US Citrus Sci. Council v. U.S. Dep't of Agric.
This text of 312 F. Supp. 3d 884 (US Citrus Sci. Council v. U.S. Dep't of Agric.) is published on Counsel Stack Legal Research, covering District Court, E.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
Opinion
Lawrence J. O'Neill, UNITED STATES CHIEF DISTRICT JUDGE
*891I. INTRODUCTION
Plaintiffs US Citrus Science Council, Santa Paula Creek Ranch, CPR Farms, Green Leaf Farms, Inc., Bravante Produce, and Richard Bagdasarian, Inc. (collectively, "Plaintiffs") bring this action against Defendants United States Department of Agriculture ("USDA"), Sonny Perdue, Secretary of Agriculture, and Kevin Shea, Administrator, Animal and Plant Health Inspection Service ("APHIS") (collectively, "Defendants" or the "Government"), to challenge a rule lifting the ban on lemons imported from Argentina (the "Rule" or "Final Rule"). Both parties move for summary judgment. This matter is suitable for disposition without oral argument. See Local Rule 230(g). For the reasons set forth below, Plaintiffs' motion for summary judgment is DENIED, and Defendants' cross-motion for summary judgment is GRANTED.
II. BACKGROUND
A. Statutory Framework
1. Plant Protection Act
The Plant Protection Act ("PPA") authorizes the Secretary of the USDA to issue regulations "to prevent the introduction of plant pests into the United States or the dissemination of plant pests within the United States."
2. Regulatory Flexibility Act
The Regulatory Flexibility Act ("RFA") requires that agencies issuing rules under the Administrative Procedure Act ("APA") publish a final regulatory flexibility analysis assessing the negative impact of the rule on small businesses.
Such an analysis must meet certain statutory requirements. It must state the purpose of the relevant rule and the estimated number of small businesses that the rule will affect, if such an estimate is available. In addition, each analysis must summarize comments filed in response to the agency's initial regulatory flexibility analysis, along with the agency's assessment of those comments. Finally, each analysis must include "a description of the steps the agency has taken to minimize the significant economic impact" that its rule will have on small businesses, "including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected." § 604(a)(5).
B. Regulatory History
Since 1947, regulations under the PPA and its predecessor statutes have barred *892the importation of lemons and other citrus from Argentina. See
In May 2016, APHIS proposed a new regulation permitting the importation of lemons from northwest Argentina. Importation of Lemons from Northwest Argentina ,
The Proposed Rule was accompanied by an initial regulatory flexibility analysis.
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Lawrence J. O'Neill, UNITED STATES CHIEF DISTRICT JUDGE
*891I. INTRODUCTION
Plaintiffs US Citrus Science Council, Santa Paula Creek Ranch, CPR Farms, Green Leaf Farms, Inc., Bravante Produce, and Richard Bagdasarian, Inc. (collectively, "Plaintiffs") bring this action against Defendants United States Department of Agriculture ("USDA"), Sonny Perdue, Secretary of Agriculture, and Kevin Shea, Administrator, Animal and Plant Health Inspection Service ("APHIS") (collectively, "Defendants" or the "Government"), to challenge a rule lifting the ban on lemons imported from Argentina (the "Rule" or "Final Rule"). Both parties move for summary judgment. This matter is suitable for disposition without oral argument. See Local Rule 230(g). For the reasons set forth below, Plaintiffs' motion for summary judgment is DENIED, and Defendants' cross-motion for summary judgment is GRANTED.
II. BACKGROUND
A. Statutory Framework
1. Plant Protection Act
The Plant Protection Act ("PPA") authorizes the Secretary of the USDA to issue regulations "to prevent the introduction of plant pests into the United States or the dissemination of plant pests within the United States."
2. Regulatory Flexibility Act
The Regulatory Flexibility Act ("RFA") requires that agencies issuing rules under the Administrative Procedure Act ("APA") publish a final regulatory flexibility analysis assessing the negative impact of the rule on small businesses.
Such an analysis must meet certain statutory requirements. It must state the purpose of the relevant rule and the estimated number of small businesses that the rule will affect, if such an estimate is available. In addition, each analysis must summarize comments filed in response to the agency's initial regulatory flexibility analysis, along with the agency's assessment of those comments. Finally, each analysis must include "a description of the steps the agency has taken to minimize the significant economic impact" that its rule will have on small businesses, "including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected." § 604(a)(5).
B. Regulatory History
Since 1947, regulations under the PPA and its predecessor statutes have barred *892the importation of lemons and other citrus from Argentina. See
In May 2016, APHIS proposed a new regulation permitting the importation of lemons from northwest Argentina. Importation of Lemons from Northwest Argentina ,
The Proposed Rule was accompanied by an initial regulatory flexibility analysis.
After a period of notice and comment, APHIS published its Final Rule governing the importation of Argentine Lemons. Importation of Lemons From Northwest Argentina ,
C. Procedural Background
Plaintiffs filed the instant lawsuit on May 17, 2017, challenging the Final Rule and the Amendment promulgated by APHIS under the PPA, APA, National Environmental Policy Act ("NEPA"), and RFA. (ECF No. 2.) Plaintiffs brought six counts in the First Amended Complaint: failure to disclose for public comment data, notes, or a trip report for the 2015 harvest season site visit under the PPA and APA (Count I); failure to consider properly SENASA's failed history, and unjustified reliance on SENASA workplan under the PPA and APA (Count II); failure to use notice and comment procedures to amend, and failure to provide reasoned decision-making in amending, the rule to restrict importation to northeastern ports under the PPA and APA (Count III); failure to provide reasoned decision-making under the APA (Count IV); failure to comply with NEPA (Count V); and failure to comply with the RFA (Count VI). Defendants previously moved to dismiss the FAC on the basis that Plaintiffs lacked standing. The Court dismissed Count III, but concluded that Plaintiffs had standing to pursue Counts I, II, IV, V, and VI. ECF No. 36 ("October 25 Order"). Both parties now move for summary judgment on all remaining claims. (ECF Nos. 35, 37.)
