[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Proposed Rules]
[Pages 41157-41158]
[FR Doc No: 2011-17457]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 118

[Docket No. FDA-2011-D-0398]

Guidance for Industry: Questions and Answers Regarding the Final
Rule, Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Questions and Answers Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation'' (the draft guidance). The draft guidance provides
guidance to egg producers and other persons who are covered by FDA's
final rule entitled ``Prevention of Salmonella Enteritidis in Shell
Eggs During Production, Storage, and Transportation'' (the final rule).
The draft guidance contains questions FDA has received on the final
rule since its publication and responses to those questions.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on the
draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by September 12, 2011.

ADDRESSES: Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Division of Plant and Dairy Food Safety/Office of Food Safety, Center
for Food Safety and Applied Nutrition (HFS-315), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax
your request to<PHONE_NUMBER>. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a
final rule requiring shell egg producers to implement measures to
prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm
and from further growth during storage and transportation, and
requiring these producers to maintain records concerning their
compliance with the final rule and to register with FDA. This final
rule became effective September 8, 2009, with a compliance date of July
9, 2010, for producers with 50,000 or more laying hens. For producers
with fewer than 50,000, but at least 3,000 laying hens, the compliance
date is July 9, 2012. The compliance date for persons who must comply
with only the refrigeration requirements was July 9, 2010.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the Agency's current thinking on how to
interpret the requirements in the final rule, including questions and
answers on compliance dates; coverage; definitions; SE prevention
measures; sampling and testing for SE; registration; and compliance and
enforcement. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternate
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 118.5, 118.6, 118.10, and 118.11
have been approved under OMB control number 0910-0660.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm or
http://www.regulations.gov.

    Dated: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17457 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P


1 Final Draft November 2004 EVALUATION AND CHARACTERISATION OF REACTIVITY METRICS Report to the United States Environmental Protection Agency Research Triangle Park, NC27711 Order No. 4D 5844 NATX By R. G. ( Dick) Derwent rdscientific Newbury, United Kingdom 2 EXECUTIVE SUMMARY This report describes the evaluation and characterisation of reactivity metrics to support the United States Environmental Protection Agency's efforts to update its reactivity policy for the attainment of ozone air quality standards. The review is based on three detailed computer modelling studies which taken together have made a significant contribution to basic understanding of the likely role that reactivity considerations could play in ozone control strategies. Reactivity based policies should work efficiently on both the urban and regional scales by reducing episodic peak ozone levels and by reducing exceedances of the ozone air quality standards. Two preferred metrics have been selected as the most promising for policy development and these are the EKMA and Regional or 3 D Maximum Incremental Reactivity metrics. 3 D Eulerian regional air quality models have been demonstrated to be ideal tools for the visualisation of the ozone impacts of reactivity based VOC substitution strategies across central California, the south western and south eastern United States of America. The choice of chemical mechanism, together with its adequacy and completeness, are crucial to the estimation of reactivity metrics and the compilation of reactivity scales.

If the potential value of reactivity based VOC control strategies is to become accepted by policy makers for the attainment of ozone air quality standards, then two basic tools will be required. The first is an evaluated reactivity scale that expresses our best understanding of the relative importance of each of upwards of 100 to 200 VOCs in photochemical ozone formation under given environmental conditions. The second is a 3 D Eulerian regional air quality model to provide the best possible visualisation of the urban and regional scale ozone impacts of candidate reactivity based VOC control strategies. 3 1. Introduction Sunlight driven photochemical reactions in the atmospheric boundary layer involving volatile organic compounds ( VOCs) and nitrogen oxides ( NOx) result in the formation of ozone and fine particles. Each VOC has widely differing reaction rates and shows differing propensities to form ozone. Each VOC will therefore make a different contribution to the elevated ozone concentrations found in each pollution episode in each situation. Basic understanding of these different reaction rates and reaction pathways for each VOC has increased steadily in recent years to the extent that, the United States Environmental Protection Agency is considering whether it is possible to use this increased understanding to develop more efficient, accurate and cost effective control strategies for meeting the ozone air quality standards.

The focus of controls on the emissions of ozone precursors has been largely on the reductions in mass emissions of VOCs without regard to their different contributions to photochemical ozone production ( Dimitriades, 1999). However, included in the policy framework has been the provision for the exclusion from the emission control regulations of those compounds that are considered to be of negligible reactivity. Inherent in this approach is the view that selective control of VOC emissions is more cost effective than the indiscriminate mass control approach.

The contribution made by any individual VOC to photochemical ozone formation depends crucially on environmental conditions. However, the contributions made by one VOC relative to another, or pairs or groups of VOCs relative to each other, are much less variable. Ethane is thus relatively unreactive compared with most VOCs and isoprene is relatively more highly reactive, under most conditions. The relative rankings of VOCs in a quantitative table is termed a reactivity scale and the most frequently quoted such scale is the Maximum Incremental Reactivity ( MIR) scale ( Carter, 1994). The MIR scale is the most appropriate scale to quantify VOC reactivity under photochemical ozone formation conditions most sensitive to VOC emissions under the highest NOx conditions associated with intense ozone source regions in the Los Angeles basin. It has been adopted in the state of California for the purpose of implementing reactivity based regulations ( CARB, 1993).

The Reactivity Research Working Group ( RRWG, 1999) coordinates policy relevant research related to VOC reactivity and has overseen three studies performed by Carter et al. ( 2003), Arunachalam et al. ( 2003) and Hakami et al. ( 2003, 2004). Taken together, these three studies have made a significant contribution to basic understanding of the likely role that reactivity considerations could play in ozone control strategies. These studies have shown that reactivity based policies should work efficiently on both the urban and regional scales by reducing episodic peak ozone levels and by reducing the exceedances of the ozone air quality standards.

This report describes the evaluation and characterisation of reactivity metrics to support the United States Environmental Protection Agency's efforts to update its reactivity 4 policy for the attainment of ozone air quality standards. The review is based on the above three studies performed by Carter et al. ( 2003), Arunachalam et al. ( 2003) and Hakami et al. ( 2003, 2004) and on the existing VOC reactivity literature, as appropriate.

2. Review and Assessment of VOC Reactivity Metric Studies The incremental reactivity of a VOC species is estimated from the incremental increases in ozone exposure levels caused by the incremental increases in the emissions of particular VOCs. A ranked table of incremental reactivities for a series of VOCs comprises a reactivity scale. Because ozone exposure levels can be represented in a number of ways, these different representations or metrics can be used to define a number of reactivity scales.

Since reactivity based policies are ultimately about achieving ambient air quality standards for ozone, the most appropriate quantification of ozone exposure levels is to use the 1 hour and 8 hour air quality standards. In addition, however, there may be many alternative methodologies for the integration of the ozone impacts across the model domains and over each episode day. Only a subset of the many possibilities have been considered here in the studies by Carter et al. ( 2003) and Hakami et al. ( 2003, 2004).

Before reactivities and reactivity scales can be quantified, it is necessary to specify the time period being studied, the model domains that are being analysed, the methods used to quantify ozone exposure levels in a given cell and the methodologies used to derive a single reactivity metric for the entire model domain.

Question 1. What are the attributes of the reactivity metrics that influence their suitability for use in large scale policy applications ?

The main attribute of the reactivity metrics that influences their suitability for policy applications is robustness across model domains and between episode days. It is crucial that the relative positions of the VOCs or groups of VOCs in a reactivity scale, estimated for a given reactivity metric, do not shift significantly or change or reverse between different domains and episode days. An important issue is whether a reactivity scale that works in New York, with its high population density will also work in Atlanta with its large biogenic VOC emissions ( Hakami et al. 2004).

