newer technologies that use less cooling water that existing facilities 59/) should be upheld as reasonable.  95  2. EPA's Protection Of The Natural Thermal Stratification In Lakes and Reservoirs Is Reasonable.

Under EPA's rule, the intake flow into a facility on a lake or reservoir must be at a level that will not disrupt the natural thermal stratification or turnover pattern of the water body, unless the relevant fisheries agency determines that such disruption will be beneficial. 40 C. F. R. § 125.84( b)( 3)( ii). This requirement is appropriate because the natural thermal stratification in lakes and reservoirs is typically important to maintain the physical and chemical conditions in these waterbodies that support essential life cycles, such as reproduction and growth of plants and animals that make up the food chain, and decomposition. CR 068.078 at 1310 11 ( JA XX) . UWAG argues that the protection of thermal stratification is irrational because ( 1) " any" withdrawal of water will disrupt stratification " to some extent" and thus this requirement effectively " zones out" new facilities on lakes and reservoirs; and ( 2) some destratification is beneficial. UWAG Br. at 38.

First, UWAG's contention that this requirement will " zone out" all new facilities on lakes and reservoirs ( UWAG Br. at 38) is incorrect. In promulgating this requirement, EPA noted that " most existing facilities meet the proportional flow requirement for lakes and reservoirs." 66 Fed. Reg. at 65, 277/ 1 ( JA XX).

Because most existing facilities meet the standard even without a legal requirement to do so, it is reasonable for EPA to conclude that new facilities   60/ On this point, EPA also notes that facilities in many arid parts of the country do not currently withdraw their cooling water from waters that are governed by the Clean Water Act, and instead get their cooling water from sources such as groundwater, municipal water suppliers, and treated wastewater. EPA found that 80% of the existing facilities in Arizona, California, Nevada, New Mexico, Oklahoma and Texas do not withdraw water from Clean Water Act regulated waters in their operations. EPA's rule would not affect the location or design of new facilities that do not use Clean Water Act regulated waters. 66 Fed. Reg. at 65,281/ 1 2 ( JA XX).

 96  which have greater flexibility in design and location that existing facilities   will be able to as well. 66 Fed. Reg. at 65,277/ 1 ( JA XX). 60/

Second, UWAG's argument concerning the beneficial effects of destratification ( UWAG Br. at 38) ignores the fact that the stratification requirement in 40 C. F. R. § 125.84( b)( 3)( ii) expressly provides an exception for situations where the relevant fisheries management agency determines that destratification is beneficial. It was reasonable for EPA to design a general rule that is appropriate to the most common situations, while allowing case by case exceptions where local conditions warrants.

3. EPA Considered How Facilities Would Meet The Proportional Flow Limitation And The Costs Of Doing So.

UWAG complains that EPA did not identify " technologies" that will allow facilities to meet the proportional flow limitations in 40 C. F. R. § 125.84( b)( 3).

UWAG Br. at 38 39. UWAG's argument here is off base. EPA considered how new facilities could meet this requirement, and found that facilities could do so by  97  " locating [ the facility] in an appropriate location, or obtaining water from groundwater, grey water [ treated wastewater], or municipal sources." CR 068.103 at 1376 ( JA XX). The fact that these options are not design technologies is not telling. CWA § 316( b) expressly includes " location" as one of the ways in which adverse environmental impact may be minimized. Further, facilities always have the option of choosing a water source other than Clean Water Act regulated waters and thereby avoiding this rule entirely.

UWAG further claims ( UWAG Br. at 39) that EPA did not consider a number of factors such as access to transmission lines and fuel, cumulative impacts on air and water, and others. First, UWAG in its brief does not even attempt to demonstrate how EPA's Rule actually ( as opposed to potentially) affects these concerns. Second, EPA did in fact consider and respond to comments on these issues during the administrative process. See, e. g., CR 204.003 at 1844 ( JA XX)

( transmission lines and fuel supply); CR 068.100 at 1368 ( JA XX) (" EPA has analyzed the increased air emissions expected as a result of the final rule . . . .

EPA's conclusion is that the expected air emissions increases due to this rule are small"). See also 66 Fed. Reg. at 65,296/ 3 ( JA XX) ( emissions of sulfer dioxide,

nitrogen oxides, carbon dioxide and lead from power plants will increase less than  98  0.02% annually as a result of this rule; emissions from manufacturers under this rule not projected to increase at all.)

Further, as noted above, 90% of existing facilities on rivers and 92% of existing facilities on estuaries are in locations that allow them to meet these requirements, even without any obligation to do so. 66 Fed. Reg. at 65,277/ 1 ( JA XX). Moreover, EPA again notes that sufficient flow to meet the proportional flow requirement is available along tens of thousands of miles of rivers and other sources of water besides Clean Water Act regulated waterbodies are available to be used as cooling water. 66 Fed. Reg. at 65,281/ 1 2 ( JA XX). Thus, the availability of numerous locations that will allow a facility to meet the proportional flow requirement offer sufficient flexibility to accommodate the concerns listed by UWAG.