This Court has federal question jurisdiction pursuant to
III. STANDARD OF DECISION
A. Summary Judgment
The remedy for challenging an agency's decision not to authorize testimony is a separate action in federal court pursuant to the APA. See In re Boeh ,
"Under the arbitrary and capricious standard, a reviewing court must determine whether an agency's decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment." Mt. St. Helens ,
"Unlike substantive challenges, however,....review of an agency's procedural compliance is exacting, yet limited." Kern Cty. Farm Bureau v. Allen ,
Under the APA, the district court's review of an agency's decision is usually limited to the administrative record.
B. Standing
This Court's Article III jurisdiction "depends on the existence of a 'case or controversy.' " GTE California, Inc. v. FCC ,
In addition, where an organization or association is bringing suit on behalf of its members, that organization or association must demonstrate that: (i) at least one of its members would otherwise have standing to sue in their own right; (ii) the interests it seeks to protect are germane to the organization's purpose; and (iii) neither the claim asserted nor the relief requested requires the participation of individual members in the lawsuit.
*895Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc. ,
IV. ANALYSIS
A. Standing
The Court previously determined that Plaintiffs had Article III standing under the doctrines of competitive and environmental standing to bring their claims in Counts I, II, IV, V, and VI. ECF No. 36. The Court further concluded that Plaintiffs had statutory authority under the RFA to pursue Count IV. Id. at 19-21. In their motion for summary judgment, Defendants ask the Court to reconsider Plaintiffs' standing, arguing that, in light of the complete administrative record, Plaintiffs have not established economic or environmental injuries. Plaintiffs also argue that the Court erred in determining that Plaintiffs have standing as indirectly regulated entities under the RFA. The Court addresses that argument separately below. Infra at 909-10.
With respect to Defendants' renewed arguments about competitive standing, the Court is persuaded that its initial reasoning was correct. See ECF No. 36 at 7-12. According to Defendants, Plaintiffs' declarations in support of their motion for summary judgment suggest that there is an attenuated chain of causation between Argentine lemon imports and competitive injury to domestic growers that rests on "speculative contingencies." The Court disagrees. Its initial conclusion that the Rule caused injury to domestic lemon growers was based primarily on APHIS's own conclusions about likely economic harm to domestic lemon growers. See ECF No. 36 at 10 ("APHIS's own predictions show that the increase in supply will lead to a drop in price relative to what the price would otherwise be, and predicts that domestic lemon growers will suffer millions of dollars of economic loss as a result"); see also AR16-17, 28, 30. The other arguments raised by Defendants were previously considered and rejected by the Court.2 Plaintiffs have economic injury sufficient for Article III standing based on a theory of competitor standing.
Likewise, the record also supports a finding that Plaintiffs have suffered a *896non-speculative environmental injury, giving rise to environmental standing. The Pest Risk Assessment conducted by APHIS identified no fewer than seven quarantine pests that would have the potential to be introduced to the United States through exported fruit. AR106-107. Defendants argue that the risk of such pests establishing in the United States is speculative, but that conclusion is contradicted by APHIS's own Pest Risk Assessment. It is undisputed that the unregulated import of Argentine lemons would pose a risk to domestic citrus. The question, therefore, is whether that risk is adequately addressed by the regulation. Whether the systems approach described in the Final Rule is an arbitrary and capricious exercise of APHIS's judgment-or whether it sufficiently mitigates the risks of any quarantine pest establishing on domestic soil-is a question that is bound up in the merits of this case. See ECF No. 36 at 15 ("The 'likelihood and extent of impact' of the alleged environmental harm are questions should be addressed with the merits" (quoting Save Our Heritage, Inc. v. FAA ,
B. Procedural Challenges to the Rulemaking Process
1. 2015 Trip Report
Plaintiffs argue that APHIS failed to satisfy its obligations to use "transparent and accessible" "processes" under the PPA,
An agency is obligated to "identify and make available technical studies and data that it has employed in reaching the decisions to propose particular rules." Kern Cty. Farm Bureau v. Allen ,
If the undisclosed 2015 Trip Report contained information critical to the agency's determination that was also "unique information that was not duplicated in other reports," the nondisclosure deprived Plaintiffs and others of the opportunity for public comment, and the agency determination should be reversed and the comment period reopened. Idaho Farm Bureau Fed'n ,
Plaintiffs contend that the information in the 2015 Trip Report was critical because APHIS needed to verify SENASA's oversight of, and compliance with, the harvesting, production, and packinghouse procedures that APHIS was contemplating as part of the systems approach. Defendants dispute the characterization of the report as critical, stating that the purpose of the trip was to assist in the development of the operational work plan, and disputing Plaintiffs' contention that the 2015 site visit was "among the primary bases for concluding that SENASA can comply with the systems approach[.]" (ECF No. 35-1 at 15.) Defendants note that the report summarizing the later September 2016 site visit, which was disclosed to the public for comment, was used in assessing SENASA's oversight capabilities and relied on by APHIS in formulating the Final Rule. (ECF No. 39-1 at 18.)