A further important characteristic of a reactivity scale and hence an important attribute of a reactivity metric, from a policy perspective is its effective range ( Carter et al. 2003). The effective range of a reactivity scale is the range of reactivity values generated between the most reactive VOC and an unreactive VOC such as ethane. If a reactivity scale is used with too low an effective range then there would be insufficient incentive for the consideration of reactivity based policies. A reactivity scale with an unreasonably 5 high an effective range may lead to unacceptable ozone impacts with some large substitutions of low reactivity VOCs.

Hakami et al. ( 2004) consider six properties of reactivity scales and metrics that are relevant for air quality management purposes. These include spatial robustness, uncertainty, risk of being inaccurate, population weighting, fairness and regionally representivity. Ease of calculation is not considered to be an important attribute for a reactivity metric. Whilst spatial robustness is the most important property of a reactivity scale, the other five properties are best evaluated when candidate reactivity based strategies have been visualized in a 3 D Eulerian air quality model.

Question 2. What are the most suitable reactivity metrics from both scientific and practical application perspectives for potential development of VOC control strategies based on VOC reactivity ?

Carter et al. ( 2003) describe how they have employed the CAMx model to study reactivity metrics across the eastern United States. The study period chosen was the NARSTO NE episode which covered four days during July 1995. The model employed the Carbon Bond 4 ( CB4) mechanism and was run at 4 km x 4 km, 12 km x 12 km and 36 km x 36 km scales. Reactivity metrics were estimated using the direct decoupled method ( DDM) for 7 methods, 4 episode days, 3 grid resolutions and two ozone standards. In each case, a reactivity scale was produced comprising the following nine VOC species: OLE, formaldehyde, acetaldehyde, ethane, xylenes, ethanol, PAR, ethane and TOL.

Table 1 summarises the evaluation of each of the reactivity metrics over the different episode days, model domains and grid resolutions based on Carter et al. ( 2003). Carter et al. ( 2003) comment that the differences between the different reactivity metrics for the same species were less than the differences between the species for the same metric. Hence, in each case, a usable reactivity scale could be constructed from the available results. In general, the use of the 8 hour or 1 hour ozone standards made little difference to the reactivity metrics and the use of cut offs in the ozone levels of up to 80 ppb also did not significantly change the reactivity metrics. Significant differences were seen between the 4 km x 4 km grid resolutions and the 12 km x 12 km and 36 km x 36 km resolutions because of the better representation at the 4 km x 4 km resolution of urban source regions which are more VOC sensitive.

In summarizing their results, Carter et al. ( 2003) noted that for most model species the EKMA reactivity metrics were surprisingly close to the regional model relative reactivity metrics. The three 3 D grid model reactivity metrics that were favoured were: Regional MIR, Regional MIR to MOIR and Minimum Substitution Error   Method 1. The EKMA and Regional MIR reactivity scales showed the largest effective ranges, whilst those of the Regional MIR to MOIR and Minimum Substitution Error   Method 1, showed reduced effective ranges. 6 Table 1. The evaluation of the reactivity metrics over the different episode days, model domains and grid resolutions described by Carter et al. ( 2003).

Reactivity metric Evaluation Regional Average Ozonea Disadvantage is that this metric includes many low ozone cells that are the least VOC sensitive Regional Maximum Ozoneb Disadvantage is that it is highly variable between episode days and model domains and sometimes the absolute peak ozone is insensitive to VOC emissions Regional Average Ozone Over Standardc This is a robust metric that shows little variability and gives the best estimates for regions in exceedance of standards Minimum Substitution Error   Method 1d Disadvantage that this method does not work well for low and negative reactivity species but weights heavily VOC sensitive cells Minimum Substitution Error   Method 2e Disadvantage that this method is sometimes unreliable for some species Regional Maximum Incremental Reactivityf This is a robust metric because all the cells used have similar VOC sensitivities and negative NOx sensitivities. Disadvantage is that this is not a truly global metric Regional MIR to MOIRg This is a robust metric that shows little variability because all the cells used have similar VOC sensitivities and are where NOx controls would be counter productive Notes: a. the average incremental reactivity over the entire model domain. b. the incremental reactivity in the cell with the domain wide peak concentration. c. the average incremental reactivity for all grid cells exceeding the standard. d. the incremental reactivity that minimizes the sum of squares of ozone changes in all cells caused by substituting a VOC by the base ROG. e. the incremental reactivity that minimizes the sum of squares of ozone changes in all cells caused by substituting the base ROG by a VOC. f. The incremental reactivities in the cells with the highest base ROG sensitivity. g. The incremental reactivities for all grid cells with negative NOx sensitivity. 7 Table 2. The evaluation of the reactivity metrics over the different episode days, model domains and grid resolutions described by Hakami et al. ( 2004).

Reactivity metric Evaluation 3 D Maximum Incremental Reactivity MIR 3D Consistent across model domains and days and protective of urban populations with high NOx levels 3 D Peak Ozone Incremental Reactivitya POIR 3D or 3 D Maximum Ozone Incremental Reactivity MOIR 3D Based on the relative reactivity at one point and perhaps relatively rare conditions of most NOx limited, less typical of population centres, least VOC sensitive Least Square Relative Reactivity LS  RR Consistent across model domains and episode days Regional Average Ozone AVG Showed considerable inter domain variability Regional Average Ozone Above Standard AVS Showed considerable inter domain variability 3 D Maximum Incremental Reactivity to Maximum Ozone Incremental Reactivity M2M Showed greatest inter domain consistency, little variability between episode days Notes: a. for the conditions where the sensitivity of the maximum ozone to the initial NOx is zero.

Hakami et al. ( 2003, 2004) describe how they have used the Urban to Regional Multiscale ( URM) and MAQSIP 3 D models to estimate reactivity metrics over the Eastern United States and in central California. The NARSTO NE episodes during May and July 1995 were used for the former domain and the SARMAP episode for the latter. The models were applied at a spatial resolution of 24 km x 24 km with other grid sizes up to 48 km, 96 km and 192 km and used the SAPRC 99 chemical mechanism. This mechanism represented 42 explicit VOC species of which 9 were lumped VOC species. Reactivity metrics using 6 different methodologies were calculated using the direct decoupled method.

In summarizing their results, Hakami et al. ( 2003) observed that the Peak or Maximum Ozone Incremental Reactivity POIR 3D or MOIR 3D reactivity metric was not adequately robust across the episode days and model domains. The Maximum Incremental Reactivity MIR 3D metric gave the best agreement with the box model reactivity scales for all episodes. The Least Square   Relative Reactivity LS   RR metric showed the best spatial consistency over the model domains. Reactivity metrics based on the 1 hour and 8 hour ozone standards behaved similarly and there was little difference between the metrics calculated with 80 ppb and 60 ppb ozone cut offs. There were also 8 little differences between the reactivity metrics calculated with the different model emission inventories. However, the reactivities of aldehydes in the 3 D model were generally lower than those reported from box model studies due to the more efficient carry over of radical sources in the 3 D model. Reactivities of   pinene and the trimethylbenzenes were lower than box model values and that of methanol was higher in the 3 D model.

Table 2 summarises the evaluation of the different reactivity metrics put forward by Hakami et al. ( 2004) covering the different models, episodes and domains. The three 3 D reactivity metrics that show the required consistency between the different model domains and episode days were reported as: Least Square Relative Reactivity LS   RR, Regional Maximum Incremental Reactivity to Maximum Ozone Incremental Reactivity M2M and Maximum Incremental Reactivity MIR 3D.

Question 3. What are the two or three most promising metrics from the science and policy perspective for use in developing reactivity based control policies ?

Taking together the Carter et al. ( 2003) and the Hakami et al. ( 2003, 2004) studies, the most promising metrics for the development of reactivity policies are:   EKMA MIR, Regional MIR or MIR 3D,   Regional MIR to MOIR or M2M and   Minimum Substitution Error   Method 1 or Least Square Relative Reactivity.