Finally, with respect to UWAG's one sentence argument that EPA did not adequately consider cost ( UWAG Br. at 39), neither UWAG nor any other commentor raised this issue during the administrative process and so may not raise it here. L. A. Tucker Truck Lines, 344 U. S. at 37. In any event, EPA believes that the costs of the proportional flow requirement will not pose an unbearable economic burden because the majority of existing facilities meet the requirement now. 66 Fed. Reg. at 65, 277/ 1 ( JA XX) ( 90% of existing facilities on freshwater  99  rivers and 92% of existing facilities in estuaries). Moreover, for any facility that can demonstrate that this requirement will impose disproportionate costs, it may seek to be governed by less stringent requirements under 40 C. F. R. § 125.85.

E. The Provision Related To State Law Requirements In 40 C. F. R. § 125.84( e) Is Authorized by the Clean Water Act In 40 C. F. R. § 125.84( e), EPA placed language in the rule recognizing that facilities must comply with more stringent requirements than required under EPA's regulations where the permitting authority deems that meeting those more stringent requirements is reasonably necessary to comply with state law. UWAG argues that this provision is improper because it is not authorized by CWA § 316( b). UWAG Br. at 39 42 UWAG's argument is fundamentally flawed, because EPA did not base this provision on CWA § 316( b). 40 C. F. R. § 125.84( e) is founded on the statutory provisions relating to state law and authority in CWA § § 401( d) and 510, 33 U. S. C. § § 1341( d) and 1370, and is consistent with the goals of the CWA, as identified in CWA § 101. 33 U. S. C. § 1251( a), ( b). See EPA's full discussion of these provisions in 66 Fed. Reg. at 65,277 78 ( JA XX XX). By including 40 C. F. R. § 125.84( e) in this rule, EPA is not attempting to expand the scope of CWA § 316( b), nor does this provision impose any specific requirements; EPA is simply placing in the regulations, as a reminder to permitting authorities, a provision  100  recognizing the authority preserved to states under these other statutory provisions.

CR 068.316 at 1502 ( JA XX) (" EPA's approach in the final rule to allowing the permit authority to implement any additional requirement of state law is a simple recognition of section 510 of the CWA.").

Further, EPA does not rest its case " mainly on section 401" of the Clean Water Act, as UWAG states. UWAG Br. at 41. EPA relies primarily on CWA § 510, 33 U. S. C. § 1370, which recognizes that the Clean Water Act does not preempt state authority to regulate more stringently. CWA § 510 is linked to CWA § 401( d), 33 U. S. C. § 1341( d), in that where EPA issues a permit, the permit must include provisions necessary to comply with state law in accordance with 40 C. F. R. § § 124.53( d) and ( e). Indeed, UWAG itself states that CWA § 401, 33 U. S. C. § 1341, " authorizes states to impose requirements of state law as conditions in federal permits." UWAG Br. at 41. This is all that 40 C. F. R. § 125.84( e) does.

UWAG further states that CWA § 510 " reserves certain powers to the states"

( which is correct), but then argues that it does not give EPA authority to " set federal requirements, and particularly not to add requirements to 316( b)." UWAG Br. at 41. In this Rule, however, EPA is not adding requirements to CWA § 316( b). The Rule simply reflects in its text the statutory authority reserved to the states under CWA § § 401( d) and 510, by requiring the facility to comply with any 61/ In response to UWAG's statement that it is not clear why EPA's CWA § 401 regulations do not " fill the bill" ( UWAG Br. at 41), EPA included 40 C. F. R. § 125.84( e) to assist the permit writer and public by noting that there may be applicable state laws relating to cooling water intake structures. Moreover, in the 45 states where the state is the permit authority, the requirement for a state certification under CWA § 401( a)( 1) does not apply, so the inclusion of this provision reminds and/ or informs state permit writers of the possibility of applicable state requirements as recognized in CWA § 510.

 101  state law provision that is applicable to cooling water intake structures as part of the NPDES permit. 40 C. F. R. § 125.84( e). Where the state is the permitting authority ( which is the case in 45 states), the permitting authority does this as a matter of state law. Where EPA issues the permit, CWA § 401( d) authorizes states to impose requirements of state law as conditions in federal permits. 33 U. S. C. § 1341( d). See P. U. D. No. 1 v. Washington Dep't of Ecology,

511 U. S. 700, 705 ( 1994) ( discussing CWA § 401). 61/

UWAG's other arguments on this point are simply wrong. First, whether " a single state has adopted water quality standards for entrainment or impingement"

or whether " any waterbody . . . is [ currently] designated as impaired due to entrainment or impingement" ( UWAG Br. at 40) are both irrelevant; states may adopt such standards or make such a designation in the future. Moreover,

recognizing the possibility of future state action is not " authorizing permit writers to interpret in stream water quality standards to require additional limits on intake structures" ( UWAG Br. at 40). That authority was already preserved to the States  102  by Congress in CWA § § 401( d) and 510, 33 U. S. C. § § 1341( d) and 1370. Second,

UWAG's claim that 40 C. F. R. § 125.84( e) will " require states to create new requirements for state issued NPDES permits" ( UWAG Br. at 42) is incorrect.