Whether or not the document was "critical," it certainly was not unique, nor did its non-disclosure prevent meaningful comment on SENASA's oversight capabilities. The 2016 Trip Report addresses the same central issue addressed in the 2015 Trip Report-Argentina's progress in implementing the systems approach. Compare AR 26207-34 with AR25905-24. Plaintiff argues that disclosure of the 2016 Trip Report was not sufficient, because the 2016 trip took place after the harvest season, and therefore the delegation was not able to observe Argentine growers' compliance with, and SENASA's oversight of, harvesting and packinghouse procedures. However, this subject was addressed in several documents available for public comment, including the Risk Management Document, the Proposed Rule itself, and the 2016 Trip Report. AR25905-24; AR156-59; AR168-70. Indeed, the 2016 Trip Report discusses pesticides used by Argentine growers (including dosages), the fruit fly trapping requirement, harvest and packing requirements, the number of SENASA inspectors, and more. See AR25907-13. The information contained in the 2015 Trip Report was duplicative of other information contained in the September 2016 Trip Report, and identified elsewhere throughout the Proposed Rule. However, the September 2016 trip came later in the process, therefore was arguably more central and relevant to APHIS's determination of whether SENASA could reach compliance than the 2015 trip. Therefore, the failure to disclose this report was not material and does not require the reopening of the public comment period. See Aina Nui Corp. v. Jewell ,
Defendant also draws a distinction between the 2015 Trip Report and the types of "scientific studies" and "complex factual surveys" that courts concluded should have been disclosed in other cases. (ECF No. 42 at 5.); See also, e.g. , Idaho Farm Bureau ,
Plaintiffs do not identify any entirely unique and material argument or comment that it would have made had the report been disclosed before the conclusion of the notice and comment period. Plaintiffs argue that the report evinces SENASA's continued failure to implement procedures in line with APHIS's requirement-an argument that could equally be based on the disclosed 2016 Trip Report or any number of other documents. In other words, Plaintiffs are not arguing that their comments would have made any substantively unique comments if they had an opportunity to comment on the 2015 Trip Report. Rather, Plaintiff objects that the agency should have considered the information in the report to come to a different conclusion. That argument will be addressed with Plaintiffs' other substantive arguments and APHIS's conclusion will be subject to review to determine whether it was arbitrary, capricious, or an abuse of discretion. Bear Valley Mut. Water Co. ,
Moreover, a number of interested parties, including Plaintiffs, did address SENASA's oversight capabilities in response to the Proposed Rule. See, e.g. AR25656 (identifying potential issues with SENASA oversight under the heading "Questions on SENASA Inspectors"). The robust comments from the public on the issues related to SENASA's oversight and the site visits leading up to the implementation demonstrates that there was no prejudice in the non-disclosure. Kern Cty. Farm Bureau ,
Defendant also notes that the 2015 Trip Report was disclosed primarily in response to comments questioning the nature of the visit. Courts have consistently concluded that an agency may add supporting documentation to the record in response to a comment without having to offer an additional opportunity for public comment, so long as the additional information is not both critical and unique. See Rybachek v. U.S. EPA ,
2. Operation Work Plan
Plaintiffs similarly argue that Defendants' failure to produce the Operation Work Plan ("OWP") for public comment was a procedural error warranting reopening of the comment period. The OWP is a document developed jointly by the USDA, APHIS, and SENASA to "detail[ ] the *899phytosanitary measures required for production, packing, safeguarding, treatment (if applicable), export certification, and shipping in order to comply with regulations governing the importation of fresh lemon fruit." AR28341. In support of these contentions, Plaintiffs make two principal arguments.
First, Plaintiffs argue that the OWP itself is a legislative rule that should have been subject to notice and comment rulemaking under the APA. They point to apparent discrepancies between the Final Rule and the OWP and suggest that such discrepancies render the OWP a legislative rule that itself should have been subject to notice and comment procedures. Specifically, they argue that the OWP eliminates the requirement that SENASA visit production facilities, eliminates the requirement that discovery of honeydew moths or citrus borers in any stage of development trigger corrective measures, alters the rule regarding how much fruit will be prohibited from export in the event that pests are found, and omits procedures to ensure compliance with other aspects of the Final Rule.
Second, Plaintiffs argue that under the Idaho Farm Bureau standard, the OWP contains critical and unique information regarding the implementation of the systems approach and therefore should have been disclosed during the notice and comment period prior to finalization of the Final Rule. The Final Rule makes frequent reference to the OWP, and the OWP contains specifics about how day to day operations will be overseen and monitored that were not available in any other materials.
Defendants counter each of these arguments. Defendants argue that the OWP is at most an interpretive rule that merely clarifies and explains, but does not replace, the Final Rule. Second, Defendants counter each of the alleged discrepancies between the OWP and the Final Rule, explaining why the two documents are consistent.3 Lastly, Defendants argue that the scope of the proposed OWP was identified in the Proposed Rule such that Plaintiffs and the public had ample opportunity to comment on it, and that it does not provide essential support for the Final Rule itself under Idaho Farm Bureau .
a. Legislative Rule v. Interpretive Rule
Under the APA, an agency generally may only lawfully issue a legislative rule by using notice and comment procedures.
In general terms, interpretive rules merely explain, but do not add to, the substantive law that already exists in the form of a statute or legislative rule. Yesler Terrace Community Council v. Cisneros,37 F.3d 442 , 449 (9th Cir. 1994). Legislative rules, on the other hand, create rights, impose obligations, or effect a change in existing law pursuant to authority delegated by Congress.Id. ... [W]hen an agency does not hold out a rule as having the force of law, it may still be legislative if it is inconsistent with a prior rule having the force of law.
*900Hemp Indus. Ass'n v. DEA ,
Plaintiffs identify several provisions in the OWP that they assert are inconsistent with the Final Rule. Plaintiffs argue that the work plan does not require SENASA to "visit and inspect registered places of production regularly throughout the exporting season," as required by the Final Rule.