However, there is an important requirement to develop reactivity metrics that generate reactivity scales with the widest effective ranges consistent with our understanding of the atmospheric chemistry of VOCs. On this basis, the most promising reactivity metrics are EKMA MIR and Regional MIR or MIR 3D.

3. Review and assessment of the ozone impacts of reactivity based policies for VOC controls Based on the detailed studies performed by Arunachalam et al. ( 2003), Carter et al. ( 2003) and Hakami et al. ( 2003, 2004) a number of basic questions can be answered about the likely efficacy of reactivity based strategies for VOC emission control policies.

Arunachalam et al. ( 2003) have used the Multi scale Air Quality Simulation Platform ( MAQSIP) model to investigate the impact of reactivity based VOC emission control policies on the attainment of ozone air quality standards. The MAQSIP model was run for the August September 2000 period of the Texas AQS campaign and for a period during June 1996 over the eastern United States. For the Texas study, the model resolutions were 5 km x 5 km, 15 km x 15 km and 45 km x 45 km whereas for the eastern United States study, they were set at 12 km x 12 km and 36 km x 36 km. Two different 9 chemical mechanisms were employed, namely Carbon Bond CB4 and RADM 2 ( Stockwell et al. 1990) and 7 different ozone exposure metrics were calculated. The reactivity based substitution scenarios evaluated were: a 15% reduction in man made VOC emissions, substitution of 15% of all man made VOC emissions with butanone and the substitution of non mobile xylene emissions with 2 butoxyethanol.

The key finding presented by Arunachalam et al. ( 2003) was that reactivity based VOC substitution strategies resulted in reduced ozone levels, particularly in source regions and in areas downwind of major urban and industrial centres. Noticeable changes in ozone were seen with the 15% substitution by butanone in a region dominated by natural biogenic emissions and not usually thought to be VOC sensitive. The substitution of the highly reactive xylene with 2 butoxyethanol was beneficial in reducing exceedances of the ozone standards but small increases were noted in some ozone metrics, in some model domains and on some days. VOC substitution strategies appear to work better on peak ozone levels. Finally, gram based VOC substitutions seem to produce more favourable ozone outcomes compared with mole or mol C based strategies.

In addition to the studies of reactivity metrics discussed above, Carter et al. ( 2003) also performed some VOC substitution experiments with a view to evaluating the impact of the substitution of current VOC emissions with low reactivity or borderline exempt VOCs. Ethane was the chosen surrogate for these low reactivity VOCs. Varying amounts of ethane were added back to replace the entire man made VOC emission inventory. This type of substitution led to almost as much ozone reduction as the complete curtailment of man made VOC emissions. If enough of a low but positive reactivity VOC such as ethane was added, then ozone levels would eventually equal or exceed current levels. This level of substitution was found to involve replacing all man made VOC emissions with about five times the mass of ethane.

Question 4. Is it possible to use incremental reactivities to develop more efficient control strategies for meeting the ozone air quality standards ?

Taken together, the studies by Carter et al. ( 2003), Arunachalam et al. ( 2003) and Hakami et al. ( 2003, 2004) have made a significant contribution to basic understanding of the likely role that reactivity considerations could play in ozone control policies. These studies have shown that reactivity based policies should work efficiently on both the urban and regional scales by reducing episodic peak ozone levels and by reducing the exceedances of the ozone air quality standards. Regional air quality 3 D models have been shown to be ideal platforms with which to visualize the likely impacts of VOCsubstitution strategies on the attainment of the ozone standards. 10 Question 5. What view should be taken on the increases in ozone found in some highly NOx sensitive regions with large substitutions of low reactivity VOC species ?

In principle, if the ozone increases in highly NOx sensitive regions, following large substitutions of low reactive VOC species, do not take ozone levels above the ozone standards then they are probably of little policy significance. However, they may still be of some scientific interest. Some form of process analysis should be conducted to understand the mechanism of any such ozone increases found in 3 D Eulerian regional air quality models. An important issue is whether such ozone increases are likely to be a real feature of the atmospheric chemistry of the VOC substitution or an artifact of the cutdown representation of the oxidation of those VOCs with NOx sinks, together with free radical sources and sinks, in the chemical mechanisms adopted in 3 D models.

Question 6. Are reactivity based controls ineffective or counter productive in multiday transport or stagnation scenarios ?

The studies by Carter et al. ( 2003), Arunachalam et al. ( 2003) and Hakami et al. ( 2003, 2004) certainly addressed multi day ozone episodes but this is a long way from addressing multi day transport or stagnation scenarios. This question therefore remains largely unanswered in the current studies evaluated above.

Further work will be required to address these issues in the North American context. This will entail developing an improved set of EKMA or trajectory scenarios so that box model reactivity scales can be estimated for multi day and stagnation conditions. Although box models cannot represent the meteorological aspects of multi day effects, they can represent the relevant issues of atmospheric chemistry. Stockwell et al. ( 2001) have shown that the EKMA type models can be readily adapted to calculate multi day effects and that the resulting reactivity scales generated are more representative of nonurban areas. 3 D Eulerian regional air quality models, in contrast, can fully represent the meteorological processes driving multi day and stagnation effects. However, caution must be exercised in the representation of the oxidation of those VOCs with NOx sinks, together with free radical sources and sinks, in the cut down chemical mechanisms employed in 3 D Eulerian models.

In Europe, long range transboundary transport and multi day formation are paramount and reactivity scales already fully take these issues into account ( Derwent et al. 1998). Multi day reactivity refers to the process by which emitted VOCs contribute to ozone formation on time scales beyond the day during which they were emitted. All VOCs, including the most reactive alkenes and carbonyls, have a capacity to produce ozone during the day following their emission and multi day ozone formation is driven by the carry over of unreacted parent VOC, of organic nitrogen compounds and by the step wise formation and destruction of carbonyl compounds ( Derwent et al. 2004). The cut down chemical mechanisms used in 3 D Eulerian air quality models may not fully represent all 11 these processes and so they consequently underestimate the extent of multi day ozone formation with the reactive alkenes and carbonyls.

4. Discussion of the major issues involved in estimating reactivity metrics Question 7. How important is the choice of chemical mechanism in estimating reactivity metrics ?

The choice of chemical mechanism, together with its adequacy and completeness, are crucial to the estimation of reactivity metrics and the compilation of reactivity scales. The main task in the development of a reactivity scale is the distillation of all that is known concerning the kinetics and mechanism of the oxidation of individual VOCs into the one single number for each VOC in the reactivity scale.

The three reactivity studies employed three distinctly different chemical mechanisms: CB4, SAPRC 99 and RADM 2. These are all widely used mechanisms, each with its own strengths and weaknesses. It is a relatively straightforward task to evaluate them against each other under particular environmental conditions. Such an evaluation would not significantly help with the evaluation of reactivity metrics because the above three mechanisms have been designed largely to represent photochemical ozone formation in the base case environment. To develop a reactivity scale, we need chemical mechanisms for each of the many hundreds of VOCs that may not necessarily be explicitly represented in the base case but are an essential component of the perturbed cases in which incremental reactivities are being estimated.

To illustrate this point, it is useful to examine the three reactivity studies considered above. An explicit mechanism for ethane photo oxidation had to be added to the CB4 mechanism to represent the contribution to photochemical ozone formation from a VOC which is exempt because of its low reactivity. Explicit mechanisms for 2 butoxyethanol and butanone were also added to CB4. RADM 2 has no explicit representation of butanone ( Stockwell et al. 1990) and so it was assumed to behave in the same manner as the lumped species, KET, which represents all ketones of all carbon chain lengths. An explicit mechanism for 2 butoxyethanol was also added to RADM 2. How are such extensions and assumptions to be adequately and robustly evaluated ?