This provision does not require that states create new, more stringent requirements;

it only recognizes the fact that facilities must comply with any such requirements that states choose to adopt.

Finally, 40 C. F. R. § 125.84( e) will not place future intake requirements beyond judicial review ( as claimed in UWAG Br. at 42). NPDES permits are subject to judicial review either ( 1) under state procedures ( for state issued permits), see 40 C. F. R. § 123.30 ( requiring states that administer the NPDES program to provide an opportunity for judicial review of permit decisions), or ( 2) following an administrative appeal within EPA under 40 C. F. R. § 124.19, after which a party may obtain review in federal court under 33 U. S. C. § 1369( b) ( for EPA issued permits). Thus, while future intake requirements under 40 C. F. R.

§ 125.84( e) will not be subject to review in this case, judicial review will be available.

For all of these reasons, this Court should uphold 40 C. F. R. § 125.84( e).

III. MISC'S PETITION SHOULD BE DENIED.  103  The Manufacturers Intake Structure Coalition (" MISC"), representing facilities that use cooling water in the process of manufacturing goods, challenges three provisions:

° The provision requiring that " below threshold" intake structures ( those that withdraw less than 2 million gallons per day (" MGD") or where less than 25% of the withdrawn water is used for cooling purposes, and thus are not regulated under the Track I/ Track II requirements) must meet requirements determined " on a case bycase best professional judgment ( BPJ) basis," 40 C. F. R. § 125.80( c);

° The provision that requires permitting agencies to review the permits before reissuance to determine whether additional or different requirements are needed to minimize impingement and entrainment, 40 C. F. R. § 125.89( b)( 1)( i); and ° Certain provisions stating that more stringent requirements might be necessary under state law. 40 C. F. R. § 125.84( e). MISC Br. at 3 5.

MISC challenges these provisions on the grounds that ( 1) they are beyond EPA's authority under the statute, ( 2) they were adopted without adequate notice and comment, and ( 3) they are an unexplained departure from prior regulations. Each of MISC's arguments should be rejected, for the reasons discussed below.

A. The Three Provisions Challenged by MISC Are Within EPA's Authority.

MISC argues that three provisions are beyond EPA's authority, because they go beyond the " best technology available" requirement set forth in CWA § 316( b). MISC Br. at 5 8. MISC is incorrect.  104  First, with respect to the smaller " below threshold" facilities being subject to case by case requirements under 40 C. F. R. § 125.80( c) , EPA reasonably concluded that these facilities are best addressed on an individual basis rather than by attempting to fashion a national rule for all such facilities. CR 053.017 at 874 ( JA XX) ( provision allows " a certain degree of flexibility for a permit writer to consider available technologies and unique factors posed by new facilities that are below the threshold"); CR 026.009 at 296 ( JA XX) ( smaller facilities " may face issues of economic affordability and are therefore more appropriately addressed on a case by case basis using [ best professional judgment]"); CR 028.006 at 374 ( JA XX) ( same). Contrary to MISC's contention, the case by case provision for smaller facilities does not require those facilities to go beyond the " best technology available." This provision simply recognizes that determining the " best technology available" for these smaller facilities is most appropriately done on a case by case basis using the best professional judgment of the permitting authority that is looking at the specific facility being permitted.

Second, with respect to the provision in 40 C. F. R. § 125.89( b)( 1)( i)

requiring review at time of permit reissuance ( MISC Br. at 7), EPA concluded that this provision is appropriate to ensure that facilities continue to implement " best technology available." Under this provision, permitting authorities will review the  105  performance of the technologies at the facility and the current conditions in the waterbody, and determine if additional or different design and construction technologies are needed to meet the requirements in 40 C. F. R. § 125.84.

CR 068.066 at 1289 ( JA XX). This provision is consistent with the statute, which requires all permits to require intake structures to reflect the best technology available for minimizing adverse environmental impacts. 33 U. S. C. § 1316( b).

There is no language in CWA § 316( b) that requires EPA to provide a " grandfather" period for permittees. By contrast, CWA § 306( c), 33 U. S. C. § 1316( c), expressly provides that any facility that is constructed to meet existing standards will be grandfathered for 10 years. The absence of any such express language in CWA § 316( b) demonstrates that Congress did not intend to require EPA to provide grandfather protection. In sum, EPA was not required to establish a " grandfather" rule for facilities being repermitted and reasonably decided to require a review at the time of permit reissuance. This is entirely consistent with the language and purpose of CWA § 316( b) and should be upheld.