Plaintiffs also argue the Final Rule's requirement that "if a single C. gnidiella [honeydew moth] or G. aurantianum [citrus borer] in any stage of development is found on the lemons, the entire consignment is prohibited from export to the United States," AR 00014,
Relatedly, Plaintiffs argue that the Final Rule prohibits export of the "entire consignment" whenever inspectors discover pests or mites,
*901Lastly, Plaintiffs argue that the OWP impermissibly allows packinghouses to process fruits destined for the United States and other markets at the same time. Defendants respond that the Final Rule requires all fruits being simultaneously processed in packinghouses exporting fruit to the U.S. to process according to U.S. standards. This is not inconsistent with the Final Rule, which requires only that "[d]uring the time registered packinghouses are in use for packing lemons for export to the continental United States, the packinghouses may only accept lemons that are from registered places of production and that have been produced in accordance with the requirements of this section." Therefore, there is no discrepancy between the Final Rule and the OWP in this regard; packinghouses may simultaneously pack fruit for export to the United States and other markets so long as all fruit is processed and packed according to the standards set forth in the Final Rule and required for export to the United States.
In sum, the Court does not believe that a reasonable reading of the Final Rule and the OWP evinces any material discrepancies such that the OWP substantively changes the regulation, thereby rendering it a legislative rule. Therefore, the OWP is correctly categorized as an interpretive rule that offers guidance on the day-to-day implementation of the Final Rule under the Hemp Industries standard.
Moreover, as a practical matter, the agency should not be hamstrung by the current form of the OWP. So long as their operational work plan complies with the strictures of the Final Rule, the agency has discretion to make incremental decisions regarding how best to execute the systems approach. Requiring notice and comment on the OWP would serve only to lock the agency into specific methods for executing the systems approach. The agency requires some discretion, always within the bounds of the Final Rule, to execute certain aspects of the Rule, especially taking into account technological advances. For example, as the agency points out, it should have "the administrative flexibility to decide that different types of fruit fly traps should be used, or a different attractant should be used." ECF No. 39-1 at 21. The agency has discretion to give further guidance on a Final Rule without subjecting that additional guidance to notice and comment.
b. Critical Or Unique Information
Plaintiffs further contend that the OWP should have been disclosed to the public for notice and comment under the Idaho Farm Bureau standard, discussed above with respect to the non-disclosure of the 2015 Trip Report, supra at 896-97. Under Idaho Farm Bureau , the agency must produce material if it was critical to the agency's determination and constituted unique information that was not duplicated in other reports.
Here, the OWP functions not as a document that provides the underlying basis for the agency's determinations in the Final Rule, but as a further expression of the *902Final Rule, and one consistent with its requirements. Moreover, the Proposed Rule clearly set forth the intended subject matter and scope of the OWP, which allowed Plaintiffs ample opportunity to comment on it. AR168-70. For example, the Proposed Rule indicated that the OWP would address treatment for Medfly in lemons harvested yellow, specifications for how lemons destined for export to the United States are safeguarded during transport from production places to packinghouses, and the means of identification for tracing each lemon exported through the United States back to its place of production. AR169. Indeed, the OWP was formulated using the same documents that provided the essential support for the Final Rule-such as the Pest Risk Assessment and Risk Management document. See AR61-153; AR154-166. Those documents were properly disclosed, and the OWP does not deal with subject matter outside the scope of what was provided for in the Final Rule or the other essential documents disclosed for notice and comment.
Plaintiffs argue that "changes to the Medfly trapping protocol...appear for the first time" in the OWP. The OWP calls for Medfly trapping 35 days before the estimated date of harvest in the second and subsequent years of exporting (AR28364), where the previously disclosed Risk Management Document had called for a one-year period (AR 169). However, the Proposed Rule clearly indicated that the Medfly trapping protocol would appear in the OWP, AR170, and the disclosed 2016 Trip Report, which was available to the public for notice and comment, noted that APHIS and SENASA might shorten the length of time necessary for trapping, AR25905-06, giving the Plaintiffs ample notice and opportunity to provide comment on the appropriate length of time for Medfly trapping. The OWP did not provide any truly unique information such that its non-disclosure deprived the public of opportunity for notice and comment.
In support of their argument that the OWP should have been disclosed under Idaho Farm Bureau , Plaintiffs cite Center for Biological Diversity v. Norton ,
Plaintiffs also cited Friends of the Earth v. Hall ,
The agency did not commit procedural error in not disclosing the OWP, or any interim version of it, for notice and comment.
C. Substantive Challenges To APHIS's Decision-Making
1. Reliance on SENASA
According to Plaintiffs, APHIS's determination that SENASA was capable of complying with and enforcing the systems approach was arbitrary and capricious. First, Plaintiffs argue, the agency could not have made this determination in the first instance prior to completing the OWP, because the agency had not defined the rules with which SENASA was required to comply. Second, APHIS did not take the necessary steps to ensure that SENASA was capable of complying with the rule until they visited Argentina during harvest season only after issuing the Final Rule. Third, APHIS unreasonably ignored evidence in the record that SENASA would be unable to implement the necessary phytosanitary measures.
As an initial matter, Defendants counter that Plaintiffs overstate the agency's reliance on SENASA, noting that the agency will maintain thorough oversight under the Final Rule. Defendants also argue that the agency's determination regarding SENASA's capacity to ensure compliance with the systems approach was reasonable, and that Plaintiffs' argument that the OWP and compliance checks should have been completed prior to the promulgation of the Final Rule exceeds what is required under the APA and is otherwise unreasonable.
a. APHIS Oversight
Under the Final Rule, APHIS delegates certain compliance responsibilities to SENASA, but maintains oversight responsibility, and reserves the right to monitor places of production and packinghouses itself "as APHIS deems warranted."