For a reactivity scale to be a practical and policy relevant tool, it will need to address upwards of 100 to 200 VOCs. Detailed explicit chemical mechanisms will be required that can address accurately, the fate and behaviour of a large number of VOCs. Without access to these detailed and explicit chemical mechanisms, it will not be possible to check out the simplifications, assumptions and extensions made when additional VOCs are added to the simplified chemical mechanisms that are employed in 3 D Eulerian regional air quality models. 12 Additional laboratory, field and smog chamber experimental data may be required to construct and validate the detailed and explicit chemical mechanisms for individual VOCs. There are still many uncertainties in the explicit chemical mechanisms for the aromatics and other important classes of VOCs.

Question 8. What is the appropriate modelling framework, 3 D or box model, for the development of reactivity scales ?

Calculating reactivity scales using 3 D Eulerian air quality models is a significant undertaking, as the three studies discussed above have shown. It has been possible to calculate reactivities for up to 42 VOCs in the URM model ( Hakami et al. 2003, 2004) but this is a long way off the number that would be required for the development of a practical and policy relevant reactivity scale. A significant effort will be required in the preparation of accurate but simplified representations of the fates and behaviour of each VOC so that computer run times do not become inordinately long. It is not clear whether such simplifications will necessarily be available for all candidate VOCs.

A more practical alternative is the development of an improved set of EKMA type box model or trajectory model scenarios that can be used to evaluate reactivities. Although box models cannot represent specific episodes in detail, they permit the use of fully detailed and explicit chemical mechanisms. They can represent the major conditions that control VOC reactivity ( Carter, 1994) and they can represent the atmospheric chemistry issues relevant to multi day and stagnation conditions ( Derwent et al. 2004).

To exploit fully the potential of reactivity based strategies in the future, both box and 3 D Eulerian regional air quality models will be required. Indeed, one of the important conclusions of the Carter et al. ( 2003) study addressed the concern as to whether reactivity scales generated using EKMA type box models could represent reactivity issues over the regional scale. The close similarity between the EKMA type box model scales and the corresponding 3 D regional MIR scale on the 4 km x 4 km model domain, shows that, indeed, both box models and 3 D Eulerian models are capturing the same important features of regional scale photochemical ozone formation ( Carter et al. 2003).

This viewpoint necessarily represents, at first sight, a departure from that set out by the Reactivity Research Working Group ( RRWG, 1999) which considered that 3 D Eulerian regional scale air quality models are the only tools that can realistically capture the longrange impacts of VOCs.

Hakami et al. ( 2003, 2004) describe how 3 D Eulerian models account for the carry over of species that provide a source of free radicals into the next day's chemistry and how this feature accounts for the lower reactivities for aldehydes compared with box models. It may well also account for the lower reactivity found for   pinene and the higher reactivity found for methanol. This is an important observation and it strongly supports the viewpoint that only 3 D Eulerian models can realistically simulate the long range 13 impacts of VOCs. However, there is a potential danger here if the carry over of radical source species were not a real feature of VOC chemistry but an artifact of the simplifications and non stoichiometric factors introduced in the cut down representations of VOC chemistry in the 3 D models. If the carry over of radical sources were an artifact of the chemical mechanism then its importance would have been considerably overstated by the 3 D Eulerian models and this would have led to the estimation of biased reactivities.

Whatever results are generated by 3 D Eulerian models, they are only as reliable as the simplified chemical mechanisms employed in them. Without access to box models, there will be no route by which the situation envisaged by the Reactivity Research Working Group can be reached and 3 D Eulerian regional scale air quality models become the only reliable tools that can realistically simulate the long range impacts of VOCs.

5. Next steps in the development of reactivity based policies for VOC controls If the potential value of reactivity based VOC control strategies become accepted by policymakers for the attainment of ozone air quality standards, then a number of steps will need to be taken to underpin their development. These steps are laid out in the following paragraphs.

Two sets of basic tools will be required, as follows:

  An evaluated reactivity scale containing evaluated reactivity values for upwards of 100 to 200 VOCs, and   3 D Eulerian regional air quality models to visualise the impacts of potential reactivity based strategies on the attainment of ozone air quality standards.

The basic principles being that the evaluated reactivity scale expresses our best understanding of the relative importance of each VOC in photochemical ozone formation under given environmental conditions and that the 3 D Eulerian regional air quality models provide the best possible visualization of the urban and regional scale impacts of potential reactivity based strategies.

Step 1: Development of an interim reactivity scale There are currently two independent methodologies for estimating reactivity values for upwards of a 100 VOCs under North American conditions. The first methodology has led to the production of the MIR scale and is based on the SAPRC family of chemical mechanisms ( Carter, 1994). The second has led to the POCP scale and is based on the Master Chemical Mechanism ( Derwent et al., 2001). Both adopt EKMA like box models and both employ the same input data based on Baugues ( 1990). 14 The general level of agreement between the MIR and POCP values is excellent for a wide range of VOCs and VOC classes. The remaining differences need to be resolved where they exist. The two reactivity scales should then be reviewed and a combined interim reactivity scale should be constructed.

Step 2: Development of candidate reactivity based strategies Using the interim reactivity scale, all stake holders should be encouraged to develop candidate reactivity based strategies. In this way policy makers can obtain some understanding of the types of substitutions and their geographic scales, that are being contemplated.

Step 3: Development of the SMOKE emissions processing system It is likely that some changes will be required to the SMOKE emissions processing system in CMAQ so that the candidate reactivity based strategies can be visualized in CMAQ and other 3 D Eulerian regional air quality models.

Step 4: Development of EKMA type scenarios The input data employed in the construction of the MIR and POCP scales were taken from Baugues ( 1990) and represent 39 urban areas at some point in time in the past when peak ozone concentrations were far greater than currently observed ( Carter et al., 2003). There is a case for the development of an updated set of EKMA type scenarios for intense urban ozone episodes and for those conditions responsible for multi day transport and stagnation. Once these scenarios are available, it would be a straightforward task to generate MIR and POCP scales and to produce an updated and evaluated reactivity scale. The proposal would be to generate up to 100 of these updated scenarios from 3 D Eulerian regional air quality model simulations for a range of different air basins and ozone episodes, using present and future emission levels.

Step 5: Development of an evaluated reactivity scale Whilst reactivity scales and the reactivity values that populate them are not basic geophysical constants, they are derived from them. In this context, basic geophysical constants include reaction rate coefficients, quantum yields and absorption cross sections. There is a case for extending the work of the JPL and IUPAC chemical kinetic data 15 evaluation panels to the review of the chemical kinetic data for the reactions of OH, NO3 and O3 with VOCs and of the reactions of the alkyl, oxy, peroxy and peroxyacyl radicals produced by them. Such a panel could also review quantum yield and absorption crosssection data for the VOCs and their degradation products.

Evaluated chemical kinetic data could then be fed into the SAPRC mechanisms and Master Chemical Mechanism as they become available. These mechanisms would then be used with the updated EKMA scenarios to develop an evaluated reactivity scale which would replace the interim scale for the development of candidate reactivity based strategies.

Step 6: Assemble a 3 D Eulerian regional air quality model with an explicit mechanism There is a case for taking a 3 D regional air quality model and adding an explicit chemical mechanism for each candidate VOC species and performing a ` gold standard' visualisation of one reactivity based strategy in one air basin. This model run would then be used to bench mark cut down chemical mechanisms for that VOC species.

Step 7: Establish cut down representations of VOC oxidation for 3 D Eulerian regional air quality models The SAPRC and Master Chemical Mechanisms provide a framework within which cutdown representations of VOC oxidation could be developed for 3 D Eulerian regional air quality models. Protocol would need to be laid out, setting out the basic principles to be adhered to in mechanism simplification and the accuracy to be achieved in the representation of the production of ozone, temporary NOx reservoirs, free radical sources and sinks and major oxidation products. Cut down representations could then be tested against the ` gold standard' visualisation produced in step 6 above, on a VOC by VOC basis.