CR 068.155 at 1468 ( JA XX) (" EPA has chosen not to include a 10 year grace period after implementation of controls because EPA believes that permit authorities ( states and territories) should determine when and how to reissue permits under Section 316( b).").  106  Third, with respect to the " state law" provision in 40 C. F. R. § 125.84( e)

( MISC Br. at 8), EPA's authority for this provision is discussed above in Section II. E above, which addresses the argument on this provision by UWAG.

For these reasons, this Court should reject MISC's argument that these provisions are beyond EPA's authority.

B. EPA Provided Adequate Notice and Opportunity For Comment On The Three Provisions Challenged by MISC.

MISC argues that EPA failed to provide opportunity for public comment on the three challenged provisions. MISC Br. at 9 11. In considering this issue, it is important to remember that a final rule is not required to be identical to the proposed rule; notice is adequate where it would " fairly apprise interested persons of the subjects and issues" of the rulemaking. National Black Media Coalition v.

F. C. C., 791 F. 2d 1016, 1022 ( 2d Cir. 1986). Here, that test was satisfied and MISC's notice and comment argument should be rejected.

First, with respect to the smaller " below threshold" facilities being subject to case by case requirements under 40 C. F. R. § 125.80( c) , EPA during the administrative process requested comments on two alternatives for addressing facilities using smaller amounts of cooling water, one of which was to implement CWA § 316( b) on a case by case basis for such facilities. 66 Fed. Reg. at 28,854/ 2 ( JA XX) ( EPA seeks comment on option in which "[ n] ew facility intake structures 62/ EPA also notes that other commentors   including Petitioner UWAG   submitted comments on the issue of whether facilities below a certain threshold should face regulation on a case by case, best professional judgment basis, which further demonstrates that this issue was sufficiently raised to allow comment. CR 524.008 at 2429 ( JA XX).

 107  not subject to this rule because of the amount of cooling water they use may be subject to requirements established by permit authorities under the CWA section 316( b) on a case by case basis."). Then, in the final rule, EPA implemented this case by case option, stating "[ n] ew facilities that do not meet the threshold requirements regarding amount of water withdrawn for cooling water purposes in [ 40 C. F. R.] § 125.81( a) must meet requirements determined on a case by case, best professional judgment ( BPJ) basis." 40 C. F. R. § 125.80( c). By identifying two options and asking for comments on them, and then implementing one of the two noticed options, EPA fairly apprized interested persons of the subjects and issues of the rulemaking. 62/

Second, with respect to the " review at time of permit reissuance" provision in 40 C. F. R. § 125.89( b)( 1)( i) ( MISC Br. at 10), EPA gave notice in the proposed rule that the Agency was planning to require a review of the design and construction technologies at the time of permit reissuance. EPA stated in the proposed rule preamble that the CWA § 316( b) requirements must be implemented at reissuance, 65 Fed. Reg. at 49,101/ 1 ( JA XX) (" The requirements proposed [ in 63/ " The Director" refers to the relevant permitting authority, which is either the director of the state authority ( where the permits are issued by a state) or the EPA Regional Administrator ( where the permits are issued by EPA). See 40 C. F. R. § § 122.2, 124.2 ( these definitions apply to Part 125 under 40 C. F. R. § 125.2).

64/ MISC attempts to make much of the slightly different phrasing, arguing that the phrase " changes in facility operations or physical and biological attributes of the source water body" ( as it was phrased in the proposed rule, 65 Fed. Reg. at 49,121/ 3 ( JA XX) ( proposed 40 C. F. R. § 125.89( b)) was changed to a review of " the performance of the technologies implemented" ( as it was phrased in the final rule, 66 Fed. Reg. at 65,344/ 3 ( JA XX) ( 40 C. F. R. § 125.89( b)( 1)( i)) and that this change in phrasing precluded MISC from having a meaningful opportunity to comment. MISC Br. at 10. This minor rephrasing, however, was not significant. ( continued...)

 108  this rule] must be implemented upon permit issuance and reissuance."). The preamble also said that such review would require " the review and approval or disapproval of a permit applicant's plan for installation of additional design and construction technologies to maximize the survival of impinged fish and minimize entrainment of eggs and larvae." 65 Fed. Reg. at 49,101/ 1 ( JA XX). See also proposed rule language at 65 Fed. Reg. at 49,121/ 3 ( proposed 40 C. F. R. § 125.89( b)). In the final rule, EPA implemented this same " review at reissuance"

requirement, though with slightly different phrasing: " Under subsequent permits,

the Director[ 63/] must review the performance of the technologies implemented and require additional or different design and construction technologies, if needed to minimize impingement mortality and entrainment of all life stages of fish and shellfish." 66 Fed. Reg. at 65,344/ 3 ( JA XX). 64/ 64/(... continued) The central concept in the final rule was the same as in the proposed rule: permitting authorities would review how well the installed technologies were addressing the specific conditions at the facility at the time of permit renewal to determine if different technologies were needed to meet the CWA § 316( b) requirements of minimizing impingement and entrainment. MISC cannot reasonably argue that this rephrasing demonstrates that it was not fairly apprized of the substance and issues of the rulemaking.