Moreover, APHIS did take significant steps to evaluate SENASA's capacity for oversight, and to work with SENASA to ensure that they would be able to implement the systems approach. The agency determined that the "routine reviews and inspections" outlined in the Final Rule *904were adequate, and determined that heightened oversight "tantamount to [a] mandatory preclearance program" was not necessary under the circumstances. AR8. This assessment was based on APHIS's site visits, during which time it "looked at SENASA's infrastructure and asked questions to address their capacity to provide oversight" AR2, and also verified information provided by SENASA regarding pests. AR3. The agency also considered the fact that Argentina is a member of the World Trade Organization, and has "demonstrated the[ir] ability to comply with U.S. regulations with respect to other export programs. AR5. The agency further reiterated that APHIS would be "directly involved in monitoring and auditing implementation of the systems approach in Argentina" and that "[a] determination that the systems approach had not been fully implemented or maintained would result in remedial actions, including possible suspension of the export program for Argentine lemons."
In Harlan Land Co. v. U.S. Department of Agriculture , this court expressed concerns regarding SENASA's oversight capabilities based in large part on its failure to report an outbreak of foot-and-mouth disease for several months in 2000.
Plaintiffs also argue that the agency erred in relying on Argentina's export program to the European Union as evidence that SENASA was capable of complying with the systems approach, pointing out that the European Union "repeatedly intercepted citrus shipments from Argentina with the causal agent of Citrus Black Spot." ECF No. 35-1 at 25 (citing AR250 & n.20). As Defendants point out, the majority of those interceptions occurred before February 2016, when the EU and SENASA implemented new measure targeted at intercepting Citrus Black Spot ("CBS"). AR1501-1533. Prior to that time, the EU did not require specific mitigations for CBS.4
Although the interception of any quarantine pests is concerning, the record indicates that SENASA worked with the EU
*905following these interceptions to implement an action plan aimed at mitigating the risk of exporting CBS-infected fruit. APHIS also put in place more stringent measures than those required by the EU which will be overseen by APHIS. It was not unreasonable for the agency to conclude that SENASA could be relied on to implement its more stringent procedures in light of the full record. Moreover, this approach is particularly reasonable in light of APHIS's scientific judgment that CBS is unlikely to follow the commercial fruit pathway, infra at 905-07, and therefore unlikely to present a risk to domestic crops even if infected fruit did make its way to the United States.
b. APHIS's Evaluation Of SENASA Prior To Completion Of The OWP
Plaintiffs argue that it was irrational for APHIS to conclude that it could rely on SENASA prior to completing the final OWP. Plaintiffs reason that until APHIS outlined exactly what SENASA's oversight responsibilities would be, it could not adequately assess whether SENASA was capable of providing that oversight. This position misconstrues the nature of the OWP and the rulemaking process. As an initial matter, and as this Court concluded above, the OWP is an interpretive rule. The Final Rule sets the parameters of the systems approach, and governs SENASA's responsibilities. The OWP merely flushes out that systems approach. Therefore, APHIS's determination that SENASA was capable of carrying out the oversight outlined in the Final Rule, with APHIS's oversight, was sufficient. APHIS did not need to make additional findings of SENASA's capacity for oversight with respect to the OWP. Moreover, it would be illogical to require APHIS to have an OWP, necessarily dependent on the requirements put in place by the Final Rule, in place before the Rule was finalized.
c. APHIS's Evaluation Of SENASA Prior To 2017 Site Visit
Lastly, Plaintiffs argue that it was irrational for APHIS to conclude that SENASA was capable of compliance with the Final Rule prior to completing a final site visit. Plaintiffs argue that Defendants could not reasonably be assured that SENASA was capable of oversight based on the prior site visits alone, which each indicated that SENASA was not yet in full compliance with the Final Rule. Defendants counter that the regulated party, in this case SENASA, need not be in full compliance with the Rule prior to its enactment, and that imposing such a requirement exceeds what is required under the law.
The Final Rule lifts the ban on Argentine lemon imports and imposes a system for imports going forward. It does not authorize any particular entity to begin exporting lemons. The administrative record indicates that authorization will be given to producers and packinghouses that demonstrate full compliance with the requirements of the Final Rule. AR28378. There is no legal or logical support for the notion that APHIS must wait to lift the ban until it ensures 100% compliance with the terms of the Final Rule. APHIS made several site visits to ensure that SENASA and the Argentine lemon industry were moving towards compliance with the likely terms of the Final Rule prior to its enactment. It was not irrational to rely on its judgment that those entities would continue to move toward compliance in an effort to comply with the Final Rule after it was promulgated, particularly given APHIS's role in overseeing and supervising compliance with the Rule.
2. Scientific Evidence Regarding Citrus Black Spot
Plaintiffs argue that APHIS arbitrarily and capriciously dismissed new scientific *906evidence bearing on the risk of the transmission of CBS, one of the quarantine pests present in Argentine lemons. Specifically Plaintiffs accuse the agency of ignoring a 2014 study from the European Union calling into question the conventional understanding-expressed in the agency's Pest Risk Assessment-that CBS cannot be transmitted on citrus fruit without leaves. In the Final Rule, the agency indicated only that they "disagree[d] with the EU regarding the transmissibility of CBS via commercially produced fruit." AR5. Plaintiffs argue that this summary dismissal of the EU study, without additional explanation, was arbitrary and capricious.
Defendants counter that, having thoroughly reviewed the 2014 EU study, APHIS stands by the conclusion of its own 2010 peer-reviewed study, which found that the risk of CBS is unlikely to be meaningfully increased by the commercial importation of citrus. Defendants further assert that their reasoning for rejecting that study can be properly discerned from the administrative record as a whole, and therefore they need not have provided additional rationale in their response to comments in the Final Rule.
