SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer or food manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111),e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS code 112).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

II. Background

A. What action is the agency taking?

This final rule, under the provisions of section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), amends EPA's regulations governing crop group tolerances for pesticides. Specifically, the rule: (1) Creates a new crop group for oilseeds; (2) expands existing crop groups by adding new commodities; (3) establishes new crop subgroups for two groups; (4) changes the representative crops for two groups; and (5) deletes 40 CFR 180.1(h), which addresses when tolerances apply to post-harvest uses.

The crop grouping concept leads to an estimate of the maximum residue that could occur on any crop within the group. The minimum data required for a group tolerance consists of residue data for all representative commodities for a group. This action is intended to promote more extensive use of crop group tolerances and, in particular, will assist in making available lower-risk pesticides for minor crops both domestically and in countries that export food to the United States.

This final rule is the second in a series of planned crop group updates expected to be promulgated in the next several years.

B. What is the agency's authority for taking this action?

EPA is authorized to establish tolerances for pesticide chemical residues in food under FFDCA section 408. EPA establishes tolerances for each pesticide based on the potential risks to human health posed by that pesticide. A tolerance is the maximum permissible residue level established for a pesticide in raw agricultural produce and processed foods. The crop group regulations currently in 40 CFR 180.40 and 180.41 enable the establishment of tolerances for a group of crops based on residue data for certain crops that are representative of the group. Crop group regulations are promulgated under section 408(e)(1)(C) which authorizes EPA to establish “general procedures and requirements to implement [section 408].” 21 U.S.C. 346a(e)(1)(C).

III. The Proposed Rule

EPA published a notice of proposed rulemaking in the Federal Register of January 6, 2010 (75 FR 807). Written comments were solicited and were received from five parties in response to the proposal. Comments were received from Bayer CropScience, a commercial applicator, The National Sunflower Association, The California Citrus Quality Council and the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China.

IV. Response to Comments

In this section EPA describes the major provisions of the proposed rule, the comments received on each provision, and EPA's responses to those comments, including EPA's determination if any modification of the proposed rule is warranted.

A. Crop Group 8-10: Fruiting Vegetable Group

The final rule retains the pre-existing Crop Group 8 and adds a new group titled “Crop Group 8-10 Fruiting Vegetable Group.”

1. Add commodities. Newly added Crop Group 8-10, expands the fruiting vegetable crop group from the existing 6 commodities in Crop Group 8 to 21 commodities.

2. Change the name. The final rule changes the name of “Crop Group 8 Fruiting Vegetables (Except Cucurbits)” by dropping the parenthetical “(Except Cucurbits)” from the name.

3. Change the name of representative commodities. The final rule changes the name of the representative commodities for the revised crop group from “one cultivar of non-bell pepper” to “one cultivar of small nonbell pepper” by designating a small variety of nonbell pepper and by deleting the hyphen from the term non-bell.

4. Create new subgroups. The final rule retains the proposed addition of three subgroups to crop group 8-10.

i. Tomato subgroup 8-10A—Representative crop. Tomato, standard size and one cultivar of small tomato. Eleven commodities are included in this subgroup.

ii. Pepper/Eggplant subgroup 8-10B—Representative crop. Bell pepper and one cultivar of small nonbell pepper. Ten commodities are included in this subgroup.

iii. Nonbell Pepper/Eggplant subgroup 8-10C—Representative crop. One cultivar of small nonbell pepper or one cultivar of small eggplant. Nine commodities are included in this subgroup.

One comment was received regarding whether residue data are being collected on only bell pepper. The commenter asked whether tolerances should be ( printed page 76286) established for the crop subgroup 8-10B except nonbell pepper.

EPA believes that in order to obtain a tolerance for the Pepper/Eggplant subgroup 8-10B, residue data are required for both of the representative commodities, bell pepper and one cultivar of small nonbell pepper. Of these two commodities, small nonbell pepper is the commodity that will typically result in the higher residues and therefore, best represents expected residues for all of the commodities in subgroup 8-10B. However, bell pepper is included as a representative commodity since it is more widely grown and consumed. Therefore, if residue data for only bell pepper are submitted, EPA will not recommend a tolerance for crop subgroup 8-10B except nonbell pepper, but will only recommend for a tolerance on pepper, bell.

