E6-12971. Lepidopteran Pheromones; Exemption from the Requirement of a Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation amends the existing exemption from the requirement of a tolerance for residues of the biochemicals classified as lepidopteran pheromones, which are naturally occurring compounds, or identical or substantially similar synthetic compounds to include use as a “post-harvest treatment” on all stored food commodities. Bedoukian Research, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of biochemicals classified as lepidopteran pheromones.

DATES:

This regulation is effective August 9, 2006. Objections and requests for hearings must be received on or before October 10, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2006-0529. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Andrew Bryceland, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

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

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• 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.

B. How Can I Access Electronic Copies of this Document?

-In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this “Federal Register” document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/​ecfr. To access OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm.

C. Can I File an Objection or Hearing Request?

-Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0529 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 10, 2006.

-In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0529, by one of the following methods.

-• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.

-• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

-• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is [phone].

II. Background and Statutory Findings

-In the Federal Register of April 12, 2006 (71 FR 18735-18736) (FRL-7773-8), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6F7044) by Bedoukian Research, Inc., 21 Finance Drive, Danbury, CT 06810-4192. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of biochemicals classified as lepidopteran pheromones, which are naturally occurring compounds, or identical or substantially similar synthetic compounds, designated by an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde, or acetate functional group and containing up to 3 double bonds in the aliphatic backbone. This notice included a summary of the petition prepared by the petitioner Bedoukian Research, Inc.. There were no comments received in response to the notice of filing.

-Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.... ” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues ” and “other substances that have a common mechanism of toxicity.”

-EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

III. Toxicological Profile

-Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

-A pheromone (including identical or substantially similar synthetic compounds) as defined by the Agency is a compound produced by an arthropod which, alone or in combination with other compounds, modifies the behavior of other individuals of the same species. Straight Chain Lepidopteran Pheromones (SCLPs) are those produced by a member of the order Lepidoptera, which includes butterflies and moths.

The toxicity profile of SCLPs has already been assessed for their pesticidal use by the Agency and published in support of the tolerance exemption in or on all raw agricultural commodities for all straight chain lepidopteran pheromones (SCLPs) that are naturally occurring compounds, or identical or substantially similar synthetic compounds, designated by an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde or acetate functional group and containing up to 3 double bonds in the aliphatic backbone, when the pheromone is applied to growing crops at a rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices. (See § 180.1153, 60 FR 45060, August 30, 1995). This final rule is amending the current Lepidopteran pheromone tolerance exemption, 40 CFR 180.1153, to include indoor post-harvest treatment in or on all stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 square feet/year (3.5 g a.i./1,000/ft²/year) (equivalent to 150 grams active ingredient/acre/year) in accordance with good agricultural practices. The toxicity profile and use pattern of SCLPs, as mentioned above, have been fully characterized by the Agency. SCLPs are lowly toxic, are released in very small quantities in the environment, and act on a select group of insects. They are biodegradable by enzyme systems present in most living organisms and therefore, there is a reasonable certainty that no harm will result from their use as pesticides on food. For the purposes of this tolerance exemption amendment, the Agency has relied on the data and/or information previously submitted, in addition to comprehensive reviews and risk assessments already conducted by the Agency, and has reassessed that data in order to evaluate the request to add post harvest uses to the tolerance exemption. The Agency believes that in combination, the data and other information relied upon for this tolerance exemption supports its conclusion that there is reasonable certainty of no harm from the use of SCLPs as a post-harvest treatment in or on all stored food commodities at a rate not to exceed 3.5 grams active ingredient (a.i.)/1,000 ft²/year (equivalent of 150 grams a.i./acre/year in accordance with good agricultural practices.

The registrant did not submit any toxicity data testing the technical grade of the active ingredient. Data waivers were requested by the registrant and granted by the Agency based on the body of extensive knowledge from the public literature and comprehensive reviews and risk assessments conducted by the Agency on SCLPs. The toxicity of the SCLPs via the oral, dermal, inhalation, eye, skin, and genotoxicity routes of exposure have been assessed by the Agency (Refs. 1 and 5) and reassessed in light of the request to add indoor post harvest treatment. The toxicity profile of SCLPs when used as a post-harvest treatment in or on all stored food commodities does not change, and SCLPs when used in this manner are lowly toxic. EPA therefore concludes that there is a reasonable certainty of no harm resulting from the use of SCLPs as indoor post-harvest treatment in or on all stored food commodities. The data waivers that were granted are as follows:

1. OPPTS 870.1100 Acute oral toxicity (rat) (Ref 2)—LD50 > 5,000 milligrams/kilogram (mg/kg). The test material is classified as a Toxicity Category IV for acute oral toxicity and demonstrates that there is little potential of the active ingredient to cause acute toxic effects. There were no adverse effects reported at 5,000 mg/kg.