Step 8: Visualisation of the impacts of reactivity based VOC controls on the attainment of ozone standards Using the evaluated reactivity scale, potential reactivity based VOC control strategies could be generated for ozone non attainment areas. Cut down representations of the oxidation mechanisms of the VOCs involved would then be added to the 3 D Eulerian regional air quality models, together with the required speciated VOC emission inventories generated using SMOKE. The 3 D Eulerian regional air quality models would 16 then be able to visualize the impacts of the reactivity based strategies on ozone nonattainment The model results would also show up any areas where ozone concentrations had increased and any impacts of meteorological and transport processes that cannot be allowed for in simple box models.

In this context, it is useful if the evaluated reactivity scale has the largest effective range that is consistent with our understanding of the atmospheric chemistry of VOCs. In this way, there would be maximum incentive given to the consideration of reactivity based policies. The reactivity scale would then give an upper limit to the magnitude of the substitutions of low reactivity VOCs for highly reactive VOCs. Visualisation with 3 D Eulerian models would then provide a vital check that there were no unacceptable ozone increases, exactly as envisaged by Carter et al. ( 2003), Hakami et al. ( 2003, 2004) and Arunachalam et al. ( 2003).

6. References Arunachalam, S., Mathur, R., Holland, A., Lee, M. R., Olerud, D., Jeffries, H. ( 2003). Final report: Investigation of VOC reactivity. Assessment with comprehensive air quality modelling. Carolina Environmental Program, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Baugues, K. ( 1990). Preliminary planning information for updating the ozone regulatory impact analysis version of EKMA, U. S. Environmental Protection Agency, Research Triangle Park, North Carolina.

CARB. ( 1993). Proposed regulations for low emission vehicles and clean fuels. California Air Resources Board, Sacramento, California.

Carter, W. P. L. ( 1994). Development of ozone reactivity scales for volatile organic compounds. Journal of Air and Waste Management Association 44, 881 889.

Carter, W. P. L., Tonnesen, G., Yarwood, G. ( 2003). Investigation of VOC reactivity effects using existing regional air quality models. Center for Environmental Research and Technology, University of California, Riverside, California.

Derwent, R. G., Jenkin, M. E., Saunders, S. M., Pilling, M. J. ( 1998). Photochemical ozone creation potentials for organic compounds in north west Europe calculated with a Master Chemical Mechanism. Atmospheric Environment 32, 2429 2441,

Derwent, R. G., Jenkin, M. E., Saunders, S. M., Pilling, M. J. ( 2001). Characterization of the reactivites of volatile organic compounds using a Master Chemical Mechanism. Journal of Air and Waste Management Association 51, 699 707. 17 Derwent, R. G., Jenkin, M. E., Saunders, S. M., Pilling, M. J., Passant, N. R. ( 2004). Multiday ozone formation for alkenes and carbonyls investigated with a Master Chemical Mechanism under European conditions. Atmospheric Environment, in press.

Dimitriades, B. ( 1999). Scientific basis of an improved EPA policy on control of organic emissions for ambient ozone reduction. Journal of Air and Waste Management Association 49, 831 838.

Hakami, A., Bergin, M. S., Russell, A. S. ( 2003). Assessment of the ozone and aerosol formation potentials ( reactivities) of organic compounds over the eastern United States. Atlanta, Georgia.

Hakami, A., Arhami, M., Russell, A. G. ( 2004). Further analysis of VOC reactivity metrics and scales. Atlanta, Georgia.

RRWG ( 1999). VOC reactivity science assessment: Executive Summary. Reactivity Research Working Group. http:// www. cgenv. com/ narsto/ reactinfo. html.

Stockwell, W. R., Middleton, P., Chang, J. S., Tang, X. ( 1990). The second generation regional acid deposition model chemical mechanism for regional air quality modelling. J. Geophys. Res. 95, 16,343 16,367.

Stockwell, W. R., Geiger, H., Becker, K. H. ( 2001). Estimation of incremental reactivities for multiple day scenarios: An application to ethane and dimethoxymethane. Atmospheric Environment 35, 929 939.


[Federal Register Volume 78, Number 123 (Wednesday, June 26, 2013)]
[Notices]
[Pages 38313-38314]
[FR Doc No: 2013-15181]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
joint stakeholder meeting related to the transmission planning
activities of PJM Interconnection, L.L.C., ISO New England, Inc., and
New York Independent System Operator, Inc.:

Inter-Regional Planning Stakeholder Advisory Committee--New York/New
England

June 20, 2013, 8:30 a.m.-9:30 a.m., Local Time

    The above-referenced meeting will be held over conference call.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at www.pjm.com/committees-and-groups/stakeholder-meetings/stakeholder-groups/ipsac-ny-ne.aspx.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket No. ER08-1281, New York Independent System Operator, Inc.
Docket No. EL05-121, PJM Interconnection, L.L.C.

Docket No. ER11-1844, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER12-1178, PJM Interconnection, L.L.C.
Docket No. ER13-90, Public Service Electric and Gas Company and PJM
Interconnection, L.L.C.
Docket No. ER13-102, New York Independent System Operator, Inc.
Docket No. ER13-193, ISO New England Inc.
Docket No. ER13-195, Indicated PJM Transmission Owners
Docket No. ER13-196, ISO New England Inc.
Docket No. ER13-198, PJM Interconnection, L.L.C.
Docket No. ER13-1052, PJM Interconnection, L.L.C. and the Midwest
Independent Transmission System Operator, Inc.
Docket No. ER13-1054, PJM Interconnection, L.L.C. and the Midwest
Independent Transmission System Operator, Inc.

    For more information, contact Jonathan Fernandez, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (202) 502-
6604 or<EMAIL_ADDRESS>
    Dated: June 19, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-15181 Filed 6-25-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Page 60423]
[FR Doc No: 2012-24356]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13483-001]

FFP Project 72 LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On September 4, 2012, FFP Project 72, LLC filed an application for
a preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of a hydropower project
located on the Mississippi River, near Winterville, in Washington
County, Mississippi and Chicot County, Arkansas. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed Miller Bend hydrokinetic project would consist of the
following: (1) Up to 280 SmarTurbine generating units installed in
arrays on the bottom of the river; (2) the total capacity of the
installation would be up to 11,200 kilowatts; (3) flexible cables would
convey each arrays power to a metering station; and (4) a transmission
line would interconnect with the power grid. The proposed project would
have an average annual generation of 25,471,000 kilowatt-hours (kWh),
which would be sold to a local utility.
    Applicant Contact: Ramya Swaminathan, Free Flow Power Corporation,
239 Causeway Street, Boston, MA 02114; phone<PHONE_NUMBER>.
    FERC Contact: Michael Spencer,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13483) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: September 27, 2012.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-24356 Filed 10-2-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83120-83124]
[FR Doc No: 2023-26146]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2023-0268; FRL [10613-01-OW]

Draft National Pollutant Discharge Elimination System (NPDES)
Pesticide General Permit for Point Source Discharges From the
Application of Pesticides; Reissuance

AGENCY:  Environmental Protection Agency (EPA).

ACTION: Notice of draft permit and request for public comment.