As an initial matter, Defendants are correct that the rationale for favoring the 2010 study over the EU study need not be apparent from the response to comments in the Final Rule, so long as "the record as a whole satisfies the APA's requirements[.]" Epsilon Elecs., Inc. v. Dep't of Treasury ,
Here, the record indicates that APHIS has thoroughly reviewed the body of academic literature regarding the risk of CBS through imported citrus, both before and in response to the EU study, and reaffirmed their conclusion that imported fruit was not a likely pathway for CBS. AR1619-1735; AR2601-16; AR1589-91; AR1593-1603; AR1736; AR1901-08; AR2844 (final rule lifting ban on citrus imports from Uruguay). APHIS reviewed and considered the EU study in 2013, and submitted a detailed response explaining why the conclusions of the EU study were incorrect. AR2601. APHIS also addressed the EU study and its own scientific conclusions about the unlikelihood of CBS transmission through infected fruit in the Final Rule itself. AR5 ("We disagree with the EU regarding the transmissibility of [CBS] via commercially produced fruit."); AR7 ("pycnidiospores, the asexual stage, do not play a significant role in the disease cycle");
The agency considered the proper factors and determined that the risk of CBS transmission through infected fruit was unlikely. That determination was not arbitrary and capricious or an abuse of discretion. Alaska Ctr. For Env't v. U.S. Forest Serv. ,
The agency did not act arbitrarily and capriciously, nor did it abuse its discretion, when it determined that the Final Rule eliminated the risk of CBS spreading through the import of Argentine lemons under the procedures set forth in the Final Rule.
3. Presence of Residential Citrus in California
Plaintiffs argue that the agency acted unreasonably in failing to account for the ubiquity of residential and commercial citrus in California in promulgating the Final Rule. As both parties acknowledge, the presence of such trees, which can serve as host material for pests and diseases, increases the risk that any pest or disease that makes it to the United States will spread in domestic fruit crops. Defendants argue that the systems approach mitigates the risk that any pest or disease will be introduced in the United States in the first instance. If the pests or diseases are never introduced on U.S. soil, they cannot spread in domestic citrus, thus eliminating the need to consider the prevalence of citrus in California at all. Defendants also point out that they did consider the availability of host material in the Pest Risk Assessment. ECF No. 42 at 16 (citing AR3044 ("While California...could reasonably receive the highest number of infected fruit only a small portion of the state has a climate suitable for CBS development...and the majority of commercial citrus grown in California is not grown in in that area[.]"); AR103 (Pest Risk Assessment noting that Brevipalpus spp. mites colonize "more than 900 plant species.").
The administrative record indicates that the agency did not abuse its discretion in failing to consider explicitly the presence of residential citrus in California. The agency did not "entirely fail to consider an important aspect of the problem" because in its scientific judgment, the systems approach would prevent quarantine pests from ever reaching the United States, thus obviating the need to consider the density of residential citrus in California as potential *908host material. Ranchers Cattlemen Action Legal Fund v. U.S. Dep't of Agric. ,
Moreover, implicitly, the agency did consider the issue of domestic citrus plants overall in designing the systems approach. The Pest Risk Assessment included an "[a]ssessment of the probability that a plant pest will come into contact with host material" taking into account "the availability, in time and space, of its host plants." AR121. Those assessments led to a protocol for pest-specific mitigation that started well before imported fruit ever reached the port of entry inspection. Plaintiffs have not demonstrated that the agency erred in its assessment of the risks posed by the availability of host material. Whether the agency's planned approach is wise is not for the Court to decide. So long as the requirements of the APA are satisfied, the agency is charged with making such policy decisions within the guidelines set forth by statute and regulation.
4. Foreign Policy Considerations
Plaintiffs argue that APHIS was impermissibly influenced by foreign policy considerations "rather than science alone" in promulgating the Final Rule lifting the ban on Argentine lemon imports. In support of their argument that foreign policy was impermissibly considered, Plaintiffs point to the fact that after years of considering the Argentine lemon industry, the lifting of the ban was announced just six weeks after President Obama visited Argentina. Thereafter, in April 2017, the President Trump met with President Macri of Argentina. President Trump indicated that he intended to use the lifting of the lemon import ban as a bargaining chip in exchange for Argentina's support in the United States' efforts to negotiate with North Korea. See ECF No. 37-2 ¶ 33. Four days after the meeting, APHIS announced that the Rule, the implementation of which had previously been delayed due to the intervening change in administration, would go into effect May, 26, 2017. Defendants counter that there is no evidence in the record to suggest that the timing of these meetings alone is meaningful, nor that these meetings had any bearing on the substance of the Final Rule.
There is simply no support in the record for the proposition that foreign policy considerations overcame the agency's scientific judgment in formulating the rule. Plaintiffs' argument that the timing of President Obama's presidential visit was the impetus for the lifting of the ban is purely speculative and not supported by the record.6 Even if foreign policy was the impetus for the announcement that the ban was being lifted,7 there is no evidence *909in the record, or outside it, to suggest that the agency disregarded scientific evidence in favor of foreign policy considerations in coming to its decision, nor that foreign policy considerations had any bearing whatsoever on the substance of Rule. Indeed, Plaintiffs argue that President Trump's 2017 meeting with President Macri evinced improper interference with the rulemaking process, but at the time that meeting took place, the Final Rule had already been issued . Therefore, President Trump's negotiations with President Macri could not have had any bearing on the notice and comment rulemaking process or the substance of the Final Rule. There is nothing in the record to indicate that foreign policy concerns had an improper bearing on the agency's rulemaking process.