 109  Third, with respect to the " state law" provision in 40 C. F. R. § 125.84( e), the final rule is not " dramatically broader" than the proposed rule, as MISC contends.

MISC Br. at 10 11. The error in MISC's argument on this point is to only look at a comparison of 40 C. F. R. § 125.84( e) in the final rule with 40 C. F. R. § 125.84( g) in the proposed rule ( 65 Fed. Reg. at 49,119/ 1 ( JA XX)). When one looks at other parts of the proposed rule, one can see that the final language in 40 C. F. R.

§ 125.84( e) is consistent with the proposed rule. In the proposed rule, in addition to proposed 40 C. F. R. § 125.84( g) ( which is what MISC looks at), EPA also proposed 40 C. F. R. § 125.80( c) ( 65 Fed. Reg. at 49,115/ 3 116/ 1 ( JA XX)), stating:

Nothing in this subpart shall be construed to preclude or deny the right of any State or political subdivision of a State or any interstate agency under [ CWA § 510] to adopt or enforce any requirement with respect to control or abatement of pollution that is more stringent that those required by federal law.

This language parallels the language of CWA § 510, 33 U. S. C. § 1370, which reserves the right of states to adopt and enforce requirements that are more stringent than federal law. By proposing this language in 40 C. F. R. § 125.80( c), 65/ Indeed, rather than broadening the rule in the final language, EPA actually narrowed the rule in an important respect. At proposal, and based on CWA § 301( b)( 1)( C), 33 U. S. C. § 1311( b)( 1)( C), EPA proposed requiring states to ensure that a cooling water intake would result in compliance with state water quality standards even without any state law authorizing controls on cooling water intake structures. By contrast, in the final rule, EPA set aside CWA § 301( b)( 1)( C) ( see 66 Fed. Reg. at 65,277/ 2 ( JA XX)), and simply adopted a rule that requires the ( continued...)

 110  EPA raised the issue of preserving the authority of states to impose more stringent requirements, and that is all the final 40 C. F. R. § 125.84( e) does:

You must comply with any more stringent requirements relating to the location, design, construction, and capacity of a cooling water intake structure or monitoring requirements at a new facility that the Director deems are reasonably necessary to comply with any provision of state law, including compliance with applicable state water quality standards ( including designated uses, criteria and antidegradation requirements).

Further, even focusing on the provisions that MISC compares, these provisions are parallel in substance. EPA provided language in both the proposed and final " what must facilities do to comply" provision that repeated the same point concerning compliance with more stringent state laws, but from the facilities'

perspective: that states could impose   and facilities were required to comply with   any more stringent state requirements relating to intake structures as needed to meet water quality standards. Compare 65 Fed. Reg. at 49,119/ 1 ( 40 C. F. R.

§ 125.84( g)) ( proposed rule) with 66 Fed. Reg. at 65,341/ 2 ( 40 C. F. R. § 125.84( e))

( final rule). 65/ 65/(... continued) facility to comply with any more stringent requirements reasonably necessary to comply with state law. Compare 65 Fed. Reg. at 49,115 116 ( 40 C. F. R. § 125.80( c)) ( proposed rule) with 66 Fed. Reg. at 65,338/ 2 3 ( 40 C. F. R. § 125.80( d)) ( final rule).

 111  After considering MISC's argument here, EPA recognizes that the final language in 40 C. F. R. § 125.84( e) might be read as creating a broad " any state law" requirement, but that is not EPA's intent. As EPA explained in the preamble to the final rule and in comment responses, 40 C. F. R. § 125.84( e) is simply intended to protect the authority of states to include more stringent requirements,

as recognized by Congress in CWA § § 401 and 510, 33 U. S. C. § § 1341 and 1370,

and is consistent with CWA § 101( a) and ( b) ( recognizing the primary role of states to protect waters). 66 Fed. Reg. at 65,277 78 ( JA XX) (" At § 125.84( e), the final rule recognizes that a State may, under sections 401 and 510, ensure the inclusion of any more stringent requirements . . . . "); CR 068.316 at 1502 ( JA XX). In short, EPA does not interpret 40 C. F. R. § 125.84( e) to be " dramatically broader" than the protection of a state's authority to adopt and enforce more stringent requirements that was discussed in the proposed rule, and thus the proposed rule " fairly appri[ zed] interested persons of the subjects and issues" of the rulemaking. National Black Media Coalition v. F. C. C., 791 F. 2d at 1022.  112  C. EPA's Case By Case Provisions Are Consistent With Prior Regulations.

MISC's final argument is that the existing regulations governing discharges under the NPDES program make no mention of cooling water intake structures or CWA § 316( b), and thus that the " case by case" provisions in this rulemaking are inconsistent with these prior regulations. MISC Br. at 11 12. This argument is fundamentally flawed.