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

SUMMARY: All ten Environmental Protection Agency (EPA) Regions are
proposing for public comment the draft 2026 National Pollutant
Discharge Elimination System (NPDES) Pesticide General Permit (PGP)--
the draft 2026 PGP. The draft 2026 PGP covers point source discharges
from the application of pesticides to waters of the United States. Once
finalized, the draft 2026 PGP will replace the existing permit, the
2021 PGP, which was issued for a five-year term in the Federal Register
on October 31, 2021, and expires October 31, 2026, at midnight. The
draft 2026 PGP largely has the same conditions and requirements as
EPA's previously issued PGPs, and would authorize certain point source
discharges from the application of pesticides to waters of the United
States in accordance with the terms and conditions described therein.
EPA proposes to issue this permit for five (5) years in all areas of
the country where EPA is the NPDES permitting authority. EPA solicits
public comment on all aspects of the draft 2026 PGP. This Federal
Register document describes the draft 2026 PGP in general and seeks
comment as described in Section III.C of this document. The Fact Sheet
accompanying the permit contains supporting documentation. EPA
encourages the public to read the Fact Sheet to better understand the
draft 2026 PGP.

DATES: Written comments on the draft 2026 PGP must be received by
January 12, 2024.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2023-0268, by any of the following methods:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Office of Water Docket, Mail Code 28221T, 1200 Pennsylvania
Avenue NW, Washington, DC 20460.
     Hand Delivery or Courier: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operations are 8:30 a.m. to 4:30 p.m.,
Monday through Friday (except Federal Holidays).
    Instructions: All submissions received must include the Docket ID
No. EPA-HQ-OW-2023-0268. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Public Participation''
heading of the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Contact the appropriate EPA Regional
office listed in Section I.D of this document, email [email protected], or
contact Lauren Mosesso, EPA Headquarters, Office of Water, Office of
Wastewater Management (4203M), 1200 Pennsylvania Avenue NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected]. Electronic versions of the draft 2026 PGP and
Fact Sheet are also available on EPA's NPDES website at https://www.epa.gov/npdes/pesticide-permitting.

SUPPLEMENTARY INFORMATION: This section is organized as follows:

Table of Contents

I. General Information
    A. Does this action apply to me?
    B. Public Participation
    C. Finalizing the Draft 2026 PGP
    D. Who are the EPA regional contacts for this draft permit?
II. Background
III. Scope and Applicability
    A. Geographic Coverage
    B. Categories of Pesticide Use-Patterns Covered
    C. Summary of the Permit and Changes From the 2021 PGP
IV. Cost Impacts of the Draft 2026 PGP
V. Statutory and Executive Orders Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulations and Regulatory Review
    B. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations and Executive Order 14096: Revitalizing Our Nation's
Commitment to Environmental Justice for All
    C. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments

I. General Information

A. Does this action apply to me?

    You may be affected by this action if you apply pesticides under
the use patterns in section III.B of this document that result in a
discharge to waters of the United States in one of the geographic areas
identified in section III.A of this document. Potentially affected
entities, as categorized in the North American Industry Classification
System (NAICS), may include, but are not limited to:

      Table 1--Entities Potentially Regulated by the Draft 2026 PGP
------------------------------------------------------------------------
                                                        Examples of
           Category                   NAICS         potentially affected
                                                          entities
------------------------------------------------------------------------
Agricultural entities--General  111 Crop           Producers of crops
 agricultural interests,         Production.        mainly for food and
 farmers/producers, forestry,                       fiber, including
 and irrigation.                                    farms, orchards,
                                                    groves, greenhouses,
                                                    and nurseries that
                                                    have irrigation
                                                    ditches requiring
                                                    pest control.
                                113110 Timber      The operation of
                                 Tract Operations.  timber tracts for
                                                    the purpose of
                                                    selling standing
                                                    timber.
                                113210 Forest      Growing trees for
                                 Nurseries          reforestation and/or
                                 Gathering of       gathering forest
                                 Forest Products.   products, such as
                                                    gums, barks, balsam
                                                    needles, rhizomes,
                                                    fibers, Spanish
                                                    moss, ginseng, and
                                                    truffles.
                                221310 Water       Operating irrigation
                                 Supply for         systems.
                                 Irrigation.
Pesticide parties (includes     325320 Pesticide   Formulation and
 pesticide manufacturers,        and Other          preparation of
 other pesticide users/          Agricultural       agricultural pest
 interests, and consultants).    Chemical           control chemicals.
                                 Manufacturing.
Public health parties           923120             Government
 (includes mosquito or other     Administration     establishments
 vector control districts and    of Public Health   primarily engaged in
 commercial applicators that     Programs.          the planning,
 service these). Resource       .................   administration, and
 management parties (includes   924110              coordination of
 State departments of fish and   Administration     public health
 wildlife, State departments     of Air and Water   programs and
 of pesticide regulation,        Resource and       services, including
 State environmental agencies,   Solid Waste        environmental health
 and universities).              Management         activities.
                                 Programs.         Government
                                .................   establishments
                                .................   primarily engaged in
                                .................   the administration,
                                .................   regulation, and
                                924120              enforcement of air
                                 Administration     and water resource
                                 of Conservation    programs; the
                                 Programs.          administration and
                                                    regulation of water
                                                    and air pollution
                                                    control and
                                                    prevention programs;
                                                    the administration
                                                    and regulation of
                                                    flood control
                                                    programs; the
                                                    administration and
                                                    regulation of
                                                    drainage development
                                                    and water resource
                                                    consumption
                                                    programs; and
                                                    coordination of
                                                    these activities at
                                                    intergovernmental
                                                    levels.
                                                   Government
                                                    establishments
                                                    primarily engaged in
                                                    the administration,
                                                    regulation,
                                                    supervision and
                                                    control of land use,
                                                    including
                                                    recreational areas;
                                                    conservation and
                                                    preservation of
                                                    natural resources;
                                                    erosion control;
                                                    geological survey
                                                    program
                                                    administration;
                                                    weather forecasting
                                                    program
                                                    administration; and
                                                    the administration
                                                    and protection of
                                                    publicly and
                                                    privately owned
                                                    forest lands.
                                                    Government
                                                    establishments
                                                    responsible for
                                                    planning,
                                                    management,
                                                    regulation and
                                                    conservation of
                                                    game, fish, and
                                                    wildlife
                                                    populations,
                                                    including wildlife
                                                    management areas and
                                                    field stations; and
                                                    other administrative
                                                    matters relating to
                                                    the protection of
                                                    fish, game, and
                                                    wildlife are
                                                    included in this
                                                    industry.
Utility parties (includes       221 Utilities....  Provide electric
 utilities).                                        power, natural gas,
                                                    steam supply, water
                                                    supply, and sewage
                                                    removal through a
                                                    permanent
                                                    infrastructure of
                                                    lines, mains, and
                                                    pipes.
------------------------------------------------------------------------

B. Public Participation

1. Written Comments
    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2023-
0268, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. EPA may publish
any comment received to its public docket. Do not submit to EPA's
docket at https://www.regulations.gov any information you consider to
be Confidential Business Information (CBI), Proprietary Business
Information (PBI), or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e., on the web, cloud, or
other file sharing system). Please visit https://www.epa.gov/dockets/commenting-epa-dockets for additional submission methods; the full EPA
public comment policy; information about CBI, PBI, or multimedia
submissions; and general guidance on making effective comments.
2. Will public hearings be held on this action?
    EPA has not scheduled any public hearings to receive public comment
concerning the draft 2026 PGP. However, interested persons may request
a public hearing concerning the draft 2026 PGP pursuant to 40 CFR
124.12. Requests for a public hearing must be sent or delivered in
writing to the same address as provided above for public comments prior
to the close of the comment period. Requests for a public hearing must
state the nature of the issues proposed to be raised in the hearing.
Pursuant to 40 CFR 124.12, EPA shall hold a public hearing if it finds,
on the basis of requests, a significant degree of public interest in a
public hearing on the draft 2026 PGP. If EPA decides to hold a public
hearing, a public notice of the date, time, and place of the hearing
will be made at least 30 days prior to the hearing. Any person may
provide written or oral statements and data pertaining to the draft
2026 PGP at any such public hearing.