5. Northeast Port Limitation 8
As mentioned, for 2017 and 2018, Argentine lemons will be imported only into the northeastern United States. Plaintiffs argue that the northeast port limitation undermines the substantive rationality of the Rule, because it implies that the systems approach is not sufficient in the short term to protect domestic citrus crops in California from the threat of quarantine pests. (ECF No. 35-1 at 33.) Defendants deny that the northeast port limitation is an implicit concession that the Rule itself is flawed. Rather, Defendants posit that the limitation was a concession, proposed by the Argentine government, to U.S. lemon producers who expressed concerns about the importation of Argentine lemons from both a phytosanitary and an economic perspective.
The northeast port limitation is a temporary restriction on importing Argentine lemons to the west coast. It is set to expire after 2018. (ECF No. 36 at 9-10.) The Final Rule itself does not restrict imports to northeast ports.
There is no evidence in the record to support Plaintiffs' theory that the northeast port limitation undermines the scientific basis for the Final Rule. The record contains a letter from an official from the Argentine Ministry of Agriculture, who wrote that he "read about the concerns of US lemon producers regarding introduction of pests and diseases and of Argentine lemons flooding the US market." AR28334. Although the official characterized the concerns as "unfounded," and affirmed that he believed that there was "thorough scientific support" for the Final Rule, he proposed restricting lemon imports to the North Atlantic "during the first few marketing *910seasons."
Contrary to Plaintiffs assertions, there is no "unexplained inconsistency" between the agency's words and its actions. (ECF No. 40 (citing Dist. Hosp. Partners v. Burwell ,
D. RFA Claim
Plaintiffs argue that they are entitled to summary judgment under the RFA because the agency's assessment of the economic impact of the rule on small businesses was arbitrary and capricious. Plaintiffs also argue that under the APA, the agency failed to consider an important aspect of the problem-namely, the economic impact of the Rule on the domestic citrus industry.
Defendants first ask the Court to reassess its conclusion in the October 25 Order that Plaintiffs have standing, as parties who are only indirectly regulated by the Rule, to challenge the Rule under the RFA. Plaintiffs argue that the Court should not address the question, because it was already raised and addressed in the October 25 Order, and therefore Defendant's request to reconsider is untimely ( Fed R. Civ. P. 59(e) ) and not in compliance with the Court's rules (Local Rule 230(j) ).9
*911In addition to the constitutional requirements of Article III, Plaintiffs' cause of action under the RFA must fall within the "zone of interest" protected by the RFA. Sometimes framed as a question of "prudential standing," the zone-of-interest test "looks to the statutory provisions at issue and asks whether Congress authorized the plaintiff to sue under them." Ray Charles Found. v. Robinson ,
In its October 25 Order, the Court held:
As to Defendants' second contention that indirectly regulated entities cannot bring challenges under the RFA, their contention is undermined by the plain language of the statute. Section 611(a)(1) provides that "a small entity that is adversely affected or aggrieved by final agency action is entitled to judicial review of agency compliance with the requirements of" the RFA.5 U.S.C. § 611 (a)(1). The statutory language itself does not preclude entities that are aggrieved but not directly regulated from challenging agency compliance. Defendants point to Mid-Texas Electric Co-operative, Inc., v. FERC ,773 F.2d 327 , 340-41 (D.C. Cir. 1985), to support their position that indirectly regulated entities lack standing under the RFA, but do not explain how the case supports their interpretation. When Mid-Texas Electric was decided, § 611(b) explicitly precluded judicial review of the regulatory flexibility analysis prepared under the RFA.5 U.S.C. § 611 (b) (West 1980). That provision of the law was amended in 1996 to allow explicitly for judicial review of the regulatory flexibility analysis as part of the "entire record of agency action."5 U.S.C. § 611 . To the extent that Defendants argue that judicial review should be limited based on the Mid-Texas Electric court's examination of the law and its legislative history, that analysis is no longer relevant in light of the intervening change in law.
ECF No. 36 at 20-21. In their summary judgment briefing, Defendants cite two more recent out of circuit cases that explicitly conclude that indirectly regulated small entities do not have statutory authority to challenge an agency action under the RFA. See White Eagle Co-op. Ass'n v. Conner ,
*912Defendants also point to the fact that the specified remedies for prevailing in a challenge under the RFA are "remand[ ]...to the agency" and "deferr[al of] the enforcement of the rule against small entities ." § 611(a)(4). "[E]nforcement of the rule against small entities" implies that those entities are directly regulated by the rule. Here, Plaintiffs and other small entities affected by the Rule would not be subject to deferred enforcement-nothing is being enforced against them at all. Of course, as Plaintiffs point out, remedies are not limited to those enumerated in the statute, and remand to the agency could redress any potential injury of a non-regulated party.
The Ninth Circuit has not addressed whether the RFA applies to indirectly regulated small entities, although in at least one case, the Ninth Circuit implicitly assumed that indirectly affected small entities had standing to challenge an agency decision under the RFA. Ranchers Cattlemen Action Legal Fund United Stockgrowers of Am. v. U.S. Dep't of Agric. ,
However, the Ninth Circuit employs a similar approach to the D.C. Circuit, albeit using different language, to determine whether a plaintiff falls within the zone of interest of a particular statute. As the Ninth Circuit has noted, "[w]hether a plaintiff comes within the zone of interests is an issue that requires us to determine, using traditional tools of statutory interpretation, whether a legislatively conferred cause of action encompasses a particular plaintiff's claim." Ray Charles Found. v. Robinson ,
*913Even if Plaintiffs did fall within the zone of interest under the RFA, and the agency was therefore obliged to complete a regulatory flexibility analysis that assessed the effect of the Rule on domestic growers, the agency's regulatory flexibility analysis was not arbitrary and capricious. Plaintiffs principal contention is that the agency irrationally and arbitrarily assumed that the volume of lemons imported would be 15,000 to 20,000 metric tons. Plaintiffs posit that the correct number is higher, based on a public statement made by a representative of the Argentine Citrus Federation (AR275 (speculating that imports would range from 20,000 to 30,000 metric tons), and a report prepared by Plaintiff U.S. Citrus Science's own economist (AR275; AR284). Defendants counter that the volume determined by agency experts was based on historical data and was not arbitrary and capricious. Moreover, they contend that even if the export assumption used was lower than what it should have been, more exports would only increase the overall welfare of consumers and thus would not ultimately change the agency's opinion that the Rule has a net social benefit under the RFA.