EPA's decision to apply a case by case approach in certain circumstances under the new regulations is not inconsistent with past regulations. Indeed, EPA and state permitting authorities have been implementing CWA § 316( b) entirely on a case by case basis for over 25 years. 66 Fed. Reg. at 65,262/ 1 ( JA XX). It is difficult to see how MISC can reasonably conclude that maintaining the case

bycase approach for the smaller facilities is " inconsistent" with existing regulations.

Further, it is irrelevant that the existing NPDES regulations   which govern discharges   say nothing about EPA's approach to regulating intake. See MISC Br. at 11. Indeed, it is this silence that has resulted in the case by case approach that has been in effect.

Finally, to the extent that any explanation for these provisions was required,

EPA's explanation for these provisions was adequate, as discussed above in  113  Section II. E. This Court should reject MISC's " unexplained inconsistency"

argument.

CONCLUSION For these reasons, the Court should deny these petitions.


[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Rules and Regulations]
[Pages 19145-19149]
[FR Doc No: 2021-07517]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0639; FRL-10020-79]

MCPA; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of MCPA in
or on tea and intermediate wheatgrass forage, grain, hay, and straw.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 13, 2021. Objections and
requests for hearings must be received on or before June 14, 2021, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0639, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

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).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    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-2019-0639 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
June 14, 2021. 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-2019-0639, 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 at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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
9E8797) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.339 be amended by establishing tolerances for
residues of the herbicide MCPA ((4-chloro-2-methylphenoxy) acetic
acid), both free and conjugated, resulting from the direct application
of MCPA or its sodium or dimethylamine salts, or its 2-ethylhexyl ester
in or on the following agricultural commodities: Tea, plucked leaves at
0.3 parts per million (ppm); Wheatgrass, intermediate, forage at 20
ppm; Wheatgrass, intermediate, grain at 1 ppm; Wheatgrass,
intermediate, hay at 115 ppm; and Wheatgrass, intermediate, straw at 25
ppm. That document referenced a summary of the petition prepared by
Nufarm, the registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing but
was unrelated to the chemical MCPA, this action, or pesticides in
general.
    Based upon review of the data supporting the petition, EPA has
modified the levels at which the wheatgrass tolerances are being
established as well as the commodity

definition for tea. The reasons for these changes are explained in Unit
IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    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 MCPA including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with MCPA follows.

A. Toxicological Profile

    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.
    The kidney is the major target organ following MCPA exposure. In
the subchronic inhalation toxicity study, respiratory tract effects
were observed following repeat inhalation exposure. Additional toxic
effects include neurotoxicity, which was observed in the acute and
subchronic neurotoxicity (ACN/SCN) studies and in a rat developmental
toxicity study. The developmental neurotoxicity study (DNT) did not
identify developmental neurotoxicity.
    Quantitative susceptibility was observed in the rat developmental
toxicity study with MCPA acid based on increased incidence of skeletal
retardation and decreased fetal body weight at a dose that was a
maternal no observed adverse effect level (NOAEL). There was also
quantitative susceptibility in the 2-generation rat reproductive
toxicity study with MCPA acid as evidenced by decreased lactational pup
body weight at an offspring lowest observed adverse effect level
(LOAEL) corresponding to a parental NOAEL. Qualitative susceptibility
was noted in the DNT study based on increased pup mortality and
decreased body weights at the same LOAEL as the maternal LOAEL
(decreased body weight and food consumptions).
    MCPA is classified as ``Not Likely to Be Carcinogenic to Humans'',
based on long-term studies in rats and mice, and there are low
mutagenicity concerns. There is no concern for immunotoxicity.
    Additional information on the toxicological profile can be found at
http://www.regulations.gov in the document titled ``MCPA. Human Health
Risk Assessment to Support a New Use on Intermediate Wheatgrass and the
Establishment of a Tolerance without a U.S. Registration for Tea''
(hereinafter ``MCPA Human Health Risk Assessment'') in docket ID number
EPA-HQ-OPP-2019-0639.

B. Toxicological Points of Departure/Levels of Concern

    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, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for MCPA used for human
risk assessment can be found in the MCPA Human Health Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to MCPA, EPA considered exposure under the petitioned-for
tolerances as well as all existing MCPA tolerances in 40 CFR 180.339.
EPA assessed dietary exposures from MCPA 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 MCPA.
    In conducting the acute dietary exposure assessment, EPA used the
2003-2008 food consumption data from the U.S. Department of
Agriculture's (USDA) National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). The acute dietary exposure
assessment is unrefined and is based on tolerance-level residues and
100 percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the 2003-2008 food consumption data from the
USDA's NHANES/WWEIA. The chronic dietary exposure assessment is
unrefined and is based on tolerance-level residues and 100 PCT.
    iii. Cancer. MCPA is classified as ``Not Likely to Be Carcinogenic
to Humans'' therefore, a cancer assessment is not needed.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
MCPA. 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 MCPA in drinking water. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