2. OPPTS 870.1200 Acute dermal toxicity (rat) (Ref 2)—LD50 > 2,000 mg/kg. The test material is classified as a Toxicity Category III for acute dermal toxicity and demonstrates that there is little potential for toxic effects. There were no adverse effects reported at 2,000 mg/kg.

3. OPPTS 870.5100, 870.5300, and 870.5375 Genotoxicity (Ref. 2). No evidence of mutageniticity.

4. OPPTS 870.3700 Teratogenicity (Ref. 7). A developmental toxicity study (rats), involving inhalation exposure to unbranched, primary alcohols with chain length C₈ to C₁₀, indicated no detectable developmental toxicity (Ref. 7).

Published mammalian toxicity data on SCLPs indicate no significant acute toxicity to humans (Ref. 6). A 90-day feeding study (870.3100) (rats) was conducted at doses up to 1 g/kg, of a commercial blend of branched acetates with an aliphatic chain length between C₁₀ to C₁₄. The results indicated no significant signs of toxicity other than those expected with longer term exposure to high doses of a hydrocarbon, namely, histopathologic evidence of nephropathy in males and increased liver and kidney weights in both sexes (Ref. 8).

IV. Aggregate Exposures

-In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

A. Dietary Exposure

The Agency calculated an estimate of total dietary exposure, for adults and children, to pheromones used in agricultural and food commodity storage areas. This estimate was calculated assuming an application rate of 3.5 g a.i./1,000 ft²/year (the maximum application rate for SCLPs), assuming 100% of commodities (fruits, vegetables, and grains) are treated, and assuming that stored commodities absorb 100% of the pheromone and that 100% of the population eats all three commodity types each day. This scenario produces a dietary exposure of 0.1 to 1 mg/kg/day. This calculation demonstrates that there is an unlikely potential for significant dietary exposure to SCLPs. As a result of the risk assessment the Agency concludes that the use of SCLPs as a indoor post-harvest treatment in or on all stored food commodities at the maximum use rate of 3.5 g a.i./1,000 ft²/year will not add any new exposures or risks and is considered safe.

1. Food. The Agency has determined that post harvest treatment of SCLPs to stored food commodities at the maximum application rate of 3.5 g a.i./1,000 ft²/year may reduce any new anticipated exposure of SCLPs due to their indoor use. However, even if dietary exposure to SCLPs are not reduced due to their use as pesticides, the acute toxicity information demonstrating relatively low mammalian toxicity (Refs 1, 2, 5, 6, 7, and 8) and biodegradability of SCLPs (Refs 1 and 5) indicate that any possible risk associated with acute exposures by the oral route would be low to non-existent.

2. Drinking water exposure. No significant drinking water exposure is expected to result from the use of SCLPs when applied as a post-harvest treatment in or on all stored food commodities because they are applied in storage facilities, biodegradable, and are lowly toxic.

B. Other Non-Occupational Exposure

There are no residential, school or day care uses proposed for this product. Since this use pattern is for agricultural food crops and indoor post-harvest treatment in or on all stored food commodities, the potential for non-occupational, non-dietary exposures to SCLPs by the general population, including infants and children, is highly unlikely.-

1. Dermal exposure. Non-occupational dermal exposures to SCLP when used as a post-harvest treatment to stored food commodities are expected to be negligible because it is limited to agricultural use. --

2. Inhalation exposure. Non-occupational inhalation exposures to SCLPs silicate when used as a post-harvest treatment to stored food commodities are expected to be negligible because they are limited to agricultural use.

V. Cumulative Effects

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity. The information available at this time indicates that SCLPs, when applied at a rate not greater than 3.5 g a.i./1,000 ft²/year, do not have a toxic effect. Therefore accumulative effects form residues of SCLPs are not anticipated.

VI. Determination of Safety for U.S. Population, Infants and Children

1. U.S. population. The Agency has determined that there is a reasonable certainty that no harm will result to the U.S. population from aggregate exposure to residues of SCLPs when used for post harvest treatment in or on all stored food commodities at a rate not to exceed 3.5 g a.i./1,000 ft²/year. This includes all anticipated dietary exposures and other non-occupational exposures for which there is reliable information. The Agency arrived at this conclusion based on the low acute and subchronic toxicity of these pheromones, the metabolic pathways for long-chain fatty acids derived from straight chain alcohols, aldehydes and acetates are well understood, the low exposure to these pheromones subsequent to application from aging, volatilization, and the new use will be indoors, found that there is a reasonable certainty of no harm that will result form the use of SCLP and as a post-harvest treatment in or on all stored food commodities.