The People's Republic of China asked EPA to clarify whether the “goji berry” that is being included in Crop Group 8-10 is intended to cover fresh goji berry, dried goji berry, or both. China expressed the view that the pesticide tolerance level should be different between fresh and dried berry due to the different moisture contents. China requested that EPA specify the coefficient of conversion between dried and fresh goji berry if both are put into Crop Group 8-10. According to China, the coefficient between fresh and dried berry is approximately 6:1 based on producing and processing practice.

The United States generally establishes tolerances for raw agricultural commodities, which also apply to all processed forms of the same commodity. A separate tolerance for the processed commodity is only necessary when residues in the processed commodity may be higher than the raw agricultural commodity tolerance. In most cases, separate tolerances for processed commodities are not needed. Adding goji berry to Crop Group 8-10 means that future tolerances established for this group will apply to goji berry in all its forms, including dehydrated (dry) goji berry. EPA is not including in the rule the coefficient of conversion between dried and fresh goji berries. The information is not included in any U.S. tolerances and such information is unnecessary for the enforcement of tolerances.

EPA adopts this proposal as final without change.

B. Crop Group 10-10: Citrus Fruit Group

The final rule adds a new citrus crop group, but retains pre-existing Crop Group 10 and titles it “Crop Group 10-10 Citrus Fruit Group.”

1. Add commodities. Added Crop Group 10-10 expands from the existing 12 commodities in Crop Group 10 to 28 commodities.

2. Change the crop group name. The final rule changes the name of “Crop Group 10: Citrus Fruits Group ( Citrus spp., Fortunella spp.)” to “Crop Group 10: Citrus Fruit Group.

3. Create crop subgroups. The final rule retains the proposed addition of three new subgroups to newly added Crop Group 10-10.

i. Orange Subgroup 10-10A. Representative commodities. Orange or Tangerine/Mandarin. Twelve commodities are included in this subgroup.

ii. Lemon/Lime Subgroup 10-10B. Representative commodities. Lemon or Lime. Twelve commodities are included in this subgroup.

iii. Grapefruit Subgroup 10-10C. Representative commodities. Grapefruit. Five commodities are included in this subgroup.

EPA received no comments on this section and adopts the proposed changes as final without change.

C. Crop Group 11-10: Pome Fruit Group

The final rule adds a new pome fruit crop group which is titled “Crop Group 11-10 Pome Fruit Group.” Newly added crop group 11-10 expands the pome fruit crop group, but retains pre-existing Crop Group 11.

Add commodities. Newly added Crop Group 11-10 expands from the existing 7 commodities in Crop Group 11 to 12 commodities.

EPA received no comments on this section and adopts its proposed changes as final without change.

D. New Crop Group 20 Oilseed Group

EPA received no comments on the addition of a new group, Crop Group 20 Oilseed Group, and adopts its proposed addition without change.

E. Amendment to Definitions and Interpretations

EPA proposed to revise the commodity definition in 40 CFR 180.1(g) for Citrus Group as follows:

Tangerine = Tangerine (mandarin or mandarin orange), Clementine, Mediterranean mandarin, Satsuma mandarin, Tangelo, Tangor, cultivars, varieties and/or hybrids of these.

No comments were submitted on this section and EPA adopts the change as proposed without change.

F. Amendment to 40 CFR 180.1(h)

The final rule deletes 40 CFR 180.1(h) that reads: “Unless otherwise specified, tolerances and exemptions established under the regulations in this part apply to residues from only preharvest application of the chemical.”

One comment was received concerning how a person would know if a tolerance is based on pre-harvest or post-harvest use. The commenter asserted that growers need to know what residues they should expect from pre-harvest use in order to compare maximum residue limits (MRLs, the international term for residue standards comparable to tolerance regulations under U.S. law) abroad to know if such commodities may be exported.