    Based on the Pesticide in Water Calculator (PWC), for the acute
dietary risk assessment, EPA used an estimated drinking water
concentration (EDWC) of 236 ppb into the DEEM-FCID Model. For the
chronic exposure assessment, EPA used a value of 208 ppb.
    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).
    MCPA is currently registered for uses that may result in
residential handler and post-application exposures, including
commercial and residential use on lawns, as well as commercial use on
ornamental turf and trees, golf courses, and parks.
    For the residential exposure scenarios, the most conservative, or
worst case, residential adult and child scenarios have been selected to
be included in the aggregate risk assessment. The scenarios are as
follows:
    Adult aggregate assessment: Granular formulations: dermal post-
application exposure from high contact activities on treated lawns (Day
0 turf transferable residue (TTR)) at both the 1.85 lb acid equivalent
(ae)/A and 1.5 lb ae/A rate.
    Liquid formulations: dermal post-application exposure from high
contact activities on treated lawns (average TTR) at both the 1.5 lb
ae/A and 1.25 lb ae/A rate.
    Children 11 to <16 years old and children 6 to <11 years old
aggregate assessments: Liquid formulations: dermal post-application
exposures from golfing (Day 0 TTR) on treated turf.
    Children 1 to <2 years old aggregate assessment: Granular
formulations: combined (dermal plus incidental oral) post-application
exposures from high contact activities on treated lawns (Day 0 TTR) at
both the 1.85 lb ae/A and 1.5 lb ae/A rate.
    Liquid formulations: combined (dermal plus incidental oral) post-
application exposures from high contact activities on treated lawns
(average TTR) at both the 1.5 lb ae/A and 1.25 lb ae/A rate.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to MCPA and any other
substances and MCPA does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that MCPA has a common mechanism
of toxicity with other substances.

D. Safety Factor for Infants and Children

    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. In the developmental rat
study with MCPA acid, quantitative susceptibility was demonstrated
based on increased incidence of skeletal retardation and decreased
fetal body weight at a dose that was a maternal NOAEL. MCPA acid,
however, did not produce developmental toxicity in rabbits.
Quantitative susceptibility was also evident in the 2-generation
reproduction study in rats with MCPA acid, in which lactational pup
body weight decrements were noted at a dose in offspring that was a
parental NOAEL. Qualitative susceptibility was noted in the
developmental neurotoxicity (DNT) study with MCPA acid based on
increased pup mortality and body weights at the same LOAEL as the
maternal LOAEL (decreased body weight and food consumptions). There was
no evidence of quantitative or qualitative susceptibility in the
developmental rat studies with MCPA dimethylamine (DMA) salt and MCPA
ester forms.
    Considering the overall toxicity profile and the doses and
endpoints selected for risk assessment, the degree of concern for the
effects observed in the studies are low because the developmental/
offspring effects observed in the studies are well characterized and
clear NOAELs/LOAELs have been identified in the studies for the effects
of concern. Additionally, the endpoints and PODs selected for risk
assessment are protective of potential developmental/reproductive
effects.
    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, except for acute dietary (general
population) and inhalation scenarios where a 10X SF is retained for
extrapolation of a LOAEL to a NOAEL. That decision is based on the
following findings:
    i. The toxicity database for MCPA is complete.
    ii. Evidence of neurotoxicity was observed in the acute and
subchronic neurotoxicity studies in rats, as indicated by various
clinical signs of neurotoxicity. There were no developmental neurotoxic
effects in the rat DNT study. There is a low degree of concern for the
potential neurotoxic effects of MCPA since clear NOAELs were identified
for the effects described above, there were no adverse
neuropathological effects, and the endpoints chosen for risk assessment
are protective of any potential neurotoxicity.
    iii. As noted above, quantitative susceptibility was demonstrated
in the developmental rat study, but not in rabbits. Quantitative
susceptibility was also evident in the 2-generation reproduction study
in rats. However, the degree of concern for the effects observed in the
studies is low for the reasons summarized in Unit III.D.3.ii.
    iv. There are no residual uncertainties identified in the exposure
databases. The Agency has used high-end assumptions in the dietary
exposure assessment, including the use of 100 PCT and tolerance-level
residues, and upper-bound estimates of potential exposure through
drinking water. In addition, the residential exposure assessment was
conducted using chemical-specific data (where available) and the
Agency's 2012 Residential SOPs; as such, residential exposures are
unlikely to be underestimated.