2. Infants and children. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure for infants and children in the case of threshold effects. Margins of exposure are often referred to as uncertainty or safety factors, and are used to account for potential prenatal and postnatal toxicity and any lack of completeness of the data base. Based on available data and other information, EPA may determine that a different margin of exposure will define a level of concern for infants and children or that a margin of exposure approach is not appropriate. Based on all the available information the Agency reviewed on SCLPs, including a lack of threshold effects, the Agency concluded that SCLPs are practically non-toxic to mammals, including infants and children. Since there are no effects of concern, the provision requiring an additional margin of safety does not apply

VII. Other Considerations

A. Endocrine Disruptors

EPA is required under section 408(p) of FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA has authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

At this time, the Agency is not requiring information on the endocrine effects of SCLPs. Based on the weight of the evidence of the available data and the absence of any reports to the Agency of sensitivity or other adverse effects, no endocrine system related effects are identified for SCLPs and none are expected because of their use. To date there is no evidence that SCLPs affect the immune system, functions in a manner similar to any known hormones, or that they act as endocrine disruptors. Thus, there is no impact via endocrine-related effects on the Agency's safety finding set forth in this final rule amending the SCLPs exemption from the requirement of a tolerance.

B. Analytical Method(s)

An enforcement analytical method (OPPTS Harmonized Guideline 830.1800) was provided by the petitioner. The method is gas chromatography with flame ionization detection. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Sciece Center, 701 Mapes Rd., Ft. Mead, MD 20755-5350; telephone number: [phone]; e-mail address: [e-mail].

C. Codex Maximum Residue Level

There are no CODEX maximum residue levels for residues for any SCLPs for indoor post-harvest treatment in or on all stored food commodities.

VIII. Conclusions

The Agency concludes that if products containing SCLPs as active ingredients are applied for post harvest treatment in or on all stored food commodities at a rate not to exceed 3.5 g a.i./1,000 ft²/year, there is a reasonable certainty that no harm to the U.S. population, including infants and children, will result from aggregate exposure to residue of SCLPs, when used in or on all stored food commodities.

IX. References

1. Toughey, J.G. (ca 1990). “White Paper - A review of the current bases for the United States Environmental Protection Agency's policies for the regulation of pheromones and other semiochemicals, together with the review of the available relevant data which may impact the assessment of risk for these classes of chemicals. Part No.1, Straight Chain Alcohols, Acetate Esters, and Aldehydes.” (unpublished report, 474 pp.)

2. Federal Register. 59 FR 3687-3684, Jan. 26, 1994. EPA Notice: Arthropod pheromones in solid matrix dispensers; Experimental Use Permits.

3. Federal Register. 59 FR 34812-34814, Jul. 7, 1994. EPA Notice: Arthropod pheromones; Experimental Use Permits.

4. Federal Register. 60 FR 45060-45062, Aug. 30,1995. EPA Rule: Lepidopteran pheromones; Tolerance Exemption.

5. EPA Final Rule: Lepidopteran Pheromones: Tolerance Exemption.Environmental Directorate, 26 February, 2002, OECD Series on Pesticides No. 12. Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control. ENV/JM/MONO(2001)12, Organization of Economic Co-operation and Development. Paris, France. (http://www.epa.gov/​pesticides/​biopesticides/​regtools/​index.htm).

6. Inscoe & Ridgway. 1992.

7. Nelson et al. 1990.

8. Daughtrey et al. 1990.

IX. Statutory and Executive Order Reviews

This final rule establishes an exemption from the requirement of a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption from the requirement of a tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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 Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule

X. Congressional Review Act

-The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to 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 this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

• -Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: July 26, 2006.

Phil Hutton,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180—[AMENDED]

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

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

2. Section 180.1153 is revised to read as follows:

§ 180.1153

Lepidopteran pheromones; exemption from the requirement of a tolerance.

Lepidopteran pheromones that are naturally occurring compounds, or identical or substantially similar synthetic compounds, designated by an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde or acetate functional group and containing up to 3 double bonds in the aliphatic backbone, are exempt from the requirement of a tolerance in or on all raw agricultural commodities. This exemption only pertains to those situations when the pheromone is: Applied to growing crops at a rate not to exceed 150 grams active ingredient/acre/year in accordance with good agricultural practices; and applied as a post-harvest treatment to stored food commodities at a rate not to exceed 3.5 grams active ingredient/1,000 ft²/year (equivalent to 150 grams active ingredient/acre/year) in accordance with good agricultural practices.