Given the enforcement concerns articulated in the proposed rule, EPA does not think that the commenter has provided a sufficient rational for maintaining 40 CFR 180.1(h). EPA does not believe that the issue raised by the commenter—the need to determine whether pre-harvest residues comport with international MRLs—will often be a problem. The overwhelming majority of pesticide tolerances are set based on pre-harvest use of a pesticide. Further, EPA attempts to harmonize tolerances with foreign MRLs, and generally, harmonization is not a problem. Thus, in most cases, comparing the U.S. tolerance level with the international MRL will indicate to a grower that pre-harvest treatment of a commodity will not be inconsistent with international MRLs. If a grower comes across an instance where a U.S. tolerance is higher than a MRL and the grower thinks that a higher U.S. tolerance is due to a post-harvest use, the grower may contact EPA for more information about that particular tolerance. EPA currently collects valuable information about tolerances on its Web site. ( http://www.epa.gov/​opp00001/​regulating/​part-180.html#info). If information on what tolerances are driven by post-harvest uses turns out to be critical information EPA will consider adding that information to its Web site.

EPA is adopting its proposal without change.

G. Other Comments

One comment was received concerning the new crop group and crop subgroups; the commenter asked whether the residue chemistry guidelines will be updated or an EPA memorandum issued to address the number of trials and locations needed?

EPA does not believe that the residue chemistry guidelines need to be updated at this time or a separate memorandum issued to address the number of trials and locations. EPA plans to update these guidelines when more of the crop groups are revised, as this is an ongoing ( printed page 76287) effort. For the present, the current residue chemistry guidelines which address the number of field trials and locations should still be used for the newly added crop groups and crop subgroups.

The People's Republic of China suggested that this crop group rule should be regarded as a measure under the Agreement on Application of Sanitary and Phytosanitary Measures (SPS Agreement) because this crop grouping regulation has a direct relation on the establishment of pesticide tolerances. According to the WTO/SPS agreement, the U.S. should submit a notification to WTO. The commenter hoped that the U.S. will fulfill its transparency obligation and provide other members notice of the measure and an opportunity to comment on it.

EPA notes that the WTO was notified of the proposed rule as of March 17, 2010, under the SPS Agreement. The notification, WTO Document G/SPS/N/USA/1980, included a link to the public docket, where the proposed rule can be found in its entirety.

The People's Republic of China inquired as to the next steps after this revision, since the proposed revision did not specify the pesticide tolerances for the products. The commenter hoped that the U.S. would provide a timetable for the establishment of MRLs for the products in the revision, especially goji berry. Additionally the commenter asked if EPA would notify the WTO in a timely fashion and provide other members with a 60-day comment period when EPA establishes MRLs. Finally, the People's Republic of China indicated that it will continue to follow this issue closely and hopes to comment on any future tolerances for goji berry.

No specific tolerances are established by this rule revising the crop group. Tolerances for pre-existing crop groups continue in effect and do not apply to the revised crop group.

As discussed in Unit II.C. of the Proposed Rule (75 FR 807), tolerances established for revised crop groups will include the new crop group number (and new name, if applicable) so that it is apparent on the face of the tolerance regulation what commodities are covered. EPA will initially retain pre-existing crop groups that have been superseded by revised crop groups, but EPA will not establish new tolerances for the pre-existing groups. EPA plans to eventually convert tolerances for any pre-existing crop groups to tolerances with the coverage of the revised crop group. This conversion will be effected both through the registration review process and in the course of establishing new tolerances for a pesticide. Therefore, no specific fruiting vegetable group 8 pesticide tolerances will be converted to tolerances for fruiting vegetable group 8-10, including goji berry, upon codifying the revised fruiting vegetable crop group 8-10 in the CFR. Pesticide residues on any additional members of a revised crop group will not be legal until the EPA establishes a new tolerance for that pesticide on the revised crop group.

EPA will propose new tolerances for the revised crop group in the Federal Register and provide an opportunity for public comment, consistent with U.S. law. The U.S. also plans to continue to notify the WTO of proposed tolerance actions, consistent with the WTO/SPS Agreement. If commenters believe that any of the tolerances that are proposed in the future will not be adequate for any form of a commodity that is in the crop group, they should submit comments and supporting data on the specific tolerances when they are proposed and notified.

Another commenter noted that it would be beneficial for the European Union (E.U.) and North American Free Trade Agreement (NAFTA) crop groups to be harmonized, in much the same way as the U.S. and Canada are working with the Codex Committee on Pesticide Residues (CCPR) to harmonize NAFTA crop groups with those being developed as part of the revision of the Codex Classification of Foods and Feeds.

EPA recognizes the benefits of internationally harmonized crop groups, and notes that the E.U. has been involved in the efforts to develop the Codex crop groups and to revise the NAFTA crop groups.