C. Finalizing the Draft 2026 PGP

    EPA intends to issue a final 2026 PGP on or prior to December 17,
2024, a condition of the Settlement Agreement in Center for Biological
Diversity v. EPA and FWS, No. 21-71306 (9th Cir.). The final 2026 PGP
will be issued after all public comments received during the public
comment period have been considered and any appropriate changes are
made to the draft 2026 PGP. EPA will include its response to
significant comments received in the docket as part of the final permit
decision. Once the final 2026 PGP becomes effective on October 31,
2026, eligible Operators may seek authorization under the new PGP as
outlined in the permit. To ensure uninterrupted permit coverage from
the 2021 PGP to the 2026 PGP, Operators who are required to submit a
Notice of Intent (NOI) must submit their NOI for coverage under the new
permit prior to discharge as outlined in the permit (e.g., no later
than 10 or 30 days before discharge). See Part 1.2.4 of the draft 2026
PGP.

D. Who are the EPA regional contacts for this draft permit?

    For EPA Region 1, contact George Papadopoulos at tel.: (617) 918-
1579; or email at [email protected].
    For EPA Region 2, contact Sergio Bosques at tel.:<PHONE_NUMBER> or
[email protected].
    For EPA Region 3, contact Carissa Moncavage at tel.: (215) 814-
5798; or email at [email protected].
    For EPA Region 4, contact Sam Sampath at tel.:<PHONE_NUMBER>; or
email at [email protected].
    For EPA Region 5, contact John Colletti at tel.:<PHONE_NUMBER>; or
email at [email protected].
    For EPA Region 6, contact William F. Cooper at tel.:<PHONE_NUMBER>
or email at [email protected].
    For EPA Region 7, contact Alex Owutaka at tel.:<PHONE_NUMBER> or
email at: [email protected].
    For EPA Region 8, contact Margaret Kennedy at tel.:<PHONE_NUMBER>
or email at: [email protected].
    For EPA Region 9, contact Prasad Gullapalli at tel.:<PHONE_NUMBER>
or email at: [email protected].
    For EPA Region 10, contact Bilin Basu at tel.:<PHONE_NUMBER> or
email at: [email protected].

II. Background

    Section 301(a) of the CWA provides that ``the discharge of any
pollutant by any person shall be unlawful'' unless the discharge is in
compliance with certain other sections of the Act. 33 U.S.C. 1311(a).
The CWA defines ``discharge of a pollutant'' as ``(A) any addition of
any pollutant to navigable waters from any point source and (B) any
addition of any pollutant to the waters of the contiguous zone or the
ocean from any point source other than a vessel or other floating
craft.'' 33 U.S.C. 1362(12). A ``point source'' is any ``discernible,
confined and discrete conveyance'' but does not include ``agricultural
stormwater discharges and return flows from irrigated agriculture.''
1362(14). The term ``pollutant'' includes among other things ``garbage
. . . chemical wastes, biological materials . . . and industrial,
municipal, and agricultural waste discharged into water.'' 33 U.S.C.
1362(6).
    A person may discharge a pollutant without violating the Section
301 prohibition by obtaining authorization to discharge (referred to
herein as ``coverage'') under a Section 402 NPDES permit (33 U.S.C.
1342). Under Section 402(a), EPA may ``issue a permit for the discharge
of any pollutant, or combination of pollutants, notwithstanding Section
1311(a)'' upon meeting certain conditions required by the Act.
    EPA issued the first Pesticide General Permit (``2011 PGP'') on
October 31, 2011, in response to the United States Sixth Circuit Court
of Appeals ruling vacating EPA's 2006 Final Rule on Aquatic Pesticides.
National Cotton Council of America. v. EPA, 553 F.3d 927 (6th Cir.
2009). EPA developed the PGP to control point source discharges of
biological pesticides and chemical pesticides that leave a residue into
waters of the United States. The PGP provides coverage for certain
point source discharges of pollutants to waters of the United States in
areas where EPA is the permitting authority. In 2016, EPA issued the
second PGP (``2016 PGP'') and, in 2021, issued the third PGP (``2021
PGP''). In October 2021, the Center for Biological Diversity filed a
petition in the U.S. Court of Appeals for the Ninth Circuit challenging
EPA's issuance of the 2021 PGP. The petition alleged that EPA failed to
comply with the CWA in issuing the 2021 PGP, and that EPA and the U.S.
Fish and Wildlife Service (FWS) failed to comply with the Endangered
Species Act (ESA) in issuing the 2021 PGP. A Settlement Agreement in
Center for Biological Diversity v. EPA and FWS, No. 21-71306 (9th Cir.)
was finalized on July 25, 2023. The settlement agreement committed EPA
(1) to initiate formal ESA consultation on the draft 2026 PGP by
February 1, 2024; (2) to propose certain revisions to the monitoring
and recordkeeping provisions for public comment when proposing the
draft 2026 PGP; and (3) to issue the 2026 PGP on or before December 17,
2024.

III. Scope and Applicability

A. Geographic Coverage

    EPA provides permit coverage for classes of point source discharges
of pollutants that occur in areas where EPA is the NPDES permitting
authority. The geographic coverage of the draft 2026 PGP is listed in
Appendix C of the permit.

B. Categories of Pesticide Use-Patterns Covered

    The draft 2026 PGP has largely the same requirements and conditions
as the 2021 PGP and regulates the same discharges of pollutants to
waters of the United States from the application of (1) biological
pesticides, and (2) chemical pesticides that leave a residue. The draft
2026 PGP applies to the following same pesticide use patterns:

 Mosquito and Other Flying Insect Pest Control
 Weed and Algae Pest Control
 Animal Pest Control
 Forest Canopy Pest Control

    The scope of activities encompassed by these pesticide use patterns
is described in greater detail in Part III.1.1 of the Fact Sheet for
the draft 2026 PGP.