The agency's assumption was based on sound reasoning, drawn from Argentina's historical export levels during the 2000-2001 period when Argentina did export lemons to the United States. AR43. The agency did not act irrationally or arbitrarily in adopting this assumption in its analysis in lieu of those proposed by Plaintiffs. Pac. Coast Fed'n of Fishermen's Ass'ns ,
E. NEPA
Lastly, Plaintiffs argue that APHIS violated NEPA,
An agency may prepare an environmental assessment ("EA") to determine whether an EIS is needed.
Under NEPA, each agency may identify "categorical exclusions" which are categories of actions which do not, individually or cumulatively, have a significant *914effect on the human environment and therefore, do not require an EIS or an EA.
It is undisputed that APHIS did not produce any environmental document pursuant to NEPA. Defendants argue that the Final Rule falls within APHIS's established categorical exclusion for routine measures,
Here, Defendants argue that the procedures outlined in the systems approach implemented by the Final Rule fall within the agency's exception for "routine measures"-"such as identifications, inspections, surveys, sampling that does not cause physical alteration of the environment, testing, seizures, quarantines, removals, sanitizing, inoculations, control, and monitoring employed by agency programs to pursue their missions and functions."
At first glance, it seems counter-intuitive co conclude that the lifting of the ban itself is a "routine measure." Although the systems approach includes some activities that fall within the category of routine measures, lifting a ban on imports that has spanned eight decades can hardly be categorized as "routine." However, there is language within APHIS's categorical exclusion rule that permits such an interpretation. Under APHIS regulations governing the classification of actions for NEPA purposes, agency actions in which "the means through which adverse environmental impacts may be avoided or minimized have actually been built right into the actions themselves" may be categorically excluded from the requirement to prepare an EA or an EIS.
This Court's decision in Cactus Corner, LLC v. U.S. Department of Agriculture , provides some guidance in reviewing APHIS's application of that provision.
[T]he nature and purpose of the Rule itself, aimed at the prevention of Medfly introduction into the United States, is designed to protect human health and the environment. Its risk analyses adequately address all issues of environmental concern, particularly the threat of the spread of Medflies, the risk to plant life (crops), and the risk to consumers who could encounter larvae in a fruit....Plaintiffs have not shown that the Secretary's assertion of categorical exclusions, supported by substantial record evidence, requires the Secretary's further explanation under NEPA or what such an explanation would address *915....The Rule itself is aimed at effectively preventing Medfly importation into the United States, to protect human health and the environment. The Rule's corrective measures do not pose new environmental hazards (such as the application of new or untested pesticides post-entry); rather, the environmental impact of the Rule itself is salutary. Phytosanitary practices are to be implemented in Spain; cold storage will be supplied in Spain, in transit, and in the U.S.; sampling and testing of fruit will be conducted at all stages from production in the field, through import and ultimate delivery to the consumer. The "hard look" analysis required by the NEPA is unnecessary and inapplicable because the Rule's design and its overall purpose is protection of the environment and human health. Even assuming a "hard look" must be taken, the Secretary has done so. The agency correctly relies on applicable categorical exclusions from the NEPA's EIS and EA requirements.
Cactus Corner is indistinguishable from the facts of this case. Here too, the Final Rule's "design and overall purpose is the protection of the environment and human health." The Final Rule contains the means for avoiding environmental impacts within the Rule itself. Indeed, the purpose of the Rule is to permit Argentine lemons to be imported to the United States under "conditions designed to prevent the introduction of...quarantine pests."
The purpose of the Rule is to prevent the introduction of quarantine pests in the United States. Likewise, as the Court concluded above, the agency's determination that the Final Rule mitigated the risk of quarantine pests establishing in the United States was not arbitrary and capricious. The record further shows that, as in Cactus Corner , the systems approach itself does not introduce new environmental risks to the United States. Therefore, the agency's interpretation that the Final Rule falls within a categorical exclusion to NEPA for rules designed to avoid or minimize adverse environmental impacts is entitled to deference.
Plaintiffs do not suggest that Cactus Corner was wrongly decided.10 Rather, *916they maintain that the record in this case supports a finding that the risks posed by the Rule are "environmentally significant." In evaluating this argument, the Court looks to Center for Food Safety v. Johanns ,
The present case is different. Not only is there no specific example provided in the exception provision that even arguably applies here,11 as discussed above, APHIS correctly concluded that the Rule and its systems approach will be sufficiently protective to avoid environmentally significant impacts.
V. CONCLUSION AND ORDER
For the reasons set forth above, Plaintiffs' motion for summary judgment (ECF No. 35) is DENIED, and Defendants' motion for summary judgment (ECF No. 37) is GRANTED as to the remaining counts in the Amended Complaint.
*917The Clerk of Court is directed to ENTER JUDGMENT in favor of Defendants and against Plaintiffs and to CLOSE THIS CASE.
IT IS SO ORDERED.
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312 F. Supp. 3d 884, Counsel Stack Legal Research, https://law.counselstack.com/opinion/us-citrus-sci-council-v-us-dept-of-agric-caed-2018.