Petitions submitted to the EPA to revise crop groups are developed by the International Crop Groupings Consulting Committee (ICGCC), which is an international body that includes NAFTA, Codex, and E.U. members. The ICGCC workgroup members provide valuable international perspectives, including commodity and MRL information, in developing crop group proposals to be submitted to the EPA. Beyond the NAFTA partner involvement in developing Codex crop groups, other CCPR delegations from the E.U. and around the world provide international input and participate in the process. Through the partnership with the CCPR, the EPA believes that the NAFTA crop group revisions are being harmonized with Codex to the extent possible at this time; the E.U. will have to ultimately determine to what degree it will align with the Codex crop groups that are established.

Finally, EPA received a comment concerning “zero tolerance” being unachievable.

The purpose of the crop revisions is to provide a vehicle to establish tolerances for residues of pesticides on food commodities. Therefore, the comment regarding “zero tolerance” does not apply to this action.

V. The Final Rule

After fully considering all comments, EPA is promulgating the rule as proposed.

VI. Implementation

When a crop group is amended in a manner that expands or contracts its coverage of commodities, EPA will (1) retain the pre-existing crop group in 40 CFR 180.41; (2) insert the revised crop group immediately after the pre-existing crop group in the Code of Federal Regulations; and (3) title the revised crop group in a way that clearly differentiates it from the pre-existing crop group.

The revised crop group will retain roughly the same name and number as the pre-existing group except the number will be followed by a hyphen and the final digits of the year established. ( e.g., Crop Group 8-10).

EPA will initially retain pre-existing crop groups that have been superseded by revised crop groups. EPA will not establish new tolerances under the pre-existing groups. Further, EPA plans to eventually convert tolerances for any pre-existing crop group to tolerances with coverage under the revised crop group. This conversion will be effected both through the registration review process and in the course of evaluating new uses for a pesticide. EPA requests that petitioners for tolerances address this issue in their petitions.

For existing petitions for which a Notice of Filing has been published, the Agency will attempt to conform these petitions to this rule.

VII. Statutory and Executive Order Reviews

A. Executive Order 12866

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has designated this proposed rule as a not-significant regulatory action under section 3(f) of the Executive Order.

This action is one in a series of planned crop group updates. EPA prepared an analysis of the potential costs and benefits related to its pesticide tolerance crop grouping regulations for ( printed page 76288) the first crop grouping final rule, published December 7, 2007 (72 FR 69150). This analysis is contained in “Economic Analysis of the Expansion of the Crop Grouping Program.” A copy of the analysis is available in the docket and is briefly summarized here.

This is a burden-reducing regulation. Crop grouping has saved money by allowing the results of pesticide exposure studies for one crop to be applied to other, similar crops. This regulation exploits this opportunity for saving money by expanding certain existing crop groups and adding one new crop group. Crop groupings will assist in making available lower risk pesticides for minor crops both domestically and in countries that export food to the U.S. Minor crop and specialty crop producers will benefit because lower registration costs will encourage pesticide manufacturers to register more pesticides for use on minor and/or specialty crops, providing these growers with additional lower-risk pesticide options. The increased coverage of tolerances to imported commodities may result in a larger supply of imported and domestically produced specialty produce at potentially lower costs and treated with lower-risk pesticides which also benefit consumers. EPA believes that data from representative crops will not underestimate the public exposure to pesticide residues through the consumption of treated crops. EPA and the Interregional Research Project Number 4 (IR-4), will more efficiently use resources as a result of the rule. EPA will conserve resources if, as expected, new or expanded crop groups result in fewer emergency pesticide use requests from specialty crop growers. Further, new and expanded crop groups will likely reduce the number of separate risk assessments and tolerance rulemakings that EPA will have to conduct. Further benefits come from international harmonization of crop classification and nomenclature, harmonized commodity import and export standards and increased potential for resource sharing between EPA and pesticide regulatory agencies in other countries. Revisions to the crop grouping program will result in no appreciable costs or negative impacts to consumers, minor crop producers, specialty crop producers, pesticide registrants, the environment, or human health. No crop group tolerance for a pesticide can be established unless EPA determines that it is safe.