E. Aggregate Risks and Determination of Safety

    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. Using the exposure assumptions described in this unit
for acute exposure, EPA has concluded that acute exposure to MCPA from
food and water will utilize 29% of the aPAD for all infants less than 1
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
MCPA from food and water will utilize 28% of the cPAD for all infants
less than 1 year old, the population group receiving the greatest
exposure.
    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). MCPA is
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 MCPA.
    For the granular formulation exposure scenarios, the short-term
aggregate MOEs using Day 0 residues for adults and children 1 to less
than 2 years old are not of concern, at 230 and 120, respectively.
    Some residential exposure scenarios on treated turf (liquid
formulations) resulted in risk estimates of concern for adults and
children when using the day of application (Day 0; screening level)
residues from the chemical specific turf transferable residue (TTR)
data. For these scenarios, aggregate assessments using risk estimates
resulting from refinement of the TTR values (i.e., using average
modeled TTR values) were conducted.
    For the liquid formulation scenarios using Day 0 residues, the
short-term aggregate MOEs are as follows: for children 6 to <11 years
old the MOE = 330, and for children 11 to <16 years old, the MOE = 390.
These MOEs are equal to or above the LOC (100) and are therefore not of
concern. For the liquid formulation scenarios using average TTR (a
refinement in the risk assessment), the short-term aggregate MOEs are
not of concern for adults (MOE = 210) and for children 1 to <2 years
old (MOE = 100) using 11-day average TTR. As noted above, a MOE equal
to or greater than 100 is 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).
    An intermediate-term adverse effect was identified; however, MCPA
is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for MCPA.
    5. Aggregate cancer risk for U.S. population. MCPA is classified as
``Not Likely to Be Carcinogenic to Humans''; therefore, EPA does not
expect MCPA exposures to pose an aggregate cancer risk.
    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 MCPA residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For enforcement of tolerances for residues of MCPA, Pesticide
Analytical Manual (PAM) Vol. II lists PAM Vol. I Sections 221.1, 421,
and 422. No limit of quantitation is specified. It is noted that
Section 221.1 has now become Section 402 (gas chromatography (GC)
method for acids and phenols) and Sections 421 and 422 (thin-layer
chromatography (TLC) methods) no longer exist. The Residue Chemistry
Chapter of the Registration Standard dated 8/31/1981 noted that the PAM
Vol. I method is adequate for enforcement of tolerances for residues of
MCPA in livestock commodities as-is, but recommended that the method be
modified with a hydrolysis step for enforcement of MCPA tolerances for
plant commodities. The current PAM Vol II methods are adequate for the
enforcement of MCPA on plants and livestock commodities and no further
modifications are required at this time

B. International Residue Limits

    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).
    There are no Codex MRLs for MCPA in or on tea or intermediate
wheatgrass.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing the tolerance on ``tea, dried'' rather than
``tea, plucked leaves'' to be consistent with Agency nomenclature.
    The petitioner proposed tolerance levels for wheatgrass commodities
based on the current tolerance levels for wheat commodities in 40 CFR
180.339. While EPA agrees that it is appropriate to base the tolerance
levels for wheatgrass commodities on the tolerance levels for wheat
commodities, given the similarities in crops, the Agency has reviewed
the tolerances for wheat, grain and wheat, hay and determined that the
current tolerances are too high. Upon review, crop field trial studies
reflecting the use of MCPA showed residue levels that were lower than
current tolerances. The OECD calculation procedure recommended
tolerance levels of 0.2 ppm for wheat, grain and 40 ppm for wheat, hay.
This discrepancy was identified during Registration Review; see ``MCPA.
Second Revision: Draft Human Health Risk Assessment in Support of
Registration Review'', which is available in docket ID EPA-HQ-OPP-2014-
0180. Moreover, the current Codex MRLs for wheat, forage, hay and straw
are set at 50 ppm. Therefore, EPA intends to revise the existing wheat
tolerances to reflect this analysis and to harmonize with Codex MRLs
when updating the MCPA tolerances as part of Registration Review.
Applying the same logic to the wheatgrass commodities, EPA is
establishing those tolerances at 0.2 ppm for intermediate wheatgrass,
grain and at 50 ppm for intermediate wheatgrass, forage, hay, and
straw.

V. Conclusion

    Therefore, tolerances are established for residues of MCPA in or on
Tea, dried at 0.3 ppm; Wheatgrass, intermediate, forage at 50 ppm;
Wheatgrass,

intermediate, grain at 0.2 ppm; Wheatgrass, intermediate, hay at 50
ppm; and Wheatgrass, intermediate, straw at 50 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been
exempted from review under Executive Order 12866, this action 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. 3501 et 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 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. 601 et
seq.), do not apply.
    This action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et 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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et 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 the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 7, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.339, amend paragraph (a)(1) by designating the table as
Table 1 to paragraph (a)(1) and adding in alphabetical order to newly
designated Table 1 to paragraph (a)(1) entries for ``Tea, dried'';
``Wheatgrass, intermediate, forage''; ``Wheatgrass, intermediate,
grain''; ``Wheatgrass, intermediate, hay'' and ``Wheatgrass,
intermediate, straw'' to read as follows:

Sec.  180.339   MCPA; tolerances for residues.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Tea, dried...................................................        0.3

                                * * * * *
Wheatgrass, intermediate, forage.............................         50
Wheatgrass, intermediate, grain..............................        0.2
Wheatgrass, intermediate, hay................................         50
Wheatgrass, intermediate, straw..............................         50
------------------------------------------------------------------------

* * * * *
[FR Doc. 2021-07517 Filed 4-12-21; 8:45 am]
BILLING CODE 6560-50-P