C. Summary of the Permit and Changes From the 2021 PGP

    Once effective, the final 2026 PGP will replace the 2021 PGP, which
became effective for a five-year term on October 31, 2021 (86 FR
51665), and expires October 31, 2026, at midnight. The draft 2026 PGP
is largely similar to the 2021 PGP, and is structured in the same nine
parts: (1) Coverage Under This Permit, (2) Technology-Based Effluent
Limitations, (3) Water Quality-Based Effluent Limitations, (4)
Monitoring, (5) Pesticide Discharge Management Plan, (6) Corrective
Action, (7) Recordkeeping and Annual Reporting, (8) EPA Contact
Information and Mailing Addresses, and (9) Permit Conditions Applicable
to Specific States (including Territories) and Indian Country.
Additionally, as with the 2021 PGP, the draft 2026 PGP includes nine
appendices with additional conditions and guidance for permittees: (A)
Definitions, Abbreviations, and Acronyms, (B) Standard Permit
Conditions, (C) Areas Covered, (D) Notice of Intent (NOI) form, (E)
Notice of Termination (NOT) form, (F) Pesticide Discharge Evaluation
Worksheet (PDEW), (G) Annual Reporting Template, (H) Adverse Incident
Report Template, and (I) Endangered Species Procedures.
    The following is a summary of the draft 2026 PGP's proposed
requirements:
     The PGP defines ``Operator'' (i.e., the entity required to
obtain NPDES permit coverage for discharges) to include any (a)
Applicator who performs the application of pesticides or has day-to-day
control of the application of pesticides that results in a discharge to
waters of the United States, or (b) Decision-maker who controls any
decision to apply pesticides that results in a discharge to waters of
the United States. There may be instances when a single entity acts as
both an Applicator and a Decision-maker.
     All Applicators are required to minimize pesticide
discharges by using only the amount of pesticide and frequency of
pesticide application necessary to control the target pest, maintain
pesticide application equipment in proper operating condition, control
discharges as necessary to meet applicable water quality standards, and
monitor for and report any adverse incidents.
     All Decision-makers are required, to the extent not
determined by the Applicator, to minimize pesticide discharges by using
only the amount of pesticide and frequency of pesticide application
necessary to control the target pest. All Decision-makers are also
required to control discharges as necessary to meet applicable water
quality standards and monitor for and report any adverse incidents.
     Certain Decision-makers are required also to submit an NOI
to obtain authorization to discharge and to implement pest management
options to reduce the discharge of pesticides to waters of the United
States. These Decision-makers are: agencies for which pest management
for land resource stewardship is an integral part of the organization's
operations; entities with a specific responsibility to control pests
(e.g., mosquito and weed control districts); local governments or other
entities that apply pesticides in excess of specified annual treatment
area thresholds; and entities that discharge pesticides to Tier 3
waters (Outstanding National Resource Waters, 40 CFR 131.12(a)(3)) or
to waters of the United States containing Fish and Wildlife Service
(FWS) Listed Resources of Concern and/or National Marine Fisheries
Service (NMFS) Listed Resources of Concern.
     Within this group, certain large Decision-makers (any (1)
public entity that serves a population greater than 10,000 or (2)
private enterprise that exceeds the Small Business Administration size
standard as identified in 13 CFR 121.201) must also develop a Pesticide
Discharge Management Plan (PDMP), submit annual reports, and maintain
detailed records. Whereas certain small Decision-makers (any (1) public
entity that serves a population of 10,000 or less or (2) private
enterprise that does not exceed the Small Business Administration size
standard as identified in 13 CFR 121.201) are required to complete a
pesticide discharge evaluation worksheet for each pesticide application
(in lieu of the more comprehensive PDMP), an annual report, and
detailed recordkeeping.
     Deadlines for submittal of an NOI to be covered, if
required, are provided in Part 1.2.3, Table 1-2, of the draft 2026 PGP.
    EPA encourages the public to review and comment on all aspects and
provisions in the draft 2026 PGP. The draft 2026 PGP is largely similar
to the 2021 PGP but includes the changes listed below. See Part III of
the draft 2026 PGP fact sheet for further discussion.
    (1) Adds Part 4.3, Documentation of Visual Monitoring, to reiterate
the requirement to record visual monitoring as required under the
Recordkeeping portions of the permit Parts 7.2, 7.3, and 7.4;
    (2) Adds Part 4.4, Additional Monitoring, to emphasize additional
monitoring could be required by EPA to ensure compliance with PGP;
    (3) Requires Decision-makers to submit Pesticide Discharge
Management Plan (PDMP) with NOI submission (Part 5);
    (4) Updates PDMP contents to include visual monitoring procedures
(Part 5);
    (5) Adds that if visual monitoring was performed, the record must
include the date, time, and location (Part 7);
    (6) Requires Decision-makers to submit visual monitoring records
with an Annual Report (Part 7);
    (7) Adds a field for NAICS Code on the Notice of Intent form
(Appendix D);
    (8) Adds a field for latitude and longitude of the Pest Management
Area on the Notice of Intent form (Appendix D);
    (9) Adds the terms ``Fish and Wildlife Service Listed Resources of
Concern'' and ``Lands of Exclusive Federal Jurisdiction'' to Appendix
A, Definitions and Acronyms;
    (10) Updates Appendix C, Areas Covered, to add permit numbers for
other areas of Indian Country and Lands of Exclusive Federal
Jurisdiction.
    (11) Adds the term, ``Fish and Wildlife Service (FWS) Listed
Resources of Concern'' where the permit already includes the term,
``National Marine Fisheries Service (NMFS) Listed Resources of
Concern'' to reflect proposed permit changes to address

listed species and designated critical habitats under the jurisdiction
of FWS;
    (12) Notes in Part <IP_ADDRESS> that aerial image of the pest management
area(s) may not be needed if EPA's geospatial mapping tool is available
to provide supporting documentation when selecting ESA eligibility
Criterion A;
    (13) Directs Decision-makers who are required to submit an NOI to
include activities resulting in a discharge to waters of the United
States containing FWS Listed Resources of Concern on the NOI (Part
1.2.2), and updates the NOI form to reflect this change (Appendix D);
    (14) Updates Appendix I, Endangered Species Procedures, to clarify
the procedures with a worksheet format to guide Operators through the
ESA eligibility criteria.

IV. Cost Impacts of the Draft 2026 PGP

    Based on the cost analyses performed for EPA's previously issued
PGPs, EPA expects the costs that covered entities, including small
businesses, will bear to comply with this permit will be minimal. Since
the draft 2026 PGP is largely similar to the 2021 PGP, EPA projects
that the proposed changes will have minimal incremental cost impacts on
regulated entities. Copies of EPA's economic analyses and cost impact
analyses for EPA's previously issued PGPs are available in the docket
for this permit. See Appendix D of the draft 2026 PGP Fact Sheet for
further discussion of the potential incremental costs of the draft 2026
PGP.

V. Statutory and Executive Orders Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    The draft 2026 PGP is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All

    EPA believes that the human health and environmental conditions
that exist prior to this action is not likely to result in
disproportionate and adverse effects on communities with EJ concerns.
As part of the general permit development process, EPA reviews
available information to evaluate whether issuance of a permit could
affect overburdened communities. The information supporting this
Executive Order review is contained in Appendix E of the draft 2026 PGP
Fact Sheet.

C. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. It will neither impose substantial direct
compliance costs on federally recognized tribal governments, nor
preempt tribal law. EPA directly implements the NPDES Program,
including the 2026 PGP when it is finalized, in Indian Country;
therefore, in compliance with EPA Policy on Consultation and
Coordination with Indian Tribes, EPA consulted with tribal officials
early in the process to provide tribes an opportunity to have
meaningful and timely input into the renewal of the PGP. To gain an
understanding of, and where necessary, to address tribal implications
of the draft 2026 PGP, EPA conducted the following activities:
     August 22, 2023--EPA emailed notification letters to
tribal leaders initiating consultation and coordination on the renewal
of the PGP. The initiation letter was also posted on EPA's Tribal
Consultation Opportunities Tracking System (TCOTS) at https://tcots.epa.gov/.
     September 19 and 21, 2023--EPA held two informational
webinars open to all tribal representatives and reserved the last part
of each webinar for official consultation comments. Eighteen tribal
representatives participated in the webinar. No official comments were
received during the webinar. The presentation was posted on the tribal
portal website at http://tcots.epa.gov.
    EPA received one comment from tribes and tribal organizations
during the consultation and coordination period. Records of the tribal
informational webinar and a consultation summary are included in the
docket for this proposed action (Docket ID No. EPA-HQ-OW-2023-0268).
EPA has considered the comment received in the proposal. The Agency
specifically solicits additional comment on this proposed permit during
the public comment period. EPA also notes that as part of the
finalization of this proposed permit, the Agency will complete the
Clean Water Act section 401 certification procedures with all
authorized tribes where this permit will apply.
    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

David W. Cash,
Regional Administrator, EPA Region 1.

Christine Ash,
Acting Director, Water Division, EPA Region 2.

Carmen R. Guerrero-P[eacute]rez,
Director, Caribbean Environmental Protection Division, EPA Region 2.

Catherine Libertz,
Director, Water Division, EPA Region 3.

Christopher Thomas,
Acting Director, Water Division, EPA Region 4.

Tera L. Fong,
Director, Water Division, EPA Region 5.

Dzung Kim Ngo Kidd,
Acting Director, Water Division, EPA Region 6.

Dana Skelley,
Acting Director, Water Division, EPA Region 7.

Darcy O'Connor,
Director, Water Division, EPA Region 8.

Tom[aacute]s Torres,
Director, Water Division, EPA Region 9.

Michael J. Szerlog,
Acting Director, Water Division, EPA Region 10.
[FR Doc. 2023-26146 Filed 11-27-23; 8:45 am]
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