An example of the benefits of crop groupings can be shown through the impact of changes to Crop Group 3 in a prior rulemaking (72 FR 69150, December 7, 2007). That rulemaking expanded Crop Group 3, Bulb Vegetables from 7 to 25 crops, an increase of 18 from the original crop group. Prior to the expansion of the subgroup, adding tolerances for the 18 new crops would have required at least 18 field trials at a cost of approximately $5.4 million (assuming $300,000 per field trial), whereas after promulgation of the expanded group these 18 new crops could obtain coverage under a Crop Group 3-07 tolerance with no field trials in addition to those required on the representative commodities (which did not change with the expansion of the group). Fewer field trials means a greater likelihood that these commodities will obtain tolerance coverage under the FFDCA, aiding growers, and the administrative costs of both the IR-4 testing process and the EPA review process will be reduced.

No comments were received on the costs or burdens. The Economic Analysis was not revised.

B. Paperwork Reduction Act

This rule does not contain any new information collection requirements that would need approval by OMB under the provisions of the Paper Reduction Act (PRA), 44 U.S.C. 3501 et seq. However, the rule is expected to reduce mandatory paperwork due to a reduction in required studies. The rule will have the effect of reducing the number of residue chemistry studies because fewer representative crops would need to be tested under a crop grouping scheme, than would otherwise be required.

C. Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., the Agency hereby certifies that this rule will not have a significant adverse economic impact on a substantial number of small entities. This rule does not have any direct adverse impacts on small businesses, small non-profit organizations, or small local governments.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business according to the small business size standards established by the Small Business Administration (SBA); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the final rule on small entities” (5 U.S.C. 603 and 604). Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burdens, or otherwise has positive economic effects on all of the small entities subject to the rule.

This rule provides regulatory relief and regulatory flexibility because the new or expanded crop groups ease the process for pesticide manufacturers to obtain pesticide tolerances on greater numbers of crops and make it likely that pesticides will be more widely available to growers for use on crops, particularly specialty crops.

D. Unfunded Mandates Reform Act

Under Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538, EPA has determined that this action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any 1 year. Accordingly, this rule is not subject to the requirements of sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 13132

Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), EPA has determined that this rule does not have federalism implications, because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in the Order. Thus, Executive Order 13132 does not apply to this rule.

F. Executive Order 13175

As required by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined that this rule does not have Tribal implications because it will not have any affect on Tribal governments, on the relationship between the Federal government and the Indian Tribes, or on the distribution of power and responsibilities between ( printed page 76289) the Federal government and Indian Tribes, as specified in the Order. Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), does not apply to this rule because this action is not designated as an economically significant regulatory action as defined by Executive Order 12866 ( see Unit II.A.), nor does it establish an environmental standard, or otherwise have a disproportionate effect on children.

H. Executive Order 13211

This rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because it is not designated as a regulatory action as defined by Executive Order 12866 ( see Unit II.A.), nor is it likely to have any adverse effect on the supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or impractical. Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, and sampling procedures) that are developed or adopted by voluntary consensus standards bodies. This rule does not impose any technical standards that would require EPA to consider any voluntary consensus standards.

J. Executive Order 12898

Under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), the Agency has not considered environmental justice-related issues because this rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities.

VIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

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

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

2. Section 180.1 is amended as follows:

a. Revise the entry for tangerine in the table in paragraph (g).

b. Remove paragraph (h).

c. Redesignate paragraphs (i) through (o) as paragraphs (h) through (n), respectively.

The revised text reads as follows:

3. Section 180.41 is amended as follows:

a. Remove the term “okra,” from paragraph (b).

b. Revise the paragraph heading for paragraph (c)(9).

c. Redesignate paragraphs (c)(10) through (c)(22) as paragraphs (c)(11) through (c)(23), and add a new paragraph (c)(10).

d. Revise the heading for newly redesignated paragraph (c)(12).

e. Redesignate newly redesignated paragraphs (c)(13) through (c)(23) as paragraphs (c)(14) through (c)(24), respectively, and add a new paragraph (c)(13).

f. Redesignate newly redesignated paragraphs (c)(15) through (c)(24) as paragraphs (c)(16) through (c)(25), respectively, and add new paragraph (c)(15).

g. Redesignate newly redesignated paragraph (c)(25) as paragraph (c)(26) and add new paragraph (c)(25).

The amendments read as follows: